1 00:00:05,760 --> 00:00:08,040 >>WELCOME TO 2 00:00:08,040 --> 00:00:13,680 THE WEBINAR ON VACCINES AND 3 00:00:13,680 --> 00:00:14,760 GLOBAL HEALTH. 4 00:00:14,760 --> 00:00:19,720 MY NAME IS -- OF ALLERGY AND 5 00:00:19,720 --> 00:00:25,560 INFECTIOUS DISEASE ALSO KNOWN 6 00:00:25,560 --> 00:00:26,840 AS NIAID. 7 00:00:26,840 --> 00:00:29,880 ON BEHALF OF MY COLLEAGUES WHO 8 00:00:29,880 --> 00:00:31,400 ARE PART OF THESE COMMITTEES, 9 00:00:31,400 --> 00:00:33,920 WE WOULD LIKE TO WELCOME YOU 10 00:00:33,920 --> 00:00:34,680 TO TODAY'S WEBINAR. 11 00:00:34,680 --> 00:00:42,960 FIRST A LITTLE BIT OF 12 00:00:42,960 --> 00:00:46,360 INFORMATION ABOUT GVIRF. 13 00:00:46,360 --> 00:00:49,720 THE FVIRF AND ORGANIZATION 14 00:00:49,720 --> 00:00:57,440 WEBINAR SERIES ARE ORGANIZED 15 00:00:57,440 --> 00:01:01,840 BY NIAID AND THE BILL AND 16 00:01:01,840 --> 00:01:03,480 MELINDA GATES FOUNDATION WITH 17 00:01:03,480 --> 00:01:06,880 THE SPECIFIC GOAL OF 18 00:01:06,880 --> 00:01:09,640 IMMUNIZATION AGENDA 2030. 19 00:01:09,640 --> 00:01:17,560 TODAY'S TALK IS ABOUT A TANS 20 00:01:17,560 --> 00:01:24,120 AND -- A TANS AND FORMULATION 21 00:01:24,120 --> 00:01:25,240 TECHNOLOGY. 22 00:01:25,240 --> 00:01:27,080 WE ALSO PROVIDE A SERIES OF 23 00:01:27,080 --> 00:01:30,240 FLASH TALKS AT THE END TO 24 00:01:30,240 --> 00:01:32,200 FACILITATE GLOBAL ACCESS TO 25 00:01:32,200 --> 00:01:32,840 THIS TECHNOLOGY. 26 00:01:32,840 --> 00:01:34,960 WE HAVE LINED UP A PANEL OF 27 00:01:34,960 --> 00:01:37,680 EXPERTS FOR TODAY AND HOPE YOU 28 00:01:37,680 --> 00:01:41,040 WILL ENJOY TODAY'S WEBINAR. 29 00:01:41,040 --> 00:01:42,360 WITHOUT FURTHER ADIEU, LET'S 30 00:01:42,360 --> 00:01:47,400 MOVE ON TO SECTION 1, GLOBAL 31 00:01:47,400 --> 00:01:50,080 DEMANDS FOR VACCINE ADJUTANTS. 32 00:01:50,080 --> 00:01:54,160 IT WILL BE CHAIRED BY Dr. 33 00:01:54,160 --> 00:01:55,480 FINANCIAL OFFICER AND ME SO 34 00:01:55,480 --> 00:02:01,080 CHRIS, TAKE IT AWAY. 35 00:02:01,080 --> 00:02:04,360 >>HI, I AM VERY PLEASED TO 36 00:02:04,360 --> 00:02:09,480 CO-CHAIR THIS SESSION WITH 37 00:02:09,480 --> 00:02:13,440 ANNIE AND A SERIES OF 38 00:02:13,440 --> 00:02:14,520 PANELISTS AND SPEAKERS I THINK 39 00:02:14,520 --> 00:02:17,200 YOU WILL FIND VERY ENGAGING SO 40 00:02:17,200 --> 00:02:20,880 LET'S MOVE ON TO NICHOLAS 41 00:02:20,880 --> 00:02:22,840 COLLINS WHO FORMULATED THE 42 00:02:22,840 --> 00:02:25,360 VACCINE INSTITUTE AND SERVES 43 00:02:25,360 --> 00:02:32,120 AS ITS CEO. 44 00:02:32,120 --> 00:02:32,480 NICHOLAS? 45 00:02:32,480 --> 00:02:33,160 CHRISTOPHER FOX. 46 00:02:33,160 --> 00:02:34,000 >>THANK YOU VERY MUCH. 47 00:02:34,000 --> 00:02:43,720 CAN YOU SEE MY SCREEN? 48 00:02:43,720 --> 00:02:44,800 >>YES. 49 00:02:44,800 --> 00:02:46,480 >>IS IT PRESENTATION MODE? 50 00:02:46,480 --> 00:02:47,680 SUCH A PLEASURE TO BE HERE AND 51 00:02:47,680 --> 00:02:50,920 THANK YOU VERY MUCH CHRIS FOR 52 00:02:50,920 --> 00:02:51,680 THIS KIND INTRODUCTION. 53 00:02:51,680 --> 00:02:53,840 THANK YOU VERY MUCH TO THE 54 00:02:53,840 --> 00:02:56,760 ORGANIZER AND TO BE PART OF A 55 00:02:56,760 --> 00:02:58,600 PRODUCTION ON A VERY IMPORTANT 56 00:02:58,600 --> 00:02:59,120 TOPIC. 57 00:02:59,120 --> 00:03:04,120 I AM GOING TO SPEAK ON VACCINE 58 00:03:04,120 --> 00:03:05,800 ADJUVANTS AND THE NEED FOR A 59 00:03:05,800 --> 00:03:06,720 GLOBAL MARKET. 60 00:03:06,720 --> 00:03:08,760 TO START OFF, I WOULD LIKE TO 61 00:03:08,760 --> 00:03:11,040 SHARE A STORY ABOUT A FEW 62 00:03:11,040 --> 00:03:13,800 PEOPLE WHO HAD A VISION, 63 00:03:13,800 --> 00:03:15,400 COMMON VISION FROM 2012. 64 00:03:15,400 --> 00:03:18,640 WHEN WE CREATED THE VACCINE 65 00:03:18,640 --> 00:03:20,240 FORMULATION INSTITUTE THANKS 66 00:03:20,240 --> 00:03:22,120 TO THE WORLD HEALTH 67 00:03:22,120 --> 00:03:25,200 ORGANIZATION, WE HAD TWO 68 00:03:25,200 --> 00:03:27,480 MISSIONS IN MIND, ONE TO BE 69 00:03:27,480 --> 00:03:35,240 THE GATEKEEPER OF ADJUTANTS 70 00:03:35,240 --> 00:03:37,760 AND PROVIDE THEM UNDER OPEN 71 00:03:37,760 --> 00:03:43,680 ACCESS TO THE COMMUNITY AND TO 72 00:03:43,680 --> 00:03:44,600 DISSEMINATE FORMULATION 73 00:03:44,600 --> 00:03:46,760 KNOW-HOW TO VACCINE 74 00:03:46,760 --> 00:03:50,600 RESEARCHERS AND DEVELOPERS. 75 00:03:50,600 --> 00:03:54,560 TEN YEARS LATER, WE HAVE THIS 76 00:03:54,560 --> 00:03:56,200 IN PLACE AND OF COURSE WOULD 77 00:03:56,200 --> 00:03:58,520 NOT BE POSSIBLE WITHOUT THE 78 00:03:58,520 --> 00:04:06,240 FOUNDERS AND ARE REALLY 79 00:04:06,240 --> 00:04:10,680 GRATEFUL FOR THE CHEMISTS, 80 00:04:10,680 --> 00:04:11,920 FORMULATION EXPERTS, 81 00:04:11,920 --> 00:04:13,520 IMLODGISTS AND PROJECT 82 00:04:13,520 --> 00:04:14,240 MANAGERS. 83 00:04:14,240 --> 00:04:16,680 WE HAVE TWO LABORATORIES AND 84 00:04:16,680 --> 00:04:23,640 NOW THE VACCINES ARE STRIPPED 85 00:04:23,640 --> 00:04:26,080 AT LARGE SCALE WITH OPEN 86 00:04:26,080 --> 00:04:26,680 ACCESS. 87 00:04:26,680 --> 00:04:33,240 MY COLLEAGUE WILL COME BACK TO 88 00:04:33,240 --> 00:04:35,680 THE ADJUTANT PORTFOLIO FOR 89 00:04:35,680 --> 00:04:35,960 YOU. 90 00:04:35,960 --> 00:04:38,120 THIS WILL BE PRESENTED IN TWO 91 00:04:38,120 --> 00:04:38,560 PARTS. 92 00:04:38,560 --> 00:04:49,040 I WOULD LIKE TO DO A VERY 93 00:04:50,400 --> 00:04:53,600 QUICK ADJUTANT TALK ON THE 94 00:04:53,600 --> 00:04:58,080 LANDSCAPE BEFORE AND AFTER 95 00:04:58,080 --> 00:04:59,680 H1N1 ININFLUENZA AND COVID-19 96 00:04:59,680 --> 00:05:01,600 AND THEN THE CURRENT NEEDS AND 97 00:05:01,600 --> 00:05:03,920 HOW TO IMPROVE EQUITABLE 98 00:05:03,920 --> 00:05:08,160 ACCESS AND AFFORD FORDABILITY 99 00:05:08,160 --> 00:05:12,000 OF ADJUVANTED VACCINES AND HOW 100 00:05:12,000 --> 00:05:16,000 TO FIND SOLUTIONS FOR OPEN 101 00:05:16,000 --> 00:05:19,400 ACCESS PERSPECTIVES. 102 00:05:19,400 --> 00:05:20,800 SO TO LOOK AT THE SOLUTION, 103 00:05:20,800 --> 00:05:24,320 THERE ARE ONLY THREE ADJUVANTS 104 00:05:24,320 --> 00:05:25,120 IN THE VACCINE. 105 00:05:25,120 --> 00:05:27,280 ONLY THREE WERE AVAILABLE TO 106 00:05:27,280 --> 00:05:34,840 THE VACCINE COMMUNITY WITHOUT 107 00:05:34,840 --> 00:05:40,200 ANY LICENSING DEGREE REQUIRED. 108 00:05:40,200 --> 00:05:47,680 THESE ARE ONLY ALUMINUM SALTS 109 00:05:47,680 --> 00:05:49,560 UNDER OPEN-ACCESS TERMS, 110 00:05:49,560 --> 00:06:00,000 AVAILABLE WITHOUT ANY 111 00:06:15,840 --> 00:06:18,920 LICENSING AGREEMENT. 112 00:06:18,920 --> 00:06:20,200 FOR THE PANDEMIC THERE WERE 113 00:06:20,200 --> 00:06:23,760 SPEC NEEDS AND SEVERAL BILLION 114 00:06:23,760 --> 00:06:26,240 DOSES OF ININFLUENZA VACCINES 115 00:06:26,240 --> 00:06:31,360 AT AN AFFORDABLE PRICE IN A 116 00:06:31,360 --> 00:06:34,760 SHORT TIME FRAME AND THERE 117 00:06:34,760 --> 00:06:36,720 WERE CHALLENGES IN DEVELOPMENT 118 00:06:36,720 --> 00:06:45,280 WITH THE VACCINE COMMUNITY TO 119 00:06:45,280 --> 00:06:48,160 GAIN IMPROVED ACCESS, IMPROVED 120 00:06:48,160 --> 00:06:56,160 FORMULATION AND EVALUATION OF 121 00:06:56,160 --> 00:06:57,160 ADJUVANTED VACCINES. 122 00:06:57,160 --> 00:07:01,040 TEN YEARS LATER, THEN WE CAN 123 00:07:01,040 --> 00:07:05,600 SAY THAT IT HAS BEEN PROPERLY 124 00:07:05,600 --> 00:07:07,480 TRANSFORMED AND REACHED AN 125 00:07:07,480 --> 00:07:10,240 AMOUNT OF SUCCESS, AN 126 00:07:10,240 --> 00:07:11,280 IMPORTANT ACHIEVEMENT. 127 00:07:11,280 --> 00:07:15,640 THERE HAVE BEEN MANY, MANY NEW 128 00:07:15,640 --> 00:07:17,960 ADJUVANTS THAT HAVE REACHED 129 00:07:17,960 --> 00:07:27,200 THE STATE OF BEING INCLUDED IN 130 00:07:27,200 --> 00:07:27,920 VACCINES. 131 00:07:27,920 --> 00:07:31,080 THEY ARE BENEFITTING A LOT OF 132 00:07:31,080 --> 00:07:37,120 DIFFERENT AGES, THEY ARE 133 00:07:37,120 --> 00:07:43,680 IMPROVING THE RESPONSES AND 134 00:07:43,680 --> 00:07:49,480 COVERING A MAGNITUDE OF IMMUNE 135 00:07:49,480 --> 00:07:49,920 RESPONSES. 136 00:07:49,920 --> 00:07:54,120 THIS IS REFLECTED WHEN WE SEE 137 00:07:54,120 --> 00:07:56,920 THE ADJUTANT INCLUDED IN 138 00:07:56,920 --> 00:07:58,720 VACCINES SINCE 2009 BUT STILL 139 00:07:58,720 --> 00:08:02,960 THE CHALLENGE AS YOU CAN SEE 140 00:08:02,960 --> 00:08:13,440 HERE, THERE ARE ONLY A FEW 141 00:08:14,360 --> 00:08:16,720 ADJUVANTS AND WITH NO LICENSE 142 00:08:16,720 --> 00:08:21,040 REQUIRED, ONLY TWO OF THEM 143 00:08:21,040 --> 00:08:22,360 WITH THE LIMITATIONS FOR THE 144 00:08:22,360 --> 00:08:25,320 VACCINE AND ON TOP OF THAT, MY 145 00:08:25,320 --> 00:08:26,400 COLLEAGUES WILL TALK ABOUT 146 00:08:26,400 --> 00:08:30,640 THIS IN MORE DETAIL, WE HAVE 147 00:08:30,640 --> 00:08:31,960 LEARNED FROM COVID-19 PANDEMIC 148 00:08:31,960 --> 00:08:34,600 THAT THERE WERE ISSUES WITH 149 00:08:34,600 --> 00:08:37,600 ACCESS TO VACCINES AND 150 00:08:37,600 --> 00:08:38,760 AFFORDABLE VACCINE ACCESS. 151 00:08:38,760 --> 00:08:41,640 THAT BRINGS ME TO THE SECOND 152 00:08:41,640 --> 00:08:52,240 PART OF MY PRESENTATION WHERE 153 00:08:52,960 --> 00:08:58,520 PROPOSED RELIEF NEEDS TO BE 154 00:08:58,520 --> 00:09:03,480 FOR THE -- AND HOW TO IMPROVE 155 00:09:03,480 --> 00:09:07,600 EQUITABLE ACCESS AND 156 00:09:07,600 --> 00:09:08,440 AFFORDABILITY. 157 00:09:08,440 --> 00:09:11,800 THE FIRST PART, IF A TANS ARE 158 00:09:11,800 --> 00:09:17,040 NOT AVAILABLE AT GM P, LIMITED 159 00:09:17,040 --> 00:09:21,680 INTEREST FROM VACCINE 160 00:09:21,680 --> 00:09:23,280 DEVELOPERS. 161 00:09:23,280 --> 00:09:29,360 WE ALSO WANT TO ELICIT AN 162 00:09:29,360 --> 00:09:33,720 ADJUTANT OPTION BECAUSE EVERY 163 00:09:33,720 --> 00:09:39,080 SINGLE ADJUTANT HAS THEIR OWN 164 00:09:39,080 --> 00:09:42,000 PROPERTIES. 165 00:09:42,000 --> 00:09:44,640 THEY HAVE THEIR OWN STUDIES 166 00:09:44,640 --> 00:09:46,200 AND PROVIDE CRITICAL 167 00:09:46,200 --> 00:09:49,160 INFORMATION ON THE CLASS OR 168 00:09:49,160 --> 00:09:55,240 TYPE OF ADJUVANT REQUIRED FOR 169 00:09:55,240 --> 00:09:59,320 A GIVEN ANTIGEN OR INDICATION. 170 00:09:59,320 --> 00:10:02,040 IT NEEDS TO BE IDEALLY 171 00:10:02,040 --> 00:10:05,040 PERFORMED BY A NEUTRAL 172 00:10:05,040 --> 00:10:08,040 LABORATORY EARLY ON FOR A 173 00:10:08,040 --> 00:10:09,960 SPECIFIC ADJUTANT CLASS OR 174 00:10:09,960 --> 00:10:11,280 SPECIFIC ADJUTANT TYPE IS 175 00:10:11,280 --> 00:10:15,040 REQUIRED FOR ONE VACCINE. 176 00:10:15,040 --> 00:10:16,280 ANOTHER NEED, CORRELATION FROM 177 00:10:16,280 --> 00:10:21,640 THE FIRST ONE IS TO LIBERATE 178 00:10:21,640 --> 00:10:22,840 MORE IN ADJUTANT COOPERATION 179 00:10:22,840 --> 00:10:23,640 AND SAFETY. 180 00:10:23,640 --> 00:10:30,480 YOU GET TO SEE HERE A RATHER 181 00:10:30,480 --> 00:10:39,640 COMPLEX SOLUTION ON EQUAL BASE 182 00:10:39,640 --> 00:10:40,600 WITH TWO COMPOSITIONS. 183 00:10:40,600 --> 00:10:50,120 ONE NEEDS TO FIND THE BEST 184 00:10:50,120 --> 00:10:55,080 COMPOSITION, THEN MANUFACTURE 185 00:10:55,080 --> 00:10:58,000 THE CONCENTRATIONS. 186 00:10:58,000 --> 00:10:59,640 THEN MORE ACTIVITY IS REQUIRED 187 00:10:59,640 --> 00:11:02,600 WHEN WE START MANUFACTURING 188 00:11:02,600 --> 00:11:06,480 AND FINALLY WE LOOK AT THE 189 00:11:06,480 --> 00:11:12,040 LIMITATION ON THE BEST 190 00:11:12,040 --> 00:11:15,640 MODERATE DEL BUT THIS IS NOT 191 00:11:15,640 --> 00:11:26,200 WHERE IT STARTS BECAUSE IN THE 192 00:11:27,360 --> 00:11:28,840 LIPID IMMUNOPROCESS, WE NEED 193 00:11:28,840 --> 00:11:30,560 TO MONITOR AND KEEP GOING WITH 194 00:11:30,560 --> 00:11:31,400 THE PROCESS. 195 00:11:31,400 --> 00:11:33,800 ANOTHER NEED IS NOT TO JUST 196 00:11:33,800 --> 00:11:38,520 GET MORE ADJUTANT BUT DEVELOP 197 00:11:38,520 --> 00:11:49,120 NEW A TANS AND THIS PROCESS IS 198 00:11:50,360 --> 00:11:52,080 VERY SURE WHERE THEY CAN MAKE 199 00:11:52,080 --> 00:11:54,160 A DIFFERENCE AND WHERE THEY 200 00:11:54,160 --> 00:11:57,400 ARE NOT. 201 00:11:57,400 --> 00:12:03,760 THIS FROM A PAPER FROM LYKINS 202 00:12:03,760 --> 00:12:07,360 AND FOX ON THE NEED TO DEVELOP 203 00:12:07,360 --> 00:12:17,880 NEW A TANS FOR THE NEXT HE 204 00:12:32,840 --> 00:12:38,680 NEXT GENERATION OF VACCINE. 205 00:12:38,680 --> 00:12:44,320 WE HAVE FOR EACH COUNTRY OF 206 00:12:44,320 --> 00:12:47,360 COMPONENT PRODUCTION AND FINAL 207 00:12:47,360 --> 00:12:49,160 VACCINE ADMINISTRATION BUT WE 208 00:12:49,160 --> 00:12:52,880 NEED TO BE AWARE THERE IS A 209 00:12:52,880 --> 00:12:54,360 PARTICULAR BROADER SCOPE 210 00:12:54,360 --> 00:13:02,120 NEEDED AND WE NEED TO BE AWARE 211 00:13:02,120 --> 00:13:04,080 OF THE TIMELINE VERSUS THE 212 00:13:04,080 --> 00:13:05,760 REMAINING TIME OF PATENT LIFE. 213 00:13:05,760 --> 00:13:08,000 WE NEED TO KEEP IN MIND THIS 214 00:13:08,000 --> 00:13:11,440 IS ALL A MOVING TARGET AND 215 00:13:11,440 --> 00:13:12,640 REGULAR UPDATES ARE REQUIRED 216 00:13:12,640 --> 00:13:18,400 WHICH ARE COSTLY AND 217 00:13:18,400 --> 00:13:18,880 TIME-CONSUMING. 218 00:13:18,880 --> 00:13:19,720 ONCE WE HAVE THE DECISION 219 00:13:19,720 --> 00:13:30,280 MADE, THEN WE NEED TO MOVE 220 00:13:31,040 --> 00:13:34,560 FORWARD WITH ITERATION. 221 00:13:34,560 --> 00:13:40,800 KEEPING IN MIND THE EXEMPTIONS 222 00:13:40,800 --> 00:13:46,800 TO PATENT PROTECTION AND LEGAL 223 00:13:46,800 --> 00:13:50,480 PROVISIONS TO PROGRESS DURING 224 00:13:50,480 --> 00:13:53,560 THE FINAL-YEAR-OLD -- YEARS OF 225 00:13:53,560 --> 00:13:57,680 A PATENT TERM TO BE READY FOR 226 00:13:57,680 --> 00:14:00,440 RAPID MARKET ENTRY, KNOWLEDGE 227 00:14:00,440 --> 00:14:01,880 OF NATIONAL PATENT LAWS AND 228 00:14:01,880 --> 00:14:05,880 ALSO TO KEEP IN MIND THAT 229 00:14:05,880 --> 00:14:11,000 SOMETIMES THERE IS NEGOTIATION 230 00:14:11,000 --> 00:14:13,320 WITH A PATENT OWNER WHICH IS 231 00:14:13,320 --> 00:14:15,400 OFTEN LENGTHY AND COMPLICATED 232 00:14:15,400 --> 00:14:19,320 AND THE VACCINE CAN BE BLOCKED 233 00:14:19,320 --> 00:14:25,400 BECAUSE OF SOME OLDER IP 234 00:14:25,400 --> 00:14:28,560 GENERATED FOR A DIFFERENT 235 00:14:28,560 --> 00:14:29,720 TIMELINE. 236 00:14:29,720 --> 00:14:33,280 AND FINALLY WE NEED TO LOOK AT 237 00:14:33,280 --> 00:14:34,320 THE BUSINESS MODEL. 238 00:14:34,320 --> 00:14:37,040 WE ARE AWARE OF THE MOST 239 00:14:37,040 --> 00:14:42,600 CLASSIC MODEL FOR ADJUTANT 240 00:14:42,600 --> 00:14:51,320 FORMATION, A CLASSICAL OUTLIES 241 00:14:51,320 --> 00:14:52,080 LICENSING-- OUTLICENSING MODEL 242 00:14:52,080 --> 00:14:54,080 BETWEEN THE OWNER AND THE 243 00:14:54,080 --> 00:14:56,280 DEVELOPER AS YOU SEE HERE. 244 00:14:56,280 --> 00:15:00,720 IN MANY CASES, THE OWNER IS 245 00:15:00,720 --> 00:15:04,320 ALSO THE VACCINE DEVELOPER 246 00:15:04,320 --> 00:15:06,920 WHICH COMPLICATED THE 247 00:15:06,920 --> 00:15:09,960 SITUATION BECAUSE LOGICALLY 248 00:15:09,960 --> 00:15:15,160 THERE WILL BE LESS FOR THE 249 00:15:15,160 --> 00:15:21,880 OWNER FOR CERTAIN TYPE OF 250 00:15:21,880 --> 00:15:22,440 INDICATION. 251 00:15:22,440 --> 00:15:29,680 IF THERE IS A NEW OWNER FOR 252 00:15:29,680 --> 00:15:32,160 OUTLICENSING AGREEMENT, THEN A 253 00:15:32,160 --> 00:15:42,720 NEW MODEL NEEDS TO BE PUT IN 254 00:15:44,200 --> 00:15:45,200 PLACE. 255 00:15:45,200 --> 00:15:51,600 AND IN A NUTSHELL, THE ACCESS 256 00:15:51,600 --> 00:15:54,560 MODEL WHICH WE WORKED FROM OUR 257 00:15:54,560 --> 00:15:56,320 OWN EXPERIENCE COULD PROVIDE 258 00:15:56,320 --> 00:15:56,960 DIFFERENT POSSIBILITIES. 259 00:15:56,960 --> 00:16:00,520 HERE YOU HAVE A DEAL BETWEEN 260 00:16:00,520 --> 00:16:02,880 AN ADJUTANT OWNER AND ADJUTANT 261 00:16:02,880 --> 00:16:06,000 PRODUCER WHICH IS A 262 00:16:06,000 --> 00:16:07,960 SPECIALIZED COMPANY WHERE 263 00:16:07,960 --> 00:16:10,400 THERE IS ONE DEAL BETWEEN THE 264 00:16:10,400 --> 00:16:14,480 TWO COMPANIES AND IN THERE, WE 265 00:16:14,480 --> 00:16:25,000 HAVE A SITUATION WHERE THE 266 00:16:27,400 --> 00:16:30,720 PRODUCTION IS APPLIED FOR BOTH 267 00:16:30,720 --> 00:16:34,480 FOR AN OPEN ACCESS MODEL. 268 00:16:34,480 --> 00:16:39,480 THIS IS THE MODEL IN WHICH WE 269 00:16:39,480 --> 00:16:40,960 ARE USING FROM 2020. 270 00:16:40,960 --> 00:16:43,640 IN CONCLUSION, THERE IS A NEED 271 00:16:43,640 --> 00:16:45,320 FOR MORE ADJUTANTS, THERE IS A 272 00:16:45,320 --> 00:16:47,560 NEED FOR MORE PREPARATION FOR 273 00:16:47,560 --> 00:16:48,360 TESTING. 274 00:16:48,360 --> 00:16:58,920 WE NEED TO BETTER UNDERSTAND 275 00:17:02,120 --> 00:17:06,240 THE FTO AND TO IMPLEMENT 276 00:17:06,240 --> 00:17:09,240 BUSINESS MODELS COMPATIBLE 277 00:17:09,240 --> 00:17:10,480 WITH GLOBAL HEALTH CHALLENGES. 278 00:17:10,480 --> 00:17:18,120 THANK YOU FOR YOUR ATTENTION. 279 00:17:18,120 --> 00:17:19,920 >>THANK YOU SO MUCH, 280 00:17:19,920 --> 00:17:22,840 NICHOLAS. 281 00:17:22,840 --> 00:17:25,160 OUR NEXT SPEAKER WILL BE DAN 282 00:17:25,160 --> 00:17:35,640 FULLEN WHO IS THE SENIOR 283 00:17:36,520 --> 00:17:39,880 MANAGER AT SEPI AND WE WILL BE 284 00:17:39,880 --> 00:17:40,640 GIVEN A TWO-MINUTE WARNING 285 00:17:40,640 --> 00:17:44,440 WHEN YOU NEED TO BRING YOUR 286 00:17:44,440 --> 00:17:45,800 TALK TO AN END. 287 00:17:45,800 --> 00:17:56,320 >>CAN I SHARE MY SCREEN? 288 00:18:02,040 --> 00:18:02,520 >>YES, PLEASE. 289 00:18:02,520 --> 00:18:04,720 >>CAN YOU PUT IT IN 290 00:18:04,720 --> 00:18:06,000 PRESENTATION MODE, PLEASE? 291 00:18:06,000 --> 00:18:07,120 >>YES, THANK YOU. 292 00:18:07,120 --> 00:18:13,920 SO MY NAME IS DANIEL FULLEN, I 293 00:18:13,920 --> 00:18:24,520 AM A SENIOR SCIENTIST MANAGER 294 00:18:26,040 --> 00:18:36,520 OFFICE OF TECHNOLOGY AT CEPI. 295 00:18:43,360 --> 00:18:45,320 NOW THAT WE ARE POST PANDEMIC 296 00:18:45,320 --> 00:18:55,920 OVER A YEAR, YOU CAN SEE FROM 297 00:18:57,720 --> 00:19:01,040 THE LINE AND DEVELOPMENT -- 298 00:19:01,040 --> 00:19:01,640 [INDISCERNIBLE] 299 00:19:01,640 --> 00:19:07,120 SO TODAY WE WILL GO THROUGH 300 00:19:07,120 --> 00:19:14,960 THE VACCINE AND THE LABELING 301 00:19:14,960 --> 00:19:18,320 AND SO TODAY WE WILL GO 302 00:19:18,320 --> 00:19:22,240 THROUGH WHAT MAKES AN OPTIMAL 303 00:19:22,240 --> 00:19:24,080 ADJUVANT, REQUIREMENTS FOR THE 304 00:19:24,080 --> 00:19:25,840 PANDEMIC PREPAREDNESS AND HOW 305 00:19:25,840 --> 00:19:27,600 WE ENSURE THAT ADJUVANTS ARE 306 00:19:27,600 --> 00:19:31,320 WHERE THEY ARE WHEN WE NEED 307 00:19:31,320 --> 00:19:31,640 THEM. 308 00:19:31,640 --> 00:19:37,360 SO WHAT WE HAVE TODAY FOR THE 309 00:19:37,360 --> 00:19:38,360 OPTIMAL ADJUVANT, AND THE 310 00:19:38,360 --> 00:19:45,080 ANSWER IS IT DEPENDS ON ON THE 311 00:19:45,080 --> 00:19:45,880 COMPOUND SPECIFICS. 312 00:19:45,880 --> 00:19:54,800 IS IT FOR THE ENTIRE 313 00:19:54,800 --> 00:20:00,680 POPULATION, PEDIATRIC AND THE 314 00:20:00,680 --> 00:20:02,080 PLATFORM, MRNA, DNA, ET 315 00:20:02,080 --> 00:20:02,640 CETERA. 316 00:20:02,640 --> 00:20:06,080 AND WHAT TYPE OF IMMUNE 317 00:20:06,080 --> 00:20:09,360 RESPONSE ARE WE LOOKING FOR, 318 00:20:09,360 --> 00:20:16,520 QUALITY OF RESPONSE, EFFICACY, 319 00:20:16,520 --> 00:20:17,480 BREADTH, DURATION AND ALSO 320 00:20:17,480 --> 00:20:23,200 NEED TO LOOK AT THE PATHOGEN 321 00:20:23,200 --> 00:20:25,960 AS WELL. 322 00:20:25,960 --> 00:20:29,720 THE SIGNALING AS WELL MUST BE 323 00:20:29,720 --> 00:20:31,240 TAKEN INTO CONSIDERATION AND 324 00:20:31,240 --> 00:20:32,320 ROUTE OF ADMINISTRATION AS 325 00:20:32,320 --> 00:20:32,800 WELL. 326 00:20:32,800 --> 00:20:36,320 THIS IS JUST ONE EXAMPLE OF 327 00:20:36,320 --> 00:20:42,560 WHAT ADJUTANT WAS USED IN WHAT 328 00:20:42,560 --> 00:20:43,400 SITUATION. 329 00:20:43,400 --> 00:20:53,880 RUNNING A HEAD TO HEAD 330 00:20:56,800 --> 00:20:59,200 COMPARISON TO DATE, THE 331 00:20:59,200 --> 00:21:02,080 ADJUVANTS THAT APPEAR MORE 332 00:21:02,080 --> 00:21:05,000 EFFECTIVE FOR ACUTE INFECTIONS 333 00:21:05,000 --> 00:21:15,400 AS YOU CAN SEE HERE. 334 00:21:20,200 --> 00:21:22,960 [INDISCERNIBLE] 335 00:21:22,960 --> 00:21:25,400 WE HAVE LIPOSOMAL ADJUVANTS 336 00:21:25,400 --> 00:21:31,240 THAT APPEAR MOST EFFECTIVE FOR 337 00:21:31,240 --> 00:21:36,280 CHRONIC INFECTIONS FOR HBV SO 338 00:21:36,280 --> 00:21:41,720 WHAT ARE THE KEY ADJUTANTS FOR 339 00:21:41,720 --> 00:21:43,720 DISTRIBUTION? 340 00:21:43,720 --> 00:21:50,440 WE HAVE ONE HERE THE 341 00:21:50,440 --> 00:21:53,200 REQUIREMENTS OF ADJUVANT FOR 342 00:21:53,200 --> 00:21:56,440 PANDEMIC PREPAREDNESS AND LOOK 343 00:21:56,440 --> 00:22:01,360 AT THE IMMUNE RESPONSE, 344 00:22:01,360 --> 00:22:03,640 LOOKING AT A WIDE POPULATION, 345 00:22:03,640 --> 00:22:05,040 ELDERLY AND FOR CHILDREN AS 346 00:22:05,040 --> 00:22:12,440 WELL AND IT NEEDS TO BE 347 00:22:12,440 --> 00:22:15,040 ADAPTABLE AS WELL. 348 00:22:15,040 --> 00:22:20,840 THE SOURCE OF ADJUTANT NEEDS 349 00:22:20,840 --> 00:22:27,440 TO BE HAVE AS FEW COMPONENTS 350 00:22:27,440 --> 00:22:37,760 AS POSSIBLE AND TESTED 351 00:22:37,760 --> 00:22:41,120 CLINICALLY, VERY IMPORTANT FOR 352 00:22:41,120 --> 00:22:51,520 IT TO BE STABLE -- 353 00:22:59,640 --> 00:23:00,000 [INDISCERNIBLE] 354 00:23:00,000 --> 00:23:01,960 AS MENTIONED AS WELL, IT HAS 355 00:23:01,960 --> 00:23:05,840 TO BE REALLY AVAILABLE AND NOT 356 00:23:05,840 --> 00:23:16,400 LIMITED BY IP RESTRICTIONS. 357 00:23:24,160 --> 00:23:26,920 IT MUST BE ABLE TO BE PRODUCED 358 00:23:26,920 --> 00:23:32,800 AT SCALE AND IN DIFFERENT 359 00:23:32,800 --> 00:23:33,200 TERRITORIES. 360 00:23:33,200 --> 00:23:43,360 THERE IS A NEED TO REGULATE 361 00:23:43,360 --> 00:23:46,120 IT -- 362 00:23:46,120 --> 00:23:46,600 [INDISCERNIBLE] 363 00:23:46,600 --> 00:23:51,840 THE PANDEMIC STRAIN IS 364 00:23:51,840 --> 00:23:55,720 IMPORTANT BUT THERE COULD BE 365 00:23:55,720 --> 00:23:58,520 DOSE SPARING POTENTIAL. 366 00:23:58,520 --> 00:24:03,960 FORTUNATELY WE HAVE SEEN THAT 367 00:24:03,960 --> 00:24:07,360 IT MAY NOT BE THE PERFECT 368 00:24:07,360 --> 00:24:09,160 ADJUTANT BUT IT CAN BE DONE. 369 00:24:09,160 --> 00:24:13,440 I THINK IT VERY IMPORTANT TO 370 00:24:13,440 --> 00:24:16,040 HAVE ADJUTANTS AVAILABLE AT 371 00:24:16,040 --> 00:24:20,120 LEAST FOR THE FIRST RESPONSE 372 00:24:20,120 --> 00:24:30,720 WHEREAS PREVIOUSLY AS THE NEXT 373 00:24:52,880 --> 00:24:55,720 SLIDE SHOWS, WE HAVE 374 00:24:55,720 --> 00:25:03,360 ESTABLISHED SAFETY PROFILE AND 375 00:25:03,360 --> 00:25:03,720 STABLE. 376 00:25:03,720 --> 00:25:07,640 IT MUST BE CLINICALLY TESTED 377 00:25:07,640 --> 00:25:11,000 FOR A BROAD IMMUNE RESPONSE 378 00:25:11,000 --> 00:25:13,600 AND COMPATIBILITY. 379 00:25:13,600 --> 00:25:16,360 THE ADJUTANT AVAILABLE NEEDS 380 00:25:16,360 --> 00:25:21,760 TO BE AVAILABLE WHERE WE NEED 381 00:25:21,760 --> 00:25:23,240 THEM AND SOMETIMES USING 382 00:25:23,240 --> 00:25:33,840 TECHNOLOGY TO GET THEM TO THE 383 00:25:52,160 --> 00:25:54,120 RIGHT PLACE. 384 00:25:54,120 --> 00:25:57,360 [INDISCERNIBLE] 385 00:25:57,360 --> 00:26:08,080 AND THE SCALE AS WELL, IT IS 386 00:26:08,080 --> 00:26:11,680 REALLY IMPORTANT TO GET THE 387 00:26:11,680 --> 00:26:14,880 VACCINES OUT THERE. 388 00:26:14,880 --> 00:26:25,400 SO THERE ARE TWO TYPES THEN. 389 00:26:32,320 --> 00:26:42,800 THE SQUALENE PACED ADJUVANTS 390 00:26:46,680 --> 00:26:49,000 AND ALUM ADJUVANTS. 391 00:26:49,000 --> 00:26:51,760 IN AN OUTBREAK SCENARIO, THESE 392 00:26:51,760 --> 00:27:02,240 CAN BE PRODUCED FOR THE 393 00:27:03,000 --> 00:27:13,440 VACCINE AND ROLLED OUT IN A 394 00:27:13,880 --> 00:27:14,360 PROGRAM. 395 00:27:14,360 --> 00:27:18,000 THERE IS ALSO THE QUESTION OF 396 00:27:18,000 --> 00:27:21,400 STOCKPILE, WHERE WE WILL 397 00:27:21,400 --> 00:27:22,760 STOCKPILE, PHYSICAL LOCATION 398 00:27:22,760 --> 00:27:32,120 AND ALSO THE STRENGTH OF THE. 399 00:27:32,120 --> 00:27:32,600 [INDISCERNIBLE] 400 00:27:32,600 --> 00:27:38,440 GIVEN THERE IS A PLACE TO 401 00:27:38,440 --> 00:27:44,800 STOCKPILE, WE NEED TO LOOK AT 402 00:27:44,800 --> 00:27:52,600 LONGER PERIODS FOR STOCKPILE. 403 00:27:52,600 --> 00:28:03,040 THERE IS ALSO ADJUTANT 404 00:28:10,000 --> 00:28:11,800 FORMULATION. 405 00:28:11,800 --> 00:28:12,440 [INDISCERNIBLE] 406 00:28:12,440 --> 00:28:23,040 SO A SMALLER PRODUCTION WOULD 407 00:28:40,200 --> 00:28:42,480 MINIMIZE THE VACCINE. 408 00:28:42,480 --> 00:28:44,360 IT IS ALSO IMPORTANT IN IT IS 409 00:28:44,360 --> 00:28:46,560 DEVELOPED IN A COUNTRY WITH A 410 00:28:46,560 --> 00:28:50,200 WARM BASE SO YOU HAVE YOUR 411 00:28:50,200 --> 00:28:54,400 VACCINE MANUFACTURING MAKING, 412 00:28:54,400 --> 00:28:56,320 MALARIA, HIV, ET CETERA, AND 413 00:28:56,320 --> 00:29:03,960 THE PRODUCTION CAN BE SWITCHED 414 00:29:03,960 --> 00:29:05,440 FOR THE ADJUTANT. 415 00:29:05,440 --> 00:29:13,760 AND TO ENABLE IT AS WELL, WE 416 00:29:13,760 --> 00:29:18,360 LOOK AT THE ADJUTANT PLATFORM. 417 00:29:18,360 --> 00:29:28,920 THE IDEAL WOULD BE IF WE HAVE 418 00:29:33,200 --> 00:29:35,400 LOW ADJUTANT SUPPLY, WE HAVE 419 00:29:35,400 --> 00:29:39,200 THE POTENTIAL FOR DOSE 420 00:29:39,200 --> 00:29:41,120 SPARING. 421 00:29:41,120 --> 00:29:47,120 SO THE VACCINE IS GROWING 422 00:29:47,120 --> 00:29:57,640 ESSENTIALLY IN A VERY LOW 423 00:29:59,880 --> 00:30:00,880 REGION -- 424 00:30:00,880 --> 00:30:01,680 [INDISCERNIBLE] 425 00:30:01,680 --> 00:30:06,320 LIMITING THE BORDERS WHEN 426 00:30:06,320 --> 00:30:11,480 BORDERS CLOSE AND ALSO -- 427 00:30:11,480 --> 00:30:13,560 [INDISCERNIBLE] 428 00:30:13,560 --> 00:30:15,040 ANALYSIS. 429 00:30:15,040 --> 00:30:15,600 SO. 430 00:30:15,600 --> 00:30:16,360 >>TIME'S UP. 431 00:30:16,360 --> 00:30:21,840 >>SO IN SUMMARY, WE HAVE THE 432 00:30:21,840 --> 00:30:24,600 ADJUVANTS FOR EXACTLY WHAT WE 433 00:30:24,600 --> 00:30:26,320 NEED, HOWEVER THE BIG ISSUE IS 434 00:30:26,320 --> 00:30:34,440 THE SUPPLY WHERE YOU NEED THEM 435 00:30:34,440 --> 00:30:40,000 AND THE INTRODUCTION TO BE 436 00:30:40,000 --> 00:30:41,520 MORE GLOBAL. 437 00:30:41,520 --> 00:30:46,600 WE NEED MORE INDEPENDENCE BY 438 00:30:46,600 --> 00:30:49,400 EACH COUNTRY AND EXPORT -- 439 00:30:49,400 --> 00:30:49,840 [INDISCERNIBLE] 440 00:30:49,840 --> 00:30:50,240 THANK YOU. 441 00:30:50,240 --> 00:30:52,600 >>THANK YOU DANIEL FOR THAT 442 00:30:52,600 --> 00:30:54,960 PERSPECTIVE. 443 00:30:54,960 --> 00:31:05,520 OUR THIRD SPEAKER WILL BE THE 444 00:31:11,120 --> 00:31:14,920 CEO OF MADVAC. 445 00:31:14,920 --> 00:31:15,320 MICHELLE? 446 00:31:15,320 --> 00:31:15,960 >>HELLO EVERYONE, I WOULD 447 00:31:15,960 --> 00:31:17,960 LIKE TO THANK THE ORGANIZER 448 00:31:17,960 --> 00:31:20,120 AND CHAIR FOR THIS OPPORTUNITY 449 00:31:20,120 --> 00:31:26,800 TO TELL ABOUT OUR ADJUVANTS 450 00:31:26,800 --> 00:31:28,600 FOR GLOBAL HEALTH. 451 00:31:28,600 --> 00:31:31,080 MY TALK IS IN TWO SECTIONS. 452 00:31:31,080 --> 00:31:40,080 FIRST, LET ME TELL YOU ABOUT 453 00:31:40,080 --> 00:31:45,440 THE VACCINES. 454 00:31:45,440 --> 00:31:47,200 I STARTED IN 2016 AFTER WHAT 455 00:31:47,200 --> 00:31:49,440 WE GET FROM THE U.S. FOR THE 456 00:31:49,440 --> 00:31:51,520 VACCINE AND GLOBAL HEALTH 457 00:31:51,520 --> 00:31:53,560 PROJECT. 458 00:31:53,560 --> 00:32:04,040 SO THE COMPANIES NOW FROM 459 00:32:12,800 --> 00:32:15,880 CHINA AND AND THE U.S. 460 00:32:15,880 --> 00:32:25,080 ALL OF THE VACCINES USING THE 461 00:32:25,080 --> 00:32:28,440 COMPONENTS FROM MAXVAX VACCINE 462 00:32:28,440 --> 00:32:28,800 PIPELINE. 