PG256121802S
THE ADJUVANT DISCOVERY CONTRACT PROPOSED HEREIN WILL IDENTIFY, CHARACTERIZE, AND ADVANCE NOVEL SYNTHETIC IL-1R-BASED ADJUVANTS FOR USE IN COMBINATION WITH AN INFLUENZA VACCINE TO INDUCE RAPID AND SUSTAINED BROADLY PROTECTIVE IMMUNITY TO SEASONAL AND/OR PANDEMIC INFLUENZA VIRUS. THIS PROPOSAL BRINGS TOGETHER HIGHLY EXPERIENCED RESEARCH TEAMS FROM THE UNIVERSITY OF MONTANA, DUKE UNIVERSITY, THE ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI AND INIMMUNE CORPORATION, EACH WITH UNIQUE EXPERTISE AND PREVIOUS EXPERIENCE IN NIAID ADJUVANT DISCOVERY AND DEVELOPMENT PROGRAMS. DR. EVANS, DIRECTOR OF THE CTM, AND COLLEAGUES AT UM WILL LEAD THE DISCOVERY EFFORTS AND COORDINATE ACTIVITIES OF ALL SUBCONTRACTORS. THE RESEARCH TEAM AT UM WILL BE RESPONSIBLE FOR HIGH THROUGHPUT IN SILICO SCREENING, PEPTIDE LIBRARY PRODUCTION, COMPOUNDS SYNTHESIS AND SAR, MECHANISTIC STUDIES, FORMULATION, SAFETY ASSESSMENTS AND EFFICACY STUDIES. DR. STAATS, PROFESSOR OF PATHOLOGY, ASSOCIATE PROFESSOR OF IMMUNOLOGY AND MEDICINE, DUKE, AND COLLEAGUES WILL WORK CLOSELY WITH THE TEAM FROM UM TO COMPLETE THE HTS SCREENING OF SYNTHETIC PEPTIDE LIBRARIES, APTAMER LIBRARY PRODUCTION AND SCREENING, CONFIRMATION SCREEN OF SELECTED HITS USING IL-1R REPORTER CELLS, EVALUATION OF BINDING AND INTERNALIZATION, CRITICALLY EVALUATE THE INTRACELLULAR SIGNALING PATHWAYS OF LEAD IL- 1R AGONISTS AND ASSESS THE ROUTE OF ADMINISTRATION AND SCHEDULE TO OPTIMIZE BOTH PARENTERAL (IM) AND MUCOSAL (IN, SL) VACCINATION THROUGH ADJUVANT SELECTION AND FORMULATION. DR. KRAMMER, ASSOCIATE PROFESSOR OF MICROBIOLOGY, AND COLLEAGUES AT THE ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI BRING EXPERTISE AND CONSIDERABLE KNOWLEDGE IN INFLUENZA VIRUS ANIMAL MODELS AND THE PRODUCTION OF RECOMBINANT INFLUENZA ANTIGENS. DR. KRAMMER WILL PROVIDE RECOMBINANT INFLUENZA ANTIGENS AND LEAD EFFORTS TOWARDS THE IN VIVO INFLUENZA CHALLENGE MODELS (MOUSE AND FERRET) FOR EVALUATION OF IL-1 ADJUVANTED INFLUENZA VACCINES. THE TEAM AT MOUNT SINAI ALSO BRINGS SPECIALIZED EXPERTISE IN THE SEROLOGICAL MECHANISM OF PROTECTION AND A WIDE ARRAY OF ANTIGENS AND VIRUSES TO ASSESS HETEROSUBTYPIC PROTECTION AGAINST SELECTED SEASONAL AND HIGHLY PATHOGENIC INFLUENZA VIRUS STRAINS. DR. BAZIN-LEE, VICE PRESIDENT OF DISCOVERY RESEARCH, ALONG WITH HER COLLEAGUES AT INIMMUNE CORPORATION, WILL OVERSEE ANALYTICAL ASSAY DEVELOPMENT, PHYSIOCHEMICAL CHARACTERIZATION, STABILITY AND SCALE-UP SYNTHESIS OF LEAD IL-1R ADJUVANTS IDENTIFIED IN RESEARCH AREAS 1-3.
