International Vaccine Institute

SEE SCHEDULE O

THE JOINT RESEARCH AND CLINICAL DEVELOPMENT CONSORTIUM AGREEMENT BETWEEN IVI AND SK BIOSCIENCE WAS SIGNED IN JUNE 2021. AS PER THIS AGREEMENT, COVID VACCINE CLINICAL AND OPERATIONAL ALLIANCE (COCOA) PROJECT STARTED IN JUNE 2021 TO COLLABORATE PHASE III CLINICAL TRIAL FOR GBP510. THE PURPOSE OF THIS STUDY IS TO ASSESS THE IMMUNOGENICITY AND SAFETY OF SK SARS-COV-2 RECOMBINANT PROTEIN NANOPARTICLE VACCINE ADJUVANTED WITH AS03 (GBP510) IN ADULTS AGED 18 YEARS AND OLDER. IVI IS RESPONSIBLE FOR THE CLINICAL TRIAL CONDUCT OUTSIDE OF KOREA WHILE SK BIOSCIENCE IS RESPONSIBLE FOR THE CLINICAL TRIAL CONDUCT WITHIN KOREA. IN Q3-Q4 2021, IVI REVIEWED AND SELECTED 3 CROS AND THROUGH THOSE CROS, IVI SELECTED 22 STUDY SITES ACROSS 5 COUNTRIES, THAILAND, PHILIPPINES, VIETNAM, NEW ZEALAND AND UKRAINE. AFTER EXPEDITED REGULATORY REVIEW AND APPROVAL PROCESS FOR EACH COUNTRY, PARTICIPANT ENROLL BEGAN IN THE END OF 2021.

IN YEAR 2021, THE GCCDP TEAM SUCCESSFULLY SUBMITTED REGULATORY DOSSIERS IN FIVE COUNTRIES AND NINE CLINICAL STUDY SITES (I.E., PANAMA, COLOMBIA, THAILAND, GUATEMALA AND COSTA RICA) AND RECEIVED IRB AND NATIONAL REGULATORY AUTHORITY (NRA) APPROVALS IN ALL OF THEM. PHASE I STUDY WITH 40 MICROGRAM IN INDIA WAS COMPLETED, AND WITH THESE DATA THE PROJECT TEAM MOVED AHEAD WITH THE PLANNED PHASE II/III CLINICAL TRIALS IN INDIA AND OUTSIDE OF INDIA. REGARDING THE CLINICAL TRIALS OUTSIDE OF INDIA CONDUCTED BY IVI, THE FIRST SUBJECT FIRST VISIT (FSFV) OF INITIAL PART OF PHASE II STUDY WAS COMPLETED IN PANAMA AND COSTA RICA IN AUGUST 2021 AND COLLECTED THE SAFETY DATA OF 90 PARTICIPANTS. AFTER OBTAINING A "GO" DECISION FROM DSMB TO PROCEED TO THE SUBSEQUENT PARTS OF THE STUDY, RECRUITMENT OF REMAINING PHASE II STUDIES COMPLETED BY DECEMBER 2021 IN ALL COUNTRIES. NO SERIOUS UNEXPECTED ADVERSE REACTIONS (SUSARS) HAVE OCCURRED. IN ADDITION TO THE CLINICAL STUDIES, THE PARTNER LABORATORY FOR NON-HUMAN PRIMATE (NHP) STUDY, NIBSC, UK COMPLETED THE ACTIVE IMMUNIZATION STUDY AND THE STUDY DATA DEMONSTRATED POTENT PROTECTION WITH THE CANDIDATE VACCINE (BBV87 20 UG) BY BOTH THE IMPACT ON VIRUS REPLICATION AND HOST RESPONSE TO INFECTION.

IVI HAS DEVELOPED A NEW TYPHOID CONJUGATE VACCINE (VI-POLYSACCHARIDE CONJUGATED TO DIPHTHERIA TOXOID [DT]), WHICH HAS THE POTENTIAL TO PROTECT CHILDREN <2 YEARS OF AGE AND TO PROVIDE A LONGER DURATION OF PROTECTION THAN THE EXISTING VACCINES. IVI TRANSFERRED THE TECHNOLOGY FOR PRODUCTION AND QUALITY CONTROL OF THE VI-DT CONJUGATE VACCINE TO SK BIOSCIENCE IN AUGUST 2013. THE SCOPE OF THIS PROJECT INVOLVED IVI TAKING THE LEAD IN THE CLINICAL DEVELOPMENT OF SK'S VI-DT VACCINE BY PROVIDING SUPPORT TO SK IN PROCESS DEVELOPMENT, CLINICAL DEVELOPMENT, REGULATORY REQUIREMENTS, AND PROJECT MANAGEMENT. THIS GRANT COVERS THE CONDUCT OF PHASE III CLINICAL TRIAL, LEADING UP TO LICENSURE AND WHO PQ. THE SPECIFIC PROJECT SCOPE IS TO CONDUCT MAIN IMMUNE NON-INFERIORITY STUDY WITH BBIL'S VI-TT, WHICH IS PREQUALIFIED BY WHO, IN NEPAL AND TO CONDUCT ADDITIONAL IMMUNE EQUIVALENCE AND SAFETY STUDY IN THE PHILIPPINES TO MEET THE REQUIREMENT OF WHO PQ. IN 2021, THE VI-DT BLA DOSSIER WAS SUBMITTED TO KMFDS AND WENT THROUGH THE PRE-EVALUATION PROCESS.

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