463 00:32:28,800 --> 00:32:29,960 SINGLES WE HAVE IN THE U.S. 464 00:32:29,960 --> 00:32:31,920 AND CHINA AS WELL. 465 00:32:31,920 --> 00:32:36,640 ALL THE ADJUTANT USING THIS 466 00:32:36,640 --> 00:32:40,440 VACCINE FORMULATION IS MADE 467 00:32:40,440 --> 00:32:45,240 IN-HOUSE BY MAX MAXVAX. 468 00:32:45,240 --> 00:32:46,080 THIS IS PART OF THE PLATFORM 469 00:32:46,080 --> 00:32:48,600 WE ARE WORKING ON. 470 00:32:48,600 --> 00:32:52,920 FIRST OF ALL, WOULD I WE ARE 471 00:32:52,920 --> 00:32:59,560 WORKING ON ADJUTANTS, THE 472 00:32:59,560 --> 00:33:00,880 PROGRAM ACCESSIBILITY HAS 473 00:33:00,880 --> 00:33:03,400 SHOWN THAT ADJUVANTS ARE NOT 474 00:33:03,400 --> 00:33:05,040 ONE SIZE FITS ALL FOR 475 00:33:05,040 --> 00:33:13,280 DIFFERENT TYPES OF VACCINES. 476 00:33:13,280 --> 00:33:15,920 MAXVAX HAS A LIBRARY OF 477 00:33:15,920 --> 00:33:17,000 ADJUTANT MOLECULES AND 478 00:33:17,000 --> 00:33:19,000 FORMULATION THAT CAN BE 479 00:33:19,000 --> 00:33:20,560 TAILORED BY DIFFERENT 480 00:33:20,560 --> 00:33:21,360 VACCINES. 481 00:33:21,360 --> 00:33:25,640 THERE IS QUALITY AND SCALE, 482 00:33:25,640 --> 00:33:26,200 AFFORDABILITY AND 483 00:33:26,200 --> 00:33:27,320 SUSTAINABILITY AND SUPPLY 484 00:33:27,320 --> 00:33:28,240 SECURITY. 485 00:33:28,240 --> 00:33:37,400 THESE ARE THE ISSUES FOR 486 00:33:37,400 --> 00:33:39,400 GLOBAL VACCINE AND WE SEE 487 00:33:39,400 --> 00:33:43,160 OTHER ISSUES WHEN WE FIRST 488 00:33:43,160 --> 00:33:53,720 DEVELOPED OUR COMPANY SO WE AT 489 00:34:00,520 --> 00:34:09,240 MAXVAX LOOK AT THE 490 00:34:09,240 --> 00:34:14,040 AVAILABILITY WITH THE GOAL TO 491 00:34:14,040 --> 00:34:15,080 BECOME SELF-SUFFICIENT FOR 492 00:34:15,080 --> 00:34:17,280 PARTNERS INTERESTED IN 493 00:34:17,280 --> 00:34:18,200 ADJUVANTS AND FORMULATIONS. 494 00:34:18,200 --> 00:34:21,240 OUR FOCUS IS ON IMPROVING THE 495 00:34:21,240 --> 00:34:23,200 QUALITY, ACCESS AND 496 00:34:23,200 --> 00:34:25,240 AFFORDABILITY OF ADVANCED 497 00:34:25,240 --> 00:34:25,600 ADJUVANTS. 498 00:34:25,600 --> 00:34:30,760 IN HOUSE, WE LOOK AT EXPERTISE 499 00:34:30,760 --> 00:34:37,160 IN CHEMICAL SYNTHESIS OF 500 00:34:37,160 --> 00:34:45,480 ADJUVANTS AND NUCLEIC ACIDS, 501 00:34:45,480 --> 00:34:48,000 R&D AND INDUSTRIAL PLANTS 502 00:34:48,000 --> 00:34:50,240 AVAILABLE TO PRO PRODUCE 503 00:34:50,240 --> 00:34:51,440 ADJUVANTS AND FORMULATIONS. 504 00:34:51,440 --> 00:34:56,520 SO WHAT WE HAVE TODAY, 505 00:34:56,520 --> 00:35:00,680 PRODUCED AT MAXVAX WE HAVE 20 506 00:35:00,680 --> 00:35:02,160 RESEARCH-GRADE ADJUVANT 507 00:35:02,160 --> 00:35:04,520 MOLECULES COVERING COMMON 508 00:35:04,520 --> 00:35:10,760 CLASSES AND HIGH DEGREE OF IND 509 00:35:10,760 --> 00:35:13,680 READY GM P GRADE MATERIALS. 510 00:35:13,680 --> 00:35:16,760 WE HAVE FOUR ADJUVANT 511 00:35:16,760 --> 00:35:19,520 MOLECULES WITH THREE DELIVERY 512 00:35:19,520 --> 00:35:30,080 SYSTEMS AND FOUR COMBINATION 513 00:35:34,320 --> 00:35:34,760 ADJUVANTS. 514 00:35:34,760 --> 00:35:40,320 SO WE SEE WHAT WE HAVE FOR 515 00:35:40,320 --> 00:35:44,120 ADJUVANT CLASSES, WE HAVE 516 00:35:44,120 --> 00:35:53,440 QS-21, P.M. OLY, MPL, CPG AND 517 00:35:53,440 --> 00:35:57,640 LIPIDS FOR LIPOSOMES AND 518 00:35:57,640 --> 00:36:00,920 AGOIFTS AND INKT CLASS. 519 00:36:00,920 --> 00:36:07,280 SO LET ME EXPLAIN WHAT THEY 520 00:36:07,280 --> 00:36:08,560 ARE. 521 00:36:08,560 --> 00:36:11,520 WE HAVE MATERIAL PURIFIED FROM 522 00:36:11,520 --> 00:36:17,640 PLANT EXTRACT USED IN VACCINE 523 00:36:17,640 --> 00:36:21,160 IN PHASE II STUDY. 524 00:36:21,160 --> 00:36:27,280 THIS BATCH SIZE IS EQUIVALENT 525 00:36:27,280 --> 00:36:30,240 TO 1 MILLION DOSES. 526 00:36:30,240 --> 00:36:33,920 WE PLAN FOR SMALL SCALE 527 00:36:33,920 --> 00:36:39,240 PRODUCTION NEXT YEAR. 528 00:36:39,240 --> 00:36:49,760 BUT THIS MATERIAL IS LOOKING 529 00:36:54,760 --> 00:37:00,880 AT PO LY OR I: C. 530 00:37:00,880 --> 00:37:03,240 THE MOLECULES ARE NOT 531 00:37:03,240 --> 00:37:04,280 OPTIMIZED FOR MAX PRODUCTION 532 00:37:04,280 --> 00:37:14,880 SO WE HAVE O OPTIMIZE THE I: 533 00:37:17,400 --> 00:37:24,960 C. 534 00:37:24,960 --> 00:37:33,800 THIS IS OPTIMIZED FOR TWO 535 00:37:33,800 --> 00:37:37,680 MILLION DOSES. 536 00:37:37,680 --> 00:37:42,880 WE HAVE FOUR SYNTHETIC MPL 537 00:37:42,880 --> 00:37:43,520 MOLECULES. 538 00:37:43,520 --> 00:37:51,640 THE GM P MP L.A. IS MADE AT 539 00:37:51,640 --> 00:37:53,640 AROUND 200 BATCH SIZE AND 540 00:37:53,640 --> 00:37:55,440 EQUIVALENT TO FOUR MILLION 541 00:37:55,440 --> 00:37:55,800 DOSES. 542 00:37:55,800 --> 00:38:01,880 THE SCALE IS MUCH HIGHER THAN 543 00:38:01,880 --> 00:38:04,600 THE PURIFIED AND ALSO CAN BE 544 00:38:04,600 --> 00:38:09,200 UTILIZED TO SCALE AND 545 00:38:09,200 --> 00:38:19,520 TRANSFERRED. 546 00:38:26,800 --> 00:38:30,000 THE NEXT MOLECULE IS FOR WPG 547 00:38:30,000 --> 00:38:32,960 AND WE DO HAVE A PLAN TO MAKE 548 00:38:32,960 --> 00:38:38,560 THIS COMMERCIAL SCALE NEXT 549 00:38:38,560 --> 00:38:40,800 YEAR. 550 00:38:40,800 --> 00:38:42,280 MOST MATERIAL MOLECULE 551 00:38:42,280 --> 00:38:50,600 REQUIRED TO MAKE ADJUVANT, WE 552 00:38:50,600 --> 00:38:54,560 USE ALUMINUM HYDROXIDE, OIL IN 553 00:38:54,560 --> 00:38:56,240 WATER, LIPOSOMES AND THIS CAN 554 00:38:56,240 --> 00:39:06,800 BE MADE IN COMMERCIAL SCALE. 555 00:39:13,800 --> 00:39:17,720 THE ADJUVANT FOR 2.5 MILLION 556 00:39:17,720 --> 00:39:18,480 DOSES OF VACCINE. 557 00:39:18,480 --> 00:39:22,760 WE HAVE THE RIGHT COMBINATION, 558 00:39:22,760 --> 00:39:26,840 WE CALL THAT COMBINATION 559 00:39:26,840 --> 00:39:30,920 ADJUVANT FOR OUR OWN VACCINES 560 00:39:30,920 --> 00:39:32,320 TO USE. 561 00:39:32,320 --> 00:39:40,000 THIS OUR OWN FORMULATION AND 562 00:39:40,000 --> 00:39:45,280 GET WIDE IMMUNE RESPONSE. 563 00:39:45,280 --> 00:39:55,840 THE OIL IN WATER EMULSION WITH 564 00:39:58,840 --> 00:40:02,280 ONE ADJUVANT PROMOTE 565 00:40:02,280 --> 00:40:04,280 ANTIBODIES AND DEVELOP 566 00:40:04,280 --> 00:40:04,680 PRECLINICAL. 567 00:40:04,680 --> 00:40:07,400 WE HAVE USED THIS ADJUVANT IN 568 00:40:07,400 --> 00:40:09,520 COVID VACCINE IN CHINA. 569 00:40:09,520 --> 00:40:11,720 WE ARE ALSO USING THIS 570 00:40:11,720 --> 00:40:14,560 ADJUVANT FOR SEVERAL OTHER 571 00:40:14,560 --> 00:40:15,240 VACCINES IN DEVELOPMENT LATER 572 00:40:15,240 --> 00:40:24,040 THIS YEAR AND THE NEXT YEAR. 573 00:40:24,040 --> 00:40:28,200 SO THE ADJUVANT MA 105, IT IS 574 00:40:28,200 --> 00:40:34,760 LIPOSOME AND TWO ADJUVANTS FOR 575 00:40:34,760 --> 00:40:40,000 ANTIBODIES RESPONSE, CD4, 576 00:40:40,000 --> 00:40:41,520 T-CELLS RESPONSE AND WE HAVE 577 00:40:41,520 --> 00:40:47,160 COUPLE OF VACCINES WE PLAN TO 578 00:40:47,160 --> 00:40:48,880 DEVELOP FOR PHASE II. 579 00:40:48,880 --> 00:40:52,400 WE ALSO HAVE ANOTHER 580 00:40:52,400 --> 00:40:55,320 FORMULATION CALLED AYK103, A 581 00:40:55,320 --> 00:41:00,680 LIPOSOME WITH TWO ADJUVANT 582 00:41:00,680 --> 00:41:02,720 MOLECULES. 583 00:41:02,720 --> 00:41:09,280 IT SHOW M1, CD4, CD8 AND T 584 00:41:09,280 --> 00:41:14,760 CELLS RESPONSE. 585 00:41:14,760 --> 00:41:16,040 CURRENTLY WE INVESTIGATE 586 00:41:16,040 --> 00:41:17,680 TREATMENT FOR SOLID TUMORS. 587 00:41:17,680 --> 00:41:22,280 SO ALL THESE FORMULATIONS ARE 588 00:41:22,280 --> 00:41:32,840 MADE UNDER GM P AT COMMERCIAL 589 00:41:34,560 --> 00:41:38,280 SCALE AND WORK WITH 590 00:41:38,280 --> 00:41:39,440 FORMULATION CODES. 591 00:41:39,440 --> 00:41:49,960 WE ALSO LOOK AT THE FACILITY 592 00:41:51,440 --> 00:41:54,960 FOR VACCINE AND ON TOP LEFT WE 593 00:41:54,960 --> 00:41:59,360 HAVE VACCINE R&D CENTER FOR 594 00:41:59,360 --> 00:42:03,760 FORMULATIONS AND VACCINES FROM 595 00:42:03,760 --> 00:42:08,840 PHASE 1 AND II STUDIES 596 00:42:08,840 --> 00:42:09,240 DECEMBER. 597 00:42:09,240 --> 00:42:12,080 ON ON THE TOP RIGHT, WE HAVE 598 00:42:12,080 --> 00:42:15,920 ADJUVANT R&D CENTER IN 599 00:42:15,920 --> 00:42:20,040 SHANGHAI AND CURRENTLY WE MAKE 600 00:42:20,040 --> 00:42:30,480 VACCINES TO SCALE FOR 601 00:42:32,000 --> 00:42:32,480 ANTIDOTE. 602 00:42:32,480 --> 00:42:37,560 ON BOTTOM LEFT WE HAVE VACCINE 603 00:42:37,560 --> 00:42:39,760 MANUFACTURING PLANT WHERE WE 604 00:42:39,760 --> 00:42:42,280 MAKE ADJUVANT FORMULATIONS AND 605 00:42:42,280 --> 00:42:43,600 VACCINES AT COMMERCIAL SCALE. 606 00:42:43,600 --> 00:42:46,880 WE HOPE THIS WILL BE OF 607 00:42:46,880 --> 00:42:49,920 INTEREST TO POTENTIAL 608 00:42:49,920 --> 00:42:52,520 PARTNERS. 609 00:42:52,520 --> 00:43:02,720 SO WE CURRENTLY HAVE RESEARCH 610 00:43:02,720 --> 00:43:05,800 WITH MOLECULES AND ALSO WE 611 00:43:05,800 --> 00:43:08,280 HAVE ADJUVANT PLATFORM 612 00:43:08,280 --> 00:43:15,440 AVAILABLE FOR FORMULATION. 613 00:43:15,440 --> 00:43:17,480 THANK YOU. 614 00:43:17,480 --> 00:43:19,200 >>THANK YOU. 615 00:43:19,200 --> 00:43:21,400 SO WE APPRECIATE OUR THREE 616 00:43:21,400 --> 00:43:22,880 SPEAKERS FOR THEIR UNIQUE 617 00:43:22,880 --> 00:43:23,920 PERSPECTIVE AND WILL NOW MOVE 618 00:43:23,920 --> 00:43:25,760 TO THE PANEL DISCUSSION. 619 00:43:25,760 --> 00:43:27,760 AND IN ADDITION TO THE THREE 620 00:43:27,760 --> 00:43:38,360 SPEAKERS YOU JUST HEARD FROM, 621 00:43:39,760 --> 00:43:45,560 WE HAVE TWO SPEAKERS. 622 00:43:45,560 --> 00:43:47,640 AND THE WAY THAT WE WILL DO 623 00:43:47,640 --> 00:43:49,240 THE PANEL DISCUSSION IS WE 624 00:43:49,240 --> 00:43:50,560 HAVE SELECTED A HANDFUL OF 625 00:43:50,560 --> 00:43:52,480 QUESTIONS FROM THE MANY, MANY 626 00:43:52,480 --> 00:43:53,600 QUESTIONS THAT WERE SUBMITTED 627 00:43:53,600 --> 00:43:55,760 PRIOR TO THE WEBINAR AND 628 00:43:55,760 --> 00:43:56,960 OBVIOUSLY WE WON'T HAVE TIME 629 00:43:56,960 --> 00:43:59,480 TO GET TO ALL OF THEM. 630 00:43:59,480 --> 00:44:01,280 ALSO WE SEE THERE ARE MANY 631 00:44:01,280 --> 00:44:05,320 QUESTIONS IN Q&A SECTION HERE 632 00:44:05,320 --> 00:44:09,560 OF THE WEBINAR AND THE PANEL 633 00:44:09,560 --> 00:44:11,040 SPEAKERS WILL ATTEMPT TO GET 634 00:44:11,040 --> 00:44:13,760 TO AS MANY OF THOSE AS THEY 635 00:44:13,760 --> 00:44:15,680 CAN IN THAT Q&A PORTAL. 636 00:44:15,680 --> 00:44:19,120 SO FOR NOW WE WOULD LIKE TO GO 637 00:44:19,120 --> 00:44:20,920 TO KRISHNA AND PALO AND GIVE 638 00:44:20,920 --> 00:44:23,280 THEM A FEW MINUTES TO 639 00:44:23,280 --> 00:44:23,920 INTRODUCE THEMSELVES AND 640 00:44:23,920 --> 00:44:25,200 ADDRESS ONE OF THE QUESTIONS 641 00:44:25,200 --> 00:44:26,240 WE HAVE SELECTED. 642 00:44:26,240 --> 00:44:27,280 SO KRISHNA, THE QUESTION FOR 643 00:44:27,280 --> 00:44:29,440 YOU IS WHAT ARE THE MAIN 644 00:44:29,440 --> 00:44:30,240 OBSTACLES AND POTENTIAL 645 00:44:30,240 --> 00:44:32,560 SOLUTIONS FOR KNOWLEDGE 646 00:44:32,560 --> 00:44:33,520 SHARING ON ADJUVANTS AND WE 647 00:44:33,520 --> 00:44:35,480 WILL HAND IT OVER TO YOU TO 648 00:44:35,480 --> 00:44:37,520 SHARE A COUPLE OF SLIDES AND 649 00:44:37,520 --> 00:44:44,560 ADDRESS THAT QUESTION. 650 00:44:44,560 --> 00:44:47,760 >>YEAH, THANKS, CHRIS. 651 00:44:47,760 --> 00:44:57,760 I AM ENGAGED IN SACKS -- 652 00:44:57,760 --> 00:44:58,880 VACCINE AND ADJUTANTS AND IF 653 00:44:58,880 --> 00:45:01,080 WE GO TO THE NEXT SLIDE, ONE 654 00:45:01,080 --> 00:45:08,960 OF THE KEY ISSUES ONE HAS IS 655 00:45:08,960 --> 00:45:10,280 KNOWLEDGE SHARING OF 656 00:45:10,280 --> 00:45:11,960 INFORMATION ON PARTICULARLY 657 00:45:11,960 --> 00:45:13,360 NEW ADJUTANTS AND THERE IS 658 00:45:13,360 --> 00:45:15,760 QUITE AND YOU AN INCOMPLETE 659 00:45:15,760 --> 00:45:17,040 KNOWLEDGE TRANSFER. 660 00:45:17,040 --> 00:45:18,800 THE SECOND MAJOR PROBLEM IS 661 00:45:18,800 --> 00:45:24,680 THE COMPLEXITY IN ATAPBT 662 00:45:24,680 --> 00:45:26,400 CHARACTERIZATION -- ADJUTANT 663 00:45:26,400 --> 00:45:27,640 CHARACTERIZATION, ESPECIALLY 664 00:45:27,640 --> 00:45:31,360 IF YOU ARE IN A EMERGENCY 665 00:45:31,360 --> 00:45:33,120 SITUATION, THIS NEEDS TO BE 666 00:45:33,120 --> 00:45:42,040 DONE IN SHORT TIME AND SOME OF 667 00:45:42,040 --> 00:45:45,920 THE POINTS MADE ON GM P AND 668 00:45:45,920 --> 00:45:48,640 THE PREVIOUS SPEAKER, IT IS 669 00:45:48,640 --> 00:45:50,640 MUCH MORE DEMANDING AND TO 670 00:45:50,640 --> 00:45:59,760 TALK ABOUT NEW ADJUTANTS, YOU 671 00:45:59,760 --> 00:46:01,760 NEED EXTENSIVE 672 00:46:01,760 --> 00:46:03,240 CHARACTERIZATION. 673 00:46:03,240 --> 00:46:09,040 THIS IS TO ENSURE SAFETY AND 674 00:46:09,040 --> 00:46:13,560 MAKES IT DELAY IN VACCINE 675 00:46:13,560 --> 00:46:15,920 DEVELOPMENT AND NEEDS 676 00:46:15,920 --> 00:46:16,560 EXTENSIVE CHARACTERIZATION 677 00:46:16,560 --> 00:46:19,960 THAT MAY NOT BE AVAILABLE IN 678 00:46:19,960 --> 00:46:20,920 R&D STAGE DEVELOPMENT AND THIS 679 00:46:20,920 --> 00:46:22,200 IS WHERE THE PROBLEM LIES. 680 00:46:22,200 --> 00:46:24,960 THE MOMENT YOU START GETTING 681 00:46:24,960 --> 00:46:26,880 INTO COMMERCIALIZATION AND 682 00:46:26,880 --> 00:46:30,240 START WANTING TO DO HUMAN 683 00:46:30,240 --> 00:46:40,720 TRIALS, THEN IT BECOMES A 684 00:46:41,040 --> 00:46:44,080 HERCULEAN TASK TO DO. 685 00:46:44,080 --> 00:46:45,840 SO THIS IS SOMETHING I THINK 686 00:46:45,840 --> 00:46:49,160 HAS NOT GOT TEN MUCH ATTENTION 687 00:46:49,160 --> 00:46:50,160 TILL NOW. 688 00:46:50,160 --> 00:46:52,080 WE NEED TO UNDERSTAND THE 689 00:46:52,080 --> 00:46:54,360 MECHANISM OF ACTION OF 690 00:46:54,360 --> 00:46:59,320 ADJUTANTS BUT THAT IS NOT SO 691 00:46:59,320 --> 00:47:03,240 MUCH AN OBSTACLE BECAUSE THERE 692 00:47:03,240 --> 00:47:04,480 IS BASIC FUNDAMENTAL RESEARCH 693 00:47:04,480 --> 00:47:09,240 GOING ON IN DIFFERENT LABS 694 00:47:09,240 --> 00:47:10,560 ACROSS THE WORLD. 695 00:47:10,560 --> 00:47:17,400 SO THESE ARE THE KEY TO ME, 696 00:47:17,400 --> 00:47:19,880 EXPENSIVE, SAFETY 697 00:47:19,880 --> 00:47:21,200 CHARACTERIZATION, MONITOR 698 00:47:21,200 --> 00:47:22,720 CHARACTERIZATION WITH ADJUVANT 699 00:47:22,720 --> 00:47:25,120 ALONE IN COMBINATION WITH THE 700 00:47:25,120 --> 00:47:27,080 VACCINE FOLLOWED BY THE GM P 701 00:47:27,080 --> 00:47:30,160 MANUFACTURER AND THEN LOOKING 702 00:47:30,160 --> 00:47:33,240 AT IN TERMS OF COMPATIBILITY 703 00:47:33,240 --> 00:47:34,400 WITH THE ADJUVANT. 704 00:47:34,400 --> 00:47:36,440 BECAUSE THE ADJUVANT MAY BE 705 00:47:36,440 --> 00:47:39,760 GOOD ENOUGH IN SHORT TERM 706 00:47:39,760 --> 00:47:41,720 COMBINATION BUT IN LONG-TERM 707 00:47:41,720 --> 00:47:43,680 STUDY, YOU NEED TO MAKE SURE 708 00:47:43,680 --> 00:47:45,280 YOU HAVE GOOD ADJUVANT IN 709 00:47:45,280 --> 00:47:45,880 HAND. 710 00:47:45,880 --> 00:47:49,800 SO WHAT KIND OF SOLUTION WE 711 00:47:49,800 --> 00:47:51,760 HAVE, THE NEXT SLIDE BRIEFLY 712 00:47:51,760 --> 00:47:52,480 MENTIONS THOSE. 713 00:47:52,480 --> 00:47:55,920 CERTAINLY WE NEED TO HAVE GOOD 714 00:47:55,920 --> 00:47:56,360 COLLABORATION. 715 00:47:56,360 --> 00:48:01,400 AGAIN A COUPLE OF EARLIER 716 00:48:01,400 --> 00:48:04,520 SPEAKERS DID MENTION 717 00:48:04,520 --> 00:48:05,200 COLLABORATION. 718 00:48:05,200 --> 00:48:07,600 THERE HAS TO BE VERY CLEAR 719 00:48:07,600 --> 00:48:11,600 OBJECTIVE OF USAGE BETWEEN 720 00:48:11,600 --> 00:48:14,880 PARTNERS AND TRYING TO GET A 721 00:48:14,880 --> 00:48:16,040 WIN-WIN APPROACH BY PARTIES. 722 00:48:16,040 --> 00:48:18,720 IT IS NOT ABOUT LICENSING AND 723 00:48:18,720 --> 00:48:20,080 ALL THOSE, IT IS MUCH MORE 724 00:48:20,080 --> 00:48:20,920 THAN THAT. 725 00:48:20,920 --> 00:48:25,440 AND CERTAINLY WORKING ON THE 726 00:48:25,440 --> 00:48:27,520 YOU NEW ADJUVANTS, 727 00:48:27,520 --> 00:48:29,320 SPECIFICALLY THOSE THAT ARE 728 00:48:29,320 --> 00:48:35,120 SAFE AND EFFECTIVE AND IN 729 00:48:35,120 --> 00:48:36,960 MARKET WHETHER THEY NEED 730 00:48:36,960 --> 00:48:40,400 SLIGHT MODIFICATIONS OR EXTEND 731 00:48:40,400 --> 00:48:48,280 THEM HAVE VACCINES WOULD BE 732 00:48:48,280 --> 00:48:50,520 EASIER THAN YET ANOTHER NEW 733 00:48:50,520 --> 00:48:51,680 ADJUVANT SO THESE ARE A COUPLE 734 00:48:51,680 --> 00:48:54,080 OF THINGS TO BE MINDFUL OF. 735 00:48:54,080 --> 00:48:55,000 THANK YOU, CHRIS. 736 00:48:55,000 --> 00:48:56,960 >>THANK YOU, KRISHNA, 737 00:48:56,960 --> 00:48:58,880 APPRECIATE THAT. 738 00:48:58,880 --> 00:49:00,680 >>PALO, YOUR QUESTION IS IT 739 00:49:00,680 --> 00:49:02,800 BETTER TO LOOK AT NEW ADJUVANT 740 00:49:02,800 --> 00:49:04,640 SYSTEMS OR MODIFY THE CURRENT 741 00:49:04,640 --> 00:49:15,200 AVAILABLE ONES TO INCREASE 742 00:49:16,200 --> 00:49:17,440 PRODUCTIVITY AND AVAILABILITY? 743 00:49:17,440 --> 00:49:18,960 >>HELLO EVERYBODY, THANKS FOR 744 00:49:18,960 --> 00:49:20,120 THIS OPPORTUNITY TO BE HERE 745 00:49:20,120 --> 00:49:30,680 AND ALL THE ORGANIZERS TOO. 746 00:49:36,840 --> 00:49:39,520 I AM TRYING TO SHARE MY 747 00:49:39,520 --> 00:49:40,200 SCREEN. 748 00:49:40,200 --> 00:49:41,840 CAN YOU SHARE MY SCREEN? 749 00:49:41,840 --> 00:49:42,960 >>NOT YET. 750 00:49:42,960 --> 00:49:45,920 I CAN SHARE IT FOR YOU IF YOU 751 00:49:45,920 --> 00:49:46,200 LIKE. 752 00:49:46,200 --> 00:49:49,760 >>PLEASE, IF YOU CAN -- CAN 753 00:49:49,760 --> 00:49:50,200 YOU GUYS SEE? 754 00:49:50,200 --> 00:49:51,760 >>YES, CAN YOU PLACE IT IN 755 00:49:51,760 --> 00:49:52,880 PRESENTATION MODE? 756 00:49:52,880 --> 00:50:02,680 >>OKAY, SORRY, JUST A MINUTE. 757 00:50:02,680 --> 00:50:10,840 OKAY, SO JUST TO TELL YOU A 758 00:50:10,840 --> 00:50:14,280 LITTLE BIT, I WORK IN ADJUTANT 759 00:50:14,280 --> 00:50:18,320 SCIENCE FOR MORE THAN 30 YEARS 760 00:50:18,320 --> 00:50:22,400 AND THIS YEAR WE COMPLETE 122 761 00:50:22,400 --> 00:50:24,440 YEARS OF FOUNDATION. 762 00:50:24,440 --> 00:50:34,960 WE ARE THE MAIN MAKERS OF 763 00:50:36,240 --> 00:50:41,400 VACCINES. AND THIS YEAR WE 764 00:50:41,400 --> 00:50:43,000 PRODUCED AROUND 80 MILLION FLU 765 00:50:43,000 --> 00:50:44,400 VACCINES SUPPLIED TO OUR 766 00:50:44,400 --> 00:50:55,000 MINISTRY OF HEALTH AS WELL AS 767 00:50:56,880 --> 00:51:06,880 PAHO AND UNICEF. 768 00:51:06,880 --> 00:51:11,880 WE HAD THE GLOBAL THREAT AND 769 00:51:11,880 --> 00:51:17,240 END UP WITH A TRIAL OF H7N9 770 00:51:17,240 --> 00:51:23,600 USING A DISTRIBUTION OF WHAT 771 00:51:23,600 --> 00:51:34,160 WE CALL ID160 WHICH IS A OIL 772 00:51:35,680 --> 00:51:37,080 IN WATER SOLUTION. 773 00:51:37,080 --> 00:51:39,640 SO THE QUESTION IS, IS IT 774 00:51:39,640 --> 00:51:46,440 BETTER TO LOOK AT THE ADJUTANT 775 00:51:46,440 --> 00:51:48,320 SYSTEMS OR MODIFY CURRENTLY 776 00:51:48,320 --> 00:51:52,320 AVAILABLE ONES TO INCREASE 777 00:51:52,320 --> 00:51:55,560 PRODUCTIVITY AND AVAILABILITY? 778 00:51:55,560 --> 00:51:57,080 THIS DEPENDS CASE BY CASE. 779 00:51:57,080 --> 00:52:00,600 YOU NEED A PRODUCER OF 780 00:52:00,600 --> 00:52:03,600 WELL-ESTABLISHED ADJUVANT WITH 781 00:52:03,600 --> 00:52:09,600 VOLUME CAPABILITY FOR MARKET. 782 00:52:09,600 --> 00:52:11,560 BUT THE DECISION SHOULD BE 783 00:52:11,560 --> 00:52:12,160 USED CASE BY CASE. 784 00:52:12,160 --> 00:52:18,640 IF YOU ARE A PRODUCER WITH 785 00:52:18,640 --> 00:52:20,920 VOLUME CAPABILITY FOR THE 786 00:52:20,920 --> 00:52:23,320 MARKET, THEN YOU CAN START 787 00:52:23,320 --> 00:52:24,680 LOOKING FOR NEW ADJUVANTS. 788 00:52:24,680 --> 00:52:29,200 IF YOU ARE A PRODUCER OF A 789 00:52:29,200 --> 00:52:29,800 WELL-ESTABLISHED ANTIGEN 790 00:52:29,800 --> 00:52:31,600 HOWEVER YOU HAVE NO VOLUME 791 00:52:31,600 --> 00:52:40,480 CAPABILITY FOR THE MARKET 792 00:52:40,480 --> 00:52:42,440 DEMAND, I GUESS THAT YOU 793 00:52:42,440 --> 00:52:43,760 SHOULD INCREASE YOUR 794 00:52:43,760 --> 00:52:49,000 CAPABILITY AND YOU ALSO HAVE 795 00:52:49,000 --> 00:52:54,960 SOME SPACE FOR RESOURCES -- 796 00:52:54,960 --> 00:53:01,480 FOR RESEARCH ON NEW ADJUTANTS. 797 00:53:01,480 --> 00:53:05,440 IF YOU ARE A RESEARCHER 798 00:53:05,440 --> 00:53:07,400 LOOKING FOR ANTIGEN FOR 799 00:53:07,400 --> 00:53:08,400 VACCINE DEVELOPMENT, THEN 800 00:53:08,400 --> 00:53:13,320 PROBABLY YOU HAVE THE ANTIGEN 801 00:53:13,320 --> 00:53:19,080 ASSOCIATED WITH THE CORRELATES 802 00:53:19,080 --> 00:53:20,080 OF PROTECTION. 803 00:53:20,080 --> 00:53:28,560 SO THE EASIEST WAY IS TO TEST 804 00:53:28,560 --> 00:53:31,160 FOR THE READY AND AVAILABLE 805 00:53:31,160 --> 00:53:31,520 ADJUTANT. 806 00:53:31,520 --> 00:53:33,720 IF THEY DON'T WORK AND YOUR 807 00:53:33,720 --> 00:53:35,520 ADJUTANT IS REALLY OUT OF SYNC 808 00:53:35,520 --> 00:53:36,600 WITH THE PROTECTION, THEN 809 00:53:36,600 --> 00:53:39,000 PROBABLY YOU WILL NEED TO LOOK 810 00:53:39,000 --> 00:53:41,560 FOR A COMBINATION OF ADJUVANT 811 00:53:41,560 --> 00:53:45,440 OR LOOK FOR NEW ADJUVANT. 812 00:53:45,440 --> 00:53:48,360 BUT IF YOUR ANTIGEN IS NOT SO 813 00:53:48,360 --> 00:53:49,960 STRONGLY ASSOCIATED WITH 814 00:53:49,960 --> 00:53:52,440 PROTECTION, PROBABLY YOU WILL 815 00:53:52,440 --> 00:53:59,680 NEED TO CHANGE THE ANTIGEN. 816 00:53:59,680 --> 00:54:02,480 SO I GUESS THAT IT WILL DEPEND 817 00:54:02,480 --> 00:54:06,360 ON THE PERSPECTIVE OF THE 818 00:54:06,360 --> 00:54:08,960 STAKEHOLDER AND OF COURSE WE 819 00:54:08,960 --> 00:54:15,920 WILL NEED TO EXPAND OUR 820 00:54:15,920 --> 00:54:19,720 PRODUCTION CAPABILITY OF T 821 00:54:19,720 --> 00:54:21,720 GRADE ADJUTANTS WHICH IS BELOW 822 00:54:21,720 --> 00:54:23,040 WHAT WE NEED GLOBALLY. 823 00:54:23,040 --> 00:54:25,640 BUT ALSO THERE IS A LOT OF 824 00:54:25,640 --> 00:54:33,160 SPACE FOR NEW ADJUTANTS AS 825 00:54:33,160 --> 00:54:35,000 TALKED BY PREVIOUS SPEAKER. 826 00:54:35,000 --> 00:54:38,520 THAT IS ALL, I GUESS, CHRIS. 827 00:54:38,520 --> 00:54:39,560 >>THANK YOU, PALO. 828 00:54:39,560 --> 00:54:42,080 OKAY, SO WE WILL NOW ADDRESS 829 00:54:42,080 --> 00:54:43,880 SOME QUESTIONS TO OUR PREVIOUS 830 00:54:43,880 --> 00:54:46,360 SPEAKERS AS WELL AND INVITE 831 00:54:46,360 --> 00:54:51,080 OTHER PANELISTS TO CHIME IN 832 00:54:51,080 --> 00:55:01,320 AND WHEN THEY WOULD LIKE TO. 833 00:55:01,320 --> 00:55:03,320 SO DECKSLANG, A QUESTION TO 834 00:55:03,320 --> 00:55:03,920 YOU. 835 00:55:03,920 --> 00:55:07,320 WHAT ARE THE OPTIONS TO 836 00:55:07,320 --> 00:55:12,760 ESTABLISH THE SAFETY OF 837 00:55:12,760 --> 00:55:13,120 ADJUTANTS? 838 00:55:13,120 --> 00:55:14,840 >>THAT IS A VERY GOOD 839 00:55:14,840 --> 00:55:15,320 QUESTION. 840 00:55:15,320 --> 00:55:19,400 CAN YOU HEAR ME? 841 00:55:19,400 --> 00:55:20,200 >>YES. 842 00:55:20,200 --> 00:55:29,040 >>I AM NOT SURE I HAVE A 843 00:55:29,040 --> 00:55:29,760 ANSWER TO THAT. 844 00:55:29,760 --> 00:55:40,280 YOU HAVE TO UNDERSTAND THE 845 00:55:41,280 --> 00:55:43,000 NEEDS SO WE CAN MAKE 846 00:55:43,000 --> 00:55:43,440 MODIFICATION. 847 00:55:43,440 --> 00:55:45,400 SO I THINK WE HAVE TWO 848 00:55:45,400 --> 00:55:46,480 OPTIONS. 849 00:55:46,480 --> 00:55:50,240 ONE IS TO DO IT YOURSELF. 850 00:55:50,240 --> 00:55:53,600 TWO, PREPARE THAT. 851 00:55:53,600 --> 00:56:00,480 YOU KNOW, WE CREATE POPULAR 852 00:56:00,480 --> 00:56:00,960 ETHICS. 853 00:56:00,960 --> 00:56:04,000 WE START TO DO IT OURSELVES, 854 00:56:04,000 --> 00:56:06,440 MAKE THE FORMULATION AND ALSO 855 00:56:06,440 --> 00:56:11,080 THE ADJUVANT VACCINE SO WE USE 856 00:56:11,080 --> 00:56:12,520 THOSE INFORMATION. 857 00:56:12,520 --> 00:56:17,520 THEN WE LOOK AT THE 858 00:56:17,520 --> 00:56:18,880 INFORMATION OF PIPELINE, 859 00:56:18,880 --> 00:56:22,760 WHETHER IT IS AVAILABLE AND 860 00:56:22,760 --> 00:56:27,720 USE THAT INFORMATION TO 861 00:56:27,720 --> 00:56:28,520 SUPPORT THAT. 862 00:56:28,520 --> 00:56:34,600 AND THEN WE USE THE VACCINE 863 00:56:34,600 --> 00:56:37,760 FROM CHINA AND U.S. 864 00:56:37,760 --> 00:56:40,240 SO THIS IS NOT BROADLY 865 00:56:40,240 --> 00:56:43,760 AVAILABLE TO OTHERS HOWEVER WE 866 00:56:43,760 --> 00:56:50,240 WOULD WELCOME WITH THE OTHER 867 00:56:50,240 --> 00:56:53,560 VACCINE DEVELOPERS TO VIEW 868 00:56:53,560 --> 00:56:59,080 THIS AND MAKE BROADER 869 00:56:59,080 --> 00:57:01,240 AVAILABLE AND WOULD LOOK AT 870 00:57:01,240 --> 00:57:02,360 INTERNATIONAL AGENCY FOR THIS 871 00:57:02,360 --> 00:57:05,240 PROCESS SO THERE IS MORE 872 00:57:05,240 --> 00:57:09,240 LEGITIMATE AND ALSO BE MORE 873 00:57:09,240 --> 00:57:09,840 ACCESSIBLE TO OTHERS. 874 00:57:09,840 --> 00:57:12,760 SO I AM NOT SURE THIS IS A 875 00:57:12,760 --> 00:57:16,080 GOOD ANSWER BUT HOPEFULLY 876 00:57:16,080 --> 00:57:16,920 OTHER SPEAKERS HAVE BETTER 877 00:57:16,920 --> 00:57:18,160 VIEWS ON THIS. 878 00:57:18,160 --> 00:57:21,200 THANK YOU. 879 00:57:21,200 --> 00:57:31,720 >>THANK YOU, DECKSIANG. 880 00:57:33,640 --> 00:57:34,800 ANY-- -- DEXIANG. 881 00:57:34,800 --> 00:57:36,800 ANY OTHER SPEAKERS LIKE TO 882 00:57:36,800 --> 00:57:42,560 WEIGH IN ON THIS? 883 00:57:42,560 --> 00:57:45,480 >>YES, IF YOUR APPROACH IS 884 00:57:45,480 --> 00:57:49,680 NOT AVAILABLE, YOU NEED TO 885 00:57:49,680 --> 00:57:53,920 CONSIDER MAKING IT AVAILABLE 886 00:57:53,920 --> 00:58:03,960 TO -- DISCERN. 887 00:58:03,960 --> 00:58:04,440 [INDISCERNIBLE] 888 00:58:04,440 --> 00:58:05,560 >>THIS IS SOMETHING THAT WE 889 00:58:05,560 --> 00:58:07,280 SAID IN THE BEGINNING, THAT WE 890 00:58:07,280 --> 00:58:10,800 NEED TO REALLY WORK ON IT. 891 00:58:10,800 --> 00:58:14,920 OTHERWISE NO ADJUTANT CAN BE 892 00:58:14,920 --> 00:58:16,400 COMMERCIALLY SUCCESSFUL. 893 00:58:16,400 --> 00:58:17,760 WE HAVE SIMILAR PROBLEM THAT 894 00:58:17,760 --> 00:58:20,200 THE PREVIOUS SPEAKER 895 00:58:20,200 --> 00:58:21,280 MENTIONED. 896 00:58:21,280 --> 00:58:22,880 WE HAD TO GO FOR EVERYTHING 897 00:58:22,880 --> 00:58:24,560 OUTSIDE SO THAT IS THE ONLY 898 00:58:24,560 --> 00:58:25,520 ANSWER IT LOOKS LIKE AND YOU 899 00:58:25,520 --> 00:58:28,200 HAVE TO DO IT FOR EVERY 900 00:58:28,200 --> 00:58:29,720 VACCINE IN COMBINATION WHICH 901 00:58:29,720 --> 00:58:36,960 IS QUITE A LOT OF MATERIAL. 902 00:58:36,960 --> 00:58:40,360 UNLESS THE ORGANIZATIONS HAVE 903 00:58:40,360 --> 00:58:42,000 THE NORMAL ADJUTANT ACCELERANT 904 00:58:42,000 --> 00:58:48,080 AND WILLING TO PARTNER, THEN 905 00:58:48,080 --> 00:58:57,440 YOU COULD USE THEM, OTHERWISE 906 00:58:57,440 --> 00:59:03,080 THE NORMAL ADJUTANT WOULD NOT 907 00:59:03,080 --> 00:59:05,120 BE ENOUGH. 908 00:59:05,120 --> 00:59:05,640 >>OKAY, THANK YOU. 909 00:59:05,640 --> 00:59:07,400 DANIEL, YOU MIGHT WANT TO TAKE 910 00:59:07,400 --> 00:59:11,560 THE FIRST STAB AT THIS ONE. 911 00:59:11,560 --> 00:59:12,880 WHICH NORMAL VACCINE 912 00:59:12,880 --> 00:59:14,400 CANDIDATES WILL BENEFIT FROM 913 00:59:14,400 --> 00:59:19,000 GREATER ADJUVANTS IN YOUR 914 00:59:19,000 --> 00:59:19,320 OPINION? 915 00:59:19,320 --> 00:59:22,240 >>WELL, I THINK WHATEVER IS 916 00:59:22,240 --> 00:59:24,640 COMPATIBLE TO RESEARCH. 917 00:59:24,640 --> 00:59:27,880 MOST VACCINES BENEFIT FROM 918 00:59:27,880 --> 00:59:30,600 BROADER ACCESS OF ADJUTANTS. 