Inimmune Corp
Definitive Contract 75N93019C00045
$130.9k 12/16/24 PG236129002S
HMRI (DR. DAN KISS SUB-PI) IS RESPONSIBLE FOR THE DESIGN, PRODUCTION, CHARACTERIZATION AND QA/QC OF MRNA BASED TB ANTIGENS TO BE EVALUATED AT UM AND WUSTL IN PRECLINICAL TB VACCINE MURINE MODELS. THIS MAY INCLUDE SOME SCALE-UP ACTIVITIES IN LATER YEARS OF THE CONTRACT SHOULD THEIR ANTIGEN BE SELECTED FOR NON-HUMAN PRIMATE STUDIES IN YEAR 3 OR 4.
The Methodist Hospital
Definitive Contract 75N93019C00045
$356.7k 7/30/24 PG236126901S
THE ADJUVANT DISCOVERY CONTRACT PROPOSED HEREIN WILL IDENTIFY, CHARACTERIZE, AND ADVANCE NOVEL SYNTHETIC IL-1R-BASED ADJUVANTS FOR USE IN COMBINATION WITH AN INFLUENZA VACCINE TO INDUCE RAPID AND SUSTAINED BROADLY PROTECTIVE IMMUNITY TO SEASONAL AND/OR PANDEMIC INFLUENZA VIRUS. THIS PROPOSAL BRINGS TOGETHER HIGHLY EXPERIENCED RESEARCH TEAMS FROM THE UNIVERSITY OF MONTANA, DUKE UNIVERSITY, THE ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI AND INIMMUNE CORPORATION, EACH WITH UNIQUE EXPERTISE AND PREVIOUS EXPERIENCE IN NIAID ADJUVANT DISCOVERY AND DEVELOPMENT PROGRAMS. DR. EVANS, DIRECTOR OF THE CTM, AND COLLEAGUES AT UM WILL LEAD THE DISCOVERY EFFORTS AND COORDINATE ACTIVITIES OF ALL SUBCONTRACTORS. THE RESEARCH TEAM AT UM WILL BE RESPONSIBLE FOR HIGH THROUGHPUT IN SILICO SCREENING, PEPTIDE LIBRARY PRODUCTION, COMPOUNDS SYNTHESIS AND SAR, MECHANISTIC STUDIES, FORMULATION, SAFETY ASSESSMENTS AND EFFICACY STUDIES. DR. STAATS, PROFESSOR OF PATHOLOGY, ASSOCIATE PROFESSOR OF IMMUNOLOGY AND MEDICINE, DUKE, AND COLLEAGUES WILL WORK CLOSELY WITH THE TEAM FROM UM TO COMPLETE THE HTS SCREENING OF SYNTHETIC PEPTIDE LIBRARIES, APTAMER LIBRARY PRODUCTION AND SCREENING, CONFIRMATION SCREEN OF SELECTED HITS USING IL-1R REPORTER CELLS, EVALUATION OF BINDING AND INTERNALIZATION, CRITICALLY EVALUATE THE INTRACELLULAR SIGNALING PATHWAYS OF LEAD IL- 1R AGONISTS AND ASSESS THE ROUTE OF ADMINISTRATION AND SCHEDULE TO OPTIMIZE BOTH PARENTERAL (IM) AND MUCOSAL (IN, SL) VACCINATION THROUGH ADJUVANT SELECTION AND FORMULATION. DR. KRAMMER, ASSOCIATE PROFESSOR OF MICROBIOLOGY, AND COLLEAGUES AT THE ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI BRING EXPERTISE AND CONSIDERABLE KNOWLEDGE IN INFLUENZA VIRUS ANIMAL MODELS AND THE PRODUCTION OF RECOMBINANT INFLUENZA ANTIGENS. DR. KRAMMER WILL PROVIDE RECOMBINANT INFLUENZA