Project Grant R44CA278579

INNOVATION OF BIOBANKING FOR CELLULAR ADOPTIVE IMMUNOTHERAPIES BASED ON A FIRST-IN-CLASS BIOCOMPATIBLE CRYOPRESERVATION TECHNOLOGY FOR T AND NK CELLS AND THEIR CAR-ENGINEERED PRODUCTS - SUMMARY PREVIOUS SUPPORT FROM NIH SBIR AND COULTER FOUNDATION AWARDS ALLOWED THE CRYOCRATE TEAM TO DEVELOP A FIRST- IN-CLASS BIOCOMPATIBLE CRYOPRESERVATION MEDIUM PRODUCT THAT DOESN'T NEED ANY CELL PERMEATING AND TOXIC CRYOPROTECTANT. THE PRODUCT IS TRADEMARKED AS ODINSOL, AND HAS BEEN APPROVED TO PROVIDE SIGNIFICANTLY IMPROVED EFFICIENCY IN CRYOSTORAGE OF CELL TYPES THAT ARE ESSENTIAL FOR CELL-BASED ADOPTIVE IMMUNOTHERAPIES. THE ODINSOL TECHNOLOGY ALSO REMOVES THE REQUIREMENT OF SERUM AND HUMAN PRODUCTS AND SECURES LONG-TERM STORAGE IN REGULAR -80OC DEEP FREEZERS. BASED ON OUR FORMER EXPERIENCE IN FDA 510(K) SUBMISSION, IN THIS PROJECT, WE ORGANIZED THE COLLABORATION WITH OUR REGULATORY CONSULTANT (CARDINAL HEALTH), CONTRACT MANUFACTURING ORGANIZATIONS (BRYLLAN), CONTRACT RESEARCH ORGANIZATION (WUXI APPTEC), ACADEMIC SUBCONTRACT COLLABORATOR (THE CENTER FOR PRECISION MEDICINE AT UNIVERSITY OF MISSOURI), TO ACHIEVE THE FOLLOWING MILESTONES: I. THE PRODUCTION OF ODINSOL MEETS GMP QUALIFICATIONS AND BIOCOMPATIBILITY ASSESSMENT SHOWS COMPLIANCE WITH FDA GUIDANCE FOR 510(K) SUBMISSION AS A STORAGE DEVICE FOR TRANSFUSABLE CELLS; II. THE IN VITRO AND IN VIVO EVALUATION OF SAFETY AND EFFICACY DEMONSTRATES THE ODINSOL TECHNOLOGY TO BE SUPERIOR TO EXISTING CRYOPRESERVATION PROTOCOLS WITH RESPECT TO PRESERVING VIABILITY AND FUNCTIONALITIES OF T, NK AND CAR-T CELLS; III. BASED ON THOSE QUALIFICATIONS, WE WILL COMPLETE OF THE 510(K) SUBMISSION AND FINALIZE OF THE PRODUCTION LINE BASED ON FURTHER FDA FEEDBACK BEFORE THE END OF THE PROJECT PERIOD. WE EXPECT FUTURE CLINICAL USE OF THE ODINSOL TECHNOLOGY WITHIN THREE YEARS AFTER THE FDA CLEARANCE, PROVIDING THE INDUSTRY OF CELL THERAPIES WITH A HIGHLY EFFICIENT BIOCOMPATIBLE CRYOSTORAGE PLATFORM.