919 00:59:30,600 --> 00:59:33,800 IF YOU CAN SELECT YOUR 920 00:59:33,800 --> 00:59:38,520 ADJUTANTS EARLY ON AND ARE 921 00:59:38,520 --> 00:59:41,520 ABLE TO MAKE THE VACCINE 922 00:59:41,520 --> 00:59:44,320 ADJUTANT EARLY ON, YOU -- 923 00:59:44,320 --> 00:59:46,080 [INDISCERNIBLE] 924 00:59:46,080 --> 00:59:49,000 WHEREAS IN THE PAST ALTHOUGH 925 00:59:49,000 --> 00:59:53,240 THE VACCINE DEVELOPERS MAKE 926 00:59:53,240 --> 00:59:55,040 THEIR OWN ADJUTANTS, IF THEY 927 00:59:55,040 --> 00:59:56,920 CAN'T AFFORD TO DO THAT, IT IS 928 00:59:56,920 --> 00:59:59,000 VERY MUCH USING THE ADJUTANT 929 00:59:59,000 --> 01:00:01,560 THEY CAN GET THEIR HANDS ON 930 01:00:01,560 --> 01:00:10,960 AND MAKE A SOON FOR -- VACCINE 931 01:00:10,960 --> 01:00:11,400 FOR THAT. 932 01:00:11,400 --> 01:00:16,440 WE ARE WORKING ON A PROGRAM TO 933 01:00:16,440 --> 01:00:19,120 DO THAT -- [ INDISCERNIBLE ] 934 01:00:19,120 --> 01:00:23,800 AND THE IDEA HERE IS THE 935 01:00:23,800 --> 01:00:32,160 ADJUTANT BE AVAILABLE IN A 936 01:00:32,160 --> 01:00:37,280 PRE-TERM MODEL SO TO GET THE 937 01:00:37,280 --> 01:00:39,520 ADJUTANTS EARLY ON FOR THE 938 01:00:39,520 --> 01:00:39,920 VACCINE. 939 01:00:39,920 --> 01:00:42,440 >>ANY OTHER PANELISTS WANT TO 940 01:00:42,440 --> 01:00:44,360 SPEAK TO THAT? 941 01:00:44,360 --> 01:00:47,680 >>CANNOT AGREE WITH YOU MORE 942 01:00:47,680 --> 01:00:50,280 ON THE IMPORTANCE OF THESE 943 01:00:50,280 --> 01:00:52,560 COMPARATIVE STUDIES. 944 01:00:52,560 --> 01:00:55,400 IF THE VACCINE MAKER KNOWS A 945 01:00:55,400 --> 01:00:58,800 SPECIFIC TYPE OF ADJUTANT OR 946 01:00:58,800 --> 01:01:01,000 LIPOSOME OR SPECIFIC 947 01:01:01,000 --> 01:01:02,520 CONTAINING ADJUVANT IS IT NOT 948 01:01:02,520 --> 01:01:10,680 MATCH WELL IN THE VACCINE TO 949 01:01:10,680 --> 01:01:13,480 BE USED, IT IS NOT SAVING 950 01:01:13,480 --> 01:01:13,920 TIME. 951 01:01:13,920 --> 01:01:15,560 AND FAIRLY EARLY ON IF YOU ARE 952 01:01:15,560 --> 01:01:17,080 PROMOTING THEM, THIS IS GIVING 953 01:01:17,080 --> 01:01:18,960 YOU AN INDICATION OF WHERE YOU 954 01:01:18,960 --> 01:01:27,640 CAN GO RATHER THAN MAKING 955 01:01:27,640 --> 01:01:29,600 CHOICES BY DEFAULT. 956 01:01:29,600 --> 01:01:31,320 DURING THE PANDEMIC MANY 957 01:01:31,320 --> 01:01:33,040 VACCINE MAKERS GOT THEIR HANDS 958 01:01:33,040 --> 01:01:43,600 ON THE ADJUTANT BY DEFAULT. 959 01:01:43,880 --> 01:01:46,520 SO IF YOU KNOW AHEAD OF TIME 960 01:01:46,520 --> 01:01:50,520 YOU CAN GO TO A ADJUTANT MAKER 961 01:01:50,520 --> 01:01:57,800 OR DIFFERENT MANUFACTURES WHO 962 01:01:57,800 --> 01:02:00,760 HAVE ALREADY THE ADJUTANT THAT 963 01:02:00,760 --> 01:02:03,720 IS READY BUT ESSENTIALLY IT IS 964 01:02:03,720 --> 01:02:05,880 KNOWING WHICH ADJUTANT WORKS 965 01:02:05,880 --> 01:02:09,240 FOR MY VACCINE IS CRUCIAL. 966 01:02:09,240 --> 01:02:19,560 >>THANK YOU, NICHOLAS. 967 01:02:19,560 --> 01:02:24,720 I AM SORRY, THERE WAS ANOTHER 968 01:02:24,720 --> 01:02:26,680 RESPONSE ON THAT? 969 01:02:26,680 --> 01:02:31,400 >>LOOKING AT THE VACCINE 970 01:02:31,400 --> 01:02:33,880 ADJUTANT, IF WE CAN HAVE THE 971 01:02:33,880 --> 01:02:37,200 RESULTS COMPARATIVE WITH THE 972 01:02:37,200 --> 01:02:39,640 WELL-ESTABLISHED ADJUVANT, SO 973 01:02:39,640 --> 01:02:49,280 THEN WE CAN UNDERSTAND MUCH 974 01:02:49,280 --> 01:02:51,520 MORE IF THE ADJUTANTS ARE 975 01:02:51,520 --> 01:02:52,520 WORKING. 976 01:02:52,520 --> 01:02:53,200 >>THANK YOU, PALO. 977 01:02:53,200 --> 01:02:55,080 SO I THINK THIS IS A GOOD 978 01:02:55,080 --> 01:02:56,440 QUESTION TO END ON AND 979 01:02:56,440 --> 01:02:57,920 NICHOLAS, I WILL ASK YOU TO 980 01:02:57,920 --> 01:02:59,560 START OFF THE RESPONSE ON 981 01:02:59,560 --> 01:02:59,880 THIS. 982 01:02:59,880 --> 01:03:02,320 THE QUESTION IS HOW CAN 983 01:03:02,320 --> 01:03:05,160 EQUITABLE ACCESS AND 984 01:03:05,160 --> 01:03:06,720 AFFORDABILITY OF ADJUVANT 985 01:03:06,720 --> 01:03:08,920 TECHNOLOGY BE ENABLED 986 01:03:08,920 --> 01:03:09,520 WORLDWIDE? 987 01:03:09,520 --> 01:03:10,400 >>GOOD QUESTION, CHRIS. 988 01:03:10,400 --> 01:03:12,120 I THINK WE WOULD NOT BE HERE 989 01:03:12,120 --> 01:03:15,760 IF WE COULD ANSWER THE 990 01:03:15,760 --> 01:03:17,800 QUESTION ALREADY. 991 01:03:17,800 --> 01:03:21,880 MAYBE COMPLIMENTING ON WHAT I 992 01:03:21,880 --> 01:03:24,760 SAID BEFORE DURING THE TALKS, 993 01:03:24,760 --> 01:03:32,000 I THINK WE HAVE AT LEAST TWO 994 01:03:32,000 --> 01:03:33,560 THINGS TO CONSIDER, ONE IS ON 995 01:03:33,560 --> 01:03:35,000 THE TECHNICAL SOLUTION AND 996 01:03:35,000 --> 01:03:36,360 INNOVATION AND THE SECOND ONE 997 01:03:36,360 --> 01:03:41,800 IS MORE OF A BUSINESS MODEL. 998 01:03:41,800 --> 01:03:43,600 FOR INNOVATION, WE KNOW THERE 999 01:03:43,600 --> 01:03:45,480 ARE MANY FOLKS RIGHT NOW DOING 1000 01:03:45,480 --> 01:03:49,080 SUCH THINGS BUT WE NEED TO 1001 01:03:49,080 --> 01:03:52,320 INCREASE AND IMPROVE THEM SO 1002 01:03:52,320 --> 01:03:56,280 THE FOLKS WORKING ON THESE, WE 1003 01:03:56,280 --> 01:03:57,920 NEED TO INNOVATE ON THE 1004 01:03:57,920 --> 01:04:01,720 PROCESSES BECAUSE THE CHEAPER 1005 01:04:01,720 --> 01:04:07,160 ADJUVANT WILL BE THE ONE YOU 1006 01:04:07,160 --> 01:04:10,280 GET THE MOST VACCINES. 1007 01:04:10,280 --> 01:04:12,880 THERE IS ANOTHER NOTION WHICH 1008 01:04:12,880 --> 01:04:23,440 IS IT IS NOT NECESSARILY THE 1009 01:04:23,840 --> 01:04:24,880 BEST ADJUTANT. 1010 01:04:24,880 --> 01:04:32,800 YOU NEED THE SIMPLEST 1011 01:04:32,800 --> 01:04:41,760 ADJUTANT, THE SIMPLE SOLUTION 1012 01:04:41,760 --> 01:04:52,320 SO IT GOES BACK TO WHAT PALO 1013 01:05:01,680 --> 01:05:05,120 SAID, THERE IS NOT A ONE SIZE 1014 01:05:05,120 --> 01:05:09,520 FITS ALL AND WHATEVER ADJUTANT 1015 01:05:09,520 --> 01:05:12,400 YOU HAVE NEEDS TO HAVE THE 1016 01:05:12,400 --> 01:05:19,960 BIGGEST IMPACT ON THE VACCINE. 1017 01:05:19,960 --> 01:05:22,200 THERE IS ANOTHER MODEL TO HAVE 1018 01:05:22,200 --> 01:05:26,960 IMPACT ON THE SOLUTION AND 1019 01:05:26,960 --> 01:05:31,680 THEN LOOK AT HAVING A STRONG 1020 01:05:31,680 --> 01:05:33,280 LEADERSHIP AND COMMITMENT TO 1021 01:05:33,280 --> 01:05:37,600 MAKE THE LOWER MARGIN 1022 01:05:37,600 --> 01:05:39,120 COUNTRIES COME ALONG SO TO 1023 01:05:39,120 --> 01:05:41,120 SPEAK SO THERE IS THIS VISION 1024 01:05:41,120 --> 01:05:44,360 AS WELL. 1025 01:05:44,360 --> 01:05:48,200 SO THE TECHNICAL MODEL AND 1026 01:05:48,200 --> 01:05:50,240 LEADERSHIP MODEL WOULD HELP IN 1027 01:05:50,240 --> 01:05:52,120 CREATING VACCINES. 1028 01:05:52,120 --> 01:05:52,760 >>THANK YOU, NICHOLAS, I 1029 01:05:52,760 --> 01:05:56,400 THINK THAT IS A GREAT POINT, 1030 01:05:56,400 --> 01:05:57,840 GREAT STATEMENT TO END THIS. 1031 01:05:57,840 --> 01:06:00,280 I WANT TO THANK THE PANELISTS 1032 01:06:00,280 --> 01:06:03,440 AND SPEAKERS FOR THEIR REMARKS 1033 01:06:03,440 --> 01:06:05,880 AND ANNIE, WE'LL HAND IT BACK 1034 01:06:05,880 --> 01:06:10,040 TO YOU. 1035 01:06:10,040 --> 01:06:13,840 >>OKAY, THANK YOU. 1036 01:06:13,840 --> 01:06:17,200 [INAUDIBLE] WE SHOULD TAKE A 1037 01:06:17,200 --> 01:06:19,240 FEW MINUTES BREAK [INAUDIBLE]. 1038 01:06:19,240 --> 01:06:21,920 >>WE ARE GOING TO CONTINUE 1039 01:06:21,920 --> 01:06:25,520 WITH THE WEBINAR WITH SESSION 1040 01:06:25,520 --> 01:06:29,320 2 THAT IS TITLED SELECTION OF 1041 01:06:29,320 --> 01:06:33,920 ADJUVANT AND FORMULATION FOR 1042 01:06:33,920 --> 01:06:39,120 VACCINE R&D, RATIONAL OR 1043 01:06:39,120 --> 01:06:40,360 EMPIRICAL. 1044 01:06:40,360 --> 01:06:44,800 I HAVE CESAR BOGGIANO AND I 1045 01:06:44,800 --> 01:06:47,000 HAVE THE PRIVILEGE TO CONDUCT 1046 01:06:47,000 --> 01:06:50,120 THIS SESSION WITH ANA STAZIA 1047 01:06:50,120 --> 01:06:50,480 AGUILAR. 1048 01:06:50,480 --> 01:06:52,960 PLEASE GO AHEAD AS CO-CHAIR. 1049 01:06:52,960 --> 01:06:55,800 >>THANK YOU, A PLEASURE TO BE 1050 01:06:55,800 --> 01:06:57,560 WITH YOU HERE TODAY AND I AM 1051 01:06:57,560 --> 01:06:58,840 VERY HAPPY TO INTRODUCE THE 1052 01:06:58,840 --> 01:07:03,440 FIRST OF FOUR SPEAKERS, KEVIN 1053 01:07:03,440 --> 01:07:04,440 SAUNDERS, ASSOCIATED DIRECTOR 1054 01:07:04,440 --> 01:07:06,240 AT THE DUKE HUMAN VACCINE 1055 01:07:06,240 --> 01:07:11,840 INSTITUTE AND WILL BE TALKING 1056 01:07:11,840 --> 01:07:13,320 ABOUT MOLECULAR MECHANISM OF 1057 01:07:13,320 --> 01:07:16,320 ADJUVANTS AND HOW TO BEST 1058 01:07:16,320 --> 01:07:18,600 PRESENT TO IMMUNE SYSTEM. 1059 01:07:18,600 --> 01:07:23,040 >> THANK YOU, ANA STAZIA, I 1060 01:07:23,040 --> 01:07:25,400 WILL GO RIGHT AHEAD AND JUMP 1061 01:07:25,400 --> 01:07:30,160 IN SO WE CAN STAY ON TIME. 1062 01:07:30,160 --> 01:07:32,000 AT THE VACCINE INSTITUTE WE 1063 01:07:32,000 --> 01:07:40,760 ARE FOCUSED ON PRODUCING 1064 01:07:40,760 --> 01:07:44,040 ADJUTANTS FOR ANTIBODY 1065 01:07:44,040 --> 01:07:48,600 INFECTION. 1066 01:07:48,600 --> 01:07:53,000 AS YOU KNOW WE HAVE HAD 1067 01:07:53,000 --> 01:07:54,480 SEVERAL THREATS OVER THE LAST 1068 01:07:54,480 --> 01:07:54,920 TWO DECADES. 1069 01:07:54,920 --> 01:08:00,000 WHAT WE ARE TRYING TO DO IS 1070 01:08:00,000 --> 01:08:03,680 ELICIT NEUTRALIZING BODIES 1071 01:08:03,680 --> 01:08:06,360 WITH EXTREMELY HIGH 1072 01:08:06,360 --> 01:08:10,000 CROSS-REACTIVITY AGAINST A 1073 01:08:10,000 --> 01:08:11,120 VIRAL PATHOGEN. 1074 01:08:11,120 --> 01:08:16,400 TO PROMOTE THE AFFINITY 1075 01:08:16,400 --> 01:08:18,880 MATURATION OF ANTIBODIES WHICH 1076 01:08:18,880 --> 01:08:22,680 LEADS TO CROSS-REACTIVITY AND 1077 01:08:22,680 --> 01:08:28,400 ELICIT DURABLE AND HIGH 1078 01:08:28,400 --> 01:08:28,840 TITERS. 1079 01:08:28,840 --> 01:08:31,200 WE WANT THEM TO BE A CURB 1080 01:08:31,200 --> 01:08:34,040 RESPONSE OVER TIME AS WELL. 1081 01:08:34,040 --> 01:08:36,680 SO EARLY ON IN OUR WORK, WE 1082 01:08:36,680 --> 01:08:39,400 NOTICED THAT ADJUTANTS ARE 1083 01:08:39,400 --> 01:08:42,840 CRITICAL FOR INDUCING THESE 1084 01:08:42,840 --> 01:08:44,240 TYPE OF NEUTRALIZING 1085 01:08:44,240 --> 01:08:44,760 ANTIBODIES. 1086 01:08:44,760 --> 01:08:49,560 SO AS AN EXAMPLE, WE PRODUCED 1087 01:08:49,560 --> 01:08:52,000 A PRIMATE STUDY WHERE WE 1088 01:08:52,000 --> 01:08:53,120 ADMINISTERED THE VACCINE HERE 1089 01:08:53,120 --> 01:09:02,760 ON THE LEFT AND HAD A 1090 01:09:02,760 --> 01:09:04,080 NANOMECHANICAL PARTICLE AND 1091 01:09:04,080 --> 01:09:10,280 INTRODUCED THESE THREE TIMES 1092 01:09:10,280 --> 01:09:14,480 USING THE 3M052 ALUM, ALUM BY 1093 01:09:14,480 --> 01:09:16,160 ITSELF OR ANOTHER ADJUVANT. 1094 01:09:16,160 --> 01:09:22,160 AND WHAT WE FOUND IS IF YOU 1095 01:09:22,160 --> 01:09:29,120 DON'T INTRODUCE THE IMGENUINE, 1096 01:09:29,120 --> 01:09:33,920 YOU HAVE LESS OF A RESPONSE. 1097 01:09:33,920 --> 01:09:43,640 YOU CAN SEE WITH THE TITER ON 1098 01:09:43,640 --> 01:09:46,280 THE FIRST ONE, WE HAVE NO 1099 01:09:46,280 --> 01:09:46,880 RESPONSE. 1100 01:09:46,880 --> 01:09:51,120 WE CAN GET MORE WITH 3M WITH 1101 01:09:51,120 --> 01:09:54,920 AL LUM OR AL LUM BY ITSELF SO 1102 01:09:54,920 --> 01:09:56,960 WE KNOW GOING FORWARD THAT 1103 01:09:56,960 --> 01:09:57,920 ADJUTANTS ARE REALLY 1104 01:09:57,920 --> 01:09:58,280 IMPORTANT. 1105 01:09:58,280 --> 01:10:00,360 SO WE HAVE BEEN WORKING WITH A 1106 01:10:00,360 --> 01:10:02,960 GROUP AT UNIVERSITY OF 1107 01:10:02,960 --> 01:10:06,440 PENNSYLVANIA, MO HAMMED 1108 01:10:06,440 --> 01:10:08,280 GABRIEL, ANDY WISEMAN AND 1109 01:10:08,280 --> 01:10:10,880 PARTIES WHO ARE REALLY THE 1110 01:10:10,880 --> 01:10:12,480 ENGINEERS OF THE RNA PLATFORM. 1111 01:10:12,480 --> 01:10:16,280 WE ALSO CAME ACROSS THIS 1112 01:10:16,280 --> 01:10:20,720 OBSERVATION THAT THE LIP BID 1113 01:10:20,720 --> 01:10:21,920 NANOPARTICLES HAVE SOME 1114 01:10:21,920 --> 01:10:22,320 EFFECT. 1115 01:10:22,320 --> 01:10:24,160 SOME OF YOU MAY HAVE SEEN THIS 1116 01:10:24,160 --> 01:10:26,200 PUBLICATION THAT CAME OUT BACK 1117 01:10:26,200 --> 01:10:30,040 IN 2021 WHERE WE WERE LOOKING 1118 01:10:30,040 --> 01:10:33,200 AT THE ADJUTANT EFFECTS OF LMP 1119 01:10:33,200 --> 01:10:37,000 WHEN USED IN COMBINATION WITH 1120 01:10:37,000 --> 01:10:38,400 A PROTEIN AND THIS STUDY WAS 1121 01:10:38,400 --> 01:10:42,560 ABLE TO SHOW YOU CAN GET HIGH 1122 01:10:42,560 --> 01:10:45,280 TITERS OF ANTIBODIES IN THE 1123 01:10:45,280 --> 01:10:45,960 SERUM. 1124 01:10:45,960 --> 01:10:48,520 YOU CAN ALSO INCREASE THE 1125 01:10:48,520 --> 01:10:53,200 NUMBER OF PEOPLE PRODUCING 1126 01:10:53,200 --> 01:10:56,680 HELPER CELLS, PLASMA CELLS AND 1127 01:10:56,680 --> 01:11:00,120 OVERALL YOU CAN SEE THE MIX OF 1128 01:11:00,120 --> 01:11:04,320 PROTEIN CHOICE MADE A STRONG 1129 01:11:04,320 --> 01:11:10,800 ADJUTANT SYSTEM TO USE FOR THE 1130 01:11:10,800 --> 01:11:11,640 ANTIBODY RESPONSE. 1131 01:11:11,640 --> 01:11:16,840 THE SECOND THING WE WORKED ON, 1132 01:11:16,840 --> 01:11:19,520 YOU KNOW, YOU HAVE SEEN BOTH 1133 01:11:19,520 --> 01:11:21,360 MARS STUDIES AND OTHERS IN THE 1134 01:11:21,360 --> 01:11:25,560 FIELD WORKING ON HIV AND HAVE 1135 01:11:25,560 --> 01:11:30,040 FOUND THIS ADJUTANT CALLED 1136 01:11:30,040 --> 01:11:35,640 3M052 THAT COMES FROM THE 3M 1137 01:11:35,640 --> 01:11:39,560 COMPANY, YOU SEE AN AGO FIFTH 1138 01:11:39,560 --> 01:11:44,200 THAT INDUCES A DURABLE HIV 1139 01:11:44,200 --> 01:11:47,400 ENVELOPE WITH SPECIFIC PLASMA 1140 01:11:47,400 --> 01:11:51,440 CELLS AND HUMORAL IMMUNITY IN 1141 01:11:51,440 --> 01:11:53,160 NONHUMAN PRIMATES AND THIS IS 1142 01:11:53,160 --> 01:11:56,000 ONE OF THE ADJUTANTS WE ARE 1143 01:11:56,000 --> 01:11:57,480 LOOKING FORWARD TO WORKING 1144 01:11:57,480 --> 01:11:59,640 WITH IN OUR CLINICAL TRIALS. 1145 01:11:59,640 --> 01:12:03,720 SO WE ARE LOOKING AT BISHOP 1146 01:12:03,720 --> 01:12:07,960 MID NANOPARTICLES AS WELL AS 1147 01:12:07,960 --> 01:12:09,880 TLR AGO FIFTHS WHICH WE WOULD 1148 01:12:09,880 --> 01:12:12,200 LIKE TO MORE FORWARD AS PART 1149 01:12:12,200 --> 01:12:14,200 OF OUR ADJUTANT PORTFOLIO. 1150 01:12:14,200 --> 01:12:16,200 WE CURRENTLY HAVE PHASE 1 1151 01:12:16,200 --> 01:12:18,200 TRIALS WITH THE ENVELOPE AND 1152 01:12:18,200 --> 01:12:21,040 MIXED THEM WITH THESE TWO 1153 01:12:21,040 --> 01:12:22,120 TYPES OF ADJUTANTS AND COMPARE 1154 01:12:22,120 --> 01:12:23,960 THEM IN TRIALS TO SEE WHICH 1155 01:12:23,960 --> 01:12:24,840 GIVES YOU THE RESPONSE YOU 1156 01:12:24,840 --> 01:12:27,320 WANT IN THE CONTEXT OF THE 1157 01:12:27,320 --> 01:12:28,480 HUMAN IMMUNE SYSTEM. 1158 01:12:28,480 --> 01:12:32,040 SO HOW DO WE KIND OF GET TO 1159 01:12:32,040 --> 01:12:32,680 THESE DIFFERENT ADJUTANTS? 1160 01:12:32,680 --> 01:12:34,680 ONE OF THE THINGS WE LOOK AT 1161 01:12:34,680 --> 01:12:36,720 FIRST AND FOREMOST FOR OR HIV 1162 01:12:36,720 --> 01:12:39,720 PROGRAM IS WHAT IS THE 1163 01:12:39,720 --> 01:12:50,240 ADJUTANT THAT IS AFFECTED BY 1164 01:12:51,000 --> 01:12:52,440 THE IMMUNE GENUINE. 1165 01:12:52,440 --> 01:12:58,160 WE WANT TO DEFINE THE A TAPBT 1166 01:12:58,160 --> 01:13:00,280 FORMULATION THAT CAN TRANSLATE 1167 01:13:00,280 --> 01:13:03,560 FROM ANIMAL MODELS TO CLINICAL 1168 01:13:03,560 --> 01:13:07,280 AND AFFECT WHICH TYPES OF 1169 01:13:07,280 --> 01:13:14,000 ANTIBODIES WORK WITH YOUR ULP 1170 01:13:14,000 --> 01:13:14,480 MOON POPULATION. 1171 01:13:14,480 --> 01:13:19,400 WE ARE ALWAYS TRYING TO DEFINE 1172 01:13:19,400 --> 01:13:20,720 ADJUVANT OR ADJUVANT 1173 01:13:20,720 --> 01:13:22,960 FORMULATIONS THAT CAN 1174 01:13:22,960 --> 01:13:24,200 TRANSLATE FROM ANIMAL MODELS 1175 01:13:24,200 --> 01:13:26,320 TO CLINICAL USE. 1176 01:13:26,320 --> 01:13:28,080 SOMETIMES WE WILL COME ACROSS 1177 01:13:28,080 --> 01:13:32,600 ONE THAT LOOKS GREAT BUT THEN 1178 01:13:32,600 --> 01:13:34,360 WE WORRY WE COULD LOSE A LOT 1179 01:13:34,360 --> 01:13:37,640 OF THE PRIMATES IN THE CLINIC 1180 01:13:37,640 --> 01:13:41,280 SO BEFORE WE GET INTO A STUDY 1181 01:13:41,280 --> 01:13:44,520 WE CONSIDER WHETHER THIS 1182 01:13:44,520 --> 01:13:47,040 ADJUTANT IS SAFE ENOUGH TO GO 1183 01:13:47,040 --> 01:13:47,360 FORWARD. 1184 01:13:47,360 --> 01:13:53,760 WE ALSO WANT TO LOOK AT ARE 1185 01:13:53,760 --> 01:13:56,040 THERE ANNUAL TANS FIRST IN 1186 01:13:56,040 --> 01:13:58,080 HUMAN STUDIES THAT WERE 1187 01:13:58,080 --> 01:14:02,600 ALREADY COMPLETED, WAS THERE 1188 01:14:02,600 --> 01:14:04,720 REACTOGENICITY AND WAS IT 1189 01:14:04,720 --> 01:14:05,600 ACCEPTABLE AND MILD. 1190 01:14:05,600 --> 01:14:10,280 ONE OF THE QUESTIONS AROUND 1191 01:14:10,280 --> 01:14:13,280 3M-052 IS WHETHER IT WOULD BE 1192 01:14:13,280 --> 01:14:17,360 TOXIC IF DEVELOPED AND WHETHER 1193 01:14:17,360 --> 01:14:27,240 IT COULD BE USED WIDELY. 1194 01:14:27,240 --> 01:14:37,760 BY FORMULATING THIS IN TIER 2 1195 01:14:37,760 --> 01:14:39,040 NEUTRALIZING ANTIBODY TITERS. 1196 01:14:39,040 --> 01:14:45,560 SO WHAT WE DID WAS TAKE THE 1197 01:14:45,560 --> 01:14:48,800 SAME TWO ADJUVANTS, YOU CAN 1198 01:14:48,800 --> 01:14:50,800 SEE WITH THE TWO DIFFERENT 1199 01:14:50,800 --> 01:14:53,680 FORMULATIONS WE HAVE IDENTICAL 1200 01:14:53,680 --> 01:14:54,640 TITERS FOR BOTH. 1201 01:14:54,640 --> 01:14:56,160 SO IF WE HAVE A FORMULATION 1202 01:14:56,160 --> 01:14:58,200 THAT WE THINK MIGHT BE A SAFER 1203 01:14:58,200 --> 01:15:00,240 APPROACH FOR HUMANS, WE CAN 1204 01:15:00,240 --> 01:15:01,880 SWITCH OVER TO THAT ADJUVANT 1205 01:15:01,880 --> 01:15:05,400 IN OUR STUDIES AND ALSO IN OUR 1206 01:15:05,400 --> 01:15:06,160 CLINICAL TRIALS. 1207 01:15:06,160 --> 01:15:09,040 WHEN LOOKING AT ANIMAL MODELS 1208 01:15:09,040 --> 01:15:11,320 WE HAVE ALREADY LEARNED A 1209 01:15:11,320 --> 01:15:12,000 COUPLE OF LESSONS OVER THE 1210 01:15:12,000 --> 01:15:14,040 YEARS WE WANT TO MAKE SURE 1211 01:15:14,040 --> 01:15:15,960 THAT THE TARGETS ARE 1212 01:15:15,960 --> 01:15:17,920 APPROPRIATE FOR AN ANIMAL 1213 01:15:17,920 --> 01:15:21,080 SYSTEM AND IF WE WANT TO HAVE 1214 01:15:21,080 --> 01:15:22,600 A ANIMAL SYSTEM MODEL SYSTEM, 1215 01:15:22,600 --> 01:15:26,080 WE HAVE THE WE WANT TO MAKE 1216 01:15:26,080 --> 01:15:29,360 SURE IFS PREDICTIVE OF THE 1217 01:15:29,360 --> 01:15:30,440 HUMAN ANTIBODY RESPONSE. 1218 01:15:30,440 --> 01:15:33,200 SO LOOKING AT DIFFERENT TYPES 1219 01:15:33,200 --> 01:15:34,800 OF ANTIBODIES, IT MAY BE THAT 1220 01:15:34,800 --> 01:15:41,760 THAT IS NOT MADE IN AN 1221 01:15:41,760 --> 01:15:45,440 ACACANID OR A MOUSE. 1222 01:15:45,440 --> 01:15:47,000 IF THE ANIMAL MODELS ARE NOT 1223 01:15:47,000 --> 01:15:48,880 SUCH THAT YOU COULD USE THAT 1224 01:15:48,880 --> 01:15:50,920 SYSTEM, YOU HAVE TO TRY TO 1225 01:15:50,920 --> 01:15:52,840 FIND A DIFFERENT WAY TO TEST 1226 01:15:52,840 --> 01:15:53,560 THE ADJUTANT. 1227 01:15:53,560 --> 01:15:55,600 ONE OF THE WAYS WE CAME ACROSS 1228 01:15:55,600 --> 01:15:59,640 THIS IS WORKING WITH TL4 AGO 1229 01:15:59,640 --> 01:16:00,360 FIFTHS. 1230 01:16:00,360 --> 01:16:03,200 WE FOUND THEY WORK BEST IN THE 1231 01:16:03,200 --> 01:16:07,080 SMALL ANIMALS WE WERE USING 1232 01:16:07,080 --> 01:16:09,080 WITH THE ANTIBODIES THAT WERE 1233 01:16:09,080 --> 01:16:11,400 KNOCKED INTO THE MOUSE MODEL 1234 01:16:11,400 --> 01:16:13,320 SO WE THOUGHT THIS WAS A GREAT 1235 01:16:13,320 --> 01:16:15,840 WAY TO GO AND STARTED USING 1236 01:16:15,840 --> 01:16:18,280 THIS FOR OUR PRIMATE STUDIES 1237 01:16:18,280 --> 01:16:19,200 AS WELL. 1238 01:16:19,200 --> 01:16:28,600 HOWEVER, YOU CAN SEE ONCE WE 1239 01:16:28,600 --> 01:16:30,920 MOVED THE TLR4 AGO FIFTH, WE 1240 01:16:30,920 --> 01:16:39,040 FOUND IT IS WEAK COMPARED TO 1241 01:16:39,040 --> 01:16:40,200 THE TLR7/8 IN TIER 2. 1242 01:16:40,200 --> 01:16:42,360 WE TRIED TO UNDERSTAND WHY 1243 01:16:42,360 --> 01:16:46,000 THIS MIGHT BE. 1244 01:16:46,000 --> 01:16:52,040 WE FIRST LOOKED AT THE TITER 1245 01:16:52,040 --> 01:16:54,280 RESPONSES AND CYTOKINES AND 1246 01:16:54,280 --> 01:16:56,440 LOOKED AT 30 DIFFERENT KINDS 1247 01:16:56,440 --> 01:16:58,840 AND HOW THEY WERE ACTIVATED IN 1248 01:16:58,840 --> 01:17:00,400 THE IMMUNE SYSTEM. 1249 01:17:00,400 --> 01:17:05,040 WE DID NOT SEE ANY DETECTED 1250 01:17:05,040 --> 01:17:06,520 AFTER 24 HOURS AND IF YOU 1251 01:17:06,520 --> 01:17:11,320 COMPARE THAT TO THE 1252 01:17:11,320 --> 01:17:13,480 FORMULATIONS OF 3M-052, YOU 1253 01:17:13,480 --> 01:17:18,400 CAN SEE THE STABILIZED IN 1254 01:17:18,400 --> 01:17:24,080 ONE-THIRD AND THEN WITH THE 1255 01:17:24,080 --> 01:17:29,120 3M-052 WITH AL LUM, YOU SEE 1256 01:17:29,120 --> 01:17:31,440 MORE THAN A 50 PERCENT 1257 01:17:31,440 --> 01:17:33,040 CYTOKINE RESPONSE. 1258 01:17:33,040 --> 01:17:35,480 WHEN YOU GET DOWN TO THE BASIS 1259 01:17:35,480 --> 01:17:37,200 TO GOVERN THESE DIFFERENT 1260 01:17:37,200 --> 01:17:39,040 THINGS, YOU LEARN A LOT BEFORE 1261 01:17:39,040 --> 01:17:41,600 EXPRESSION OF THE TLR AND AS 1262 01:17:41,600 --> 01:17:45,440 YOU LOOK AT THE DIAGRAM TABLES 1263 01:17:45,440 --> 01:17:48,520 HERE AND LOOK ACROSS MONKEYS 1264 01:17:48,520 --> 01:17:52,040 AND HUMANS AND THE MOUSE, 1265 01:17:52,040 --> 01:17:54,480 THERE ARE DIFFERENT 1266 01:17:54,480 --> 01:17:57,440 EXPRESSIONS IN THE DIFFERENT 1267 01:17:57,440 --> 01:18:00,360 CELL TYPES WE WERE LOOKING AT. 1268 01:18:00,360 --> 01:18:03,720 WHAT WE THOUGHT WAS MOST 1269 01:18:03,720 --> 01:18:10,400 IMPORTANT WAS IN THE LIMPOID 1270 01:18:10,400 --> 01:18:11,880 CELLS, THE ADJUTANT WAS ABLE 1271 01:18:11,880 --> 01:18:15,080 TO ACTIVATE THE B AND T CELLS 1272 01:18:15,080 --> 01:18:16,560 BUT IN MONKEYS, THEY HAVE TO 1273 01:18:16,560 --> 01:18:19,160 BE ACTIVATED IN A CERTAIN WAY 1274 01:18:19,160 --> 01:18:21,680 BEFORE YOU CAN SEE EXPRESSION. 1275 01:18:21,680 --> 01:18:24,640 SO TARGETING B AND T CELL 1276 01:18:24,640 --> 01:18:25,520 RESPONSES WOULDN'T BE 1277 01:18:25,520 --> 01:18:28,680 EFFECTIVE IF WE USED THIS TYPE 1278 01:18:28,680 --> 01:18:29,320 OF ADJUTANT. 1279 01:18:29,320 --> 01:18:34,280 SO NOW I WILL SWITCH OVER AND 1280 01:18:34,280 --> 01:18:35,480 SAY QUICKLY AND TALK ABOUT 1281 01:18:35,480 --> 01:18:40,760 SOME OF THE STUDIES WE FOUND 1282 01:18:40,760 --> 01:18:42,320 WITH ANIMAL LIPID 1283 01:18:42,320 --> 01:18:42,760 NANOPARTICLES. 1284 01:18:42,760 --> 01:18:44,840 ONE OF THE MOST AMAZING THINGS 1285 01:18:44,840 --> 01:18:50,000 WE SAW EARLY ON IS IT 1286 01:18:50,000 --> 01:18:55,640 GENERATES EXTREMELY HIGH SERUM 1287 01:18:55,640 --> 01:18:57,960 TITERS AND YOU CAN SEE THE 1288 01:18:57,960 --> 01:19:03,680 MECHANICS HERE, THE NUMBER OF 1289 01:19:03,680 --> 01:19:05,440 TIMES IMMUNIZED. 1290 01:19:05,440 --> 01:19:07,680 ON THE NEUTRALIZATION TITER, 1291 01:19:07,680 --> 01:19:11,680 WE SEE IT APPROACHING ONE TO A 1292 01:19:11,680 --> 01:19:12,120 MILLION TITERS. 1293 01:19:12,120 --> 01:19:15,240 IF YOU COMPARE THAT TO SOME OF 1294 01:19:15,240 --> 01:19:16,920 THE TITERS I SHOWED YOU 1295 01:19:16,920 --> 01:19:20,000 BEFORE, IT WAS DOWN TO AROUND 1296 01:19:20,000 --> 01:19:21,720 1 TO 10,000 SO DEFINITELY 1297 01:19:21,720 --> 01:19:24,160 USING THE NAN MOW PARTICLE 1298 01:19:24,160 --> 01:19:26,720 WITH AN ADJUTANT IS HIGHER 1299 01:19:26,720 --> 01:19:28,960 THAN THE OTHER ONES WE USED. 1300 01:19:28,960 --> 01:19:30,400 WHEN WE LOOK AT THE RESPONSES 1301 01:19:30,400 --> 01:19:33,240 IN THE MONKEYS, YOU CAN SEE 1302 01:19:33,240 --> 01:19:39,040 THEY PROVIDE A REALLY HIGH PRO 1303 01:19:39,040 --> 01:19:39,560 CYTOKINE RESPONSE. 1304 01:19:39,560 --> 01:19:41,760 THIS WAS SOMETHING WE SAW IN 1305 01:19:41,760 --> 01:19:43,040 THE MOUSE STUDY AND THAT 1306 01:19:43,040 --> 01:19:48,000 SEEMED TO BE A CHATGPTMARK OF 1307 01:19:48,000 --> 01:19:51,400 THE LM NP WORKING AS THE 1308 01:19:51,400 --> 01:19:56,920 ANTIBODY IS COMING UP. 1309 01:19:56,920 --> 01:20:00,680 ALSO SEE IL-6 AND IL-18 DATA. 1310 01:20:00,680 --> 01:20:02,600 SO THESE ARE CRITICAL FOR 1311 01:20:02,600 --> 01:20:05,720 INDUCING THE BODIES WE'RE 1312 01:20:05,720 --> 01:20:06,400 TARGETING. 1313 01:20:06,400 --> 01:20:09,520 THE STABILITY AND ADJUTANT 1314 01:20:09,520 --> 01:20:10,840 STABILITY IS A CRITICAL ASPECT 1315 01:20:10,840 --> 01:20:11,320 TO CONSIDER. 1316 01:20:11,320 --> 01:20:13,840 SO IF YOU HAVE AN ADJUTANT 1317 01:20:13,840 --> 01:20:18,600 THAT STARTS DISRUPT THE 1318 01:20:18,600 --> 01:20:19,840 STABILITY OR CONFIRMATION, WE 1319 01:20:19,840 --> 01:20:23,360 KNOW THAT IS NOT ONE WE WANT 1320 01:20:23,360 --> 01:20:27,680 TO FOCUS ON. 1321 01:20:27,680 --> 01:20:30,760 WE HAVE TO CAREFULLY CONSIDER 1322 01:20:30,760 --> 01:20:35,200 THE STABILITY OF THE ADJUTANT. 1323 01:20:35,200 --> 01:20:39,400 WE HAVE THE ADJUVANT TARGET 1324 01:20:39,400 --> 01:20:40,000 EXPRESSION IN MODEL TELL 1325 01:20:40,000 --> 01:20:42,640 SYSTEMS NEEDED TO ENSURE 1326 01:20:42,640 --> 01:20:43,520 ADJUVANT PERFORMANCE. 1327 01:20:43,520 --> 01:20:47,240 WE ARE CURRENTLY INVESTIGATING 1328 01:20:47,240 --> 01:20:51,560 TLR7/8 AGO FIFTHS AND LIPID 1329 01:20:51,560 --> 01:20:53,160 NANOPARTICLES AS POTENT 1330 01:20:53,160 --> 01:20:53,680 ADJUVANTS IN HUMANS. 1331 01:20:53,680 --> 01:20:55,800 IT IS IMPORTANT TO TEST 1332 01:20:55,800 --> 01:20:59,320 FORMULATIONS THAT CAN BE 1333 01:20:59,320 --> 01:21:00,880 MANUFACTURED AND USED IN 1334 01:21:00,880 --> 01:21:01,440 HUMANS. 1335 01:21:01,440 --> 01:21:02,760 I WANT TO THANK THE LARGE TEAM 1336 01:21:02,760 --> 01:21:05,720 OF PEOPLE THAT WORKED ON THIS 1337 01:21:05,720 --> 01:21:11,560 INCLUDING OW PARTNERS AT AHI, 1338 01:21:11,560 --> 01:21:13,000 3M AND THE COMPANY WE WORK 1339 01:21:13,000 --> 01:21:20,000 WITH TO BE ABLE TO PRODUCE THE 1340 01:21:20,000 --> 01:21:21,440 LIPID NANOPARTICLES. 1341 01:21:21,440 --> 01:21:22,400 THE COLLABORATORS, WANT TO 1342 01:21:22,400 --> 01:21:24,800 MAKE SURE WE ACKNOWLEDGE 1343 01:21:24,800 --> 01:21:26,040 THOSE, THANK YOU. 1344 01:21:26,040 --> 01:21:28,000 >>THANK YOU, THAT WAS A GREAT 1345 01:21:28,000 --> 01:21:28,440 PRESENTATION. 1346 01:21:28,440 --> 01:21:29,400 THERE ARE A COUPLE OF 1347 01:21:29,400 --> 01:21:33,800 QUESTIONS IN THE CHAT ABOUT 1348 01:21:33,800 --> 01:21:34,520 NONNEUTRALIZING ANTIBODIES AND 1349 01:21:34,520 --> 01:21:36,720 I AM WONDERING IF YOU COULD 1350 01:21:36,720 --> 01:21:41,560 TRY TO ANSWER THOSE FROM THE 1351 01:21:41,560 --> 01:21:41,840 CHAT. 1352 01:21:41,840 --> 01:21:42,720 IF IT WILL TAKE TOO MUCH TIME 1353 01:21:42,720 --> 01:21:46,120 WE CAN MOVE ON BUT OTHERWISE 1354 01:21:46,120 --> 01:21:48,240 WE CAN COVER THOSE AT THE END. 1355 01:21:48,240 --> 01:21:50,880 SO THANK YOU SO MUCH. 1356 01:21:50,880 --> 01:21:56,720 FOR OUR SECOND TALK, SHANNON 1357 01:21:56,720 --> 01:22:00,400 MILLER, PROJECT MANAGER AT 1358 01:22:00,400 --> 01:22:03,600 IMMUNE CORP TALKING ABOUT THE 1359 01:22:03,600 --> 01:22:05,480 FORMULATION IMPACT ON VACCINE 1360 01:22:05,480 --> 01:22:06,920 PERFORMANCE. 1361 01:22:06,920 --> 01:22:07,680 THANK YOU, SHANNON. 1362 01:22:07,680 --> 01:22:10,080 >>ALL RIGHT, THANKS, 1363 01:22:10,080 --> 01:22:10,440 EVERYONE. 1364 01:22:10,440 --> 01:22:12,680 LET ME JUST GET MY SLIDES IN 1365 01:22:12,680 --> 01:22:18,160 FULL SCREEN MODE HERE. 1366 01:22:18,160 --> 01:22:18,520 >>GREAT. 1367 01:22:18,520 --> 01:22:21,920 >>SO HI, I AM SHANNON MILLER, 1368 01:22:21,920 --> 01:22:25,240 I WORK AT INIMMUNE AND THIS 1369 01:22:25,240 --> 01:22:27,720 TALK WILL BE FOCUSED ON 1370 01:22:27,720 --> 01:22:30,280 FORMULATION IMPACT ON VACCINE 1371 01:22:30,280 --> 01:22:31,080 IMMUNE RESPONSES. 