ANTIGENS AND LEAD EFFORTS TOWARDS THE IN VIVO INFLUENZA CHALLENGE MODELS (MOUSE AND FERRET) FOR EVALUATION OF IL-1 ADJUVANTED INFLUENZA VACCINES. THE TEAM AT MOUNT SINAI ALSO BRINGS SPECIALIZED EXPERTISE IN THE SEROLOGICAL MECHANISM OF PROTECTION AND A WIDE ARRAY OF ANTIGENS AND VIRUSES TO ASSESS HETEROSUBTYPIC PROTECTION AGAINST SELECTED SEASONAL AND HIGHLY PATHOGENIC INFLUENZA VIRUS STRAINS. DR. BAZIN-LEE, VICE PRESIDENT OF DISCOVERY RESEARCH, ALONG WITH HER COLLEAGUES AT INIMMUNE CORPORATION, WILL OVERSEE ANALYTICAL ASSAY DEVELOPMENT, PHYSIOCHEMICAL CHARACTERIZATION, STABILITY AND SCALE-UP SYNTHESIS OF LEAD IL-1R ADJUVANTS IDENTIFIED IN RESEARCH AREAS 1-3.
Duke University
Definitive Contract 75N93019C00045
$876.6k 5/15/23 PG236129901S
 RAPID ADVANCEMENT OF A SAFE AND EFFECTIVE VACCINE TARGETING MONKEYPOX. 1) MEASUREMENT OF REACTIVE ANTIBODY LEVELS IN AND VIRUS NEUTRALIZATION POTENCY OF SERUM FROM VACCINATED MICE; AND 2) DESIGN, COORDINATION, EXECUTION, AND ANALYSIS OF VACCINATION AND CHALLENGE EXPERIMENTS INVOLVING RHESUS MACAQUES (RM).
Oregon Health & Science University
Definitive Contract 75N93019C00045
$635.4k 1/13/23 PG236129902S
THIS MULTI-FOCUSED PROJECT TO DEVELOP ADJUVENATED VACCINES FOR MONKEYPOX (MKPX) IS A NATURAL NEXT STEP TO BUILD ON OUR EXISTING COLLABORATION WITH DR. JAY EVANS AT THE UNIVERSITY OF MONTANA. THE KISS LABÂ S PORTION OF THE CONTRACT IS TO ADD GENERATE (AND PERFORM PRIMARY TESTING OF) BOTH LINEAR AND CIRCULAR RNA VACCINE CANDIDATES ENCODING A KEY MKPX ANTIGEN (PRELIMINARILY H3). SPECIFICALLY, FOR THIS CONTRACT WE WILL PROVIDE MULTIPLE LOTS OF THE LINEAR AND CIRCULAR VACCINE CANDIDATES AT A SMALLER SCALE (10-25 MG PER CANDIDATE) TO SUPPORT THEIR PRECLINICAL EVALUATION (IN THE PRESENCE OR ABSENCE OF ADJUVANTS) AGAINST THE RECOMBINANT CANDIDATES DEVELOPED AND PRODUCED BY OTHER CONTRIBUTORS TO THE CONTRACT. PART OF THE STUDY PERIOD WILL ALSO BE DEDICATED TOWARDS OPTIMIZING, UPSCALING, AND QUALIFYING THE PRODUCTION PIPELINE USED TO GENERATE THE CIRCRNA VACCINE CANDIDATES. THE GOAL IS TO STREAMLINE THE PRODUCTION AND DOCUMENTATION OF BOTH LINEAR AND CIRCULAR RNA AT THE LARGER SCALES THAT WOULD ENABLE POSSIBLE GLP-TOXICITY STUDIES. SUCH WORK COULD BE UNDERTAKEN IF THE CANDIDATE PROGRESSES BEYOND THE INITIAL STUDY PERIOD.
The Methodist Hospital
Definitive Contract 75N93019C00045
$333.9k 12/7/22