1372 01:22:31,080 --> 01:22:33,280 THIS IS DONE IN COLLABORATION 1373 01:22:33,280 --> 01:22:34,400 WITH THE UNIVERSITY OF 1374 01:22:34,400 --> 01:22:34,720 MONTANA. 1375 01:22:34,720 --> 01:22:41,120 SO I THINK ONE THING THAT IS 1376 01:22:41,120 --> 01:22:43,040 SORT OF GOOD TO THINK ABOUT 1377 01:22:43,040 --> 01:22:45,720 WHEN WE THINK ABOUT THE 1378 01:22:45,720 --> 01:22:46,680 VACCINE, THE FORMULATION. 1379 01:22:46,680 --> 01:22:48,360 SO THE WAY I LIKE TO THINK 1380 01:22:48,360 --> 01:22:49,800 ABOUT THIS IS THE FORMULATION 1381 01:22:49,800 --> 01:22:51,960 IS KIND OF THE GLUE THAT HOLDS 1382 01:22:51,960 --> 01:22:53,680 THE ADJUTANT AND THE ANTIGEN 1383 01:22:53,680 --> 01:22:54,160 TOGETHER. 1384 01:22:54,160 --> 01:22:56,040 THIS CAN HAVE A LOT OF 1385 01:22:56,040 --> 01:22:58,160 DIFFERENT EFFECTS ON THE 1386 01:22:58,160 --> 01:23:01,280 IMMUNE RESPONSE THAT YOU GET 1387 01:23:01,280 --> 01:23:03,280 IN YOUR VACCINE SO 1388 01:23:03,280 --> 01:23:03,960 FORMULATIONS CAN AFFECT 1389 01:23:03,960 --> 01:23:12,280 WHETHER OR NOT ANTIGEN AND 1390 01:23:12,280 --> 01:23:14,600 ADJUVANT ARE CODELIVERRED, 1391 01:23:14,600 --> 01:23:19,200 CELLULAR UPTAKE AND 1392 01:23:19,200 --> 01:23:21,040 POST-INJECTION TRAFFICKING, 1393 01:23:21,040 --> 01:23:23,200 THE VACCINE STABILITY AND THE 1394 01:23:23,200 --> 01:23:26,080 COST AND COMPLEXITY OF 1395 01:23:26,080 --> 01:23:27,560 MANUFACTURING AND A SAFE 1396 01:23:27,560 --> 01:23:29,760 IMMUNE RESPONSE. 1397 01:23:29,760 --> 01:23:31,440 SO ONE CAVEAT I WANT TO BRING 1398 01:23:31,440 --> 01:23:34,080 UP IS THE LINE BETWEEN 1399 01:23:34,080 --> 01:23:35,760 ADJUVANT AND FORMULATION CAN 1400 01:23:35,760 --> 01:23:36,920 BE BLURRED. 1401 01:23:36,920 --> 01:23:42,560 YOU HAVE HEARD A LOT OF TALK 1402 01:23:42,560 --> 01:23:44,400 ABOUT LIPOSOMES WHICH ARE 1403 01:23:44,400 --> 01:23:46,240 ADJUVANTS THEMSELVES AND ALSO 1404 01:23:46,240 --> 01:23:49,320 FORMULATIONS SO SOME OF THE 1405 01:23:49,320 --> 01:23:50,960 FORMULATIONS THAT INDUCE 1406 01:23:50,960 --> 01:23:51,840 IMMUNE RESPONSES THEMSELVES 1407 01:23:51,840 --> 01:23:53,720 WITHOUT THE ADDITION OF AN 1408 01:23:53,720 --> 01:23:57,560 ADJUVANT AND IN THIS TALK, AN 1409 01:23:57,560 --> 01:24:00,360 ADJUTANT IS A SPECIFIC PATTERN 1410 01:24:00,360 --> 01:24:01,200 RECEPTOR AGO FIFTH. 1411 01:24:01,200 --> 01:24:03,760 SO YOU COULD CONSIDER THESE TO 1412 01:24:03,760 --> 01:24:04,720 BE COMBINATION ADJUVANTS OR 1413 01:24:04,720 --> 01:24:06,040 CONSIDER THEM TO BE 1414 01:24:06,040 --> 01:24:06,440 FORMULATION. 1415 01:24:06,440 --> 01:24:09,600 SO THAT IS KIND OF WHAT TENDS 1416 01:24:09,600 --> 01:24:15,600 TO BLUR THE LINE BETWEEN A 1417 01:24:15,600 --> 01:24:17,040 RANT AND FORMULATION. 1418 01:24:17,040 --> 01:24:19,280 OKAY, SO FOR THIS SLIDE, WE 1419 01:24:19,280 --> 01:24:23,280 WILL BE FOCUSING ON THREE 1420 01:24:23,280 --> 01:24:25,320 DIFFERENT ADJUVANTS IN 1421 01:24:25,320 --> 01:24:28,280 DEVELOPMENT AT INIMMUNE OR 1422 01:24:28,280 --> 01:24:34,480 UNIVERSITY OF MONTANA OR IN 1423 01:24:34,480 --> 01:24:36,160 COLLABORATION. 1424 01:24:36,160 --> 01:24:46,720 SO YOU HAVE HEARD ABOUT THE 3M 1425 01:24:47,560 --> 01:24:52,720 AGO FIFTH, THE TLR7/8 AND WE 1426 01:24:52,720 --> 01:24:56,840 WILL ALSO TALK ABOUT THE 1427 01:24:56,840 --> 01:24:58,040 MINUTECLE AGO FIFTH. 1428 01:24:58,040 --> 01:25:03,840 WE HAVE A LIBRARY OF MINCLE 1429 01:25:03,840 --> 01:25:09,240 ACTIVISTS AT THE UNIVERSITY OF 1430 01:25:09,240 --> 01:25:11,040 MONTANA AND CURRENTLY THAT AGO 1431 01:25:11,040 --> 01:25:15,080 FIFTH LIBRARY IS WHAT WE CALL 1432 01:25:15,080 --> 01:25:15,640 UM-1098. 1433 01:25:15,640 --> 01:25:19,840 SO WHEN WE THINK ABOUT 1434 01:25:19,840 --> 01:25:23,080 DESIGNING NEW ADJUTANTS FOR 1435 01:25:23,080 --> 01:25:26,760 VACCINES WE AT INIMMUNE AND UM 1436 01:25:26,760 --> 01:25:28,120 HAVE A SEPARATE SCIENCE GROUP 1437 01:25:28,120 --> 01:25:33,680 THAT THINKS ABOUT THESE FOR US 1438 01:25:33,680 --> 01:25:36,920 AND DAVE BURKEHART WHO IS MY 1439 01:25:36,920 --> 01:25:38,600 COLLEAGUE AT INIMMUNE WILL BE 1440 01:25:38,600 --> 01:25:40,600 GIVING A SHORT TALK LATER 1441 01:25:40,600 --> 01:25:42,760 ABOUT ADJUTANTS SO IF PEOPLE 1442 01:25:42,760 --> 01:25:44,640 WANT TO ASK TECHNICAL 1443 01:25:44,640 --> 01:25:45,920 QUESTIONS ABOUT FORMULATIONS 1444 01:25:45,920 --> 01:25:47,920 AND HOW EXACTLY THEY ARE 1445 01:25:47,920 --> 01:25:49,280 DEVELOPED AND MANUFACTURED, 1446 01:25:49,280 --> 01:25:50,680 THOSE ARE BETTER QUESTIONS FOR 1447 01:25:50,680 --> 01:25:52,480 HIM THIS. 1448 01:25:52,480 --> 01:25:53,200 BUT IMMUNE RESPONSE QUESTIONS 1449 01:25:53,200 --> 01:25:54,960 I CAN SPEAK TO. 1450 01:25:54,960 --> 01:25:57,280 SO ONE THING WE REALLY FOUND 1451 01:25:57,280 --> 01:25:59,720 WHEN WORKING WITH DIFFERENT 1452 01:25:59,720 --> 01:26:06,480 ADJUTANTS AND FORMULATIONS IS 1453 01:26:06,480 --> 01:26:11,560 THAT, AND THIS ONE IN 1454 01:26:11,560 --> 01:26:13,320 PARTICULAR, THE PATTERN 1455 01:26:13,320 --> 01:26:15,680 RESPONSE YOU WANT TO SEE. 1456 01:26:15,680 --> 01:26:19,240 IN PARTICULAR, WHEN YOU USE 1457 01:26:19,240 --> 01:26:23,640 1098 ADJUTANT FOR SAY A TUBES 1458 01:26:23,640 --> 01:26:30,400 VACCINE, IT IS VERY DEPENDENT 1459 01:26:30,400 --> 01:26:39,520 ON THE ADJUVANT. 1460 01:26:39,520 --> 01:26:50,080 WHEN YOU SEE THE IFN RESPONSE 1461 01:26:57,280 --> 01:27:01,280 AND THEN LOOKING AT THE 1462 01:27:01,280 --> 01:27:05,840 IL-17A, YOU SEE A HIGH IMMUNE 1463 01:27:05,840 --> 01:27:06,320 RESPONSE. 1464 01:27:06,320 --> 01:27:11,200 THIS SUGGESTS THERE ARE 1465 01:27:11,200 --> 01:27:14,600 CERTAIN PROPERTIES OR WAYS 1466 01:27:14,600 --> 01:27:20,120 THAT SNP IS DELIVERED FOR THE 1467 01:27:20,120 --> 01:27:21,800 ANTIGEN MAKING IT STRONG THAT 1468 01:27:21,800 --> 01:27:31,520 WE'RE NOT GETTING WITH THE 1469 01:27:31,520 --> 01:27:33,800 FORMULA -- FORMULATION. 1470 01:27:33,800 --> 01:27:35,480 YOU CAN SEE IT IS VERY STRONG 1471 01:27:35,480 --> 01:27:39,000 AND WHEN YOU LOOK AT THE OTHER 1472 01:27:39,000 --> 01:27:39,960 FORMULATION RESPONSES, THERE 1473 01:27:39,960 --> 01:27:49,160 IS NOT A LOT OF DIFFERENCE IN 1474 01:27:49,160 --> 01:27:49,640 THE RESPONSE. 1475 01:27:49,640 --> 01:27:50,080 [ GARBLED ] 1476 01:27:50,080 --> 01:27:54,600 WHEN YOU LOOK AT THE IGG 1477 01:27:54,600 --> 01:27:57,360 RESPONSES YOU START TO SEE 1478 01:27:57,360 --> 01:27:59,240 REALLY BIG RESPONSES DEPENDING 1479 01:27:59,240 --> 01:28:01,600 ON WHICH YOU CHOOSE FOR OUR 1480 01:28:01,600 --> 01:28:03,400 ANTIGEN. 1481 01:28:03,400 --> 01:28:08,440 KIND OF ALL OVER THE PLACE, IN 1482 01:28:08,440 --> 01:28:18,960 IGG1 WE SEE A STRONG IMMUNE 1483 01:28:26,040 --> 01:28:26,800 RESPONSE. 1484 01:28:26,800 --> 01:28:33,400 SO WHEN LOOKING AT IGG2C, IT 1485 01:28:33,400 --> 01:28:36,320 WAS VERY STRONG WITH 1486 01:28:36,320 --> 01:28:37,880 FORMULATION CHANGES WHERE THE 1487 01:28:37,880 --> 01:28:40,880 OTHERS WERE LESS RESPONSIVE TO 1488 01:28:40,880 --> 01:28:41,800 OUR FORMULATION CHANGES. 1489 01:28:41,800 --> 01:28:43,920 I WANT TO SWITCH GEARS A 1490 01:28:43,920 --> 01:28:51,840 LITTLE BIT AND TALK ABOUT OUR 1491 01:28:51,840 --> 01:28:53,960 I UM-1098 ADJUTANT, WE FOUND 1492 01:28:53,960 --> 01:29:04,040 IT TENDS TO PRODUCE A REALLY 1493 01:29:04,040 --> 01:29:05,800 STRONG HA AND 4001 RESPONSE. 1494 01:29:05,800 --> 01:29:10,320 SO WITH THE PURIFIED 1495 01:29:10,320 --> 01:29:19,280 INFLUENZA, YOU GET THIS NICE 1496 01:29:19,280 --> 01:29:25,680 REALLY CLEAR FORMULATION 1497 01:29:25,680 --> 01:29:28,960 SUGGESTING THE PH RESPONSE. 1498 01:29:28,960 --> 01:29:30,680 WE FOUND INCORPORATING 4001 IN 1499 01:29:30,680 --> 01:29:31,600 DIFFERENT TYPES OF SYSTEMS 1500 01:29:31,600 --> 01:29:32,920 COULD GET YOU THAT RESPONSE 1501 01:29:32,920 --> 01:29:39,600 YOU WANTED WHILE KEEPING THE 1502 01:29:39,600 --> 01:29:40,360 INDUCTION OF 4001 ITSELF. 1503 01:29:40,360 --> 01:29:43,560 SO IF YOU LOOK HERE AT THE 1504 01:29:43,560 --> 01:29:46,880 IL-5 RESPONSE, THESE LIPOSOMES 1505 01:29:46,880 --> 01:29:49,240 ARE ALL GIVING THE RESPONSE 1506 01:29:49,240 --> 01:29:52,240 WITH ANTIGEN ALONE AND WHEN 1507 01:29:52,240 --> 01:29:59,760 YOU ADD 4001 IN THE 1508 01:29:59,760 --> 01:30:01,760 FORMULATION, INSTEAD OF THE 1509 01:30:01,760 --> 01:30:05,720 FORMULATION YOU SAW WITH THE 1510 01:30:05,720 --> 01:30:09,040 NONRESPONSE, YOU MAINTAIN THE 1511 01:30:09,040 --> 01:30:14,120 IL2 RESPONSE WITH ALSO A 1512 01:30:14,120 --> 01:30:18,400 STRONG RESPONSE IN HA AND 1513 01:30:18,400 --> 01:30:19,280 4001. 1514 01:30:19,280 --> 01:30:28,960 WE ALSO USE A STRONG IL GG2A 1515 01:30:28,960 --> 01:30:35,760 RESPONSE, YOU CAN SEE THE 1516 01:30:35,760 --> 01:30:39,480 RESPONSE WITH THE FORMULATION. 1517 01:30:39,480 --> 01:30:42,240 THERE ARE ALSO REALLY 1518 01:30:42,240 --> 01:30:43,080 INTERESTING DIFFERENCES 1519 01:30:43,080 --> 01:30:43,760 BETWEEN DIFFERENT ADJUTANTS 1520 01:30:43,760 --> 01:30:45,920 AND HOW THE SAME FORMULATION 1521 01:30:45,920 --> 01:30:47,680 CAN CHANGE THE RESPONSE OF 1522 01:30:47,680 --> 01:30:48,480 THAT ADJUTANT. 1523 01:30:48,480 --> 01:30:53,920 SO IN THIS CASE, WE FOUND THAT 1524 01:30:53,920 --> 01:30:59,640 DIFFERENT HEMULSION 1525 01:30:59,640 --> 01:31:03,640 FORMULATIONS CAN ENHANCE THE 1526 01:31:03,640 --> 01:31:06,800 20,002 DRIVEN RESPONSE BUT NOT 1527 01:31:06,800 --> 01:31:14,600 THE 4001 FOR TLR7/8 SO THEY DO 1528 01:31:14,600 --> 01:31:19,080 NOT ACTIVATE THE IL-17A. 1529 01:31:19,080 --> 01:31:21,600 SO IN THIS CASE WE WERE USING 1530 01:31:21,600 --> 01:31:24,520 BOTH ANTIGENS IN COMBINATION 1531 01:31:24,520 --> 01:31:27,960 WITH THE SAME ADJUVANT AND YOU 1532 01:31:27,960 --> 01:31:32,600 CAN SEE EACH ONE, 4001 OR 2002 1533 01:31:32,600 --> 01:31:40,800 RAY LONE, KIND OF A MINIMAL 1534 01:31:40,800 --> 01:31:42,080 VARIATION, IL-17 SEEING IS 1535 01:31:42,080 --> 01:31:44,400 RESPONSE BY ITSELF AND WHEN WE 1536 01:31:44,400 --> 01:31:52,480 ADD THE ADJUTANT OR THE 1537 01:31:52,480 --> 01:31:56,160 EMULSION ANTIGEN, YOU SEE A 1538 01:31:56,160 --> 01:32:04,240 SIGNIFICANT RESPONSE TO THE 1539 01:32:04,240 --> 01:32:10,080 IMMUNITY BUT WHEN ADDING 1540 01:32:10,080 --> 01:32:15,360 EMULSION2, YOU SEE A VERY LOW 1541 01:32:15,360 --> 01:32:15,880 RESPONSE. 1542 01:32:15,880 --> 01:32:18,400 BUT WE SEE A STRONG 1543 01:32:18,400 --> 01:32:20,600 ENHANCEMENT OF THE IL-17 1544 01:32:20,600 --> 01:32:27,160 RESPONSE THAT YOU DON'T SEE 1545 01:32:27,160 --> 01:32:30,960 WITH INI-4001 SO THIS KIND OF 1546 01:32:30,960 --> 01:32:33,560 MAKES THE CASE WITH THINKING 1547 01:32:33,560 --> 01:32:35,600 ABOUT FORMULATIONS AND KINDS 1548 01:32:35,600 --> 01:32:38,400 OF ADJUVANTS IN AND OF 1549 01:32:38,400 --> 01:32:39,760 THEMSELVES BECAUSE CLEARLY, 1550 01:32:39,760 --> 01:32:42,160 SORRY, THERE IS SOME SORT OF 1551 01:32:42,160 --> 01:32:45,960 COMBINATION RESPONSE GOING ON 1552 01:32:45,960 --> 01:32:50,520 WITH THIS EMULSION AND 1553 01:32:50,520 --> 01:32:53,200 INI-2002 THAT WE DON'T SEE 1554 01:32:53,200 --> 01:32:55,360 WITH 4001. 1555 01:32:55,360 --> 01:32:56,480 SO THEN YOU CALCULATE THE 1556 01:32:56,480 --> 01:33:01,760 ENERGY GOING ON HERE THAT MAY 1557 01:33:01,760 --> 01:33:05,200 BE UNIQUE TO 2002 OR 2004 AGO 1558 01:33:05,200 --> 01:33:07,200 FIFTH IN GENERAL. 1559 01:33:07,200 --> 01:33:11,440 INTERESTINGLY, WE HAVE ALSO 1560 01:33:11,440 --> 01:33:12,160 FOUND THAT OCCASIONALLY WE 1561 01:33:12,160 --> 01:33:13,720 WILL MAKE A FORMULATION CHANGE 1562 01:33:13,720 --> 01:33:15,080 FINANCIAL OFFICER WHATEVER 1563 01:33:15,080 --> 01:33:17,480 REASON, NOT GETTING THE IMMUNE 1564 01:33:17,480 --> 01:33:20,320 RESPONSE WE WANT, DON'T GET 1565 01:33:20,320 --> 01:33:21,480 THE STABILITY OF OUR 1566 01:33:21,480 --> 01:33:23,240 FORMULATION, WE WANT TO SEE, 1567 01:33:23,240 --> 01:33:25,880 YOU KNOW, A DIFFERENT TYPE OF 1568 01:33:25,880 --> 01:33:28,800 A IMMUNE RESPONSE, SO WE'LL 1569 01:33:28,800 --> 01:33:30,480 MAKE AM ALTERATIONS TO OUR 1570 01:33:30,480 --> 01:33:32,120 FORMULATION THAT WE THINK 1571 01:33:32,120 --> 01:33:33,960 PROBABLY WON'T HAVE MUCH OF AN 1572 01:33:33,960 --> 01:33:35,640 EFFECT ON OUR IMMUNE RESPONSE 1573 01:33:35,640 --> 01:33:38,080 AND WHAT WE ARE SEEING 1574 01:33:38,080 --> 01:33:45,520 SOMETIMES IN PARTICULAR WITH 1575 01:33:45,520 --> 01:33:46,520 COMBINATION ADJUVANT 1576 01:33:46,520 --> 01:33:48,320 APPROACHES, WE WILL FIND A 1577 01:33:48,320 --> 01:33:49,960 BODY RESPONSE WITHOUT 1578 01:33:49,960 --> 01:33:51,600 AFFECTING OUR T CELL RESPONSE 1579 01:33:51,600 --> 01:33:53,360 WHICH IS REALLY INTERESTING 1580 01:33:53,360 --> 01:33:54,560 SUGGESTING THAT SOMEWHERE 1581 01:33:54,560 --> 01:33:57,440 ALONG THE LINE WE SUPPORT TO 1582 01:33:57,440 --> 01:34:00,160 AN EXTENT THE T CELL RESPONSE 1583 01:34:00,160 --> 01:34:03,480 AND ANTIBODY RESPONSE WHERE 1584 01:34:03,480 --> 01:34:05,960 YOU MIGHT TEND TO THINK THOSE 1585 01:34:05,960 --> 01:34:10,520 TWO GO TOGETHER WHEN THINKING 1586 01:34:10,520 --> 01:34:12,760 ABOUT ANTIBODY RESPONSES AND 1587 01:34:12,760 --> 01:34:14,880 CYTOKINE PRODUCTION FROM T 1588 01:34:14,880 --> 01:34:15,200 CELLS. 1589 01:34:15,200 --> 01:34:21,480 SO IN THIS CASE WHAT WE'RE 1590 01:34:21,480 --> 01:34:27,360 LOOKING AT IS THE SYNTHETIC 1591 01:34:27,360 --> 01:34:30,400 ADJUVANT SYSTEM, OUR 2002 WITH 1592 01:34:30,400 --> 01:34:33,320 SAPONIN SO WE ARE LOOKING AT A 1593 01:34:33,320 --> 01:34:36,440 DIFFERENT ANTIGEN THAN WE WERE 1594 01:34:36,440 --> 01:34:47,040 LOOKING AT BEFORE, WHICH IS A 1595 01:34:48,680 --> 01:34:51,600 DETERGENT-SPLIT VACCINE AND 1596 01:34:51,600 --> 01:34:55,960 THIS IS MON OVALENT. 1597 01:34:55,960 --> 01:34:59,960 SO WHEN WE MIX THE ADJUVANT 1598 01:34:59,960 --> 01:35:03,640 WITH THE ANTIGEN, YOU CAN SEE 1599 01:35:03,640 --> 01:35:10,040 WE ARE STARTING TO RESPOND IN 1600 01:35:10,040 --> 01:35:18,840 THE IGG2A ANTIBODY TITERS 1601 01:35:18,840 --> 01:35:24,040 WHERE IGG1 IS CONSISTENT. 1602 01:35:24,040 --> 01:35:32,600 THEN ADDING THE ANTIINFLUENZA 1603 01:35:32,600 --> 01:35:36,320 TITER, YOU DON'T SEE WHAT YOU 1604 01:35:36,320 --> 01:35:38,640 WOULD EXPECT IN THE T CELL 1605 01:35:38,640 --> 01:35:47,520 RESPONSE HERE WHEN WE CHANGE 1606 01:35:47,520 --> 01:35:49,360 THE LIPOSOMAL RESPONSE AND WE 1607 01:35:49,360 --> 01:35:58,000 CURRENTLY DON'T SEE ANY 1608 01:35:58,000 --> 01:36:02,520 CHANGES IN OUR R2H2 WITH 1609 01:36:02,520 --> 01:36:03,040 ANTIBODY PRODUCTION. 1610 01:36:03,040 --> 01:36:07,280 SO I KNOW THIS TALK WAS 1611 01:36:07,280 --> 01:36:11,080 FOCUSED ON ADJUTANT TESTING OR 1612 01:36:11,080 --> 01:36:13,000 IS THERE ANY KIND OF 1613 01:36:13,000 --> 01:36:15,320 MODIFICATION WE CAN DO. 1614 01:36:15,320 --> 01:36:18,440 IN OUR HANDS, HAVING WORKED 1615 01:36:18,440 --> 01:36:21,360 WITH MANY, MANY DIFFERENT 1616 01:36:21,360 --> 01:36:22,760 ADJUVANTS, ANTIGENS AND 1617 01:36:22,760 --> 01:36:23,880 DIFFERENT FORMULATIONS, IT 1618 01:36:23,880 --> 01:36:25,160 TURNS OUT IT IS KIND OF A 1619 01:36:25,160 --> 01:36:27,720 COMBINATION OF THE TWO. 1620 01:36:27,720 --> 01:36:30,240 SO ADJUTANTS TEND TO HAVE 1621 01:36:30,240 --> 01:36:32,440 SPECIFIC PROPERTIES, RIGHT? 1622 01:36:32,440 --> 01:36:35,480 ESPECIALLY IF THEIR PATTERN 1623 01:36:35,480 --> 01:36:37,040 RECOGNITION AGO FIFTH, WOULD 1624 01:36:37,040 --> 01:36:39,560 HE KNOW WHAT TARGET THEY ARE 1625 01:36:39,560 --> 01:36:40,960 PREDICTING AND THE RESPONSE WE 1626 01:36:40,960 --> 01:36:42,360 CAN EXPECT. 1627 01:36:42,360 --> 01:36:46,800 THE SAME IS TRUE FOR ADJUVANT 1628 01:36:46,800 --> 01:36:48,760 FORMULATIONS OR FOR SOME 1629 01:36:48,760 --> 01:36:49,400 ORGANIZATIONS. 1630 01:36:49,400 --> 01:36:52,160 OBVIOUSLY WE HAVE NOT YET 1631 01:36:52,160 --> 01:36:55,120 EXPLORED THE FULL SORT OF 1632 01:36:55,120 --> 01:36:56,720 REPERTOIRE OF ALL FORMULATIONS 1633 01:36:56,720 --> 01:37:00,480 THAT COULD EVER BE USED BUT WE 1634 01:37:00,480 --> 01:37:02,240 DO KNOW SOME THINGS. 1635 01:37:02,240 --> 01:37:04,600 SO FOR EXAMPLE, THERE'S QUITE 1636 01:37:04,600 --> 01:37:07,120 A FEW PUBLICATIONS THAT TELL 1637 01:37:07,120 --> 01:37:10,160 US A CODELIVERY OF ADJUTANT 1638 01:37:10,160 --> 01:37:12,000 AND ANTIGEN ARE PRETTY 1639 01:37:12,000 --> 01:37:15,360 IMPORTANT ESPECIALLY FOR T 1640 01:37:15,360 --> 01:37:17,000 CELL RESPONSES, PH 1 AND T 1641 01:37:17,000 --> 01:37:18,720 CELL RESPONSES IN PARTICULAR. 1642 01:37:18,720 --> 01:37:20,480 THERE ARE ALSO PUBLICATIONS 1643 01:37:20,480 --> 01:37:23,920 OUT THERE TELLING US ABOUT HOW 1644 01:37:23,920 --> 01:37:25,560 FORMULATIONS, WHEN YOU USE A 1645 01:37:25,560 --> 01:37:28,520 FORMULATION IN A SACKS 1646 01:37:28,520 --> 01:37:32,640 VACCINE, YOU TYPICALLY GET A 1647 01:37:32,640 --> 01:37:34,880 PRETTY UNIFORM CLINICAL SIZE 1648 01:37:34,880 --> 01:37:45,440 CHARGE, SHAPE, FOR A PROPERTY 1649 01:37:48,200 --> 01:37:49,280 CALLED FPHOSPHORUS AND THESE 1650 01:37:49,280 --> 01:37:51,840 OVER TIME CAN BE PREDICTED 1651 01:37:51,840 --> 01:37:53,600 ALTHOUGH NOT ALWAYS BECAUSE AS 1652 01:37:53,600 --> 01:37:56,640 WE ALSO HEARD OR SAW, WHEN WE 1653 01:37:56,640 --> 01:37:59,040 ADD THE ANTIGEN OR CHANGE THE 1654 01:37:59,040 --> 01:38:00,280 ANTIGEN, ALL OF THESE 1655 01:38:00,280 --> 01:38:02,080 PROPERTIES CAN THEN CHANGE. 1656 01:38:02,080 --> 01:38:07,640 THE COMBINATION OF ADJUTANT 1657 01:38:07,640 --> 01:38:09,480 AND FORMULATION EXCIPIENS CAN 1658 01:38:09,480 --> 01:38:11,120 RESULT IN UNEXPECTED IMMUNE 1659 01:38:11,120 --> 01:38:16,160 RESPONSES WHICH WE SAW IN THE 1660 01:38:16,160 --> 01:38:17,960 2002 AND ILG17 RESPONSE. 1661 01:38:17,960 --> 01:38:20,240 ANOTHER IMPORTANT THING TO 1662 01:38:20,240 --> 01:38:24,280 MENTION IS SPECIES 1663 01:38:24,280 --> 01:38:24,720 SPECIFICITY. 1664 01:38:24,720 --> 01:38:25,880 SO WILL THOSE RESPONSES MEAN 1665 01:38:25,880 --> 01:38:27,520 ANYTHING DOWN THE LINE WHEN WE 1666 01:38:27,520 --> 01:38:29,160 TRY TO LOOK AT HUMAN 1667 01:38:29,160 --> 01:38:29,800 RESPONSES? 1668 01:38:29,800 --> 01:38:31,240 WHAT WE FOUND IS THAT SIMILAR 1669 01:38:31,240 --> 01:38:33,840 RESPONSES IN A NUMBER OF 1670 01:38:33,840 --> 01:38:35,360 ANIMAL MODELS CAN INCREASE THE 1671 01:38:35,360 --> 01:38:40,080 CONFIDENCE THAT ALL OF THESE 1672 01:38:40,080 --> 01:38:41,880 DATA WILL TRANSLATE TO HUMANS. 1673 01:38:41,880 --> 01:38:46,400 SO WITH THAT, I WOULD LIKE TO 1674 01:38:46,400 --> 01:38:49,880 THANK EVERYONE AT INIMMUNE AND 1675 01:38:49,880 --> 01:38:51,160 UNIVERSITY OF MONTANA. 1676 01:38:51,160 --> 01:38:55,200 MY COLLEAGUE IS GIVING A TALK 1677 01:38:55,200 --> 01:38:57,800 LATER AND LEADS THE 1678 01:38:57,800 --> 01:39:00,040 FORMULATION GROUP WITH 1679 01:39:00,040 --> 01:39:01,280 SPECIFIC TECHNICAL QUESTIONS 1680 01:39:01,280 --> 01:39:03,400 ABOUT THAT SHOULD BE DIRECTED 1681 01:39:03,400 --> 01:39:03,760 AT HIM. 1682 01:39:03,760 --> 01:39:04,600 THANKS AND I WILL ANSWER 1683 01:39:04,600 --> 01:39:06,320 QUESTIONS IF WE HAVE TIME. 1684 01:39:06,320 --> 01:39:09,720 >>THANK YOU, YEAH, UP 1685 01:39:09,720 --> 01:39:12,480 FORTUNATELY WE DON'T BUT WE 1686 01:39:12,480 --> 01:39:13,240 DEFINITELY AGREE FORMULATIONS 1687 01:39:13,240 --> 01:39:17,280 ARE THE MOST IMPORTANT THING. 1688 01:39:17,280 --> 01:39:18,200 [LAUGHTER] 1689 01:39:18,200 --> 01:39:18,680 [INDISCERNIBLE] 1690 01:39:18,680 --> 01:39:19,240 [OVERLAPPING SPEAKERS] 1691 01:39:19,240 --> 01:39:21,840 >>AND WE WILL SAVE THE 1692 01:39:21,840 --> 01:39:26,080 QUESTIONS FOR YOU FOR PANEL 1693 01:39:26,080 --> 01:39:27,920 DISCUSSION. 1694 01:39:27,920 --> 01:39:30,240 AND NOW WE WILL BRING IN THE 1695 01:39:30,240 --> 01:39:33,200 NEXT TWO SPEAKERS. 1696 01:39:33,200 --> 01:39:36,280 >>ABSOLUTELY, THANK YOU, ANA. 1697 01:39:36,280 --> 01:39:42,560 WE WILL INTRODUCE 1698 01:39:42,560 --> 01:39:43,480 JOSPHAT KOSGEI AS PRINCIPLE 1699 01:39:43,480 --> 01:39:45,960 INVESTIGATORS WITH THE U.S. 1700 01:39:45,960 --> 01:39:47,920 ARMY MEDICAL RESEARCH UNIT IN 1701 01:39:47,920 --> 01:39:50,440 KENYA AND HE WILL BE TALKING 1702 01:39:50,440 --> 01:39:53,960 ABOUT ADJUVANT PERFORMANCE IN 1703 01:39:53,960 --> 01:39:56,920 TARGET POPULATIONS, RV 460 HIV 1704 01:39:56,920 --> 01:39:58,760 VACCINE TRIAL IN KENNA I 1705 01:39:58,760 --> 01:39:59,040 CAN'T. 1706 01:39:59,040 --> 01:40:00,760 >>THANK YOU VERY MUCH, GOOD 1707 01:40:00,760 --> 01:40:02,480 MORNING AND EVENING AS WELL, I 1708 01:40:02,480 --> 01:40:04,520 BELIEVE YOU CAN HEAR ME? 1709 01:40:04,520 --> 01:40:10,840 >>WE CAN HEAR YOU WELL. 1710 01:40:10,840 --> 01:40:11,240 >>THANKS. 1711 01:40:11,240 --> 01:40:13,200 OKAY, IS THIS IN PRESENTATION 1712 01:40:13,200 --> 01:40:13,760 MODE? 1713 01:40:13,760 --> 01:40:15,440 >>THAT LOOKS PERFECT AND YOU 1714 01:40:15,440 --> 01:40:17,400 SOUND PERFECT, GO AHEAD. 1715 01:40:17,400 --> 01:40:26,400 >>OKAY, THANKS FOR THE 1716 01:40:26,400 --> 01:40:29,160 ABILITY TO TALK TO YOU ABOUT 1717 01:40:29,160 --> 01:40:39,760 ADJUVANT PERFORMANCE IN TARGET 1718 01:41:04,800 --> 01:41:05,960 POPULATIONS IN KENYA. 1719 01:41:05,960 --> 01:41:12,080 SO THIS STUDY INITIATED IN 1720 01:41:12,080 --> 01:41:14,960 MARCH 2021 WITH THE PRIMARY 1721 01:41:14,960 --> 01:41:25,120 OBJECTIVE TO ASSESS SAFETY, 1722 01:41:25,120 --> 01:41:25,800 REACTOGENICITY AND 1723 01:41:25,800 --> 01:41:29,880 TOLERABILITY OF THE VARIOUS 1724 01:41:29,880 --> 01:41:37,000 ADJUVANT FORMULATIONS WITH 1725 01:41:37,000 --> 01:41:44,560 BOTH HIV ENV PLAS MID DNA AND 1726 01:41:44,560 --> 01:41:45,560 GP145. 1727 01:41:45,560 --> 01:41:46,720 THE SECOND SECONDARY 1728 01:41:46,720 --> 01:41:50,200 OBJECTIVES ARE TO DETERMINE 1729 01:41:50,200 --> 01:41:57,800 WHETHER THE ADJUVANTS IMPROVE 1730 01:41:57,800 --> 01:42:01,440 THE IMMOONOGENICITY OF DNA 1731 01:42:01,440 --> 01:42:06,480 PRIMING, DETERMINE WHETHER THE 1732 01:42:06,480 --> 01:42:12,520 ADDITION OF ALF43 PROTEIN 1733 01:42:12,520 --> 01:42:15,960 BOOSTS FURTHER OR IMPROVES 1734 01:42:15,960 --> 01:42:19,880 IMMUNE RESPONSE TO GP145 AND 1735 01:42:19,880 --> 01:42:24,840 DETERMINE WHETHER ADJUVANTS 1736 01:42:24,840 --> 01:42:27,040 IMPROVE HUMORAL RESPONSES. 1737 01:42:27,040 --> 01:42:30,480 EVALUATE THE INFLUENCE OF 1738 01:42:30,480 --> 01:42:35,880 ADJUVANT AND CAN IT IMPROVE 1739 01:42:35,880 --> 01:42:38,000 DNA PRIMING AND FURTHER 1740 01:42:38,000 --> 01:42:39,400 IMPROVE PROTEIN BOOSTING. 1741 01:42:39,400 --> 01:42:49,960 AT THIS TIME, WE LOOK AT THE 1742 01:43:01,640 --> 01:43:08,600 ENV-CPLASMID DNA AND COMPARE 1743 01:43:08,600 --> 01:43:16,000 WITH GP145 AND HERE YOU SEE A 1744 01:43:16,000 --> 01:43:18,680 MICRO GRAM WITH THE IMGENUINE 1745 01:43:18,680 --> 01:43:29,160 AND OF COURSE THE OTHER 1746 01:43:41,800 --> 01:43:45,960 AVAILABLE ADJUVANTS AVAILABLE. 1747 01:43:45,960 --> 01:43:50,520 [INDISCERNIBLE] 1748 01:43:50,520 --> 01:43:53,840 SO THE TRIALS INTRODUCED, I 1749 01:43:53,840 --> 01:44:01,320 THINK ON THIS ONE, IT WAS NOT 1750 01:44:01,320 --> 01:44:09,040 POSSIBLE ON DNA ALONE, THEN WE 1751 01:44:09,040 --> 01:44:11,520 USE REHYDRAGEL AS THE PLACEBO. 1752 01:44:11,520 --> 01:44:22,120 AND THIS ONE HERE, WE HAVE THE 1753 01:44:23,240 --> 01:44:33,680 THREE IN THERE AND THEN FOR 1754 01:44:36,400 --> 01:44:43,440 THE BOOSTER, THE REHYDRAGEL 1755 01:44:43,440 --> 01:44:49,880 ALONE OR THESE TWO OR THREES 1756 01:44:49,880 --> 01:44:53,880 THREE AND THE TRANSMISSION WAS 1757 01:44:53,880 --> 01:44:55,120 THE SAME. 1758 01:44:55,120 --> 01:45:05,600 FOR THIS, WE HAVE THE 1759 01:45:12,120 --> 01:45:17,680 COMBINATION SO WE HAVE THREE 1760 01:45:17,680 --> 01:45:26,360 OVER TIME AND FOLLOWED THE 1761 01:45:26,360 --> 01:45:27,680 PARTICIPANTS FOR 108 WEEKS, 1762 01:45:27,680 --> 01:45:30,040 105 WEEKS OF CLINIC VISITS AND 1763 01:45:30,040 --> 01:45:31,920 THEN CONTACTED BY PHONE ONCE 1764 01:45:31,920 --> 01:45:33,560 WEEKLY FOR ADDITIONAL THREE 1765 01:45:33,560 --> 01:45:43,800 WEEKS TO INQUIRE ABOUT 1766 01:45:43,800 --> 01:45:46,960 MEDICALLY ATTENDEDS. 1767 01:45:46,960 --> 01:45:56,400 SO WE LOOK AT THE OPTIONAL 1768 01:45:56,400 --> 01:45:58,040 PROCEDURES, INGUINAL LYMPH 1769 01:45:58,040 --> 01:45:58,760 NODE. 1770 01:45:58,760 --> 01:46:03,200 SO FOR SCREENING AND 1771 01:46:03,200 --> 01:46:13,760 ENROLLMENT, WE LOOK AT THE 1772 01:46:13,760 --> 01:46:17,920 MALE AND FEMALE, MEDIAN AGE OF 1773 01:46:17,920 --> 01:46:25,800 30 YEARS, MOST OF THEM WERE 1774 01:46:25,800 --> 01:46:32,160 FEMALE, AND MOST WERE SINGLE, 1775 01:46:32,160 --> 01:46:34,720 NEVER MARRIED AND OCCUPATION 1776 01:46:34,720 --> 01:46:40,200 RANGED BY LARGEST WAS FARMER. 1777 01:46:40,200 --> 01:46:43,360 SO WE LOOKED AT THIS IN THE 1778 01:46:43,360 --> 01:46:48,000 POPULATION AND ALL VACCINES 1779 01:46:48,000 --> 01:46:51,160 WERE COMPLETED SO NOW IN 1780 01:46:51,160 --> 01:46:55,800 CLINICAL FOLLOW UP VISITS 1781 01:46:55,800 --> 01:46:58,360 CONCLUDING IN JANUARY 2024 1782 01:46:58,360 --> 01:47:08,600 NEXT YEAR. 1783 01:47:09,800 --> 01:47:15,400 SO THE SYMPTOMS OF THE PRIME 1784 01:47:15,400 --> 01:47:20,280 AND BOOST VACCINES INCLUDE 1785 01:47:20,280 --> 01:47:30,880 PAIN AND TENDERNESS, SWELLING 1786 01:47:31,440 --> 01:47:38,480 AND INDURATION, REACTION AT 1787 01:47:38,480 --> 01:47:41,280 THE SITE. 1788 01:47:41,280 --> 01:47:43,960 SO THESE ARE WHAT WAS REPORTED 1789 01:47:43,960 --> 01:47:46,160 AND NEARLY HALF OF THE 1790 01:47:46,160 --> 01:47:48,440 PARTICIPANTS DID NOT RECEIVE 1791 01:47:48,440 --> 01:47:50,600 ANY SYSTEMIC REACTION. 1792 01:47:50,600 --> 01:47:54,680 SO IF GENERAL, THIS PROTOTYPE 1793 01:47:54,680 --> 01:48:01,600 HAS BEEN WELL TOLERATED. 1794 01:48:01,600 --> 01:48:07,960 THERE IS NO REACTOGENICITY AND 1795 01:48:07,960 --> 01:48:09,680 TOLLABILITY OF VACCINE HAS 1796 01:48:09,680 --> 01:48:12,120 BEEN EXCELLENT, THERE WAS NO 1797 01:48:12,120 --> 01:48:13,520 SEVERE OR LIFE-THREATENING 1798 01:48:13,520 --> 01:48:20,960 LOCAL INJECTION OR SYSTEMIC 1799 01:48:20,960 --> 01:48:26,320 REACTIONS, THERE WAS ONE 1800 01:48:26,320 --> 01:48:29,200 SERIOUS ADVERSE EVENT FOR NEW 1801 01:48:29,200 --> 01:48:34,480 ONSET TYPE 1 DIABETES IN A 1802 01:48:34,480 --> 01:48:35,520 23-YEAR-OLD FEMALE THAT WAS 1803 01:48:35,520 --> 01:48:43,560 UNRELATED TO THE STUDY AND TWO 1804 01:48:43,560 --> 01:48:46,240 POTENTIALLY REACTIONS. 1805 01:48:46,240 --> 01:48:52,960 SO WE FOCUS ON DNA PRIME 1806 01:48:52,960 --> 01:49:01,360 VACCINATIONS WITH DNA ALONE, 1807 01:49:01,360 --> 01:49:04,240 ADDING DMLT, ALF43 AND THEN 1808 01:49:04,240 --> 01:49:04,640 USING BOTH. 1809 01:49:04,640 --> 01:49:07,560 AS YOU CAN SEE THE RESPONSES, 1810 01:49:07,560 --> 01:49:14,080 THERE WAS SIGNIFICANTLY HIGHER 1811 01:49:14,080 --> 01:49:18,720 RESPONSE RELATED TO THE DMLT 1812 01:49:18,720 --> 01:49:29,280 AND THE PROTEIN AS SEEN HERE. 1813 01:49:34,760 --> 01:49:45,040 AND THEN ADDING THE GP145 1814 01:49:45,040 --> 01:49:52,440 PROTEIN, YOU CAN SEE THE 1815 01:49:52,440 --> 01:49:52,800 RESPONSE. 1816 01:49:52,800 --> 01:49:56,520 SO YOU CAN SEE IN GROUPS 6 AND 1817 01:49:56,520 --> 01:50:00,040 GROUP 7 THERE WAS HIGHER 1818 01:50:00,040 --> 01:50:00,560 RESPONSES. 1819 01:50:00,560 --> 01:50:07,000 SO IN GENERAL, THIS IS TO SAY 1820 01:50:07,000 --> 01:50:11,480 THAT THE RESPONSES TO DMLT AND 1821 01:50:11,480 --> 01:50:21,000 THIS IS THE VISIT AFTER THE 1822 01:50:21,000 --> 01:50:27,200 PRIME BOOST IN 30 PERCENT OF 1823 01:50:27,200 --> 01:50:28,160 PARTICIPANTS. 1824 01:50:28,160 --> 01:50:34,160 AND IN GROUP 7, THESE PEOPLE 1825 01:50:34,160 --> 01:50:38,200 INCLUDE THE HIGHEST ANTIBODY 1826 01:50:38,200 --> 01:50:40,280 BINDING RESPONSES. 1827 01:50:40,280 --> 01:50:43,840 GROUPS 5 THROUGH 7 ALSO 1828 01:50:43,840 --> 01:50:53,520 BETWEEN RATED HIGHER, 1829 01:50:53,520 --> 01:50:57,120 CROSS-CLADE ANTIBODY RESPONSES 1830 01:50:57,120 --> 01:50:59,240 AGAINST GP140 HIV ANTIGENS 1831 01:50:59,240 --> 01:51:03,080 COMPARED TO GROUPS THAT 1832 01:51:03,080 --> 01:51:03,640 RECEIVED DNA ALONE. 1833 01:51:03,640 --> 01:51:07,600 AND ALSO HERE THE 1834 01:51:07,600 --> 01:51:11,880 COADMINISTRATION OF LIPOSOMAL 1835 01:51:11,880 --> 01:51:17,640 ADJUVANT ALF43 ALONG WITH 1836 01:51:17,640 --> 01:51:21,240 HIV-1 DNA VACCINE IMPROVED 1837 01:51:21,240 --> 01:51:25,800 BINDING RESPONSES AGAINST 1838 01:51:25,800 --> 01:51:26,080 HIV-1. 1839 01:51:26,080 --> 01:51:29,280 SO YEAH, THAT IS THE WORK WE 1840 01:51:29,280 --> 01:51:29,920 ARE CURRENTLY DOING. 1841 01:51:29,920 --> 01:51:35,640 IT IS A WORK IN PROGRESS AND I 1842 01:51:35,640 --> 01:51:37,760 WILL FOLLOW UP IF THERE ARE 1843 01:51:37,760 --> 01:51:38,160 ANY QUESTIONS. 1844 01:51:38,160 --> 01:51:41,360 THANK YOU VERY MUCH. 1845 01:51:41,360 --> 01:51:49,160 >>THANK YOU VERY MUCH, 1846 01:51:49,160 --> 01:51:49,600 JOSPHAN KOSGEI. 1847 01:51:49,600 --> 01:51:50,840 FASCINATING STUDY AND I LOOK 1848 01:51:50,840 --> 01:51:52,240 FORWARD TO SEEING THE FINAL 1849 01:51:52,240 --> 01:51:53,320 RESULTS OF THE DATA. 1850 01:51:53,320 --> 01:52:02,120 SO WE WILL MOVE TO THE NEXT 1851 01:52:02,120 --> 01:52:04,920 PRESENTATION BY MARION GRUBER 1852 01:52:04,920 --> 01:52:06,000 WHO IS VICE-PRESIDENT OF 1853 01:52:06,000 --> 01:52:09,120 PUBLIC HEALTH AND REGULATORY 1854 01:52:09,120 --> 01:52:12,480 SCIENCE WITH THE INTERNATIONAL 1855 01:52:12,480 --> 01:52:14,000 AIDS VACCINE INITIATIVE AND 1856 01:52:14,000 --> 01:52:15,520 WILL DISCUSS REGULATORY 1857 01:52:15,520 --> 01:52:17,080 CONSIDERATIONS FOR ADJUVANTS. 1858 01:52:17,080 --> 01:52:17,840 TAKE IT AWAY. 1859 01:52:17,840 --> 01:52:28,240 YOU ARE STILL MUTED. 1860 01:52:28,640 --> 01:52:29,800 >>OKAY, CAN SEE THE 1861 01:52:29,800 --> 01:52:30,360 PRESENTATION? 1862 01:52:30,360 --> 01:52:32,880 >>WE CAN HEAR YOU AND SEE 1863 01:52:32,880 --> 01:52:34,080 YOUR PRESENTATION PERFECTLY, 1864 01:52:34,080 --> 01:52:35,600 GO AHEAD. 1865 01:52:35,600 --> 01:52:36,040 >>VERY GOOD. 1866 01:52:36,040 --> 01:52:38,840 YEAH, THANK YOU VERY MUCH FOR 1867 01:52:38,840 --> 01:52:39,800 THE INTRODUCTION. 1868 01:52:39,800 --> 01:52:43,720 I WAS ASKED TO GIVE THE 1869 01:52:43,720 --> 01:52:48,480 REGULATORY CONSIDERATIONS 1870 01:52:48,480 --> 01:52:54,520 REGARDING FORMULATING VACCINES 1871 01:52:54,520 --> 01:52:57,240 WITH AIDS VACCINE AND THESE 1872 01:52:57,240 --> 01:53:04,160 HAVE BEEN CREATED USING TWO 1873 01:53:04,160 --> 01:53:05,680 SPECIFIC ADJUVANTS TO DEVELOP 1874 01:53:05,680 --> 01:53:10,440 THE IMMUNE RESPONSE TO VACCINE 1875 01:53:10,440 --> 01:53:12,720 ANTIGENS. 1876 01:53:12,720 --> 01:53:17,720 AND THESE ANTIGENS MAY REQUIRE 1877 01:53:17,720 --> 01:53:20,040 THE PRESENCE OF ADJUVANTS TO 1878 01:53:20,040 --> 01:53:23,640 ENHANCE THE IMMUNE RESPONSE TO 1879 01:53:23,640 --> 01:53:27,520 VACCINE ANTIGENS, REDUCE 1880 01:53:27,520 --> 01:53:29,720 DOSING FREQUENCY, INDUCE 1881 01:53:29,720 --> 01:53:32,440 CROSS-PROTECTIVE INFECTION AND 1882 01:53:32,440 --> 01:53:35,840 DIRECT THE IMMUNE RESPONSE AND 1883 01:53:35,840 --> 01:53:38,400 OR ACHIEVE ANTIGEN SPARING. 1884 01:53:38,400 --> 01:53:40,000 LIKE FOR EXAMPLE THE VACCINES 1885 01:53:40,000 --> 01:53:41,640 IN UNITED STATES AND EUROPE 1886 01:53:41,640 --> 01:53:47,960 THAT CONTAINS ALL THE 1887 01:53:47,960 --> 01:53:49,480 ADJUVANTS AND IN THE INTEREST 1888 01:53:49,480 --> 01:53:53,560 OF TIME, I WILL NOT WALK 1889 01:53:53,560 --> 01:53:56,320 THROUGH EACH OF THESE BUT THIS 1890 01:53:56,320 --> 01:53:58,840 SLIDE SHOWS THE EXAMPLES. 1891 01:53:58,840 --> 01:54:06,120 SO TO MAKE A A LONG STORY 1892 01:54:06,120 --> 01:54:07,960 SHORT, THE ADJUVANTED VACCINES 1893 01:54:07,960 --> 01:54:09,560 DEVELOPMENT STRATEGY, IT IS 1894 01:54:09,560 --> 01:54:12,480 NOT ANY DIFFERENT THAN FOR 1895 01:54:12,480 --> 01:54:15,880 VACCINES THAT WERE NOT 1896 01:54:15,880 --> 01:54:17,000 FORMULATED AND THERE ARE SOME 1897 01:54:17,000 --> 01:54:18,120 CONSIDERATIONS I WILL BE 1898 01:54:18,120 --> 01:54:20,320 DISCUSSING IN A COUPLE OF 1899 01:54:20,320 --> 01:54:20,720 MINUTES. 1900 01:54:20,720 --> 01:54:25,720 SO BASICALLY, AND THIS IS VERY 1901 01:54:25,720 --> 01:54:28,240 HIGH LEVEL, THE DATA TO 1902 01:54:28,240 --> 01:54:31,400 SUPPORT THE CLINICAL STUDIES 1903 01:54:31,400 --> 01:54:40,600 AND FOR THE VACCINE, YOU 1904 01:54:40,600 --> 01:54:44,120 CONDUCT THE PLAN AND TEST THE 1905 01:54:44,120 --> 01:54:48,000 SAFETY OF THE PRODUCT. 1906 01:54:48,000 --> 01:54:51,040 OF COURSE THE GOAL IS TO HAVE 1907 01:54:51,040 --> 01:54:53,920 A SAFE EFFECTIVE HIGH QUALITY 1908 01:54:53,920 --> 01:54:55,520 PRODUCT OF KNOWN STABILITY 1909 01:54:55,520 --> 01:54:59,040 THAT CAN BE CONSISTENTLY 1910 01:54:59,040 --> 01:54:59,480 MANUFACTURED. 1911 01:54:59,480 --> 01:55:01,600 SO THAT IS NO DIFFERENT FROM 1912 01:55:01,600 --> 01:55:03,880 OTHER VACCINES THAT DO NOT 1913 01:55:03,880 --> 01:55:04,640 CONTAIN ADJUVANTS. 1914 01:55:04,640 --> 01:55:08,120 WHY CAN I NOT -- I'M SORRY. 1915 01:55:08,120 --> 01:55:18,680 OKAY, I MENTIONED SOME SPECIAL 1916 01:55:21,480 --> 01:55:25,200 CONSIDERATIONS SO ADJUVANTS 1917 01:55:25,200 --> 01:55:26,160 REQUIRE SPECIAL 1918 01:55:26,160 --> 01:55:28,320 CONSIDERATIONS, AND CAN 1919 01:55:28,320 --> 01:55:29,320 INCLUDE COMBINATIONS OF 1920 01:55:29,320 --> 01:55:34,560 SUBSTANCES USED IN CONJUNCTION 1921 01:55:34,560 --> 01:55:38,920 TO VACCINE ANTIGEN TO ENHANCE 1922 01:55:38,920 --> 01:55:39,400 VACCINE RESPONSE. 1923 01:55:39,400 --> 01:55:42,800 THEY EXHIBIT A RANGE OF 1924 01:55:42,800 --> 01:55:44,600 PROPERTIES THAT INVOKE COMPLEX 1925 01:55:44,600 --> 01:55:46,160 IMMUNE RESPONSE AND WHAT WE 1926 01:55:46,160 --> 01:55:50,040 HEARD EARLIER THIS MORNING IS 1927 01:55:50,040 --> 01:55:50,720 THAT ANIMAL MODELS THAT 1928 01:55:50,720 --> 01:55:56,120 PREDICT SAFETY AND EFFICACY OF 1929 01:55:56,120 --> 01:55:57,240 ADJUVANT-ANTIGEN COMBINATIONS 1930 01:55:57,240 --> 01:56:02,440 ARE NOT ALWAYS AVAILABLE. 1931 01:56:02,440 --> 01:56:07,600 SO TO HELP THE VACCINE 1932 01:56:07,600 --> 01:56:18,120 DEVELOPER OUT, THERE ARE A 1933 01:56:21,120 --> 01:56:23,120 NUMBER OF EVALUATIONS AND THIS 1934 01:56:23,120 --> 01:56:27,800 ONE IS CALLED FRAMEWORK FOR 1935 01:56:27,800 --> 01:56:30,600 ASSESSMENT OF ADJUVANTED 1936 01:56:30,600 --> 01:56:31,720 VACCINES. 1937 01:56:31,720 --> 01:56:33,640 AND THIS GUIDELINE IS BY 1938 01:56:33,640 --> 01:56:35,120 NATIONAL REGULATORY AUTHORITY 1939 01:56:35,120 --> 01:56:37,080 INCLUDING FDA AND EMA. 1940 01:56:37,080 --> 01:56:41,160 AND WHEN I WAS AT FDA, THIS 1941 01:56:41,160 --> 01:56:43,600 WAS PART OF THE GUIDE 1942 01:56:43,600 --> 01:56:45,520 SUPPLEMENT. 1943 01:56:45,520 --> 01:56:56,080 SO IN SHORT, IT DESCRIBES THE 1944 01:56:57,440 --> 01:56:58,000 QUALITY, PHARMACOLOGICAL, 1945 01:56:58,000 --> 01:56:58,720 TOXICOLOGICAL AND OTHER 1946 01:56:58,720 --> 01:57:00,480 INFORMATION NEEDED TO SUPPORT 1947 01:57:00,480 --> 01:57:03,160 THE INITIATION OF CLINICAL 1948 01:57:03,160 --> 01:57:05,040 TRIALS WITH THE VACCINE 1949 01:57:05,040 --> 01:57:08,040 COMBINED WITH A NOVEL 1950 01:57:08,040 --> 01:57:09,160 ADJUVANT. 1951 01:57:09,160 --> 01:57:12,560 IT PROVIDES CONSISTENT AND 1952 01:57:12,560 --> 01:57:15,040 HARMONIZED GUIDANCE ON 1953 01:57:15,040 --> 01:57:16,560 NONCLINICAL TESTING APPROACHES 1954 01:57:16,560 --> 01:57:20,200 TO SUPPORT USE OF CANDIDATE 1955 01:57:20,200 --> 01:57:23,160 ADJUVANTED VACCINES IN ALL 1956 01:57:23,160 --> 01:57:25,360 STINGS OF CLINICAL DEVELOPMENT 1957 01:57:25,360 --> 01:57:29,280 AND DESCRIBES DESIGN ELEMENTS 1958 01:57:29,280 --> 01:57:31,440 FOR FIRST-IN-HUMAN CLINICAL 1959 01:57:31,440 --> 01:57:32,640 TRIALS. 1960 01:57:32,640 --> 01:57:34,680 HOWEVER, MANY NRAS PROVIDE A 1961 01:57:34,680 --> 01:57:37,000 REGULATORY AND LEGAL 1962 01:57:37,000 --> 01:57:42,520 CLASSIFICATION FOR ADJUVANT 1963 01:57:42,520 --> 01:57:48,080 COMPONENT OF VACCINE, THAT CAN 1964 01:57:48,080 --> 01:57:56,720 BE EXCIPIENT, ACTIVE 1965 01:57:56,720 --> 01:57:58,320 INGREDIENT OR CONSTITUENT 1966 01:57:58,320 --> 01:57:59,960 MATERIAL, DEPENDING ON THE 1967 01:57:59,960 --> 01:58:02,680 PARTICULAR DEFINITION USED BY 1968 01:58:02,680 --> 01:58:04,160 THE PARTICULAR NRA AND 1969 01:58:04,160 --> 01:58:09,160 ADDITIONAL TESTING MAY BE 1970 01:58:09,160 --> 01:58:10,080 REQUIRED. 1971 01:58:10,080 --> 01:58:19,840 SO TAKE THE OS FDA REGULATORY 1972 01:58:19,840 --> 01:58:21,840 DEFINITION AND CONSIDERATION 1973 01:58:21,840 --> 01:58:23,160 ON ADJUVANTS. 1974 01:58:23,160 --> 01:58:28,760 THE FDA SAYS ADJUVANTS ARE NOT 1975 01:58:28,760 --> 01:58:30,520 CONSIDERED ACTIVE INGREDIENTS 1976 01:58:30,520 --> 01:58:33,440 AND THEN THERE IS CONSTITUENT 1977 01:58:33,440 --> 01:58:37,440 MATERIAL SO THERE IS NO 1978 01:58:37,440 --> 01:58:39,000 VACCINE ADJUVANT ON ITS OWN 1979 01:58:39,000 --> 01:58:42,120 THAT COULD BE PICKED SO IT IS 1980 01:58:42,120 --> 01:58:48,560 ONLY COMPONENT OF PARTICULAR 1981 01:58:48,560 --> 01:58:50,640 ADJUVANTED VACCINE AND IT IS 1982 01:58:50,640 --> 01:58:53,400 THE ARE ADJUVANTED VACCINE 1983 01:58:53,400 --> 01:58:55,520 FORMULATION IN TOTO THAT IS 1984 01:58:55,520 --> 01:58:59,000 TESTED IN CLINICAL TRIALS AND 1985 01:58:59,000 --> 01:58:59,800 LICENSED. 1986 01:58:59,800 --> 01:59:02,040 OF COURSE THE ADJUVANTED 1987 01:59:02,040 --> 01:59:03,800 VACCINE FORMULATION MUST BE 1988 01:59:03,800 --> 01:59:06,520 SAFE AND EFFECTIVE AND 1989 01:59:06,520 --> 01:59:09,240 BENEFITS OUTWEIGH ITS RISK. 1990 01:59:09,240 --> 01:59:11,840 SO WE LOOK AT THE STEPS ONE 1991 01:59:11,840 --> 01:59:19,360 HAS TO GO THROUGH TO ENSURE 1992 01:59:19,360 --> 01:59:21,200 THE QUALITY AND SAFETY. 1993 01:59:21,200 --> 01:59:27,120 THERE IS OFTEN COMBINATION OF 1994 01:59:27,120 --> 01:59:31,360 COMPONENTS WITH TOO MUCH DATA 1995 01:59:31,360 --> 01:59:33,520 TO PERFORM SAFE STUDIES SO 1996 01:59:33,520 --> 01:59:37,680 THEY START USING ANIMAL TRIALS 1997 01:59:37,680 --> 01:59:41,000 AND USUALLY START WITH 1998 01:59:41,000 --> 01:59:44,880 CLINICAL TRIALS TO IDENTIFY 1999 01:59:44,880 --> 01:59:47,280 AND CHARACTERIZE POTENTIAL 2000 01:59:47,280 --> 01:59:49,200 LOCAL AND SYSTEMIC ADVERSE 2001 01:59:49,200 --> 01:59:52,120 EVENTS THAT MAY OCCUR IN THE 2002 01:59:52,120 --> 01:59:55,720 MODEL AND ALSO A FULL TISSUE 2003 01:59:55,720 --> 02:00:02,600 LIST FOR NOVEL ADJUVANTS. 2004 02:00:02,600 --> 02:00:06,240 THIS FRAMEWORK OR GUIDELINE 2005 02:00:06,240 --> 02:00:12,240 ALSO WILL TALK ABOUT AT WHAT 2006 02:00:12,240 --> 02:00:13,440 STATE REPRODUCTIVE TOXICITY 2007 02:00:13,440 --> 02:00:15,360 TESTING SHOULD BE DONE. 2008 02:00:15,360 --> 02:00:16,920 CONDUCTED IN PARALLEL WITH 2009 02:00:16,920 --> 02:00:19,840 PHASE 3 CLINICAL TRIALS FOR 2010 02:00:19,840 --> 02:00:22,320 PRODUCTS INTENDED FOR USE IN 2011 02:00:22,320 --> 02:00:25,120 FEMALES OF CHILD BEARING AGE 2012 02:00:25,120 --> 02:00:28,400 AND WHEN AND HOW SHOULD THE 2013 02:00:28,400 --> 02:00:32,960 ADDED BENEFIT OF ADJUVANT BE 2014 02:00:32,960 --> 02:00:34,560 DEMONSTRATED? 2015 02:00:34,560 --> 02:00:35,600 THE MANUFACTURER SHOULD 2016 02:00:35,600 --> 02:00:39,480 PROVIDE RATIONAL FOR USE OF 2017 02:00:39,480 --> 02:00:42,640 ADJUVANT IN VACCINE 2018 02:00:42,640 --> 02:00:43,680 FORMULATION. 2019 02:00:43,680 --> 02:00:49,720 IT CAN BE PRECLINICAL STUDIES 2020 02:00:49,720 --> 02:00:55,400 OR PROOF OF CONCEPT STUDIES IN 2021 02:00:55,400 --> 02:00:57,640 ANIMAL TRIALS. 2022 02:00:57,640 --> 02:01:04,720 IT COULD ALSO DEMONSTRATE WHAT 2023 02:01:04,720 --> 02:01:09,480 CAN HAPPEN WHEN COMPARING 2024 02:01:09,480 --> 02:01:13,080 ADJUVANTED VERSUS UNADJUVANTED 2025 02:01:13,080 --> 02:01:15,840 VACCINES WITH POLYMERS AND CAN 2026 02:01:15,840 --> 02:01:19,000 INCLUDE EVIDENCE OF LOOKING 2027 02:01:19,000 --> 02:01:21,920 FOR ENHANCED IMMUNE RESPONSES, 2028 02:01:21,920 --> 02:01:23,600 ANTIGEN SPARING EFFECTS OR 2029 02:01:23,600 --> 02:01:27,280 OTHER ADVANTAGES AND OF COURSE 2030 02:01:27,280 --> 02:01:29,560 LOOKING AT THE INFORMATION OF 2031 02:01:29,560 --> 02:01:32,280 PRESUMED MECHANISM OF ACTION 2032 02:01:32,280 --> 02:01:34,800 OF ADJUVANT IN AVAILABLE. 2033 02:01:34,800 --> 02:01:36,520 I MENTIONED BEFORE THAT THE 2034 02:01:36,520 --> 02:01:38,600 ADJUVANTS ARE NOT CONSIDERED 2035 02:01:38,600 --> 02:01:41,520 ACTIVE INGREDIENTS FROM A 2036 02:01:41,520 --> 02:01:43,400 REGULATORY PERSPECTIVE SO 2037 02:01:43,400 --> 02:01:44,640 MANUFACTURERS ARE NOT REQUIRED 2038 02:01:44,640 --> 02:01:47,480 TO DEMONSTRATE THE ADDED 2039 02:01:47,480 --> 02:01:51,840 BENEFIT OF AN ADJUVANT IN 2040 02:01:51,840 --> 02:01:56,280 COMPARATIVE PHASE 3 EFFICACY 2041 02:01:56,280 --> 02:01:57,000 AND SAFETY TRIALS. 2042 02:01:57,000 --> 02:02:00,440 SO WE LOOK IT STUDIES 2043 02:02:00,440 --> 02:02:02,960 COMPARING VACCINE ANTIGEN WITH 2044 02:02:02,960 --> 02:02:04,920 AND WITHOUT ADJUVANT HOWEVER 2045 02:02:04,920 --> 02:02:05,920 NEVER SAY NEVER BECAUSE THEY 2046 02:02:05,920 --> 02:02:08,320 MAY BE REQUESTED ON A 2047 02:02:08,320 --> 02:02:10,520 CASE-BY-CASE BASIS. 2048 02:02:10,520 --> 02:02:14,280 FOR EXAMPLE, IF A MANUFACTURER 2049 02:02:14,280 --> 02:02:19,840 WANTS TO MAKE A PRIORITY CASE, 2050 02:02:19,840 --> 02:02:26,920 AFTER THE SAFETY CONCERNS HAVE 2051 02:02:26,920 --> 02:02:31,040 BEEN IDENTIFIED AND THEN THE 2052 02:02:31,040 --> 02:02:38,240 MANUFACTURER WILL INCLUDE THE 2053 02:02:38,240 --> 02:02:44,240 SUPERIORITY CLAIMS AND THEN IT 2054 02:02:44,240 --> 02:02:45,240 MAY BE USED. 2055 02:02:45,240 --> 02:02:50,360 SO WE REALLY CALL IT PARAMOUNT 2056 02:02:50,360 --> 02:02:54,080 WHEN ANTIBODY ADJUVANTS ARE 2057 02:02:54,080 --> 02:02:56,080 DEVELOPED. 2058 02:02:56,080 --> 02:02:57,000 THERE ARE SPECIAL 2059 02:02:57,000 --> 02:02:59,400 CONSIDERATIONS FOR CLINICAL 2060 02:02:59,400 --> 02:03:03,320 SAFETY EVALUATION AND ANY 2061 02:03:03,320 --> 02:03:05,480 ADJUVANT TO ANY VACCINE 2062 02:03:05,480 --> 02:03:07,920 FORMULATION NEEDS TO BE TESTED 2063 02:03:07,920 --> 02:03:11,320 AND BALANCED WITH THE RISK OF 2064 02:03:11,320 --> 02:03:11,840 ADVERSE REACTIONS. 2065 02:03:11,840 --> 02:03:14,120 SO WHAT THEY DO EARLY IN PHASE 2066 02:03:14,120 --> 02:03:20,000 1 OR 2 STUDIES, THEY COMPARE 2067 02:03:20,000 --> 02:03:25,920 THE VACCINES WITH SALINE 2068 02:03:25,920 --> 02:03:32,160 PLACEBO WHICH IS STABLE OR THE 2069 02:03:32,160 --> 02:03:35,440 ADJUVANTED VACCINE VERSUS THE 2070 02:03:35,440 --> 02:03:39,880 UNADJUVANTED ANT ANTIGEN. 2071 02:03:39,880 --> 02:03:44,440 AND THERE ARE SPECIFIC 2072 02:03:44,440 --> 02:03:46,520 INQUIRIES REGARDING SYMPTOMS 2073 02:03:46,520 --> 02:03:51,120 CONSISTENT WITH AUTOIMMUNE AND 2074 02:03:51,120 --> 02:03:53,880 NEUROINFLAMMATORY DISEASES. 2075 02:03:53,880 --> 02:03:55,480 LONGER POST-VACCINATION FOLLOW 2076 02:03:55,480 --> 02:03:58,880 UP IS TYPICAL FOR 2077 02:03:58,880 --> 02:04:00,720 NONADJUVANTED VACCINES. 2078 02:04:00,720 --> 02:04:02,480 TYPICALLY IT IS 12 MONTHS 2079 02:04:02,480 --> 02:04:05,440 FOLLOWING VACCINATION BUT IT 2080 02:04:05,440 --> 02:04:08,120 COULD BE LONGER AND SAES WILL 2081 02:04:08,120 --> 02:04:11,040 ASK ARE THERE ANY NEW ONSET 2082 02:04:11,040 --> 02:04:12,800 MEDICAL CONDITIONS OR ADVERSE 2083 02:04:12,800 --> 02:04:20,120 EVENTS OF SPECIAL INTEREST 2084 02:04:20,120 --> 02:04:23,680 POPPING UP AS YOU FOLLOW THE 2085 02:04:23,680 --> 02:04:24,080 SUSPECT. 2086 02:04:24,080 --> 02:04:27,400 SO THE SAFETY EXPERIENCE WITH 2087 02:04:27,400 --> 02:04:31,440 THE SAME ADJUVANT FORMULATION 2088 02:04:31,440 --> 02:04:34,600 WITH OTHER VACCINE ANTIGENS 2089 02:04:34,600 --> 02:04:38,200 MAY CONTRIBUTE AND MAY SUPPORT 2090 02:04:38,200 --> 02:04:41,840 THE SAFETY OF A NEW VACCINE 2091 02:04:41,840 --> 02:04:46,280 ANTIGEN FORMULATED WITH THE 2092 02:04:46,280 --> 02:04:52,040 SAME ADJUVANT. 2093 02:04:52,040 --> 02:04:53,600 AGAIN, JUST QUICKLY, WITH 2094 02:04:53,600 --> 02:04:54,720 VACCINE FOLLOW UP, THERE IS A 2095 02:04:54,720 --> 02:04:59,080 LOT OF CONCERN BECAUSE ON THE 2096 02:04:59,080 --> 02:05:01,800 ONE SIDE, SOME POTENTIAL 2097 02:05:01,800 --> 02:05:03,360 ADVERSE EVENTS BEGINNING AFTER 2098 02:05:03,360 --> 02:05:05,480 VACCINATION MAY NOT BE 2099 02:05:05,480 --> 02:05:06,440 RECOGNIZED OR DIAGNOSED TILL 2100 02:05:06,440 --> 02:05:07,000 MUCH LATER. 2101 02:05:07,000 --> 02:05:11,280 SO THERE IS A TRADE-OFF. 2102 02:05:11,280 --> 02:05:14,000 A LONGER DURATION CAN INCREASE 2103 02:05:14,000 --> 02:05:15,200 IDENTIFICATION OF POTENTIAL 2104 02:05:15,200 --> 02:05:17,520 AES BUT MAY INCREASE NOISE, 2105 02:05:17,520 --> 02:05:17,840 RIGHT? 2106 02:05:17,840 --> 02:05:26,320 SO LONGER FOLLOW UP IS OFTEN 2107 02:05:26,320 --> 02:05:29,160 ROUTINELY OBTAINED IN EFFICACY 2108 02:05:29,160 --> 02:05:38,720 STUDIES BUT THEY MAY NOT SOME 2109 02:05:38,720 --> 02:05:40,080 SYMPTOMS MAY HAVE NOTHING TO 2110 02:05:40,080 --> 02:05:44,000 DO WITH THE VACCINE 2111 02:05:44,000 --> 02:05:45,600 COMBINATION. 2112 02:05:45,600 --> 02:05:50,800 NOW, IF THE LONGER FOLLOW UP, 2113 02:05:50,800 --> 02:06:00,800 THERE ARE VACCINES THAT ARE 2114 02:06:00,800 --> 02:06:03,320 EVALUATED FOR IMMUNEOGENICITY 2115 02:06:03,320 --> 02:06:05,360 AND THEN OF COURSE YOU DON'T 2116 02:06:05,360 --> 02:06:09,160 HAVE TO DIG INTO STUDIES OR DO 2117 02:06:09,160 --> 02:06:13,480 OTHER FOLLOW UPS SO THOSE CAN 2118 02:06:13,480 --> 02:06:18,400 PREDICT THE SAFETY STEPS WITH 2119 02:06:18,400 --> 02:06:20,200 VACCINE POPULATIONS. 2120 02:06:20,200 --> 02:06:22,520 THE AESI OR ADVERSE EVENTS OF 2121 02:06:22,520 --> 02:06:33,040 SPECIAL INTEREST FOCUS ON 2122 02:06:34,920 --> 02:06:37,480 AUTOIMMUNE, INFLAMMATORY 2123 02:06:37,480 --> 02:06:38,840 DISEASES, NEUROINFLAMMATORY 2124 02:06:38,840 --> 02:06:40,880 DISORDERS, MUSK LOW SKELETAL 2125 02:06:40,880 --> 02:06:42,720 AND CONNECTIVE TISSUE DISEASES 2126 02:06:42,720 --> 02:06:43,720 AND GI DISORDERS. 2127 02:06:43,720 --> 02:06:46,400 SO IN SUMMARY, REGULATORY 2128 02:06:46,400 --> 02:06:47,440 PATHWAYS SUPPORTING 2129 02:06:47,440 --> 02:06:49,560 DEVELOPMENT AND APPROVAL OF 2130 02:06:49,560 --> 02:06:50,640 VACCINES FORMULATED WITH NOVEL 2131 02:06:50,640 --> 02:06:54,040 ADJUVANT ARE THE SAME AS FOR 2132 02:06:54,040 --> 02:06:55,840 UNADJUVANTED VACCINES. 2133 02:06:55,840 --> 02:06:57,040 EFFICIENT PLANNING OF 2134 02:06:57,040 --> 02:06:59,560 DEVELOPMENT PATHWAY FOR ANY 2135 02:06:59,560 --> 02:07:01,760 ADJUVANTED VACCINE REQUIRES 2136 02:07:01,760 --> 02:07:04,680 CAREFUL ATTENTION TO 2137 02:07:04,680 --> 02:07:06,200 PRECLINICAL TESTING, STUDY 2138 02:07:06,200 --> 02:07:08,520 DESIGN, DOSING DECISIONS AND 2139 02:07:08,520 --> 02:07:10,520 SAFETY MONITORING AND AGAIN 2140 02:07:10,520 --> 02:07:13,240 ALTHOUGH MANUFACTURES ARE NOT 2141 02:07:13,240 --> 02:07:14,760 REQUIRED TO DEMONSTRATE THE 2142 02:07:14,760 --> 02:07:19,480 ADDED BENEFIT OF ADJUVANTED 2143 02:07:19,480 --> 02:07:21,720 VERSUS UNADJUVANTED VACCINES 2144 02:07:21,720 --> 02:07:25,000 IN CLINICAL COMPARATIVE PHASE 2145 02:07:25,000 --> 02:07:26,800 3 STUDIES, MANUFACTURERS 2146 02:07:26,800 --> 02:07:28,760 SHOULD PROVIDE A JUSTIFICATION 2147 02:07:28,760 --> 02:07:31,640 FOR INCLUDING AN ADJUVANT IN 2148 02:07:31,640 --> 02:07:35,280 THE VACCINE AND EVALUATION OF 2149 02:07:35,280 --> 02:07:37,000 SAFETY OF AN ADJUVANTED 2150 02:07:37,000 --> 02:07:38,280 VACCINE NEEDS TO INCLUDE 2151 02:07:38,280 --> 02:07:39,800 SPECIAL STATE CONSIDERATIONS 2152 02:07:39,800 --> 02:07:41,760 AND THAT CONCLUDES MY TALK AND 2153 02:07:41,760 --> 02:07:43,920 THANK YOU VERY MUCH FOR BEING 2154 02:07:43,920 --> 02:07:46,560 ABLE TO PROVIDE THIS 2155 02:07:46,560 --> 02:07:47,840 PERSPECTIVE. 2156 02:07:47,840 --> 02:07:54,080 >>THANK YOU VERY MUCH, 2157 02:07:54,080 --> 02:07:56,920 MRS. BRUBER, THAT WAS A VERY, 2158 02:07:56,920 --> 02:08:00,080 VERY INTERESTING TALK AND 2159 02:08:00,080 --> 02:08:03,640 QUITE INFORMATIVE. 2160 02:08:03,640 --> 02:08:06,400 NOW WE WILL GO TO OUR PANEL 2161 02:08:06,400 --> 02:08:10,120 AND I WILL START WITH ANA. 2162 02:08:10,120 --> 02:08:12,400 >>WE WILL START WITH THE 2163 02:08:12,400 --> 02:08:14,320 QUESTION OF COMPUTATIONAL 2164 02:08:14,320 --> 02:08:17,840 METHODS FOR OPTIMIZING OR 2165 02:08:17,840 --> 02:08:19,200 DESIGNING ADJUTANTS, DOING A 2166 02:08:19,200 --> 02:08:23,880 GREAT JOB OF IMMUNE OR SAFETY 2167 02:08:23,880 --> 02:08:28,680 DESIGNS AND THE PATHWAYS THE 2168 02:08:28,680 --> 02:08:30,920 DELIVERY CAN HAVE AND BECAUSE 2169 02:08:30,920 --> 02:08:31,760 THEY TEND TO SPIRAL OUT OF 2170 02:08:31,760 --> 02:08:36,720 CONTROL WE HAVE TO SET SOME 2171 02:08:36,720 --> 02:08:38,920 BUDGET OR REQUIREMENTS. 2172 02:08:38,920 --> 02:08:44,680 SO DO YOU HAVE ANY WAY TO 2173 02:08:44,680 --> 02:08:52,000 OPTIMIZE THESE, DO YOU FEED 2174 02:08:52,000 --> 02:08:55,920 THESE INTO THE BILL OR TO YOU 2175 02:08:55,920 --> 02:08:59,840 JUST TAKE A STAB AT IT? 2176 02:08:59,840 --> 02:09:00,520 >>DEFINITELY AT THE 2177 02:09:00,520 --> 02:09:03,040 UNIVERSITY OF MONTANA, THE 2178 02:09:03,040 --> 02:09:04,800 RESEARCHER THERE HAS STARTED 2179 02:09:04,800 --> 02:09:08,440 TO TRY TO TACKLE THIS BY 2180 02:09:08,440 --> 02:09:10,840 ANALYSIS OF THE LIMP NODES 2181 02:09:10,840 --> 02:09:14,000 PRE- AND POST INJECTION AND 2182 02:09:14,000 --> 02:09:21,320 TRYING TO BUILD A DATABASE TO 2183 02:09:21,320 --> 02:09:23,600 DIFFERENT IMMUNE RESPONSES IN 2184 02:09:23,600 --> 02:09:24,120 A BROADER SENSE. 2185 02:09:24,120 --> 02:09:29,400 I KNOW THEY ARE EVALUATING 2186 02:09:29,400 --> 02:09:32,360 VACCINES ON AND PEOPLE CAN GO 2187 02:09:32,360 --> 02:09:34,600 AND LOOK UP DIFFERENT 2188 02:09:34,600 --> 02:09:36,480 ADJUTANTS TO SEE WHAT KIND OF 2189 02:09:36,480 --> 02:09:38,480 IMMUNE RESPONSE THEY GIVE BUT 2190 02:09:38,480 --> 02:09:42,480 WE KNOW THERE ARE SO MANY IN 2191 02:09:42,480 --> 02:09:45,240 RESPONSE WITH TWO OR THREE 2192 02:09:45,240 --> 02:09:47,320 ADJUVANTS THAT ARE GIVING THE 2193 02:09:47,320 --> 02:09:48,640 RESPONSE WE HAVEN'T PICKED UP 2194 02:09:48,640 --> 02:09:49,600 ON YET. 2195 02:09:49,600 --> 02:09:50,760 SO THERE ARE SUBTLE 2196 02:09:50,760 --> 02:09:52,480 DIFFERENCES WE WILL NOT PICK 2197 02:09:52,480 --> 02:10:00,600 UP TILL WE HAVE A DATABASE OF 2198 02:10:00,600 --> 02:10:01,560 RESPONSES AND UNTIL WE HAVE 2199 02:10:01,560 --> 02:10:07,200 THAT, IT WILL BE HARD TO 2200 02:10:07,200 --> 02:10:08,440 PREDICT WHICH ADJUVANTS AND 2201 02:10:08,440 --> 02:10:13,040 FORMULATIONS PAIR WELL 2202 02:10:13,040 --> 02:10:15,600 TOGETHER. 2203 02:10:15,600 --> 02:10:16,280 >>ANYONE ELSE WITH THOUGHTS? 2204 02:10:16,280 --> 02:10:17,880 IF NOT I CAN MOVE ON TO 2205 02:10:17,880 --> 02:10:18,480 ANOTHER QUESTION. 2206 02:10:18,480 --> 02:10:22,280 >>SO I CAN MOVE AHEAD WITH 2207 02:10:22,280 --> 02:10:23,480 THE NEXT QUESTION. 2208 02:10:23,480 --> 02:10:28,840 SINCE MANY OF OUR VACCINES ARE 2209 02:10:28,840 --> 02:10:34,160 TRYING TO GAUGE THE CORE OF 2210 02:10:34,160 --> 02:10:40,720 RESPONSE FROM PROJECTION OF 2211 02:10:40,720 --> 02:10:41,600 ENTRY, SO. 2212 02:10:41,600 --> 02:10:42,640 [INDISCERNIBLE] 2213 02:10:42,640 --> 02:10:43,400 SO THE QUESTION FOR EVERYBODY 2214 02:10:43,400 --> 02:10:48,440 IS HOW MUCH YOU TAKE INTO 2215 02:10:48,440 --> 02:10:52,120 CONSIDERATION FOR CLINICAL AND 2216 02:10:52,120 --> 02:10:54,480 ANA STAZIA, I KNOW YOU HAVE A 2217 02:10:54,480 --> 02:10:57,360 CLINIC AND I WOULD LIKE TO 2218 02:10:57,360 --> 02:11:07,920 HEAR YOUR THOUGHTS ABOUT IT. 2219 02:11:08,760 --> 02:11:11,280 >>YES, THANK YOU VERY MUCH. 2220 02:11:11,280 --> 02:11:16,840 THIS IS REALLY IMPORTANT FOR 2221 02:11:16,840 --> 02:11:22,640 THE GROUP TO KNOW WHAT 2222 02:11:22,640 --> 02:11:33,240 ANTIBODY OR IMMUNE RESPONSE SO 2223 02:11:38,080 --> 02:11:40,760 WHEN THE PARTICIPANTS, LOOKING 2224 02:11:40,760 --> 02:11:51,320 AT ADJUTANTS IN THESE CASES, 2225 02:11:52,880 --> 02:11:57,200 THE ONES PROVIDED TO THE 2226 02:11:57,200 --> 02:11:59,160 PARTICIPANT AND MEASURED 2227 02:11:59,160 --> 02:12:04,200 IMMUNE RESPONSE SO AT THE END, 2228 02:12:04,200 --> 02:12:11,120 WE WERE SEEING A GOOD IFP BUT 2229 02:12:11,120 --> 02:12:17,720 BECAUSE IT TAKES SOME TIME TO 2230 02:12:17,720 --> 02:12:20,880 HAVE MORE SPECIFICS AND FOLLOW 2231 02:12:20,880 --> 02:12:31,360 UP ON THOSE SO AGAIN -- 2232 02:12:41,320 --> 02:12:41,680 [INDISCERNIBLE] 2233 02:12:41,680 --> 02:12:42,440 >>AND KEVIN, YOU HAVE ANY 2234 02:12:42,440 --> 02:12:46,120 REPORTS ON THE CLINICAL SIDE, 2235 02:12:46,120 --> 02:12:47,160 HOW MUCH SAMPLING OR 2236 02:12:47,160 --> 02:12:48,920 CONSIDERATION IS GIVEN TO 2237 02:12:48,920 --> 02:12:49,920 THAT? 2238 02:12:49,920 --> 02:12:50,880 >>SURE, I WILL JUST JUMP IN 2239 02:12:50,880 --> 02:12:51,800 REAL QUICK. 2240 02:12:51,800 --> 02:12:54,560 SO YES I THINK PARTICULARLY 2241 02:12:54,560 --> 02:12:57,120 FOR VIRUSES LIKE CORONA 2242 02:12:57,120 --> 02:12:59,040 VIRUSES OR INFLUENZA, WE'RE 2243 02:12:59,040 --> 02:13:01,640 REALLY FOCUSED ON MUCOSAL 2244 02:13:01,640 --> 02:13:03,840 RESPONSES SO FOR THOSE STUDIES 2245 02:13:03,840 --> 02:13:06,000 WE'RE LOOKING AT THE UPPER 2246 02:13:06,000 --> 02:13:07,160 RESPIRATORY AND LOWER 2247 02:13:07,160 --> 02:13:08,720 RESPIRATORY TRACT AND THE 2248 02:13:08,720 --> 02:13:10,520 STUDIES ARE NOT CONSIDERED 2249 02:13:10,520 --> 02:13:12,840 COMPLETE UNLESS YOU DO THAT SO 2250 02:13:12,840 --> 02:13:14,920 WITH SOMETHING LIKE HIV WHERE 2251 02:13:14,920 --> 02:13:21,600 WE LOOK AT SEC CREASES AND 2252 02:13:21,600 --> 02:13:23,320 RECTUM SWABS, MUCOSA RESPONSES 2253 02:13:23,320 --> 02:13:25,160 ARE IMPORTANT THERE TOO. 2254 02:13:25,160 --> 02:13:29,560 SOMETIMES IT IS DIFFICULT TO 2255 02:13:29,560 --> 02:13:30,600 SAMPLE THOSE LONGITUDINALLY 2256 02:13:30,600 --> 02:13:34,200 BECAUSE THEY ARE ALWAYS 2257 02:13:34,200 --> 02:13:36,440 WORRIED ABOUT DISRUPTING 2258 02:13:36,440 --> 02:13:39,440 MEMBRANES OR CAUSING MORE 2259 02:13:39,440 --> 02:13:40,080 PROBLEMS DOWNSTREAM BUT 2260 02:13:40,080 --> 02:13:42,440 OVERALL I THINK THOSE ARE 2261 02:13:42,440 --> 02:13:44,720 IMPORTANT TO LOOK AT, 2262 02:13:44,720 --> 02:13:53,800 PARTICULARLY FOR CORONA 2263 02:13:53,800 --> 02:13:54,160 VIRUSES. 2264 02:13:54,160 --> 02:13:56,000 >>THERE ARE THINGS YOU DO 2265 02:13:56,000 --> 02:13:57,600 WITH VACCINATION AND SPECIAL 2266 02:13:57,600 --> 02:14:00,800 CONSIDERATIONS YOU THINK ABOUT 2267 02:14:00,800 --> 02:14:10,440 IN TERMS OF MUCOSAL RESPONSES 2268 02:14:10,440 --> 02:14:20,960 DEPENDING ON THE TYPE OF 2269 02:14:23,840 --> 02:14:25,760 VACCINATION AND SOMETIMES 2270 02:14:25,760 --> 02:14:29,200 IMMUNE RESPONSE WON'T BE LOOK 2271 02:14:29,200 --> 02:14:33,280 AT AT ALL AND WILL FOCUSES ON 2272 02:14:33,280 --> 02:14:33,680 MUCOSAL. 2273 02:14:33,680 --> 02:14:36,120 >>THANK YOU VERY MUCH. 2274 02:14:36,120 --> 02:14:40,400 ONE QUESTION, HOW DO YOU THINK 2275 02:14:40,400 --> 02:14:43,200 ABOUT ADJUTANTS, IF THERE IS A 2276 02:14:43,200 --> 02:14:46,320 DIFFERENT TRIAL, HOW DO WE GET 2277 02:14:46,320 --> 02:14:50,800 TO EASE THESE ADJUTANTS? 2278 02:14:50,800 --> 02:14:54,880 >>THAT IS A VERY GOOD 2279 02:14:54,880 --> 02:15:01,480 QUESTION. 2280 02:15:01,480 --> 02:15:03,840 SO USUALLY WHEN IT IS INCLUDED 2281 02:15:03,840 --> 02:15:07,640 OR GIVEN TO THE PEDIATRIC 2282 02:15:07,640 --> 02:15:08,440 POPULATION, CLINICAL TRIALS 2283 02:15:08,440 --> 02:15:12,280 MANY TIMES ARE CONDUCTED IN AN 2284 02:15:12,280 --> 02:15:15,240 HD ESCALATION SO YOU GET 2285 02:15:15,240 --> 02:15:17,640 SAFETY DATA FIRST BEFORE YOU 2286 02:15:17,640 --> 02:15:20,480 THEN ROLL TO THE PEDIATRIC 2287 02:15:20,480 --> 02:15:25,400 SUBJECT AND YOU KNOW THAT IS 2288 02:15:25,400 --> 02:15:29,240 VERY SIMILAR WHEN YOU HAVE A 2289 02:15:29,240 --> 02:15:30,240 VACCINE POPULATION. 2290 02:15:30,240 --> 02:15:34,360 YOU HAVE TO CAREFULLY VALIDATE 2291 02:15:34,360 --> 02:15:36,320 THE SAFETY IN THE TEST GROUP 2292 02:15:36,320 --> 02:15:39,040 BEFORE YOU GIVE TO THE 2293 02:15:39,040 --> 02:15:42,680 PEDIATRIC SUBJECT BUT OVERALL, 2294 02:15:42,680 --> 02:15:44,120 THE PHYSICAL DEVELOPMENT, I 2295 02:15:44,120 --> 02:15:45,760 THINK -- AND MAYBE I AM 2296 02:15:45,760 --> 02:15:46,600 OVERSTATED BUT THIS WAS THE 2297 02:15:46,600 --> 02:15:51,240 APPROACH THAT WAS USED AND 2298 02:15:51,240 --> 02:15:53,560 THEN IF THERE WAS SOME ISSUE 2299 02:15:53,560 --> 02:15:56,480 WITH SAFETY THEN THE VACCINE 2300 02:15:56,480 --> 02:16:06,040 WOULD BE AN INVESTIGATIONAL 2301 02:16:06,040 --> 02:16:06,840 VACCINE, ADJUVANT 2302 02:16:06,840 --> 02:16:07,520 INVESTIGATION WILL BE TRIED 2303 02:16:07,520 --> 02:16:09,480 WITH THE SUBJECT AND THEN 2304 02:16:09,480 --> 02:16:12,880 CARRY ON FROM THERE BEFORE IT 2305 02:16:12,880 --> 02:16:15,600 IS GIVEN TO THE LARGER 2306 02:16:15,600 --> 02:16:18,040 POPULATION SO THERE IS NOT A 2307 02:16:18,040 --> 02:16:19,960 DIFFERENT CHUNK IN TERMS OF 2308 02:16:19,960 --> 02:16:21,560 THE OVERALL CLINICAL 2309 02:16:21,560 --> 02:16:25,120 DEVELOPMENT, JUST A MORE 2310 02:16:25,120 --> 02:16:34,920 CAREFUL DEESCALATING APPROACH 2311 02:16:34,920 --> 02:16:35,720 THAT IS GIVEN. 2312 02:16:35,720 --> 02:16:36,920 >>THANK YOU SO MUCH. 2313 02:16:36,920 --> 02:16:41,920 >>ONE MORE QUESTION OR CLOSE 2314 02:16:41,920 --> 02:16:42,360 FOR SESSION 3? 2315 02:16:42,360 --> 02:16:45,000 >>LET'S SEE IF WE CAN DO ONE 2316 02:16:45,000 --> 02:16:46,200 MORE QUESTION. 2317 02:16:46,200 --> 02:16:46,600 >>GO AHEAD. 2318 02:16:46,600 --> 02:16:48,000 >>THERE WAS ONE MORE QUESTION 2319 02:16:48,000 --> 02:16:50,680 THAT CAME UP IN THE CHAT A 2320 02:16:50,680 --> 02:16:52,640 COUPLE OF TIMES WHICH WAS 2321 02:16:52,640 --> 02:16:56,320 SHOWING A LOT OF TITER 2322 02:16:56,320 --> 02:16:59,040 NEUTRALIZING BUT NOT A LOT OF 2323 02:16:59,040 --> 02:16:59,800 TALK ABOUT DURABILITY AND THIS 2324 02:16:59,800 --> 02:17:03,080 IS TO THE GROUP, HOW YOU THINK 2325 02:17:03,080 --> 02:17:04,280 ABOUT DURABILITY IN YOUR 2326 02:17:04,280 --> 02:17:05,720 STUDIES AND IF YOU HAVE ANY 2327 02:17:05,720 --> 02:17:07,720 MAGIC BULLETS TO THE AUDIENCE? 2328 02:17:07,720 --> 02:17:10,320 >>I MEAN WE TYPICALLY LOOK AT 2329 02:17:10,320 --> 02:17:12,320 IT IN A SEPARATE STUDY SO 2330 02:17:12,320 --> 02:17:14,520 USUALLY THE FIRST STUDY IS TO 2331 02:17:14,520 --> 02:17:16,560 DETERMINE IF YOU ARE GETTING 2332 02:17:16,560 --> 02:17:18,040 THE TYPE OF ANTIBODIES YOU ARE 2333 02:17:18,040 --> 02:17:23,240 LOOKING FOR. 2334 02:17:23,240 --> 02:17:25,480 WHEN TALKING ABOUT DURABILITY, 2335 02:17:25,480 --> 02:17:26,880 IT DEPENDS WHO WE ARE LOOKING 2336 02:17:26,880 --> 02:17:29,360 FOR, IF WE ARE LOOKING FOR A 2337 02:17:29,360 --> 02:17:30,520 CERTAIN TYPE OF IMMUNE 2338 02:17:30,520 --> 02:17:33,160 RESPONSE TO COME UP BUT I 2339 02:17:33,160 --> 02:17:34,760 THINK WE DEFINITELY BEFORE WE 2340 02:17:34,760 --> 02:17:36,960 MOVE TO CLINICAL TRIAL WANT TO 2341 02:17:36,960 --> 02:17:38,160 KNOW WHAT THE DURABILITY LOOKS 2342 02:17:38,160 --> 02:17:42,120 LIKE AND UNDERSTAND WHAT IT 2343 02:17:42,120 --> 02:17:46,400 MIGHT BE IN A DIFFERENT POWER 2344 02:17:46,400 --> 02:17:48,600 POINT AND SOMETIMES IT MAY BE 2345 02:17:48,600 --> 02:17:51,680 LOOKED AT IN A SMALLER OUTCOME 2346 02:17:51,680 --> 02:17:55,560 WITH IT IS MORE DURABLE. 2347 02:17:55,560 --> 02:17:57,200 SOMETIMES IT INVOLVES THE 2348 02:17:57,200 --> 02:17:59,760 ADJUTANTS WHERE WE SEE A 2349 02:17:59,760 --> 02:18:01,280 HIGHER TITER AND SOMETIMES IT 2350 02:18:01,280 --> 02:18:04,920 TAKES LONGER FOR THE TITER TO 2351 02:18:04,920 --> 02:18:07,320 FALL BACK DOWN TO BASELINE BUT 2352 02:18:07,320 --> 02:18:10,480 IT IS SOMETHING WE WOULD DO IN 2353 02:18:10,480 --> 02:18:12,600 A DIFFERENT WAY AND STRUCTURE 2354 02:18:12,600 --> 02:18:15,040 HOW WE WOULD LOOK AT AND 2355 02:18:15,040 --> 02:18:15,920 ANSWER THOSE QUESTIONS. 2356 02:18:15,920 --> 02:18:17,960 >>OKAY, IF NO ONE ELSE HAS 2357 02:18:17,960 --> 02:18:19,480 ANYTHING TO ADD, THANK YOU ALL 2358 02:18:19,480 --> 02:18:21,160 SO MUCH. 2359 02:18:21,160 --> 02:18:23,680 THOSE WERE REALLY EXCELLENT 2360 02:18:23,680 --> 02:18:24,160 SESSIONS. 2361 02:18:24,160 --> 02:18:32,680 >>THANKS, EVERYONE 2362 02:18:32,680 --> 02:18:34,400 >>THANK YOU. 2363 02:18:34,400 --> 02:18:37,920 >>THANK YOU ANA AND CESAR FOR 2364 02:18:37,920 --> 02:18:39,680 MODERATING SECTION 2. 2365 02:18:39,680 --> 02:18:41,720 WE DON'T HAVE ENOUGH TIME FOR 2366 02:18:41,720 --> 02:18:43,760 FURTHER DISCUSSIONS AND IN THE 2367 02:18:43,760 --> 02:18:45,360 INTEREST OF TIME, WOULD LIKE 2368 02:18:45,360 --> 02:18:55,800 TO MOVE ON TO THE NEXT 2369 02:19:02,680 --> 02:19:04,880 SESSION. 2370 02:19:04,880 --> 02:19:06,720 >>THANK YOU, ANNIE. 2371 02:19:06,720 --> 02:19:10,640 WE WILL MOVE TON TO SESSION 3 2372 02:19:10,640 --> 02:19:13,680 WHERE WE WILL TALK ABOUT 2373 02:19:13,680 --> 02:19:23,360 ACCESS TO ADJUVANTS FOR 2374 02:19:23,360 --> 02:19:25,600 VACCINE DEVELOPERS. 2375 02:19:25,600 --> 02:19:30,880 THESE WILL BE VERY SHORT HIGH 2376 02:19:30,880 --> 02:19:34,000 LEVEL TALKS ON INDUCINGS A 2377 02:19:34,000 --> 02:19:36,840 VANITIES AND IF YOU HAVE ANY 2378 02:19:36,840 --> 02:19:39,600 QUESTIONS, PLEASE POP THEM IN 2379 02:19:39,600 --> 02:19:43,520 THE Q&A BOX. 2380 02:19:43,520 --> 02:19:46,720 AND WE DON'T HAVE A COMPONENT 2381 02:19:46,720 --> 02:19:48,640 OF DISCUSSION IN THIS SECTION. 2382 02:19:48,640 --> 02:19:49,960 IF YOU ARE CONCERNED ABOUT 2383 02:19:49,960 --> 02:19:51,360 THAT OR ANYTHING PRESENTED IN 2384 02:19:51,360 --> 02:19:52,760 THIS SESSION, I WOULD LIKE TO 2385 02:19:52,760 --> 02:20:03,320 POINT YOU TO THE FOLLOWING 2386 02:20:04,120 --> 02:20:06,880 RESOURCES THAT Dr. ALREADY 2387 02:20:06,880 --> 02:20:12,960 INTROACCUSED IN HER TALK. 2388 02:20:12,960 --> 02:20:22,360 THIS IS THE NIAID VACCINE 2389 02:20:22,360 --> 02:20:24,600 ADJUVANT COMPENDIUM WHICH 2390 02:20:24,600 --> 02:20:25,880 DISPLAYSA HAVEN'T CONSIDERING 2391 02:20:25,880 --> 02:20:32,080 A RIFT TICK AND META METADATA 2392 02:20:32,080 --> 02:20:33,040 AND FOSTERS COLLABORATIONS 2393 02:20:33,040 --> 02:20:43,520 BEYOND NIAID TO IDENTIFY 2394 02:21:01,520 --> 02:21:06,600 ADJUVANTS TAILOR TO SPECIFIC 2395 02:21:06,600 --> 02:21:15,120 VACCINE INDICATIONS. 2396 02:21:15,120 --> 02:21:18,640 AND I WOULD LIKE TO DISCUSS 2397 02:21:18,640 --> 02:21:20,120 ONE OF THE QUESTIONS THAT CAME 2398 02:21:20,120 --> 02:21:23,200 UP TODAY, WHAT IS THE BEST 2399 02:21:23,200 --> 02:21:25,200 ADJUVANT AND HOW DO I SELECT 2400 02:21:25,200 --> 02:21:28,600 AN ADJUVANT FOR A VACCINE. 2401 02:21:28,600 --> 02:21:31,080 AND AS OUR SPEAKERS SAID 2402 02:21:31,080 --> 02:21:34,000 TODAY, THERE IS NO PERFECT 2403 02:21:34,000 --> 02:21:38,640 ADJUVANT THAT IS SUITABLE FOR 2404 02:21:38,640 --> 02:21:40,160 ALL 16 TYPES AND JUST BECAUSE 2405 02:21:40,160 --> 02:21:43,200 IT IS GREAT IN ONE ANTIGEN 2406 02:21:43,200 --> 02:21:44,960 DOESN'T NECESSARILY MEAN IT IS 2407 02:21:44,960 --> 02:21:47,160 THE BEST FOR YOUR ANTIGEN SO 2408 02:21:47,160 --> 02:21:50,400 IN A PERFECT WORLD, THE 2409 02:21:50,400 --> 02:21:52,960 ANTIGEN WILL BE MATCHED BASED 2410 02:21:52,960 --> 02:21:56,080 ON THE ADJUVANT INDUCED IMMUNE 2411 02:21:56,080 --> 02:21:58,720 PROFILE AND THE CORRELATES OF 2412 02:21:58,720 --> 02:22:01,480 PROTECTION FOR MOST PATHOGENS. 2413 02:22:01,480 --> 02:22:04,400 HOWEVER IN A PERFECT WORLD, WE 2414 02:22:04,400 --> 02:22:06,080 DON'T HAVE ENOUGH INFORMATION 2415 02:22:06,080 --> 02:22:10,360 FOR EITHER ONE TO BE ABLE TO 2416 02:22:10,360 --> 02:22:12,360 COMBINE ANTIGENS IN OTHER 2417 02:22:12,360 --> 02:22:13,160 FORMULATIONS. 2418 02:22:13,160 --> 02:22:15,760 SO IN THE REAL WORLD, THE 2419 02:22:15,760 --> 02:22:17,920 ALTERNATIVE IS TO COMPARE AND 2420 02:22:17,920 --> 02:22:19,160 MULTIPLY WHICH IS DONE EARLY 2421 02:22:19,160 --> 02:22:21,280 IN THE PROCESS OF DEVELOPING A 2422 02:22:21,280 --> 02:22:21,600 VACCINE. 2423 02:22:21,600 --> 02:22:23,840 AND AS WE HAVE ALREADY SEEN IN 2424 02:22:23,840 --> 02:22:25,400 PREVIOUS TALKS, IT IS REALLY 2425 02:22:25,400 --> 02:22:27,120 IMPORTANT TO DO THIS EARLY ON 2426 02:22:27,120 --> 02:22:33,960 IN THE PROCESS OF DEVELOPING A 2427 02:22:33,960 --> 02:22:35,760 NOVEL VACCINE. 2428 02:22:35,760 --> 02:22:39,040 NIAID HAS SEVERAL PROGRAMS TO 2429 02:22:39,040 --> 02:22:41,120 PROMOTE ADJUVANT COMPARISONS 2430 02:22:41,120 --> 02:22:42,560 THROUGH SEVERAL PROGRAMS AND I 2431 02:22:42,560 --> 02:22:44,200 AM LISTING THEM HERE ALTHOUGH 2432 02:22:44,200 --> 02:22:45,600 I WILL NOT GO INTO THE 2433 02:22:45,600 --> 02:22:46,040 DETAILS. 2434 02:22:46,040 --> 02:22:47,080 IF YOU ARE INTERESTED IN 2435 02:22:47,080 --> 02:22:49,360 LEARNING MORE ABOUT THEM, I 2436 02:22:49,360 --> 02:22:50,600 WOULD DIRECT YOU TO THE URL 2437 02:22:50,600 --> 02:22:53,200 HERE AT THE BOTTOM OF THE 2438 02:22:53,200 --> 02:22:54,640 SCREEN. 2439 02:22:54,640 --> 02:22:56,280 AND WITH THAT, I WOULD LIKE TO 2440 02:22:56,280 --> 02:23:01,880 HAND THE STAGE OVER TO THE 2441 02:23:01,880 --> 02:23:10,640 FIRSTS PRESENTER, Dr. DAVID 2442 02:23:10,640 --> 02:23:20,640 BURKHART WHO WILL TALK ABOUT 2443 02:23:20,640 --> 02:23:22,600 THE ADJUTANTS. 2444 02:23:22,600 --> 02:23:24,680 >>THANK YOU, THANK YOU FOR 2445 02:23:24,680 --> 02:23:29,840 ALLOWING ME TO TALK ABOUT SOME 2446 02:23:29,840 --> 02:23:32,400 OF THE ADJUTANT WORK I AM 2447 02:23:32,400 --> 02:23:36,840 DOING AT UNIVERSITY OF MONTANA 2448 02:23:36,840 --> 02:23:38,880 AND WITH INIMMUNE AS A 2449 02:23:38,880 --> 02:23:39,880 PARTNER. 2450 02:23:39,880 --> 02:23:40,600 NEXT SLIDE, PLEASE. 2451 02:23:40,600 --> 02:23:42,080 THE ADJUTANTS I WILL SHOW YOU 2452 02:23:42,080 --> 02:23:44,280 TODAY ARE REALLY THE PRODUCT 2453 02:23:44,280 --> 02:23:47,080 OF A UNIQUE PUBLIC-PRIVATE 2454 02:23:47,080 --> 02:23:49,120 PARTNERSHIP BETWEEN THE CENTER 2455 02:23:49,120 --> 02:23:55,640 AND UNIVERSITY OF MONTANA WITH 2456 02:23:55,640 --> 02:23:58,360 THE COMPANY INIMMUNE. 2457 02:23:58,360 --> 02:24:02,160 BOTH WERE FOUNDED IN 2016 AND 2458 02:24:02,160 --> 02:24:04,480 HAVE GROWN FROM 15 TO 80 2459 02:24:04,480 --> 02:24:07,240 EMPLOYEES WORKING AS ONE BIG 2460 02:24:07,240 --> 02:24:08,760 TEAM. 2461 02:24:08,760 --> 02:24:11,840 OUR STRENGTHS ARE PRECLINICAL 2462 02:24:11,840 --> 02:24:18,200 CHEMISTRY, FORM OPERATION AND 2463 02:24:18,200 --> 02:24:22,200 IMMUNOLOGY GROUPS AND WORK ON 2464 02:24:22,200 --> 02:24:23,760 DISCOVERY RESEARCH, IP 2465 02:24:23,760 --> 02:24:30,200 GENERATION AND PROCESS 2466 02:24:30,200 --> 02:24:31,640 DEVELOPMENT EXPERTSE AND THIS 2467 02:24:31,640 --> 02:24:33,840 HAS GROWN INTO A STRONG AND 2468 02:24:33,840 --> 02:24:35,360 GROWING PIPELINE OF NEW 2469 02:24:35,360 --> 02:24:36,480 CANDIDATE DRUGS AND VACCINES 2470 02:24:36,480 --> 02:24:38,800 THAT ARE NOW MOVING THROUGH 2471 02:24:38,800 --> 02:24:41,400 IND AND PHASE 1 TRIALS AND 2472 02:24:41,400 --> 02:24:44,120 ALSO IN NO SPAL PART THIS IS 2473 02:24:44,120 --> 02:24:49,120 DUE TO AN INDUSTRY OF AM DEM 2474 02:24:49,120 --> 02:24:50,080 MICK AND INDUSTRY PARTNERS WE 2475 02:24:50,080 --> 02:24:51,520 HAVE IN THIS SPACE. 2476 02:24:51,520 --> 02:24:56,240 AND ALL OF OUR PROGRAMS 2477 02:24:56,240 --> 02:25:00,560 FOCUSES ON LATE STAGE 2478 02:25:00,560 --> 02:25:07,800 SYNTHETIC ADJUVANTS, THIS HAS 2479 02:25:07,800 --> 02:25:13,240 RESULTED IN THE LIGANDS. 2480 02:25:13,240 --> 02:25:18,640 THE THREE LISTED HERE, THE 2481 02:25:18,640 --> 02:25:27,800 TLR4 THAT HAVE SUPERIOR 2482 02:25:27,800 --> 02:25:29,640 THERMOSTABILITY, STRONG SAFETY 2483 02:25:29,640 --> 02:25:31,880 AND EFFICACY PROFILE ACROSS 2484 02:25:31,880 --> 02:25:33,760 MULTIPLE ANTIGENS AND ANIMAL 2485 02:25:33,760 --> 02:25:36,160 MODELS. 2486 02:25:36,160 --> 02:25:40,160 THEY ARE EXTREMELY FORMULATED 2487 02:25:40,160 --> 02:25:41,800 IN DIFFERENT CHARACTERISTICS, 2488 02:25:41,800 --> 02:25:47,960 CAN BE INCORPORATED IN 2489 02:25:47,960 --> 02:25:51,480 LIPOSOMES, EMULSANTS OR ALUM 2490 02:25:51,480 --> 02:25:55,480 AND CAN GREATLY PRODUCE THE 2491 02:25:55,480 --> 02:25:58,120 IMMUNE RESPONSE OF THE 2492 02:25:58,120 --> 02:25:58,680 ADJUVANT ITSELF. 2493 02:25:58,680 --> 02:26:03,600 THEN WE HAVE THE TLR7/8, 2494 02:26:03,600 --> 02:26:04,800 REALLY STRONG PRODUCING 2495 02:26:04,800 --> 02:26:06,400 ADJUVANTS AND AGAIN CAN BE 2496 02:26:06,400 --> 02:26:07,680 FORMULATED AND DELIVERED IN A 2497 02:26:07,680 --> 02:26:10,600 VARIETY OF DIFFERENT WAYS, 2498 02:26:10,600 --> 02:26:11,800 BOTH INTRAMUSCULAR AND 2499 02:26:11,800 --> 02:26:14,200 INTEREST THAT NAVAL DELIVERING 2500 02:26:14,200 --> 02:26:16,600 A STRONG TH1 AND CMI RESPONSE. 2501 02:26:16,600 --> 02:26:19,520 AND THEN PROBABLY OUR MOST 2502 02:26:19,520 --> 02:26:22,640 UNIQUE PR AGO FIFTH 2503 02:26:22,640 --> 02:26:27,920 REPRESENTED BY OUR MEANINGFUL 2504 02:26:27,920 --> 02:26:35,640 AGO FIFTH AND THE UM-1098 IS A 2505 02:26:35,640 --> 02:26:37,360 NOVEL MINCLE AGO FIFTH THAT 2506 02:26:37,360 --> 02:26:40,800 PRODUCES A STRONG TH17 IMMUNE 2507 02:26:40,800 --> 02:26:45,080 PROFILE WHICH CAN BE IMPORTANT 2508 02:26:45,080 --> 02:26:50,680 IN FUNGAL PATHOGENS SUCH AS TB 2509 02:26:50,680 --> 02:26:55,640 AND EASILY FORM FORMULATED IN 2510 02:26:55,640 --> 02:26:58,360 LIPOSOME 'EM MULLS OR NAN MOW 2511 02:26:58,360 --> 02:26:59,520 PARTICLES AS WELL. 2512 02:26:59,520 --> 02:27:01,120 IN LATE STAGE, WE HAVE A 2513 02:27:01,120 --> 02:27:02,880 NUMBER OF SYSTEMS THAT Dr. 2514 02:27:02,880 --> 02:27:04,520 MILLER PRESENTED ON JUST A 2515 02:27:04,520 --> 02:27:10,120 LITTLE BIT AGO WHICH IS A 2516 02:27:10,120 --> 02:27:20,720 NOVEL COMBINATION OF OUR TLR4 2517 02:27:23,080 --> 02:27:27,000 AND INI2002 AND CAN INUSE IT A 2518 02:27:27,000 --> 02:27:29,440 REALLY NICE BALANCE OF 2519 02:27:29,440 --> 02:27:33,760 ANTIBODY AND IMMUNE RESPONSE. 2520 02:27:33,760 --> 02:27:37,680 AND THEN WE HAVE A NOVEL STING 2521 02:27:37,680 --> 02:27:39,760 AGO FIFTH, THOSE WERE A LITTLE 2522 02:27:39,760 --> 02:27:42,520 EARLIER BUT WE HAVE A FEW LEAD 2523 02:27:42,520 --> 02:27:45,880 MOLECULES ADVANCING AND THEN 2524 02:27:45,880 --> 02:27:49,160 EARLIER STILL, AN IL-1 BETA AT 2525 02:27:49,160 --> 02:27:53,040 THE UNIVERSITY OF MONTANA TO 2526 02:27:53,040 --> 02:27:55,440 DISCOVER NOVEL SYNTHETIC 2527 02:27:55,440 --> 02:27:58,440 COMPOUNDS WITH ADJUVANT 2528 02:27:58,440 --> 02:27:59,000 ACTIVITY. 2529 02:27:59,000 --> 02:28:00,600 SO THIS SLIDE KIND OF 2530 02:28:00,600 --> 02:28:06,680 SUMMARIZES WHAT I JUST TOLD 2531 02:28:06,680 --> 02:28:13,080 YOU, THE DIFFERENT PAR THESE 2532 02:28:13,080 --> 02:28:15,720 ARE AGONIZING, IN 2002 AND 2533 02:28:15,720 --> 02:28:23,480 2004, THIS IS A COMBINATION OF 2534 02:28:23,480 --> 02:28:28,800 INI2002 WITH TLR4 AND THEN THE 2535 02:28:28,800 --> 02:28:31,000 SECOND SYSTEM, THE 2004 2536 02:28:31,000 --> 02:28:36,520 COMBINED WITH A COMPONENT, THE 2537 02:28:36,520 --> 02:28:47,120 4001 WITH TLR7/8 AND THEN THE 2538 02:28:49,280 --> 02:28:53,560 COMBINATION OF TRAC-478 AND 2539 02:28:53,560 --> 02:28:57,880 TLR4 WITH SAPONIN AND LEADING 2540 02:28:57,880 --> 02:29:00,720 TO THE MINCLE AND THAT INDUCES 2541 02:29:00,720 --> 02:29:08,360 THE ROUTES OF DELIVERY TO BE 2542 02:29:08,360 --> 02:29:09,800 USED UNIVERSALLY INTRANAVAL, 2543 02:29:09,800 --> 02:29:11,240 INTRAMUSCULAR AND THEN THE 2544 02:29:11,240 --> 02:29:12,440 DIFFERENT TOXICITY STAGES 2545 02:29:12,440 --> 02:29:13,040 THESE ARE AT. 2546 02:29:13,040 --> 02:29:15,720 I SHOULD POINT OUT THE 2004 2547 02:29:15,720 --> 02:29:19,760 HAS JUST STARTED A PHASE 1 2548 02:29:19,760 --> 02:29:22,680 CLINICAL TRIAL FOR ALLERGY IN 2549 02:29:22,680 --> 02:29:24,120 A NASAL IN STKPRAEULZ THAT IS 2550 02:29:24,120 --> 02:29:29,280 THE SAME DOSE WE WOULD USE AS 2551 02:29:29,280 --> 02:29:30,920 A VACCINE AGO FIFTH 2552 02:29:30,920 --> 02:29:31,800 INTRANASAL. 2553 02:29:31,800 --> 02:29:34,000 AND THEN YOU CAN SEE AT THE 2554 02:29:34,000 --> 02:29:36,360 BOTTOM THE QR CODE TO THE 2555 02:29:36,360 --> 02:29:38,000 VACCINE COMPENDIUM SO IF YOU 2556 02:29:38,000 --> 02:29:39,960 NEED MORE INFORMATION, YOU CAN 2557 02:29:39,960 --> 02:29:40,560 ACCESS IT THERE. 2558 02:29:40,560 --> 02:29:42,520 THANK YOU AND I WOULD BE HAPPY 2559 02:29:42,520 --> 02:29:46,120 TO ANSWER ANY QUESTIONS LATER. 2560 02:29:46,120 --> 02:29:51,000 >> THANK YOU VERY MUCH. 2561 02:29:51,000 --> 02:29:52,520 THE NEXT PRESENTATIONS 2562 02:29:52,520 --> 02:30:03,120 PRESENTATION WILL BE NIKOLAI 2563 02:30:03,400 --> 02:30:04,240 PETROVSKI ON ADJUVANTS. 2564 02:30:04,240 --> 02:30:06,320 >>THANK YOU, IF I COULD HAVE 2565 02:30:06,320 --> 02:30:08,480 THE SLIDES PLEASE IN NEXT 2566 02:30:08,480 --> 02:30:09,280 SLIDE. 2567 02:30:09,280 --> 02:30:12,320 SO YEAH IF WE -- SORRY, BACK 2568 02:30:12,320 --> 02:30:17,480 ONE. 2569 02:30:17,480 --> 02:30:17,960 BACK ONE SLIDE. 2570 02:30:17,960 --> 02:30:23,360 >>I THINK IT IS JUST DELAYED. 2571 02:30:23,360 --> 02:30:29,960 >>OH, I SEE, SORRY. 2572 02:30:29,960 --> 02:30:31,840 SO YEAH, YOU COULD GO TO THE 2573 02:30:31,840 --> 02:30:34,360 NEXT SLIDE. 2574 02:30:34,360 --> 02:30:37,600 SO WE STARTED THIS PROGRAM AT 2575 02:30:37,600 --> 02:30:48,160 NIH ALMOST 20 YEARS AGO WITH 2576 02:30:49,000 --> 02:30:53,520 OUR ADJUTANT DELTA INULIN, 2577 02:30:53,520 --> 02:30:57,000 CRYSTAL LIESS INTO STRUCTURES 2578 02:30:57,000 --> 02:30:59,920 AND DEVELOPS A UNIQUE INULIN 2579 02:30:59,920 --> 02:31:02,120 PROPERTY PARTICULARLY IF IT IS 2580 02:31:02,120 --> 02:31:08,040 FORMULATED WITH AN ANTIGEN AND 2581 02:31:08,040 --> 02:31:13,480 HENCE THE ANTIBODY RESPONSE 2582 02:31:13,480 --> 02:31:22,440 AND THE UNIQUE PROPERTIES WAS 2583 02:31:22,440 --> 02:31:26,840 IT HAD ANTIGEN PROPERTIES AND 2584 02:31:26,840 --> 02:31:35,720 FOR INSTANCE DIDN'T ACTIVATE 2585 02:31:35,720 --> 02:31:40,760 ANY ISSUES AND THE LONG AND 2586 02:31:40,760 --> 02:31:51,280 THE SHORT OF IT WAS EFFICACY 2587 02:31:51,800 --> 02:31:58,800 AND CONDUCTING A SWELLING IN 2588 02:31:58,800 --> 02:32:05,640 THE FOOT PAD AND A GOOD 2589 02:32:05,640 --> 02:32:07,960 ADJUTANT MAKES A HAPPY AND 2590 02:32:07,960 --> 02:32:11,920 HEALTHY BABY AND WHAT WE WERE 2591 02:32:11,920 --> 02:32:15,960 ABLE TO SEE IN LOOKING AT THE 2592 02:32:15,960 --> 02:32:17,960 SURVIVAL OF MOUSE PUPS AT ONE 2593 02:32:17,960 --> 02:32:22,680 DAY OF AGE, INJECTED WITH 2594 02:32:22,680 --> 02:32:24,320 ININFLUENZA VACCINE AND A LOT 2595 02:32:24,320 --> 02:32:26,840 OF PEOPLE ARE AWARE THEY WORK 2596 02:32:26,840 --> 02:32:30,680 IN ADULTS BUT NOT IN NEWBORNS 2597 02:32:30,680 --> 02:32:35,840 SO THE PUPS WOULD DIE AND SO 2598 02:32:35,840 --> 02:32:40,800 WE INCLUDED THE INULIN WHICH 2599 02:32:40,800 --> 02:32:42,120 RESULTED IN A COMPLETE 2600 02:32:42,120 --> 02:32:42,520 SURVIVAL. 2601 02:32:42,520 --> 02:32:45,200 SO WE WERE ABLE TO SHOW THIS 2602 02:32:45,200 --> 02:32:48,400 IS EXTREMELY DURABLE AND THE 2603 02:32:48,400 --> 02:32:52,160 SINGLE DOSE IN THE MOUSE PUPS 2604 02:32:52,160 --> 02:33:01,960 SURVIVING THESE WITH THE 2605 02:33:01,960 --> 02:33:03,000 FORMULATED INULINA VANITY AND 2606 02:33:03,000 --> 02:33:09,680 LOOK AT THEM SIX MONTHS LATER 2607 02:33:09,680 --> 02:33:11,600 AND COULD ANALYZE THE 2608 02:33:11,600 --> 02:33:12,000 PROJECTION. 2609 02:33:12,000 --> 02:33:15,120 NEXT SLIDE. 2610 02:33:15,120 --> 02:33:19,520 BUT LIKE EVERYONE, WE DIDN'T 2611 02:33:19,520 --> 02:33:26,480 REST ON OUR LAURELS WITH AND 2612 02:33:26,480 --> 02:33:33,640 USING AI TO IDENTIFY THE 2613 02:33:33,640 --> 02:33:35,040 AGOIFTS. 2614 02:33:35,040 --> 02:33:37,680 WHAT WE FOUND, THERE ARE MANY 2615 02:33:37,680 --> 02:33:42,080 DIFFERENT CLR AGOIFTS AS WELL 2616 02:33:42,080 --> 02:33:45,680 AS OTHERS AND ABLE TO PROVIDE 2617 02:33:45,680 --> 02:33:48,680 A BENEFIT AND AS A CONSTANT A 2618 02:33:48,680 --> 02:33:52,400 COUPLE OF YEARS AGO WE HAD A 2619 02:33:52,400 --> 02:33:53,160 ADJUTANT DISCOVERY CONTRACT 2620 02:33:53,160 --> 02:34:00,720 WHERE WE WERE USING ARTIFICIAL 2621 02:34:00,720 --> 02:34:10,320 INTELLIGENCE TO IDENTIFY HUMOR 2622 02:34:10,320 --> 02:34:18,360 ANIMAL AGOIFTS AND SO WE 2623 02:34:18,360 --> 02:34:28,960 ARRIVED AT THE CYS VA C2, THEN 2624 02:34:37,000 --> 02:34:39,440 CPG AND CPG AND WITH THIS 2625 02:34:39,440 --> 02:34:43,360 FUSION WE WERE ABLE TO PROTECT 2626 02:34:43,360 --> 02:34:47,800 MICE AGAINST AN AREA SO WILL 2627 02:34:47,800 --> 02:34:52,200 MICRO BACTERIAL TB CHALLENGE 2628 02:34:52,200 --> 02:34:53,480 REDUCING LUNG INFECTION ALONG 2629 02:34:53,480 --> 02:34:56,800 THE SAME ORDER YOU MIGHT SEE 2630 02:34:56,800 --> 02:34:58,320 WITH VPT VACCINE. 2631 02:34:58,320 --> 02:35:03,480 AND AGAIN, I WON'T GO INTO 2632 02:35:03,480 --> 02:35:06,200 THIS MORE AS IT WAS 2633 02:35:06,200 --> 02:35:07,400 EXPENSIVELY PUBLISHED BUT 2634 02:35:07,400 --> 02:35:12,120 SUFFICE TO SAY THAT AN 2635 02:35:12,120 --> 02:35:15,040 INTRAMUSCULAR VACCINATION MORE 2636 02:35:15,040 --> 02:35:19,440 RECENTLY HAS BEEN FOUND TO 2637 02:35:19,440 --> 02:35:22,800 CARRY THE LOAD FOR THE 2638 02:35:22,800 --> 02:35:23,600 VACCINE. 2639 02:35:23,600 --> 02:35:24,000 NEXT SLIDE. 2640 02:35:24,000 --> 02:35:26,240 SO FOR YEARS YOU WORK EASILY 2641 02:35:26,240 --> 02:35:28,520 TO PUT THIS INFORMATION IN A 2642 02:35:28,520 --> 02:35:35,880 FREE SLIDE BUT SUFFICE TO SAY 2643 02:35:35,880 --> 02:35:40,400 THERE IS QUITE A DISEASE MODEL 2644 02:35:40,400 --> 02:35:47,400 LIST USED IN ADVAX ADJUVANT 2645 02:35:47,400 --> 02:35:48,240 TESTING. 2646 02:35:48,240 --> 02:35:49,000 NEXT SLIDE. 2647 02:35:49,000 --> 02:35:52,880 AS I MENTIONED BEFORE, ONE OF 2648 02:35:52,880 --> 02:35:57,760 THE DUTIES OF THIS PLATFORM 2649 02:35:57,760 --> 02:36:02,480 APART FROM ITS EFFICACY IS IT 2650 02:36:02,480 --> 02:36:06,160 IS VERY GOOD AT DIAGNOSING 2651 02:36:06,160 --> 02:36:10,440 HUMAN EFFICACY SO WHAT YOU SEE 2652 02:36:10,440 --> 02:36:19,560 HERE, I FOCUSSED ON A VAXINE 2653 02:36:19,560 --> 02:36:21,680 WHICH IS NOW APPROVED TO BE 2654 02:36:21,680 --> 02:36:28,560 USED IN THE MIDDLE EAST AND BY 2655 02:36:28,560 --> 02:36:31,760 ADDING THE GPG ADJUVANT, IT 2656 02:36:31,760 --> 02:36:36,000 SPIKED THE NUMBER OF T CELLS 2657 02:36:36,000 --> 02:36:41,200 BUT EVEN WITH CPG, YOU CAN SEE 2658 02:36:41,200 --> 02:36:47,680 THE T CELLS ACTIVATED AND WITH 2659 02:36:47,680 --> 02:36:52,400 THE PROTEIN, IT INCREASES THE 2660 02:36:52,400 --> 02:36:55,760 T CELLS BUT ALSO CTL ACTIVITY. 2661 02:36:55,760 --> 02:37:06,280 SO IF YOU LOOK AT CYTOTOXIC 2662 02:37:18,480 --> 02:37:24,680 KILLING, YOU CAN SEE THE 2663 02:37:24,680 --> 02:37:27,040 ACTIVATED T CELLS. 2664 02:37:27,040 --> 02:37:27,520 [INDISCERNIBLE] 2665 02:37:27,520 --> 02:37:27,920 NEXT SLIDE. 2666 02:37:27,920 --> 02:37:29,840 SO AS I MENTIONED THERE WERE 2667 02:37:29,840 --> 02:37:33,480 MORE THAN A HUNDRED CASES ON 2668 02:37:33,480 --> 02:37:35,360 THESE DIFFERENT STUDIES DONE 2669 02:37:35,360 --> 02:37:35,880 WITH THE ADJUVANTS. 2670 02:37:35,880 --> 02:37:38,080 I AM HAPPY TO SHARE ANY OF 2671 02:37:38,080 --> 02:37:38,720 THESE. 2672 02:37:38,720 --> 02:37:39,680 MOSTLY ARE FREELY AVAILABLE 2673 02:37:39,680 --> 02:37:44,080 AND THIS IS LISTED ON THE 2674 02:37:44,080 --> 02:37:45,920 DATABASE SO JUST GIVE ME A 2675 02:37:45,920 --> 02:37:47,880 TOUCH AND I WILL BE HAPPY TO 2676 02:37:47,880 --> 02:37:51,320 FORWARD THEM TO YOU. 2677 02:37:51,320 --> 02:37:51,720 NEXT SLIDE. 2678 02:37:51,720 --> 02:37:55,880 SO THIS TO WRAP UP, I THINK 2679 02:37:55,880 --> 02:37:57,520 THE ADVANTAGE OF THE PLATFORM, 2680 02:37:57,520 --> 02:37:59,320 IT IS EASY TO MANUFACTURE. 2681 02:37:59,320 --> 02:38:09,880 YOU KNOW, WE CAN DO THIS WITH 2682 02:38:22,240 --> 02:38:24,880 CPG55 WITH OVER 5000 VACCINES, 2683 02:38:24,880 --> 02:38:34,640 IT HAS LOW REACTIVITY, IMMUNEO 2684 02:38:34,640 --> 02:38:39,400 GENUINE NICK, WE GET SUPERIOR 2685 02:38:39,400 --> 02:38:43,440 YOUR TRANSLATION FROM MICE TO 2686 02:38:43,440 --> 02:38:47,360 HUMANS AND WITH THE TLR 2687 02:38:47,360 --> 02:38:50,960 ADJUVANTS IN THE PIPELINE. 2688 02:38:50,960 --> 02:38:56,760 AND IS ABLE TO BE DISABLED 2689 02:38:56,760 --> 02:39:00,600 ALMOST INDEFINITELY AND WE 2690 02:39:00,600 --> 02:39:04,360 KNOW THE FORMULATION IS EASY 2691 02:39:04,360 --> 02:39:10,440 TO STORE AT ROOM TEMPERATURE. 2692 02:39:10,440 --> 02:39:13,640 AND THE CPG55.2 WE BELIEVE IS 2693 02:39:13,640 --> 02:39:17,760 THE MOST POTENT AGO FIFTH 2694 02:39:17,760 --> 02:39:23,520 AVAILABLE AND TEN TIMES MORE 2695 02:39:23,520 --> 02:39:27,080 POTENT THAN CPG18 OR TLR9. 2696 02:39:27,080 --> 02:39:32,280 THAT CAN BE FORMULATED BUT 2697 02:39:32,280 --> 02:39:34,000 FORMULATED INDIVIDUALLY WITH 2698 02:39:34,000 --> 02:39:39,400 ALUM, TO MAKE A ALUM-CPG 2699 02:39:39,400 --> 02:39:41,480 FORMULATION WHICH WE ARE NOW 2700 02:39:41,480 --> 02:39:43,320 TESTING AND SUFFICE TO SAY WE 2701 02:39:43,320 --> 02:39:52,360 CONTINUE TO DEVELOP OTHER CL T 2702 02:39:52,360 --> 02:39:54,400 L.A. ADJUVANTS WITH ADDITIONAL 2703 02:39:54,400 --> 02:39:56,360 ADJUVANTS IN THE PIPELINE AND 2704 02:39:56,360 --> 02:39:58,800 AGAIN, VERY HAPPY TO PROVIDE 2705 02:39:58,800 --> 02:40:00,960 THESE AS PART OF THE 2706 02:40:00,960 --> 02:40:01,360 COLLABORATION. 2707 02:40:01,360 --> 02:40:03,160 THANK YOU VERY MUCH. 2708 02:40:03,160 --> 02:40:04,480 >>THANK YOU VERY MUCH FOR 2709 02:40:04,480 --> 02:40:07,200 THAT PRESENTATION. 2710 02:40:07,200 --> 02:40:17,800 I AM LOOKING ON TO DOCTOR SUM 2711 02:40:22,080 --> 02:40:25,360 IL DAVID. 2712 02:40:25,360 --> 02:40:27,680 >>THANK YOU DAVID, SO THE 2713 02:40:27,680 --> 02:40:38,160 TALK TODAY WILL BE ON THE 2714 02:40:40,240 --> 02:40:41,400 ALHYDROXIQUIM-II AND AS SHOWN 2715 02:40:41,400 --> 02:40:49,440 IN RED IS A POTENT MOLECULE. 2716 02:40:49,440 --> 02:40:57,280 THIS IS BLENDED WITH ALUMINUM 2717 02:40:57,280 --> 02:40:58,920 HYDROXI AND SPECIFICALLY 2718 02:40:58,920 --> 02:41:03,240 ALLOWS BINDING ON THE SURFACE 2719 02:41:03,240 --> 02:41:13,680 TO LIGAND EXCHANGE OR 2720 02:41:15,240 --> 02:41:16,200 CHEMISORBTION WHERE IT 2721 02:41:16,200 --> 02:41:19,800 EXCHANGES ON THE LOOM HIM IN 2722 02:41:19,800 --> 02:41:20,360 HYDROXIDE SURFACE. 2723 02:41:20,360 --> 02:41:21,640 THE CONSEQUENCE OF THIS IS 2724 02:41:21,640 --> 02:41:24,000 SHOWN IN THE NEXT SLIDE AND 2725 02:41:24,000 --> 02:41:32,280 THIS ALLOWS FOR A VERY 2726 02:41:32,280 --> 02:41:35,720 SPECIFIC AND SUBSTANTIAL ALUM 2727 02:41:35,720 --> 02:41:39,960 CRUCIAL ON PRECISION INJECTING 2728 02:41:39,960 --> 02:41:43,200 THE SMALL MOLECULE INTO THE 2729 02:41:43,200 --> 02:41:44,960 CELL AND EVEN MORE 2730 02:41:44,960 --> 02:41:55,520 IMPORTANTLY, IT IS BECAUSE OF 2731 02:41:55,880 --> 02:41:59,680 THE ALUM THAT IT PROVIDES THE 2732 02:41:59,680 --> 02:42:01,080 DRAINING LYMPH NODE WHERE IT 2733 02:42:01,080 --> 02:42:05,240 IS NEEDED TO CONJUNCTION WITH 2734 02:42:05,240 --> 02:42:06,360 THE ADJUTANT WHICH WILL ALSO 2735 02:42:06,360 --> 02:42:08,880 RISE UP TO THE LYMPH NODE. 2736 02:42:08,880 --> 02:42:10,720 AND THE STRUCTURE I SHOWED YOU 2737 02:42:10,720 --> 02:42:12,920 IN THE PREVIOUS SLIDE BECAUSE 2738 02:42:12,920 --> 02:42:19,360 THE ALUM, IT IS STABLE AND THE 2739 02:42:19,360 --> 02:42:29,840 ADJUTANT CAN BE AUTOCLATED 2740 02:42:31,960 --> 02:42:34,480 WITH THE SMALL MOLECULE AGAIN 2741 02:42:34,480 --> 02:42:36,600 SHOWING THE STABILITY OF THE 2742 02:42:36,600 --> 02:42:37,880 SMALL MOLECULE. 2743 02:42:37,880 --> 02:42:38,720 NEXT SLIDE, PLEASE. 2744 02:42:38,720 --> 02:42:49,320 SHOWN ON THE RIGHT IS THE NEW 2745 02:42:50,040 --> 02:42:59,800 ANTIBODY IN HORSES COMPARING 2746 02:42:59,800 --> 02:43:04,160 THE T CELL IMMUNITY TO LIVE 2747 02:43:04,160 --> 02:43:04,680 TITERS. 2748 02:43:04,680 --> 02:43:09,240 ON THE LEFT IS SHOWN A PRETTY 2749 02:43:09,240 --> 02:43:13,560 PRONOUNCED REACTION FROM T 2750 02:43:13,560 --> 02:43:17,960 CELL THAT HAS BEEN SHOWN IN 2751 02:43:17,960 --> 02:43:21,560 MICE AND PUBLISHED, ADJUVANTED 2752 02:43:21,560 --> 02:43:30,480 WITH THE ALUM OR WITH 2753 02:43:30,480 --> 02:43:32,600 ALHYDROXIQUIM-II AND AS 2754 02:43:32,600 --> 02:43:35,320 EXPECTED FOR A USEFUL STUDY 2755 02:43:35,320 --> 02:43:43,280 LIKE THIS, THIS IS STRONG 2756 02:43:43,280 --> 02:43:46,280 SHOWING FOR AN IMMUNE 2757 02:43:46,280 --> 02:43:56,520 RESPONSE. 2758 02:44:51,960 --> 02:44:54,920 NEXT SLIDE, PLEASE SO THAT IS 2759 02:44:54,920 --> 02:44:56,560 SHOWING THE EFFICACY OF THE 2760 02:44:56,560 --> 02:45:01,360 STUDY, THANK YOU VERY MUCH. 2761 02:45:01,360 --> 02:45:02,960 >>NEXT WE HAVE GABRIEL. 2762 02:45:02,960 --> 02:45:06,560 >>THANK YOU VERY MUCH, I WILL 2763 02:45:06,560 --> 02:45:14,440 JUST CONTINUE HERE WITH THE 2764 02:45:14,440 --> 02:45:18,840 CAF ADJUVANT FORM LAKES WITH 2765 02:45:18,840 --> 02:45:20,400 CATIONIC, MIXED WITH DDA AND 2766 02:45:20,400 --> 02:45:24,680 THEN WE HAVE A MINCLE AGO 2767 02:45:24,680 --> 02:45:27,720 FIFTH WHICH IS A TD B OR MMG 2768 02:45:27,720 --> 02:45:32,320 WHICH FUNCTIONS TO STABLE ICE 2769 02:45:32,320 --> 02:45:34,720 LIPOSOMES AND SO IT COULD BE 2770 02:45:34,720 --> 02:45:35,440 USED LATER. 2771 02:45:35,440 --> 02:45:40,360 THIS GIVES A STABLE AND WELL 2772 02:45:40,360 --> 02:45:41,200 CHARACTERIZED LIPOSOME WITH 2773 02:45:41,200 --> 02:45:48,080 MORE THAN THREE YEARS' 2774 02:45:48,080 --> 02:45:55,680 SHELF-LIFE AT 2-8 DEGREES. 2775 02:45:55,680 --> 02:45:59,320 IT IS UPSCALABLE WITH GM P FOR 2776 02:45:59,320 --> 02:46:00,520 THE MANUFACTURING PROCESS. 2777 02:46:00,520 --> 02:46:02,240 NEXT SLIDE, PLEASE. 2778 02:46:02,240 --> 02:46:06,560 SO WE HAVE IN CLINICAL TRIALS, 2779 02:46:06,560 --> 02:46:17,160 WE HAVE THREE DIFFERENT ADJUVA. 2780 02:46:17,160 --> 02:46:17,760 2781 02:46:17,760 --> 02:46:21,200 ONE IS CAF01 WHICH IS USED IN 2782 02:46:21,200 --> 02:46:25,080 FIVE FINALIZED AND ONE ONGOING 2783 02:46:25,080 --> 02:46:27,200 PHASE 1 TRIALS. 2784 02:46:27,200 --> 02:46:29,080 IT HAS FOUR DIFFERENT ANTIGENS 2785 02:46:29,080 --> 02:46:34,720 AND THE PROFILE IS VERY STRONG 2786 02:46:34,720 --> 02:46:40,200 WITH TH1, TH17 AS WELL AS 2787 02:46:40,200 --> 02:46:45,600 ANTIBODY RESPONSES SO WE HAVE 2788 02:46:45,600 --> 02:46:47,600 SEEN THESE IN THESE STUDIES. 2789 02:46:47,600 --> 02:46:51,960 THEN WE HAVE THE NEXT ONE 2790 02:46:51,960 --> 02:46:56,720 WHICH IS CAF09B USED IN TWO 2791 02:46:56,720 --> 02:46:58,880 FINALIZED PHASE 1, USED IN A 2792 02:46:58,880 --> 02:47:02,280 COUPLE OF TRIALS WITH CANCER 2793 02:47:02,280 --> 02:47:11,560 WITH TAA AND NEOEPITOPES AND A 2794 02:47:11,560 --> 02:47:16,000 STRONG CTL INDUCTION IN THE 2795 02:47:16,000 --> 02:47:18,560 TWO FINALIZED PHASE 1 TRIALS. 2796 02:47:18,560 --> 02:47:23,960 AND THE NEWEST CAF ADJUVANT WE 2797 02:47:23,960 --> 02:47:27,840 HAVE IS THE 10B WHICH 2798 02:47:27,840 --> 02:47:30,080 INCORPORATESTLR9 AGO FIFTH AND 2799 02:47:30,080 --> 02:47:32,640 WE HAVE ONE SCHEDULED PHASE 1 2800 02:47:32,640 --> 02:47:33,200 CLINICAL TRIAL. 2801 02:47:33,200 --> 02:47:41,880 WA WE HAVE SEEN WITH CAF10B IS 2802 02:47:41,880 --> 02:47:45,920 INCREASED TH1 AND TH17 AND 2803 02:47:45,920 --> 02:47:48,160 ANTIBODY RESPONSES IN NONHUMAN 2804 02:47:48,160 --> 02:47:49,880 PRIMATES. 2805 02:47:49,880 --> 02:47:51,640 NEXT SLIDE, PLEASE. 2806 02:47:51,640 --> 02:47:53,480 SO THE CAF ADJUVANTS HAVE BEEN 2807 02:47:53,480 --> 02:47:58,720 FOUND TO BE SAFE IN SEVERAL 2808 02:47:58,720 --> 02:48:03,640 STUDIES, FINALIZED AND ONGOING 2809 02:48:03,640 --> 02:48:09,640 PHASE 1 TRIALS. 2810 02:48:09,640 --> 02:48:13,640 ALSO WE HAVE ESTABLISHED MOA 2811 02:48:13,640 --> 02:48:22,400 AND SIMPLE MIXING OF ANTIGEN 2812 02:48:22,400 --> 02:48:23,840 FOR ADJUVANT. 2813 02:48:23,840 --> 02:48:26,480 IT IS SIMPLE TO USE WITH THE 2814 02:48:26,480 --> 02:48:31,080 MIXING OF ANTIGEN WITH 2815 02:48:31,080 --> 02:48:35,640 ADJUVANT AND HAVE SEEN THIS 2816 02:48:35,640 --> 02:48:39,440 WITH PROTEINS, PEPTIDES, 2817 02:48:39,440 --> 02:48:42,080 INACTIVATED VIRA AND SPLIT 2818 02:48:42,080 --> 02:48:48,280 VIRUS AND MRNA AND THEY ARE 2819 02:48:48,280 --> 02:48:52,000 AVAILABLE FOR COLLABORATION 2820 02:48:52,000 --> 02:48:55,360 FOR NONGM P MATERIAL IS IT L 2821 02:48:55,360 --> 02:48:57,720 AND COLLABORATION WITH CRODA 2822 02:48:57,720 --> 02:48:59,200 FOR LARGE SCALE PRODUCTION. 2823 02:48:59,200 --> 02:49:02,000 >>THANK YOU VERY MUCH, SORRY 2824 02:49:02,000 --> 02:49:03,840 FOR THE TECHS TECHNICAL ISSUES 2825 02:49:03,840 --> 02:49:07,080 WERE BEFORE, HOPE MY AUDIO IS 2826 02:49:07,080 --> 02:49:17,320 BACK NOW. 2827 02:49:25,480 --> 02:49:32,120 THE NEXT TALK WE HAVE MANGALA 2828 02:49:32,120 --> 02:49:32,760 RA RAO. 2829 02:49:32,760 --> 02:49:34,160 >>GOOD MORNING, CAN YOU HEAR 2830 02:49:34,160 --> 02:49:35,080 ME? 2831 02:49:35,080 --> 02:49:35,600 >>YES, WE CAN. 2832 02:49:35,600 --> 02:49:38,720 >> SO TODAY I WILL TALK ABOUT 2833 02:49:38,720 --> 02:49:42,680 ARMY LIP TOMORROW FORMULATION 2834 02:49:42,680 --> 02:49:43,040 ADJUVANT. 2835 02:49:43,040 --> 02:49:46,920 OVER THE YEARS THEY HAVE BEEN 2836 02:49:46,920 --> 02:49:57,520 COMBINED AND ONE OF THEM IS U 2837 02:50:03,680 --> 02:50:07,480 AND THESE CONSIST OF LIPIDS 2838 02:50:07,480 --> 02:50:10,960 WITH ALF Q&A LFQA AND AS YOU 2839 02:50:10,960 --> 02:50:14,520 CAN SEE CAN BE MIXED TO ANY 2840 02:50:14,520 --> 02:50:16,880 STRENGTH YOU WANT. 2841 02:50:16,880 --> 02:50:26,040 THEY CAN BE USED WITH AFLQ OR 2842 02:50:26,040 --> 02:50:30,840 EXHAUST TO GENERATE ALFQ2 AND 2843 02:50:30,840 --> 02:50:33,320 ADDING IN THE LIPIDS. 2844 02:50:33,320 --> 02:50:37,320 SO WHAT IS THE DIFFERENCE? 2845 02:50:37,320 --> 02:50:47,840 THE MAJOR DIFFERENCES ARE IN 2846 02:50:48,840 --> 02:50:52,240 THE PHOSPHALLPID AND IN THE 2847 02:50:52,240 --> 02:51:02,560 AFL Q&A FLQA. 2848 02:51:03,920 --> 02:51:07,920 THE APPEARANCE OF AFLB IS BIG 2849 02:51:07,920 --> 02:51:17,960 AND YOU DO NOT GET MANY 2850 02:51:17,960 --> 02:51:18,640 PELLETS. 2851 02:51:18,640 --> 02:51:23,520 ALSO THE SIZE IS DIFFERENT, 2852 02:51:23,520 --> 02:51:34,080 WHERE YOU HAVE THE 51UM AND 2853 02:51:34,520 --> 02:51:36,720 PHOSPHOLLIPID RANGING FROM 2854 02:51:36,720 --> 02:51:38,480 30 MILLIMETERS TO ONE MICRON. 2855 02:51:38,480 --> 02:51:39,160 NEXT SLIDE. 2856 02:51:39,160 --> 02:51:48,640 SO ON THE NEXT SLIDE WE HAVE 2857 02:51:48,640 --> 02:51:55,080 THE STUDY OF THE -- THE SAMPLE 2858 02:51:55,080 --> 02:51:57,320 OF PRECLINICAL AND CLINICAL 2859 02:51:57,320 --> 02:52:04,800 STUDIES, YOU HAVE MALARIA IN 2860 02:52:04,800 --> 02:52:08,000 MICE, THE CAMPY CONJUGATE AND 2861 02:52:08,000 --> 02:52:18,720 ON THE RIGHT SIDE, THE HIV-1 2862 02:52:18,720 --> 02:52:22,080 ENVELOPE PROTEIN WITH GP120 2863 02:52:22,080 --> 02:52:23,800 SPECIFIC BONE MARROW PLASMA 2864 02:52:23,800 --> 02:52:24,200 CELLS. 2865 02:52:24,200 --> 02:52:30,880 AT THE BOTTOM, YOU SEE SARS 2866 02:52:30,880 --> 02:52:36,280 COV2 PHASE 1 STUDY WHICH WAS 2867 02:52:36,280 --> 02:52:38,720 FORMULATED SHOWING HIGH 2868 02:52:38,720 --> 02:52:42,440 NEUTRALIZING ANTIBODIES IN ALL 2869 02:52:42,440 --> 02:52:42,800 VACCINES. 2870 02:52:42,800 --> 02:52:44,520 THIS PORTION SOMEHOW IT NOT 2871 02:52:44,520 --> 02:52:46,520 COME OUT WELL BUT THAT IS 2872 02:52:46,520 --> 02:52:47,760 OKAY. 2873 02:52:47,760 --> 02:52:53,120 NEXT SLIDE, PLEASE. 2874 02:52:53,120 --> 02:52:56,000 THIS SHOWS THE PHASE 3 2875 02:52:56,000 --> 02:52:57,160 COMPLETED STUDIES WITH FOUR 2876 02:52:57,160 --> 02:52:57,960 TRIALS AND THERE ARE SEVERAL 2877 02:52:57,960 --> 02:53:01,640 MORE IN THE PIPELINE INCLUDING 2878 02:53:01,640 --> 02:53:08,600 TESTING OF SENSITIVE PEPTIDES 2879 02:53:08,600 --> 02:53:09,960 FOR INFLUENZA 2. 2880 02:53:09,960 --> 02:53:12,720 SO IN THIS CASE, YOU SEE THE 2881 02:53:12,720 --> 02:53:13,840 NUMBER OF DOSES ADMINISTERED 2882 02:53:13,840 --> 02:53:16,040 TODAY AND THE NUMBER OF PEOPLE 2883 02:53:16,040 --> 02:53:20,720 WHO HAVE BEEN ADMINISTERED AS 2884 02:53:20,720 --> 02:53:26,560 Q AND DOWN BELOW YOU SEE THE 2885 02:53:26,560 --> 02:53:28,840 ARTICLE 60 WHICH WAS MENTIONED 2886 02:53:28,840 --> 02:53:30,040 ABOUT THE PHASE 1 CLINICAL 2887 02:53:30,040 --> 02:53:32,600 TRIAL AND THE NUMBER OF PEOPLE 2888 02:53:32,600 --> 02:53:35,040 VACCINATED WHO RECEIVED THAT 2889 02:53:35,040 --> 02:53:35,480 ADJUVANT. 2890 02:53:35,480 --> 02:53:40,000 SO BASED ON THIS AS WELL AS 2891 02:53:40,000 --> 02:53:50,400 ONGOING STUDIES, THE 2892 02:53:51,520 --> 02:53:54,760 FORMULATIONS AFLQ WERE SAFE 2893 02:53:54,760 --> 02:54:00,720 AND THERE WERE NO PREVIOUS 2894 02:54:00,720 --> 02:54:07,280 EVENTS TO DATE. 2895 02:54:07,280 --> 02:54:15,160 THE ALF CAN BE READILY 2896 02:54:15,160 --> 02:54:17,040 COMBINED FOR MARKETABLE 2897 02:54:17,040 --> 02:54:19,040 EXISTING AND EMERGING LYNN 2898 02:54:19,040 --> 02:54:21,360 NEXTIOUS DISEASES. 2899 02:54:21,360 --> 02:54:25,280 THE ABILITY TO INCORPORATE 2900 02:54:25,280 --> 02:54:30,320 ALFQ ADJUVANTS IN EARLY 2901 02:54:30,320 --> 02:54:33,920 CLINICAL TRIALS, SUCCESSFULLY 2902 02:54:33,920 --> 02:54:39,000 MANUFACTURED AT 7.5 LITTERS OF 2903 02:54:39,000 --> 02:54:42,040 ALF55, CURRENTLY STABLE FOR 2904 02:54:42,040 --> 02:54:47,040 6.5 YEARS ON SAABABILITY 2905 02:54:47,040 --> 02:54:50,800 PROGRAM AND WILL SHOW 7.5 IN 2906 02:54:50,800 --> 02:54:51,280 OCTOBER. 2907 02:54:51,280 --> 02:54:57,640 THE ALFQ HAS BEEN USED IN 2908 02:54:57,640 --> 02:54:58,640 THREE RABBIT 2909 02:54:58,640 --> 02:54:59,240 PHARMACOLOGY-TOXICOLOGY 2910 02:54:59,240 --> 02:55:00,680 STUDIES WITH GOOD SAFETY 2911 02:55:00,680 --> 02:55:03,080 PROFILE AND NO ADVERSE 2912 02:55:03,080 --> 02:55:03,440 REACTIONS. 2913 02:55:03,440 --> 02:55:08,200 AND I WOULD LIKE TO THANK THE 2914 02:55:08,200 --> 02:55:10,600 LEADERSHIP, THE NUMEROUS 2915 02:55:10,600 --> 02:55:12,800 INTERNAL AND EXTERNAL 2916 02:55:12,800 --> 02:55:14,000 COLLABORATORS AND CLINICAL 2917 02:55:14,000 --> 02:55:15,240 TRIALISTS WHO WERE ALL 2918 02:55:15,240 --> 02:55:17,240 RESPONSIBLE FOR THIS 2919 02:55:17,240 --> 02:55:17,640 FORMULATION. 2920 02:55:17,640 --> 02:55:18,680 WE COULDN'T HAVE DONE IT 2921 02:55:18,680 --> 02:55:20,360 WITHOUT YOU AND ESPECIALLY 2922 02:55:20,360 --> 02:55:21,760 WITH THE CLINICAL TRIAL 2923 02:55:21,760 --> 02:55:22,200 PARTICIPANTS. 2924 02:55:22,200 --> 02:55:23,520 SO THANK YOU VERY MUCH. 2925 02:55:23,520 --> 02:55:26,880 NEXT SLIDE, IF YOU HAVE ANY 2926 02:55:26,880 --> 02:55:28,440 QUESTIONS, PLEASE SEND THEM IN 2927 02:55:28,440 --> 02:55:33,720 THE CHAT BOX. 2928 02:55:33,720 --> 02:55:35,520 THANK YOU. 2929 02:55:35,520 --> 02:55:36,120 >>THANK YOU. 2930 02:55:36,120 --> 02:55:41,160 MOVING ON TO THE NEXT 2931 02:55:41,160 --> 02:55:45,880 PRESENTATION BY Dr. CHAD 2932 02:55:45,880 --> 02:55:50,040 COSTLEY FROM BLUE WILLOW 2933 02:55:50,040 --> 02:55:50,440 BIOLOGICS. 2934 02:55:50,440 --> 02:55:51,560 >>THANK YOU, GOOD MORNING 2935 02:55:51,560 --> 02:55:52,480 ALL. 2936 02:55:52,480 --> 02:56:00,120 I WILL TALK ON THE INTRANASAL 2937 02:56:00,120 --> 02:56:01,080 VACCINE ADJUVANT PLATFORM, 2938 02:56:01,080 --> 02:56:01,920 MOVE ON. 2939 02:56:01,920 --> 02:56:06,680 SO I HAVE KEPT THIS SHORT AND 2940 02:56:06,680 --> 02:56:16,320 LEAVING OUT ANY DATA WOULD BE 2941 02:56:16,320 --> 02:56:19,160 DOING A DISSERVICE TO IT. 2942 02:56:19,160 --> 02:56:27,440 SO WE WILL TALK ABOUT THE 2943 02:56:27,440 --> 02:56:35,720 ANIMATION OF A NOVEL 2944 02:56:35,720 --> 02:56:36,720 INTRANASAL ADJUVANT PLATFORM. 2945 02:56:36,720 --> 02:56:38,520 IT IS DIFFERENTIATED BY THREE 2946 02:56:38,520 --> 02:56:40,280 THINGS, I WOULD ARGUE, THE 2947 02:56:40,280 --> 02:56:43,760 NATURE OF IMMUNE RESPONSE, THE 2948 02:56:43,760 --> 02:56:45,840 HUMAN SAFETY AND TOXICOLOGY, 2949 02:56:45,840 --> 02:56:48,720 SOME ARE PRICED WE ARE AS FAR 2950 02:56:48,720 --> 02:56:51,600 ALONG AS WE ARE, AND PLATFORM 2951 02:56:51,600 --> 02:56:52,000 FLEXIBILITY. 2952 02:56:52,000 --> 02:56:53,400 THE NATURE OF THE IMMUNE 2953 02:56:53,400 --> 02:56:58,680 RESPONSE, WE GET THE MUCOSAL 2954 02:56:58,680 --> 02:57:00,640 SYSTEMIC AND CELL-MEDIATED 2955 02:57:00,640 --> 02:57:02,480 IMMUNITY, THERE IS DECREASED 2956 02:57:02,480 --> 02:57:06,600 VIRAL CARRIAGE AND SHEDDING, 2957 02:57:06,600 --> 02:57:10,120 BIASED TH1 OVER TH2 AND B AND 2958 02:57:10,120 --> 02:57:14,320 T CELL HOMING TO MUCOSA FOR 2959 02:57:14,320 --> 02:57:15,120 LONG-TERM MEMORY. 2960 02:57:15,120 --> 02:57:17,640 WE HAVE BEEN IN A CLINICAL 2961 02:57:17,640 --> 02:57:21,120 TRIAL AND NEVER SEEN ANY 2962 02:57:21,120 --> 02:57:31,600 SERIOUS ADVERSE EVENT, 2963 02:57:32,040 --> 02:57:33,600 SPECIFICALLY ANY TOXIC 2964 02:57:33,600 --> 02:57:38,280 REACTION AND WE HAVE HAD 2965 02:57:38,280 --> 02:57:44,360 EXTENSIVE WORK FOR THAT. 2966 02:57:44,360 --> 02:57:45,520 NEXT SLIDE, PLEASE. 2967 02:57:45,520 --> 02:57:51,560 IT IS NEEDLE-FREE, LOW COST, 2968 02:57:51,560 --> 02:57:54,000 THERMOSTABLE, ESTABLISHED CMC 2969 02:57:54,000 --> 02:57:57,400 AND GM P, WELL ESTABLISHED AND 2970 02:57:57,400 --> 02:57:57,960 WELL CHARACTERIZED. 2971 02:57:57,960 --> 02:57:59,960 SO A LOT HAS BEEN ACCOMPLISHED 2972 02:57:59,960 --> 02:58:02,160 BY A SMALL COMPANY. 2973 02:58:02,160 --> 02:58:03,840 MECHANISM OF ACTION, I WILL 2974 02:58:03,840 --> 02:58:06,080 NOT SPEND MUCH TIME ON THIS 2975 02:58:06,080 --> 02:58:08,960 BUT HIGHLIGHT A FEW POINTS. 2976 02:58:08,960 --> 02:58:14,320 THE AND GENUINE IN DENDRITIC 2977 02:58:14,320 --> 02:58:19,920 CELLS, THE SAMPLING, YOU GET 2978 02:58:19,920 --> 02:58:25,320 UPREGULATION OF TLR2 AND TLR4, 2979 02:58:25,320 --> 02:58:28,360 SUPPRESSION OF TH2 SITES 2980 02:58:28,360 --> 02:58:31,800 CANES, ILC2 AND ALARMIN 2981 02:58:31,800 --> 02:58:32,200 PRODUCTION. 2982 02:58:32,200 --> 02:58:34,800 YOU GET ACTIVATION OF TH1 2983 02:58:34,800 --> 02:58:36,880 CELLS AND SITES KIND AND SEE 2984 02:58:36,880 --> 02:58:39,960 THE PRODUCTION OF SIG AN AND 2985 02:58:39,960 --> 02:58:40,640 TH17. 2986 02:58:40,640 --> 02:58:41,560 NEXT SLIDE, PLEASE. 2987 02:58:41,560 --> 02:58:43,720 THE PURPOSE OF THIS SLIDE IS 2988 02:58:43,720 --> 02:58:45,640 TO OVERWHELM YOU WITH TECH 2989 02:58:45,640 --> 02:58:47,000 BOXES WHICH I WILL NOT TALK 2990 02:58:47,000 --> 02:58:51,720 ABOUT IN THIS FORMAT BUT THE 2991 02:58:51,720 --> 02:58:55,080 POINT HERE IS THE EXTENT OF 2992 02:58:55,080 --> 02:58:55,800 THE WORK DONE. 2993 02:58:55,800 --> 02:59:02,960 ON THE LEFT YOU HAVE THE 2994 02:59:02,960 --> 02:59:04,800 PATHOGEN AND THE TYPES. 2995 02:59:04,800 --> 02:59:08,240 WE HAVE DONE HERPES PROGRAM, 2996 02:59:08,240 --> 02:59:10,880 FULL VIRUS VACCINE, SO THE 2997 02:59:10,880 --> 02:59:12,600 PLATFORM CAN INCORPORATE A 2998 02:59:12,600 --> 02:59:15,680 LARGE VARIETY OF ANTIGEN 2999 02:59:15,680 --> 02:59:16,040 TYPES. 3000 02:59:16,040 --> 02:59:17,680 PROOF OF CONCEPT HAS BEEN 3001 02:59:17,680 --> 02:59:22,000 ESTABLISHED IN SMALL AND LARGE 3002 02:59:22,000 --> 02:59:22,680 ANIMALS INCLUDING NONHUMAN 3003 02:59:22,680 --> 02:59:24,000 PRIMATES ACCORDING TO THE 3004 02:59:24,000 --> 02:59:26,720 CLINICAL WORK WE HAVE DONE AND 3005 02:59:26,720 --> 02:59:27,960 CHALLENGE SHEDDING AND ALL OF 3006 02:59:27,960 --> 02:59:29,720 THOSE THINGS LOOKED AT IN THE 3007 02:59:29,720 --> 02:59:30,880 SAFETY PROFILE. 3008 02:59:30,880 --> 02:59:33,000 WE CAN GO FORWARD. 3009 02:59:33,000 --> 02:59:34,560 THE LAST SLIDE I WILL LET 3010 02:59:34,560 --> 02:59:37,800 STAND ON ITS OWN AND WILL GO A 3011 02:59:37,800 --> 02:59:38,280 LITTLE OFFSCRIPT. 3012 02:59:38,280 --> 02:59:40,600 NOTHING I WILL SAY IS 3013 02:59:40,600 --> 02:59:42,320 DIFFERENT ON THIS SLIDE BUT I 3014 02:59:42,320 --> 02:59:45,400 WANT TO SPEAK TO SOME OF THE 3015 02:59:45,400 --> 02:59:46,720 EARLY CONVERSATIONS WE HAD 3016 02:59:46,720 --> 02:59:47,480 THIS MORNING. 3017 02:59:47,480 --> 02:59:51,480 THERE WAS TALK ABOUT THE 3018 02:59:51,480 --> 03:00:00,160 CHALLENGES PROVIDING SAFETY 3019 03:00:00,160 --> 03:00:02,480 AND GM P WITH ADJUVANTS AND 3020 03:00:02,480 --> 03:00:05,080 THAT IS CERTAINLY TRUE FOR 3021 03:00:05,080 --> 03:00:06,480 INTRANASAL AS WELL. 3022 03:00:06,480 --> 03:00:16,040 WE HAVE HAD THREE SUCCESSFUL 3023 03:00:16,040 --> 03:00:17,280 TOX STUDIES. 3024 03:00:17,280 --> 03:00:19,680 CMC IS WELL CHARACTERIZED. 3025 03:00:19,680 --> 03:00:23,880 WE HAVE DONE ALL OF THIS WITH 3026 03:00:23,880 --> 03:00:24,640 FEWER THAN 15 EMPLOYEES 3027 03:00:24,640 --> 03:00:26,400 BECAUSE OF THE GREAT SUPPORT 3028 03:00:26,400 --> 03:00:28,960 WE HAVE WITH THE GATES 3029 03:00:28,960 --> 03:00:30,720 FOUNDATION, NIAID AND A GROUP 3030 03:00:30,720 --> 03:00:32,720 OF PRIVATE INVESTORS WHO ARE 3031 03:00:32,720 --> 03:00:34,120 VERY COMMITTED TO GLOBAL 3032 03:00:34,120 --> 03:00:34,840 HEALTH. 3033 03:00:34,840 --> 03:00:39,400 IT IS SOMEWHAT OF A UNIQUE 3034 03:00:39,400 --> 03:00:39,760 STORY. 3035 03:00:39,760 --> 03:00:40,800 THE EFFICACY FROM PHASE 1 WE 3036 03:00:40,800 --> 03:00:44,400 HAVE SEEN IN CLINICAL TRIALS 3037 03:00:44,400 --> 03:00:46,640 ARE ENCOURAGING WHICH IS THE 3038 03:00:46,640 --> 03:00:50,960 FIRST FOCUS OF A INTRANASAL 3039 03:00:50,960 --> 03:00:52,120 ADJUVANT. 3040 03:00:52,120 --> 03:00:54,840 IT IS OPTIMIZED WITH DELIVERY 3041 03:00:54,840 --> 03:00:57,240 AS TALKED ABOUT IN OTHER TALKS 3042 03:00:57,240 --> 03:00:58,960 TODAY AND WE'RE AT THE PLACE 3043 03:00:58,960 --> 03:01:01,440 AS A COMPANY WHERE THIS 3044 03:01:01,440 --> 03:01:03,440 TECHNOLOGY DESERVES THE 3045 03:01:03,440 --> 03:01:05,400 SUPPORT OF THOSE WITH MORE 3046 03:01:05,400 --> 03:01:08,080 RESOURCES THAN A SMALL COMPANY 3047 03:01:08,080 --> 03:01:09,800 CAN GENERATE ON OUR OWN AND WE 3048 03:01:09,800 --> 03:01:11,440 LOOK FORWARD TO -- 3049 03:01:11,440 --> 03:01:13,160 >>WE JUST LOST YOUR AUDIO. 3050 03:01:13,160 --> 03:01:15,080 >>YOU HAVE ME NOW? 3051 03:01:15,080 --> 03:01:24,480 >>WE CAN HEAR YOU WELL. 3052 03:01:24,480 --> 03:01:26,840 >>I AM BASICALLY DONE. 3053 03:01:26,840 --> 03:01:29,080 I DON'T KNOW WHAT HAPPENED AT 3054 03:01:29,080 --> 03:01:30,520 YOUR END, SOUNDS LIKE OTHERS 3055 03:01:30,520 --> 03:01:33,200 HEARD ME SO APPRECIATE YOUR 3056 03:01:33,200 --> 03:01:37,920 TIME TODAY AND THANKS FOR 3057 03:01:37,920 --> 03:01:38,320 THAT. 3058 03:01:38,320 --> 03:01:43,840 >>WOLFGANG, CAN YOU HEAR US? 3059 03:01:43,840 --> 03:01:45,560 >>I THINK WOLFGANG IS 3060 03:01:45,560 --> 03:01:46,200 HAVING -- 3061 03:01:46,200 --> 03:01:47,760 >>I LOST MY AUDIO -- 3062 03:01:47,760 --> 03:01:49,600 >>WE CAN HEAR YOU. 3063 03:01:49,600 --> 03:01:52,200 >>OKAY, GOOD. 3064 03:01:52,200 --> 03:01:55,280 THANK YOU SO MUCH. 3065 03:01:55,280 --> 03:01:57,040 SO YOU WERE DONE WITH THE 3066 03:01:57,040 --> 03:01:57,480 PRESENTATION? 3067 03:01:57,480 --> 03:02:02,600 >>YES, I WAS, WE'RE FINE. 3068 03:02:02,600 --> 03:02:04,800 >>THANK YOU, THANK YOU SO 3069 03:02:04,800 --> 03:02:10,520 MUCH, LET'S MOVE ON NEXT TO 3070 03:02:10,520 --> 03:02:12,280 ELIZABETH NORTON FROM TULANE 3071 03:02:12,280 --> 03:02:12,680 UNIVERSITY. 3072 03:02:12,680 --> 03:02:15,000 >>THANK YOU VERY MUCH, THANK 3073 03:02:15,000 --> 03:02:16,760 YOU TO WOLFGANG AND OTHERS WHO 3074 03:02:16,760 --> 03:02:19,080 INVITED ME FOR THIS TALK, CAN 3075 03:02:19,080 --> 03:02:20,480 EVERYONE HEAR ME OKAY? 3076 03:02:20,480 --> 03:02:21,760 >> YES, WE CAN. 3077 03:02:21,760 --> 03:02:26,160 >>SO I WILL TALK ABOUT DMLT 3078 03:02:26,160 --> 03:02:28,000 AND LTA1 ADJUVANTS. 3079 03:02:28,000 --> 03:02:32,240 NEXT SLIDE. 3080 03:02:32,240 --> 03:02:39,560 SO THIS WORK WE HAVE DONE WITH 3081 03:02:39,560 --> 03:02:42,840 THE ADJUVANTS AND GIVE A NOD 3082 03:02:42,840 --> 03:02:47,120 TO MY MENTOR AND THE POINT OF 3083 03:02:47,120 --> 03:02:49,680 THESE ARE THE ADJUVANT 3084 03:02:49,680 --> 03:02:51,200 SELECTION THAT ALLOWS THE 3085 03:02:51,200 --> 03:02:54,720 DELIVERY OUT TO BE A PARTNER 3086 03:02:54,720 --> 03:02:56,680 IN VACCINATION AND ALSO ALLOWS 3087 03:02:56,680 --> 03:03:07,240 A LOT OF VARIATIONS IN INFANT 3088 03:03:08,680 --> 03:03:17,120 FORMULA SO PILLS, ORAL, NASAL, 3089 03:03:17,120 --> 03:03:22,600 INTRAMUSCULAR, INTRADERMAL AND 3090 03:03:22,600 --> 03:03:23,680 TRANSCUTANEOUS WITH 3091 03:03:23,680 --> 03:03:26,280 CONSIDERATIONS OF TISSUE 3092 03:03:26,280 --> 03:03:27,960 SPECIFIC INTERACTIONS. 3093 03:03:27,960 --> 03:03:29,640 AND THEN YOU CAN SEE THE 3094 03:03:29,640 --> 03:03:32,120 ANTIGEN FORM. 3095 03:03:32,120 --> 03:03:36,640 NEXT SLIDE. 3096 03:03:36,640 --> 03:03:44,320 SO WE HAVE THENTEROTOXIN BASED 3097 03:03:44,320 --> 03:03:46,760 ADJUVANTS DERIVED FROM HEAT 3098 03:03:46,760 --> 03:03:50,160 LABILE TOXIN OF E COLE LIE. 3099 03:03:50,160 --> 03:03:54,720 THIS HAS BEEN AROUND FOR ABOUT 3100 03:03:54,720 --> 03:04:00,120 20 YEARS, CAN BE DELIVERED BY 3101 03:04:00,120 --> 03:04:02,440 ORAL, SUBLINGUAL, INTRADERMAL, 3102 03:04:02,440 --> 03:04:03,200 INTRAMUSCULAR AND 3103 03:04:03,200 --> 03:04:03,680 TRANSCUTANEOUS. 3104 03:04:03,680 --> 03:04:05,280 IT HAS BEEN IN CLINICAL 3105 03:04:05,280 --> 03:04:05,840 TRIALS. 3106 03:04:05,840 --> 03:04:07,760 IT HAS BEEN IN TEN STUDIES, 3107 03:04:07,760 --> 03:04:10,400 MANY OF THESE PUBLISHED SO 3108 03:04:10,400 --> 03:04:15,160 PHASE 1 AND PHASE 2, ETEC, 3109 03:04:15,160 --> 03:04:20,080 POLIO, HIV AND SHIGELAA. 3110 03:04:20,080 --> 03:04:23,080 THERE HAS BEEN NO SAE IN 3111 03:04:23,080 --> 03:04:26,600 EITHER INFANTS OR ADULTS. 3112 03:04:26,600 --> 03:04:31,960 AND THEN THE NEW ADJUVANT, 3113 03:04:31,960 --> 03:04:36,480 LTA1, THIS IS AN A1 DOMAIN OF 3114 03:04:36,480 --> 03:04:46,120 LT AND THIS CAN BE USED 3115 03:04:46,120 --> 03:04:48,280 INTRANASAL, INTRAPULMONARY OR 3116 03:04:48,280 --> 03:04:50,200 INTRADERMAL OR INTRAMUSCULAR. 3117 03:04:50,200 --> 03:04:52,480 THERE HAS BEEN NO CLINICAL 3118 03:04:52,480 --> 03:04:55,760 TRIAL YET BUT WE HAVE PHASE 1 3119 03:04:55,760 --> 03:04:56,720 PLANNED FOR 2026 AND THE BASIC 3120 03:04:56,720 --> 03:05:01,840 WAY THESE WORK IS TO DELIVER 3121 03:05:01,840 --> 03:05:03,800 TO MUCOSAL TISSUE TO PROMOTE 3122 03:05:03,800 --> 03:05:05,400 LOCAL AND SYSTEMIC IMMUNITY, 3123 03:05:05,400 --> 03:05:08,680 THEY CAN BE DELIVERED BY 3124 03:05:08,680 --> 03:05:10,920 INJECTION TO PROMOTE SYSTEMIC 3125 03:05:10,920 --> 03:05:13,600 IMMUNITY AND MAY ALSO DIRECT 3126 03:05:13,600 --> 03:05:16,320 IMMUNITY TO MUCOS AL TISSUE. 3127 03:05:16,320 --> 03:05:20,760 I SAY MAY BECAUSE IT HAS A 3128 03:05:20,760 --> 03:05:21,840 STRONG RESPONSE TO THE 3129 03:05:21,840 --> 03:05:26,160 INDIVIDUAL YOU ARE TRYING TO 3130 03:05:26,160 --> 03:05:28,080 DIRECT IMMUNE ACTIVITY. 3131 03:05:28,080 --> 03:05:31,360 SO WE COMBINE IT WITH AN 3132 03:05:31,360 --> 03:05:34,760 ANTIGEN AND IT GIVES YOU A 3133 03:05:34,760 --> 03:05:43,120 TH1, TH2 AND TH17 OR IGG/IGA 3134 03:05:43,120 --> 03:05:44,560 MULTIFACETED RESPONSE. 3135 03:05:44,560 --> 03:05:48,000 IT HAS GOOD VIAL STABILITY, 3136 03:05:48,000 --> 03:05:50,120 THERE IS EASY MANUFACTURING 3137 03:05:50,120 --> 03:05:51,760 THROUGH E. COLI EXPRESSION 3138 03:05:51,760 --> 03:05:53,080 SYSTEMS FOR LARGE COUNTIES AND 3139 03:05:53,080 --> 03:05:54,800 THERE IS A LOT AVAILABLE AND I 3140 03:05:54,800 --> 03:05:58,880 WOULD LIKE TO SAY ONE OF THE 3141 03:05:58,880 --> 03:06:00,200 KEY PARTNERS FOR 3142 03:06:00,200 --> 03:06:01,960 MULTIDEVELOPMENT HAS BEEN 3143 03:06:01,960 --> 03:06:04,640 PASSED AND THEY ARE OPENING A 3144 03:06:04,640 --> 03:06:08,240 CLINICAL TRIAL SUPPORT 3145 03:06:08,240 --> 03:06:10,760 INCLUDING GM LT. 3146 03:06:10,760 --> 03:06:21,120 AND NEXT SLIDE. 3147 03:06:26,200 --> 03:06:30,520 RECENT CLINICAL TRIALS FOR 3148 03:06:30,520 --> 03:06:35,880 DMLT AND IT REDUCED SHEDDING, 3149 03:06:35,880 --> 03:06:38,520 INCREASED PLASMA MA ANTIBODY 3150 03:06:38,520 --> 03:06:41,440 RESPONSES AND INCREASED 3151 03:06:41,440 --> 03:06:42,480 PROTECTIVE EFFICACY FROM 3152 03:06:42,480 --> 03:06:48,760 23 PERCENT FROM THE ANTIGEN 3153 03:06:48,760 --> 03:06:50,680 ALONE TO 65 130EU7B 9 PERCENT 3154 03:06:50,680 --> 03:06:54,920 AND WITH THE OTHER STUDIES, 3155 03:06:54,920 --> 03:06:56,800 THE TYPE OF IMMUNE RESPONSE 3156 03:06:56,800 --> 03:06:58,680 WAS DIFFERENT IF YOU LOOK AT 3157 03:06:58,680 --> 03:07:00,000 THE DIFFERENT AGE GROUPS 3158 03:07:00,000 --> 03:07:04,000 BECAUSE WITH THE ETEC VACCINE 3159 03:07:04,000 --> 03:07:05,560 IN INFANTS VERSUS ADULTS. 3160 03:07:05,560 --> 03:07:08,400 IF YOU ARE REALLY TARGETING 3161 03:07:08,400 --> 03:07:10,800 INFANTS, I THINK TRYING TO 3162 03:07:10,800 --> 03:07:14,520 OBSERVE BOTH THE PROTEIN AND 3163 03:07:14,520 --> 03:07:16,080 HOLLY SACK RESIDE RESPONSES 3164 03:07:16,080 --> 03:07:20,280 CAN BE DIFFERENT AND GOING TO 3165 03:07:20,280 --> 03:07:22,960 THE NEXT SLIDE, WITH LTA1, WE 3166 03:07:22,960 --> 03:07:26,360 HAVE A PLANNED CLINICAL TRIAL. 3167 03:07:26,360 --> 03:07:27,160 NEXT SLIDE, PLEASE. 3168 03:07:27,160 --> 03:07:37,680 AND THIS IS FOR THE VACCINE 3169 03:07:45,200 --> 03:07:47,320 AGAINST PNEUMONIA, WE TESTED 3170 03:07:47,320 --> 03:07:51,160 LTA1 AND THE GREEN BAR IS 3171 03:07:51,160 --> 03:07:52,200 REDUCING THE BACTERIAL BURDEN 3172 03:07:52,200 --> 03:07:58,400 AND THIS IS COMPARED SHOWN IN 3173 03:07:58,400 --> 03:08:03,120 THE PURPLE BAR, THE PH 3174 03:08:03,120 --> 03:08:04,480 CONSUMER RESPONSE RELATING TO 3175 03:08:04,480 --> 03:08:06,720 THE T CELL RESPONSE AND WHEN 3176 03:08:06,720 --> 03:08:09,760 YOU LOOK AT THE T KRELS, WHAT 3177 03:08:09,760 --> 03:08:11,600 WE'RE REALLY EXCITED ABOUT IS 3178 03:08:11,600 --> 03:08:14,320 THIS WILL BE VERY INTERACTIVE 3179 03:08:14,320 --> 03:08:19,800 WITH OTHER DISEASES SUCH AS 3180 03:08:19,800 --> 03:08:21,280 PULMONARY DISEASE. 3181 03:08:21,280 --> 03:08:25,960 SO WE ARE CONTINUING TO 3182 03:08:25,960 --> 03:08:29,960 EXPLORE THIS WITH NIH SUPPORT 3183 03:08:29,960 --> 03:08:32,520 IN THE UPCOMING CLINICAL TRIAL 3184 03:08:32,520 --> 03:08:35,200 AND ALSO LOOKING FOR PARTNERS 3185 03:08:35,200 --> 03:08:35,880 IN SUPPORT. 3186 03:08:35,880 --> 03:08:39,440 AND IF YOU ARE INTERESTED IN 3187 03:08:39,440 --> 03:08:41,880 THIS, YOU CAN GO TO THE 3188 03:08:41,880 --> 03:08:42,800 DATABASE FOR ADDITIONAL 3189 03:08:42,800 --> 03:08:44,720 STUDIES OR CONTACT ME. 3190 03:08:44,720 --> 03:08:45,080 THANK YOU. 3191 03:08:45,080 --> 03:08:46,080 >>THANK YOU VERY MUCH FOR 3192 03:08:46,080 --> 03:08:56,240 THAT, MOVING ON TO THE NEXT 3193 03:08:56,240 --> 03:08:58,680 PRESENTATION BY Dr. ROBERT 3194 03:08:58,680 --> 03:09:07,920 ERNST FROM THE UNIVERSITY OF 3195 03:09:07,920 --> 03:09:08,280 MARYLAND. 3196 03:09:08,280 --> 03:09:10,480 >>I WOULD ALSO LIKE TO THANK 3197 03:09:10,480 --> 03:09:11,840 THE ORGANIZERS FOR GIVING US 3198 03:09:11,840 --> 03:09:13,640 THE OPPORTUNITY TO BE ABLE TO 3199 03:09:13,640 --> 03:09:15,680 TALK ABOUT THE FAMILY OF 3200 03:09:15,680 --> 03:09:17,640 ADJUTANTS AND THANK THEM FOR 3201 03:09:17,640 --> 03:09:18,680 OUR FUNDING OVER THE LAST 3202 03:09:18,680 --> 03:09:20,040 NUMBER OF YEARS TO GET US 3203 03:09:20,040 --> 03:09:21,360 WHERE WE ARE. 3204 03:09:21,360 --> 03:09:22,720 NEXT SLIDE, PLEASE. 3205 03:09:22,720 --> 03:09:24,560 SO THE BEST TECHNOLOGY IS A 3206 03:09:24,560 --> 03:09:29,600 NOVEL WAY OF MAKING TLR4 3207 03:09:29,600 --> 03:09:34,560 AGOIFTS AND IT IS CALLED 3208 03:09:34,560 --> 03:09:35,840 BACTERIAL ENZYME AUTOMATIC 3209 03:09:35,840 --> 03:09:38,400 CHEMISTRY AND IT STARTED AS A 3210 03:09:38,400 --> 03:09:41,680 PROCESS THAT ALLOWS YOU HAD TO 3211 03:09:41,680 --> 03:09:46,240 MAKE TLR4 IN AS SHORT AS 10 TO 3212 03:09:46,240 --> 03:09:47,000 14 DAYS. 3213 03:09:47,000 --> 03:09:49,720 OVER THE TIME WE HAVE SWITCHED 3214 03:09:49,720 --> 03:09:50,760 FROM BIOLOGICAL ON THE LEFT 3215 03:09:50,760 --> 03:09:52,440 SIDE OF THE SCREEN TO THE 3216 03:09:52,440 --> 03:09:54,240 RIGHT SIDE WHICH IS SYNTHETIC 3217 03:09:54,240 --> 03:09:57,640 AND WE HAVE TWO MOLECULES 3218 03:09:57,640 --> 03:10:01,640 CURRENTLY AVAILABLE FOR 3219 03:10:01,640 --> 03:10:03,840 VACCINE DEVELOPMENT, 438S AND 3220 03:10:03,840 --> 03:10:04,240 470S. 3221 03:10:04,240 --> 03:10:06,360 WE HAVE HAD THE PLEASURE OF 3222 03:10:06,360 --> 03:10:11,000 WORKING WITH A LOT OF PARTNERS 3223 03:10:11,000 --> 03:10:11,760 BOTH WITH GOVERNMENT AND 3224 03:10:11,760 --> 03:10:12,760 PRIVATE INDUSTRY AND ONE OF 3225 03:10:12,760 --> 03:10:15,200 THE THINGS WE WANT TO PROVE 3226 03:10:15,200 --> 03:10:16,720 EARLY ON IS SHOW BREADTH OF 3227 03:10:16,720 --> 03:10:18,280 RESPONSE AND WE WILL GET INTO 3228 03:10:18,280 --> 03:10:19,800 THAT IN A LITTLE BIT. 3229 03:10:19,800 --> 03:10:21,360 THE IDEA HERE IS WE HAVE HAD 3230 03:10:21,360 --> 03:10:23,080 THE ABILITY TO HAVE ONE 3231 03:10:23,080 --> 03:10:25,760 MOLECULE TO BE USED IN A LOT 3232 03:10:25,760 --> 03:10:26,920 OF DIFFERENT ANTIGENS AND 3233 03:10:26,920 --> 03:10:28,280 FORMULATED IN A LOT OF 3234 03:10:28,280 --> 03:10:33,200 DIFFERENT WAYS AND ON THE 3235 03:10:33,200 --> 03:10:37,880 RIGHTHAND SIDE, OUR CURRENT 3236 03:10:37,880 --> 03:10:38,520 MOLECULES. 3237 03:10:38,520 --> 03:10:39,520 SO NEXT SLIDE, PLEASE. 3238 03:10:39,520 --> 03:10:41,640 WE HAVE MADE A LOT OF ADVANCE 3239 03:10:41,640 --> 03:10:43,120 OVER THE LAST FOUR OR FIVE 3240 03:10:43,120 --> 03:10:44,640 YEARS IN THIS AREA AND ONE OF 3241 03:10:44,640 --> 03:10:48,120 THE THINGS WE CAN DO IS WE 3242 03:10:48,120 --> 03:10:49,240 GENERATE A ROBUST IMMUNE 3243 03:10:49,240 --> 03:10:51,840 RESPONSE FOR PRETTY MUCH ANY 3244 03:10:51,840 --> 03:10:53,200 ANTIGEN IN ANY MODEL WE HAVE 3245 03:10:53,200 --> 03:10:56,880 LOOKED AT SO FAR SO WHEN I SAY 3246 03:10:56,880 --> 03:10:59,960 ROBUST IMMUNE RESPONSE, WE GET 3247 03:10:59,960 --> 03:11:02,080 A BALANCED TH1 OR TH2 RESPONSE 3248 03:11:02,080 --> 03:11:03,520 ALL THE TIME. 3249 03:11:03,520 --> 03:11:14,080 WE ALSO GET INCREASED IGG2B 3250 03:11:16,000 --> 03:11:17,040 AND IGG3TITERS. 3251 03:11:17,040 --> 03:11:21,800 WE ALSO GET INCREASEDT CELL 3252 03:11:21,800 --> 03:11:22,160 RESPONSES. 3253 03:11:22,160 --> 03:11:26,280 WE ALSO GET MEMORY AND AGE 3254 03:11:26,280 --> 03:11:27,800 RESPONSES AND THIS WAS AFTER 3255 03:11:27,800 --> 03:11:29,520 THE ANIMALS WERE PRIME 3256 03:11:29,520 --> 03:11:31,720 HOUSTONED. 3257 03:11:31,720 --> 03:11:34,600 WE GET INCREASED B-CELL MEMORY 3258 03:11:34,600 --> 03:11:39,160 AND EFFICACY IN AGING ANIMALS 3259 03:11:39,160 --> 03:11:43,760 FOR INFLUENZA AND AERUGINOSA 3260 03:11:43,760 --> 03:11:46,240 IN MICE OF 18 MONTHS. 3261 03:11:46,240 --> 03:11:48,560 SO OUR BACTERIAL MODELS, WE 3262 03:11:48,560 --> 03:11:54,240 HAVE DONE RSV, P HPV, SARS 2, 3263 03:11:54,240 --> 03:11:56,080 RBD AND SOME OF THESE ARE IN 3264 03:11:56,080 --> 03:11:57,600 PROCESS AND SOME ARE ONGOING 3265 03:11:57,600 --> 03:12:00,520 BUT I WOULD LIKE TO POINT OUT 3266 03:12:00,520 --> 03:12:11,120 TWO WE HAVEN'T PUBLISHED YET, 3267 03:12:21,360 --> 03:12:21,960 FROM JULIE. 3268 03:12:21,960 --> 03:12:22,400 [INDISCERNIBLE] 3269 03:12:22,400 --> 03:12:26,520 AND WHAT WE ARE LOOKING AT IS 3270 03:12:26,520 --> 03:12:29,840 THE LESIONS, THESE ANIMALS 3271 03:12:29,840 --> 03:12:31,920 COMPLETELY HEAL THEIR SKIN 3272 03:12:31,920 --> 03:12:34,200 INFECTIONS THAT ARE PENDING. 3273 03:12:34,200 --> 03:12:36,880 THE BOTTOM ONE, INFLUENZA 3274 03:12:36,880 --> 03:12:40,680 CHALLENGE MODEL, THIS IS ONE I 3275 03:12:40,680 --> 03:12:43,960 HAVE DONE MYSELF AND WITH 3276 03:12:43,960 --> 03:12:44,680 UNIVERSITY OF BALTIMORE, SO 3277 03:12:44,680 --> 03:12:50,880 THIS IS THE LGG1 WITH ANTIGEN, 3278 03:12:50,880 --> 03:12:53,560 THIS IS A 2-WEEK PRIME BOOST 3279 03:12:53,560 --> 03:12:55,360 AND AS YOU CAN SEE IN THE 3280 03:12:55,360 --> 03:12:57,800 GREEN AND BLUE BAR, BLUE 3281 03:12:57,800 --> 03:13:02,840 CIRCLES, WE GET STRONG IGG1 3282 03:13:02,840 --> 03:13:04,400 AND STRONG IGG2A. 3283 03:13:04,400 --> 03:13:05,280 NEGOTIATION SLIDE, PLEASE. 3284 03:13:05,280 --> 03:13:10,960 WHERE WE ARE NOW IS WE CAN GET 3285 03:13:10,960 --> 03:13:20,960 ANTIGEN DOSE OF HA FOR 3286 03:13:20,960 --> 03:13:22,360 QUADRAVALENT AND CROSS 3287 03:13:22,360 --> 03:13:27,440 PROTECTION BETWEEN THE STRAINS 3288 03:13:27,440 --> 03:13:29,760 IN RISE MICE, RABBITS, DOGS 3289 03:13:29,760 --> 03:13:33,480 AND BAB BOONES AND WE CAN DO A 3290 03:13:33,480 --> 03:13:35,640 MIXED DELIVERY OF INTRANASAL 3291 03:13:35,640 --> 03:13:39,240 AND NOW MOVING ON TO MICRO 3292 03:13:39,240 --> 03:13:39,880 NEEDLES. 3293 03:13:39,880 --> 03:13:42,280 WE HAVE DONE SINGLE DOSE 3294 03:13:42,280 --> 03:13:46,400 RABBITS IN WHAT WOULD BE 3295 03:13:46,400 --> 03:13:49,960 CONSIDERED HUMAN DOSE. 3296 03:13:49,960 --> 03:13:53,360 WE HAVE FORMULATION FOR 3297 03:13:53,360 --> 03:13:57,560 BEDSIDE AND HAVEDOWN EXTENSIVE 3298 03:13:57,560 --> 03:13:58,000 BIOSIMILAR. 3299 03:13:58,000 --> 03:14:00,760 AS AN' MUGS, WE CAN DO TWO 3300 03:14:00,760 --> 03:14:03,000 WEEKS AT 40 DEGREES AND SEE NO 3301 03:14:03,000 --> 03:14:06,800 LOSS OF EFFICACY AND WHERE ARE 3302 03:14:06,800 --> 03:14:12,160 WE IN SYNTHETIC MANUFACTURING? 3303 03:14:12,160 --> 03:14:18,320 WE HAVE THE PRECLINICAL AND 3304 03:14:18,320 --> 03:14:20,680 CLINICAL WHICH IS HAS A 3305 03:14:20,680 --> 03:14:21,880 FAVORABLE REGULATORY PATHWAY 3306 03:14:21,880 --> 03:14:26,800 AS A CHEMICAL ENTITY. 3307 03:14:26,800 --> 03:14:29,080 THANK YOU. 3308 03:14:29,080 --> 03:14:34,960 >>SO THE NEXT TALK WE HAVE IS 3309 03:14:34,960 --> 03:14:36,600 SELENE LEMOINE FROM 3310 03:14:36,600 --> 03:14:37,000 SWITZERLAND. 3311 03:14:37,000 --> 03:14:40,800 >>THANK YOU FOR THE 3312 03:14:40,800 --> 03:14:47,320 OPPORTUNITY TO PRESENT VFI 3313 03:14:47,320 --> 03:14:48,520 ADJUVANT PORTFOLIO. 3314 03:14:48,520 --> 03:14:53,680 I AM SELENE LEMOINE, HEAD OF 3315 03:14:53,680 --> 03:14:55,840 VFI LABORATORY IN SWITZERLAND. 3316 03:14:55,840 --> 03:14:58,320 SO TO START OFF, WE HAVE THE 3317 03:14:58,320 --> 03:15:00,360 FIRST POINT OF OPEN ACCESS. 3318 03:15:00,360 --> 03:15:02,440 WE WILL COME BACK AT A LATER 3319 03:15:02,440 --> 03:15:04,040 STAGE WITH MORE INFORMATION. 3320 03:15:04,040 --> 03:15:12,680 OTHERWISE IN OUR VFI ADJUVANT, 3321 03:15:12,680 --> 03:15:17,920 WE HAVE A FEW, WE HAVE SQ AND 3322 03:15:17,920 --> 03:15:18,520 LQ. 3323 03:15:18,520 --> 03:15:22,280 SQ IS A CHOLESTEROL ADJUTANT, 3324 03:15:22,280 --> 03:15:26,880 LQ IS A SAPONARIA EXTRACT AND 3325 03:15:26,880 --> 03:15:32,000 LMQ IS A SYNTHETIC TLR4 AND 3326 03:15:32,000 --> 03:15:33,680 THESE ARE IN DEVELOPMENT AND 3327 03:15:33,680 --> 03:15:39,520 WITH THE SUPPORT OF THE BILL & 3328 03:15:39,520 --> 03:15:40,160 MELINDA GATES FOUNDATION. 3329 03:15:40,160 --> 03:15:42,040 I HAVE ALREADY SAID IN 3330 03:15:42,040 --> 03:15:42,760 PREVIOUS PRESENTATIONS THERE 3331 03:15:42,760 --> 03:15:48,280 IS NOT ONE BEST ADJUVANT. 3332 03:15:48,280 --> 03:15:58,720 IN ORDER DIVERSIFY OUR 3333 03:16:03,360 --> 03:16:05,840 ADJUVANT PORTFOLIO, THESE CAN 3334 03:16:05,840 --> 03:16:07,800 BE LATE DEVELOPMENT WITH THE 3335 03:16:07,800 --> 03:16:10,920 GM P MANUFACTURE IN 2024. 3336 03:16:10,920 --> 03:16:12,680 SO COMING BACK TO THE 3337 03:16:12,680 --> 03:16:16,720 SYNTHETIC, IT IS AVAILABLE AT 3338 03:16:16,720 --> 03:16:21,440 GM P AND INDUSTRIAL SCALE AND 3339 03:16:21,440 --> 03:16:22,720 CURRENTLY MANUFACTURED WITH 3340 03:16:22,720 --> 03:16:24,120 700 MILLION DOSES. 3341 03:16:24,120 --> 03:16:27,600 IT IS PROVIDED BY SEPIVAC 3342 03:16:27,600 --> 03:16:30,520 ALREADY BY SEVERAL VACCINE 3343 03:16:30,520 --> 03:16:32,640 MANUFACTURERS TO BE ELEVATED 3344 03:16:32,640 --> 03:16:35,040 IN CLINICAL TRIALS. 3345 03:16:35,040 --> 03:16:37,120 FOR EXAMPLE, PHASE 2 IS 3346 03:16:37,120 --> 03:16:40,400 PRESENTLY ONGOING FOR THE 3347 03:16:40,400 --> 03:16:43,360 VACCINE CALLED PROVAC2 3348 03:16:43,360 --> 03:16:45,640 DEVELOPED BY OUR COLLEAGUES AT 3349 03:16:45,640 --> 03:16:47,920 THE UNIVERSITY OF TORONTO IN 3350 03:16:47,920 --> 03:16:48,760 CANADA. 3351 03:16:48,760 --> 03:16:49,400 NEXT SLIDE, PLEASE. 3352 03:16:49,400 --> 03:16:51,400 SO TODAY I HAVE A SHORT AMOUNT 3353 03:16:51,400 --> 03:16:54,560 OF TIME TO SHOW YOU SOME OF 3354 03:16:54,560 --> 03:16:55,120 OUR PRECLINICAL DATA. 3355 03:16:55,120 --> 03:16:58,440 FIRST I WOULD LIKE TO SHOW YOU 3356 03:16:58,440 --> 03:17:02,160 SOME DATA FROM THE TUBES LOWS 3357 03:17:02,160 --> 03:17:06,560 VACCINE WHICH IS A BCG VACCINE 3358 03:17:06,560 --> 03:17:08,160 DEVELOPED BY UNIVERSITY OF 3359 03:17:08,160 --> 03:17:09,200 OXFORD. 3360 03:17:09,200 --> 03:17:12,960 HERE YOU SEE THE CHALLENGE 3361 03:17:12,960 --> 03:17:23,560 DATA FOR MICE AND THE LMQ AND 3362 03:17:26,000 --> 03:17:31,600 SQ OBSERVED IN MICE. 3363 03:17:31,600 --> 03:17:40,960 WE ALSO HAVE THE IMPROVED 3364 03:17:40,960 --> 03:17:44,560 PROTECTION AND WITH HIV AND 3365 03:17:44,560 --> 03:17:48,320 AIDS, THERE IS HIGHER 3366 03:17:48,320 --> 03:17:49,960 NEUTRALIZATION TITERS WITH SW 3367 03:17:49,960 --> 03:17:50,720 SKP*E SQ. 3368 03:17:50,720 --> 03:17:55,240 IN THE SCOPE OF THE ADJUVANT 3369 03:17:55,240 --> 03:17:59,400 PROGRAM, WE ALTERED THE 3370 03:17:59,400 --> 03:18:02,560 ANTIGEN AND HERE WE SEE DATA 3371 03:18:02,560 --> 03:18:06,640 FOR THE SQ AND LMQ IN 3372 03:18:06,640 --> 03:18:09,280 CONNECTION WITH THE R21 3373 03:18:09,280 --> 03:18:09,800 ANTIGEN. 3374 03:18:09,800 --> 03:18:11,920 THE GRAPHIC WE SHOW HERE, VERY 3375 03:18:11,920 --> 03:18:14,480 RECENT DATA, NOT PUBLISHED YET 3376 03:18:14,480 --> 03:18:17,560 BUT WE HAVE PREVIOUS CHALLENGE 3377 03:18:17,560 --> 03:18:20,160 DATA IN INVESTIGATION WITHIN 3378 03:18:20,160 --> 03:18:25,040 MECHANISMS OF SQ AND LMQ 3379 03:18:25,040 --> 03:18:26,560 SUMMARIZED IN A PAPER WHICH 3380 03:18:26,560 --> 03:18:32,440 WILL SOON BE PUBLISHED IN A 3381 03:18:32,440 --> 03:18:34,760 PAPER WITH CELL REPORTS 3382 03:18:34,760 --> 03:18:35,720 MEDICINE. 3383 03:18:35,720 --> 03:18:37,520 WE HAVE MANY MORE 3384 03:18:37,520 --> 03:18:39,720 COLLABORATIONS AND PAPERS ON 3385 03:18:39,720 --> 03:18:45,680 DIFFERENT INDICATIONS. 3386 03:18:45,680 --> 03:18:52,680 SOME EXAMPLES ARE WITH STREP, 3387 03:18:52,680 --> 03:18:55,920 WITH MERS AND ALSO WITH 3388 03:18:55,920 --> 03:18:58,840 COVID-19 DEVELOPED AT MIT. 3389 03:18:58,840 --> 03:18:59,760 SO TAKE-HOME MESSAGES FOR 3390 03:18:59,760 --> 03:19:02,400 TODAY, I THINK IT HAS BEEN 3391 03:19:02,400 --> 03:19:08,800 REPEATED MULTIPLE TIMES BUT 3392 03:19:08,800 --> 03:19:10,920 ONE ADJUVANT DOES NOT WORK 3393 03:19:10,920 --> 03:19:12,440 ACROSS ALL COMPARISONS SO 3394 03:19:12,440 --> 03:19:16,720 LOOKING AT THE ADJUVANT IS 3395 03:19:16,720 --> 03:19:24,840 VERY IMPORTANT TO LOOK AT THE 3396 03:19:24,840 --> 03:19:26,920 TERPATION DATA WITH BOTH 3397 03:19:26,920 --> 03:19:30,240 ANIMAL AND CLINICAL DATA WE'RE 3398 03:19:30,240 --> 03:19:30,640 PREDICTING. 3399 03:19:30,640 --> 03:19:31,080 NEXT, PLEASE. 3400 03:19:31,080 --> 03:19:34,360 THANK YOU VERY MUCH FOR 3401 03:19:34,360 --> 03:19:35,360 LISTENING AND PLEASE REACH OUT 3402 03:19:35,360 --> 03:19:37,080 TO ME IF YOU WANT TO LEARN 3403 03:19:37,080 --> 03:19:41,040 MORE ABOUT THE VFI ADJUVANT. 3404 03:19:41,040 --> 03:19:43,120 >>THANK YOU VERY MUCH AND THE 3405 03:19:43,120 --> 03:19:47,040 POINT THAT HAS BEEN MADE OVER 3406 03:19:47,040 --> 03:19:52,320 AND OVER AGAIN, ONE ADJUVANT 3407 03:19:52,320 --> 03:19:55,880 IS NOT GOOD FOR ALL. 3408 03:19:55,880 --> 03:19:58,320 WE'RE COMING FULL CIRCLE WITH 3409 03:19:58,320 --> 03:19:59,920 THE NEXT PRESENTER, 3410 03:19:59,920 --> 03:20:03,640 CHRISTOPHER FOX FROM AAHI. 3411 03:20:03,640 --> 03:20:05,480 >>THANK YOU, WOLFGANG. 3412 03:20:05,480 --> 03:20:07,120 I REALLY ENJOYED ALL THE TALKS 3413 03:20:07,120 --> 03:20:07,720 TODAY. 3414 03:20:07,720 --> 03:20:10,840 A TOUGH ACT TO FOLLOW BUT ON 3415 03:20:10,840 --> 03:20:12,800 THIS FIRST SLIDE, WE WANT TO 3416 03:20:12,800 --> 03:20:18,440 GIVE YOU AN OVERVIEW OF OUR 3417 03:20:18,440 --> 03:20:20,160 FEATURE ADJUVANT FORMULATIONS 3418 03:20:20,160 --> 03:20:21,400 CURRENTLY IN THE VACCINE 3419 03:20:21,400 --> 03:20:23,840 COMPENDIUM AND THE ASSOCIATED 3420 03:20:23,840 --> 03:20:24,200 QR CODES. 3421 03:20:24,200 --> 03:20:26,840 LIKE MANY OF THE PREVIOUS 3422 03:20:26,840 --> 03:20:28,760 SPEAKERS, OUR PORTFOLIO IS 3423 03:20:28,760 --> 03:20:33,440 GENERATED BY MIXING AND 3424 03:20:33,440 --> 03:20:40,880 MATCHING DIFFERENT MOLECULAR 3425 03:20:40,880 --> 03:20:44,880 ADJUVANTS, MOSTLY TLLIGANDS OR 3426 03:20:44,880 --> 03:20:48,840 SAPONINS WITH THE FORMULATION 3427 03:20:48,840 --> 03:20:50,760 PLATFORM INCLUDING 'EM 3428 03:20:50,760 --> 03:20:52,160 PHULGSZ, LIP SOLES AND 3429 03:20:52,160 --> 03:20:53,200 ALUMINUM SALTS. 3430 03:20:53,200 --> 03:20:59,000 SO WE END UP WITH A BIT OF 3431 03:20:59,000 --> 03:21:01,080 ALPHABET SOUP, TENDS TO BE 3432 03:21:01,080 --> 03:21:03,240 DELAYED IN A COMMON WAY BUT 3433 03:21:03,240 --> 03:21:10,720 TRADITIONALLY THESE ARE THE 3434 03:21:10,720 --> 03:21:14,760 TLH4 WITH LIGANDS OR WITH 3435 03:21:14,760 --> 03:21:15,720 SAPONINS. 3436 03:21:15,720 --> 03:21:19,360 WE HAVE ALSO DEVELOPED NEXT 3437 03:21:19,360 --> 03:21:21,200 GENERATION SYSTEMS WITH 3438 03:21:21,200 --> 03:21:22,480 FORMULATIONS OF ALUMINUM SALT 3439 03:21:22,480 --> 03:21:25,200 AND HAVE A LONG HISTORY WHERE 3440 03:21:25,200 --> 03:21:28,920 WE TRIED TO ACCRUE THE 3441 03:21:28,920 --> 03:21:33,760 STABILITY PROPERTIES AND THAT 3442 03:21:33,760 --> 03:21:36,840 IS REPRESENTED BY NANOAL LUM. 3443 03:21:36,840 --> 03:21:42,440 SO ANOTHER WAY, NEXT SLIDE 3444 03:21:42,440 --> 03:21:42,920 PLEASE. 3445 03:21:42,920 --> 03:21:46,200 ANOTHER WAY TO LOOK AT THESE 3446 03:21:46,200 --> 03:21:49,200 DIFFERENT ADJUVANT SYSTEMS IS 3447 03:21:49,200 --> 03:21:50,800 THEIR CLINICAL DEVELOPMENT 3448 03:21:50,800 --> 03:21:53,960 PROJECT AND SO SEVERAL 3449 03:21:53,960 --> 03:21:56,200 THOUSAND PARTICIPANTS HAVE 3450 03:21:56,200 --> 03:21:57,800 RECEIVED VACCINES CONTAINING 3451 03:21:57,800 --> 03:21:59,560 OUR ADJUVANT SYSTEM AND THESE 3452 03:21:59,560 --> 03:22:02,560 ARE REPRESENTED HERE BOO 3453 03:22:02,560 --> 03:22:06,520 CLINICAL DEVELOPMENT STAGE AS 3454 03:22:06,520 --> 03:22:11,200 A PARTICULAR ADJUVANT 3455 03:22:11,200 --> 03:22:12,360 FORMULATION WHERE SQUALENE 3456 03:22:12,360 --> 03:22:13,320 RECEIVED THE MOST EXPERIENCE 3457 03:22:13,320 --> 03:22:18,080 BUT ALSO SOME OF OUR ALUM 3458 03:22:18,080 --> 03:22:21,600 FORMULATIONS AND SCREENINGS 3459 03:22:21,600 --> 03:22:22,960 WITH LIPOSOMES HAVE BEEN GIVEN 3460 03:22:22,960 --> 03:22:24,360 AS WELL. 3461 03:22:24,360 --> 03:22:27,280 THESE HAVE BEEN CLINICALLY 3462 03:22:27,280 --> 03:22:31,720 DERISKED AND MULTIPLE CLINICAL 3463 03:22:31,720 --> 03:22:32,880 TRIALS THROUGH MULTIPLE 3464 03:22:32,880 --> 03:22:35,920 GENERATIONS HAVE DEVELOPED OUR 3465 03:22:35,920 --> 03:22:38,240 DATABASE THAT SHOW THESE ARE 3466 03:22:38,240 --> 03:22:40,920 SUITABLE FOR NOT JUST HEALTHY 3467 03:22:40,920 --> 03:22:42,320 ADULTS BUT DIFFERENT 3468 03:22:42,320 --> 03:22:42,800 POPULATIONS. 3469 03:22:42,800 --> 03:22:48,320 WE ALSO HAVE A HANDFUL OF 3470 03:22:48,320 --> 03:22:49,840 EARLIER STAGE ADJUVANTS IN THE 3471 03:22:49,840 --> 03:22:51,760 DEVELOPMENT PROCESS WHICH ARE 3472 03:22:51,760 --> 03:22:54,360 ADDED HERE AND WILL BE ADDED 3473 03:22:54,360 --> 03:22:56,160 TO THE VACCINE COMPENDIUM IN 3474 03:22:56,160 --> 03:22:57,360 THE COMING YEARS. 3475 03:22:57,360 --> 03:22:58,480 NEXT SLIDE, PLEASE. 3476 03:22:58,480 --> 03:23:01,200 IN RECENT YEARS, WE HAVE 3477 03:23:01,200 --> 03:23:02,240 REALLY FOCUSED, ALTHOUGH WE 3478 03:23:02,240 --> 03:23:04,240 ARE DEVELOPING NEW ADJUVANTS, 3479 03:23:04,240 --> 03:23:07,400 WE PUT OUR PRIMARY FOCUS ON 3480 03:23:07,400 --> 03:23:10,360 PRACTICAL IMPROVEMENT FOR 3481 03:23:10,360 --> 03:23:11,360 EXISTING ADJUVANT ASSETS. 3482 03:23:11,360 --> 03:23:13,040 SO THESE ARE REPRESENTED BY 3483 03:23:13,040 --> 03:23:13,840 JUST THREE PUBLICATIONS. 3484 03:23:13,840 --> 03:23:17,360 SO SOME OF THE THINGS WE 3485 03:23:17,360 --> 03:23:27,840 REALLY FOCUSED ON IS PROCURING 3486 03:23:27,840 --> 03:23:36,600 SUSTAINABLE SUPPLY. 3487 03:23:36,600 --> 03:23:38,400 SO THE NONSQUALENE THROUGH THE 3488 03:23:38,400 --> 03:23:39,920 ANIMAL PROCESS AND THEN ON THE 3489 03:23:39,920 --> 03:23:42,080 OTHER HAND TO ENSURE VACCINES 3490 03:23:42,080 --> 03:23:45,520 CAN BE MADE AT SCALE AND 3491 03:23:45,520 --> 03:23:46,120 DISTRIBUTED. 3492 03:23:46,120 --> 03:23:48,280 IN TERMS OF INNOVATIVE 3493 03:23:48,280 --> 03:23:51,320 FORMULATION WORK, WE HAVE 3494 03:23:51,320 --> 03:23:52,520 POSED RECENTLY ON ADJUVANTS 3495 03:23:52,520 --> 03:23:58,160 THAT CAN BE USED FOR INTRANATE 3496 03:23:58,160 --> 03:24:02,440 SAG DELIVERIES AND THESE HAVE 3497 03:24:02,440 --> 03:24:12,080 BEEN DEVELOPED THROUGH THE IN 3498 03:24:12,080 --> 03:24:14,760 HOUSE R&D SUITE AND THEN 3499 03:24:14,760 --> 03:24:20,440 MAKING SURE THE VACCINE IS 3500 03:24:20,440 --> 03:24:21,720 STABLE, COMPLETING PHASE 1 3501 03:24:21,720 --> 03:24:23,920 TESTING EARLIER THIS YEAR 3502 03:24:23,920 --> 03:24:25,920 SHOWING US THE THERMAL STABLE 3503 03:24:25,920 --> 03:24:32,560 VERSION OF THE VACCINE IS AS 3504 03:24:32,560 --> 03:24:36,680 IMMUNOGENIC AND STABLE AS THE 3505 03:24:36,680 --> 03:24:39,000 NONSTABLE VERSION. 3506 03:24:39,000 --> 03:24:41,400 AND IN CONCLUSION, NEXT SLIDE, 3507 03:24:41,400 --> 03:24:43,000 JUST TO EMPHASIZE WE ARE 3508 03:24:43,000 --> 03:24:45,240 COMMITTED TO LOCAL CAPACITY 3509 03:24:45,240 --> 03:24:46,800 BUILDING AND MANUFACTURING OF 3510 03:24:46,800 --> 03:24:49,080 THE ADJUVANTS IN COUNTRIES, 3511 03:24:49,080 --> 03:24:52,760 THIS WAS HIGHLIGHTED EARLIER 3512 03:24:52,760 --> 03:24:57,720 TODAY BY PALO WITH BHUTAN IN 3513 03:24:57,720 --> 03:24:59,720 BRAZIL, OUR MISSION IS TO GET 3514 03:24:59,720 --> 03:25:00,560 THESE ADJUVANTS MADE LOCALLY 3515 03:25:00,560 --> 03:25:02,960 AND I WILL STOP THERE. 3516 03:25:02,960 --> 03:25:03,720 >>THANK YOU VERY MUCH. 3517 03:25:03,720 --> 03:25:12,120 I WOULD LIKE TO THANK ALL OF 3518 03:25:12,120 --> 03:25:14,320 THE SPEAKERS AND FOR STAYING 3519 03:25:14,320 --> 03:25:14,920 ON SCHEDULE. 3520 03:25:14,920 --> 03:25:20,960 I DO WANT TO POINT OUT THE 3521 03:25:20,960 --> 03:25:24,080 SUPPORT FROM NIAID AND WE CAN 3522 03:25:24,080 --> 03:25:26,560 DAN. 3523 03:25:26,560 --> 03:25:28,560 [INDISCERNIBLE] 3524 03:25:28,560 --> 03:25:32,520 BUT ALSO WANT TO THANK 3525 03:25:32,520 --> 03:25:35,800 SPECIFICALLY THE SDIR 3526 03:25:35,800 --> 03:25:39,200 CONFERENCE IN COPELAND 3527 03:25:39,200 --> 03:25:41,440 PERSONNEL -- 3528 03:25:41,440 --> 03:25:43,200 [INDISCERNIBLE] 3529 03:25:43,200 --> 03:25:47,200 THE DEVELOPMENT OF MIMIC 3530 03:25:47,200 --> 03:25:52,840 VERSIONS TO MAKE SHE IS 3531 03:25:52,840 --> 03:25:54,000 ELEMENTS AND -- 3532 03:25:54,000 --> 03:25:54,440 [INDISCERNIBLE] 3533 03:25:54,440 --> 03:25:57,880 AND WITH THAT, I WILL PASS IT 3534 03:25:57,880 --> 03:25:59,080 BACK TO ANNIE. 3535 03:25:59,080 --> 03:26:09,560 >>THANK YOU FOR ALL THAT 3536 03:26:09,560 --> 03:26:11,120 INFORMATION. 3537 03:26:11,120 --> 03:26:21,640 OUR LAST SPEAKER, LET'S SEE, 3538 03:26:23,040 --> 03:26:23,400 MARTIN FRIEDE. 3539 03:26:23,400 --> 03:26:27,440 >>IT WAS VERY NICE TO SEE THE 3540 03:26:27,440 --> 03:26:28,720 AMAZING WORK ALTOGETHER AND 3541 03:26:28,720 --> 03:26:30,520 THANK YOU FOR PICKING UP THE 3542 03:26:30,520 --> 03:26:32,840 QUESTIONS IN THE CHAT. 3543 03:26:32,840 --> 03:26:35,480 WHAT WAS AMAZING IS TO SEE ALL 3544 03:26:35,480 --> 03:26:37,120 THE PROGRESS THAT HAS BEEN 3545 03:26:37,120 --> 03:26:37,720 MADE. 3546 03:26:37,720 --> 03:26:38,760 I ENTERED THE PROGRAM A NUMBER 3547 03:26:38,760 --> 03:26:41,720 OF YEARS AGO AND IT WAS 3548 03:26:41,720 --> 03:26:44,960 PARTICULAR TO REMEMBER IN 3549 03:26:44,960 --> 03:26:52,560 THOSE DAYS, WE HAD NOT HEARD 3550 03:26:52,560 --> 03:26:56,720 ABOUT NEW ADJUVANTS SO IT IS A 3551 03:26:56,720 --> 03:27:05,320 HUGE STEP FORWARD WITH THE 3552 03:27:05,320 --> 03:27:08,280 ADJUVANTS SO WE HAVE TO FIGURE 3553 03:27:08,280 --> 03:27:10,720 OUT WHAT ADJUVANT WE HAVE IN 3554 03:27:10,720 --> 03:27:14,720 THE NEXT 30, 40 YEARS AND IT 3555 03:27:14,720 --> 03:27:17,040 HAS BEEN BEEN WITH VACCINES, 3556 03:27:17,040 --> 03:27:19,680 WHAT HAVE WE GOT ON OUR SHELF 3557 03:27:19,680 --> 03:27:23,840 AS OPPOSED TO WHAT CAN WE COME 3558 03:27:23,840 --> 03:27:25,680 UP WITH SO THIS IS HUGE 3559 03:27:25,680 --> 03:27:28,600 PARTICULARLY THE ROLE OF THE 3560 03:27:28,600 --> 03:27:29,520 ANTIGEN. 3561 03:27:29,520 --> 03:27:34,800 I CANNOT EMPHASIZE ENOUGH THAT 3562 03:27:34,800 --> 03:27:37,360 THESE ARE POWERFUL A VANITIES 3563 03:27:37,360 --> 03:27:40,840 PUTTING IT IN A WEAK VACCINE, 3564 03:27:40,840 --> 03:27:43,520 IT DOESN'T WORK. 3565 03:27:43,520 --> 03:27:51,440 YOU NEED A POWERFUL 3566 03:27:51,440 --> 03:27:53,520 ADJUTANT -- 3567 03:27:53,520 --> 03:27:58,200 [INDISCERNIBLE] 3568 03:27:58,200 --> 03:27:59,840 [ ALMOST WHISPERING ] 3569 03:27:59,840 --> 03:28:02,200 SO ONE OF THE THINGS YOU DON'T 3570 03:28:02,200 --> 03:28:03,840 LEARN IN TEXTBOOKS, IT COMES 3571 03:28:03,840 --> 03:28:09,480 FROM EXPERIENCE. 3572 03:28:09,480 --> 03:28:12,760 SO FROM WHO, I WOULD SAY 3573 03:28:12,760 --> 03:28:13,800 EXPERIENCED FORMULATION, 3574 03:28:13,800 --> 03:28:15,440 SHARED INFORMATION, WRITE 3575 03:28:15,440 --> 03:28:17,240 PAPERS, REALLY UNDERSTAND THE 3576 03:28:17,240 --> 03:28:18,880 ASPECTS OF THE COMBINATIONS. 3577 03:28:18,880 --> 03:28:24,360 AND THEN AS A FINAL THOUGHT 3578 03:28:24,360 --> 03:28:25,960 WITH ADJUTANTS, WHAT IMPACT 3579 03:28:25,960 --> 03:28:27,040 MIGHT THIS MAKE. 3580 03:28:27,040 --> 03:28:29,520 SO WITH THE MICE, WE ARE 3581 03:28:29,520 --> 03:28:33,800 REALLY STUDYING MORE AND MORE 3582 03:28:33,800 --> 03:28:39,280 VACCINES COMING IN AND -- 3583 03:28:39,280 --> 03:28:39,800 [INDISCERNIBLE] 3584 03:28:39,800 --> 03:28:43,400 SO TO GET WHAT WE CALL A FULL 3585 03:28:43,400 --> 03:28:45,320 VALUE ASSESSMENT WITH VACCINES 3586 03:28:45,320 --> 03:28:51,320 AND IF WE MAKE THOSE VACCINES 3587 03:28:51,320 --> 03:28:51,520 -- 3588 03:28:51,520 --> 03:28:52,040 [INDISCERNIBLE] 3589 03:28:52,040 --> 03:28:53,920 SO I WOULD STOP THERE AND 3590 03:28:53,920 --> 03:28:56,480 THANK ANNIE WHO HAS DONE AN 3591 03:28:56,480 --> 03:28:58,480 AMAZING JOB AT THE NIH PULLING 3592 03:28:58,480 --> 03:28:59,160 THIS TOGETHER. 3593 03:28:59,160 --> 03:29:02,160 AND THEN FROM WHO AND THE BILL 3594 03:29:02,160 --> 03:29:04,520 & MELINDA GATES FOUNDATION, I 3595 03:29:04,520 --> 03:29:07,160 WOULD LIKE TO ANNOUNCE OUR 3596 03:29:07,160 --> 03:29:09,400 NEXT WEBINAR IN EARLY FEBRUARY 3597 03:29:09,400 --> 03:29:12,040 OF NEXT YEAR FOR THE NEXT 3598 03:29:12,040 --> 03:29:12,800 PHASE OF VACCINES. 3599 03:29:12,800 --> 03:29:14,200 THERE IS NOT ONLY A HUGE 3600 03:29:14,200 --> 03:29:16,520 AMOUNT OF POLICY WORK NEEDED 3601 03:29:16,520 --> 03:29:18,920 TO GENERATE ENOUGH INTEREST IN 3602 03:29:18,920 --> 03:29:20,120 THIS BUT -- 3603 03:29:20,120 --> 03:29:20,600 [INDISCERNIBLE] 3604 03:29:20,600 --> 03:29:26,160 AND WITH THAT FROM ALL OF YOU, 3605 03:29:26,160 --> 03:29:28,720 FOR THE PARTICIPATION OF ALL 3606 03:29:28,720 --> 03:29:29,440 THE SPEAKERS, NIAID AND 3607 03:29:29,440 --> 00:00:00,000 EVERYBODY, THANKS VERY MUCH.