{"id":270361768,"generated_unique_award_id":"ASST_NON_R43CA298530_075","fain":"R43CA298530","uri":"R43CA298530-4169704348","category":"grant","type":"04","type_description":"PROJECT GRANT (B)","description":"POINT-OF-CARE AUTOLOGOUS CAR-T CELL MANUFACTURING - THE SUCCESSFUL IMPLEMENTATION OF CHIMERIC ANTIGEN RECEPTOR (CAR)-T CELL THERAPIES RELIES ON EFFECTIVE CELL PRODUCT MANUFACTURING. THIS PROCESS NOT ONLY AFFECTS THE COST, SAFETY AND EFFICACY OF THE FINAL PRODUCT BUT ALSO PLAYS A CRUCIAL ROLE IN ENSURING BROADER PATIENT ACCESS TO THIS INNOVATIVE TREATMENT. THE INCREASING DEMAND FOR CAR-T THERAPIES HAS RESULTED IN SHORTAGES DUE TO INADEQUATE MANUFACTURING CAPACITY, PARTLY BECAUSE OF THE CENTRALIZED MANUFACTURING MODEL. REMARKABLY, APPROXIMATELY 25% OF PATIENTS WITH MULTIPLE MYELOMA DIED WHILE ON AN ELIGIBLE CAR-T TREATMENT WAITLIST. ALTHOUGH “OFF-THE-SELF” ALLOGENEIC CAR-T CELLS MAY BE MANUFACTURED IN CENTRALIZED FACILITIES AT A LARGER SCALE, THIS APPROACH IS STILL IN THE EARLY STAGES OF DEVELOPMENT WITH SEVERAL EXISTING AND PERHAPS UNFORESEEN HURDLES. CURRENTLY, AUTOLOGOUS CAR-T THERAPIES REMAIN THE MOST CLINICALLY AND REGULATORY ACCEPTABLE OPTION FOR PATIENTS. AN ALTERNATIVE APPROACH IS LOCAL MANUFACTURING USING AUTOMATED PLATFORMS LIKE CLINIMACS PRODIGY. THESE EFFORTS, AIMED AT DEMOCRATIZING SUPPLY, BOOSTING PRODUCTION CAPACITY, SIMPLIFYING LOGISTICS, AND REDUCING TURNAROUND TIME, ENCOUNTER NUMEROUS HURDLES TO IMPLEMENT. THESE BARRIERS ARISE FROM THE FACT THAT CURRENT TECHNIQUES FOR CAR-T CELL MANUFACTURING ARE ROOTED IN DECADES-OLD METHODOLOGIES USED IN RESEARCH LABORATORIES. THE COMPLEX PROCESS OF INTEGRATING THESE METHODS FOR LARGE-SCALE PRODUCTION, EVEN WITH AUTOMATION, POSES CHALLENGES IN BIOPROCESSING, ENGINEERING, AND REGULATORY COMPLIANCE. HERE WE PROPOSE AN INNOVATIVE APPROACH, FOCUSING ON T CELL BIOLOGY, TO OVERCOME THESE OBSTACLES FOR POINT-OF-CARE CAR- T PRODUCTION BY LEVERAGING TARGETED MICROBUBBLE-BASED TECHNOLOGIES. THIS SYSTEM HAS BEEN APPLIED FOR T CELL SELECTION, ACTIVATION, AND TRANSDUCTION IN A CONVENTIONAL PRECLINICAL STUDY FOR CAR-T BASED THERAPY. BY CAPITALIZING ON ROBUST BIOLOGICAL ACTIVITIES OF THE REAGENTS AND STREAMLINING THE PROCESS, WE AIM TO MAKE CAR-T CELL PRODUCTION EFFICIENT, AFFORDABLE, AND ACCESSIBLE. WE WILL DEVELOP A USER-FRIENDLY KIT THAT ENABLES CAR-T CELL PRODUCTION IN SETTINGS EQUIVALENT TO THOSE USED FOR HEMATOPOIETIC STEM CELL TRANSPLANTATION. THE CAR-T CELLS MANUFACTURED BY THIS CONSIDERABLY SIMPLIFIED PROTOCOL WILL UNDERGO STANDARD CELL RELEASE QUALITY CONTROL AND BE TESTED IN A PRECLINICAL MOUSE MODEL FOR HEMATOLOGICAL MALIGNANCY. AS WE PROGRESS TO PHASE II, WE WILL ADAPT OUR PROTOCOLS TO MANUFACTURE CAR-T CELLS FOR TREATING BOTH HEMATOLOGICAL MALIGNANCIES AND SOLID TUMORS TO ENSURE VERSATILITY AND RELEVANCE ACROSS DIFFERENT THERAPEUTIC CONTEXTS. OVERALL, THE PRIMARY GOAL OF THIS PROJECT IS TO GENERATE HIGH QUALITY POINT-OF-CARE CAR-T CELLS BY A RADICALLY SIMPLIFIED MANUFACTURING PROCESS WITHOUT SUBSTANTIAL INVESTMENT FOR NEW STAFF AND INFRASTRUCTURES. WHEN SUCCESSFUL, IT WILL DRASTICALLY LOWER THE MANUFACTURING COSTS, POTENTIALLY ELIMINATE “WAITLIST MORTALITY” AND LIKELY ALLEVIATE REGULATORY BURDENS.","subaward_count":0,"total_subaward_amount":null,"total_subsidy_cost":0.0,"total_loan_value":0.0,"total_obligation":400000.0,"date_signed":"2025-09-17","base_and_all_options":null,"base_exercised_options":null,"non_federal_funding":0.0,"total_funding":400000.0,"total_account_outlay":370000.0,"total_account_obligation":400000.0,"account_outlays_by_defc":[{"code":"Q","amount":370000.0}],"account_obligations_by_defc":[{"code":"Q","amount":400000.0}],"record_type":2,"cfda_info":[{"applicant_eligibility":"The awardee will be a university, college, hospital, public agency, nonprofit research institution, or for-profit organization that submits an application and receives a grant or cooperative agreement for support of research by a named principal investigator.  SBIR grants can be awarded only to domestic small businesses (entities that are independently owned, and operated for profit, are not dominant in the field in which research is proposed and have no more than 500 employees).  Primary employment (more than one-half time) of the principal investigator must be with the small business at the time of award and during the conduct of the proposed project. In both Phase I and Phase II, the research must be performed in the U.S. and its possessions.  To be eligible for funding, a grant application must be approved for scientific merit and program relevance by a scientific review group and a national advisory council.  STTR grants can be awarded only to domestic small business concerns (entities that are independently owned and operated for profit, are not dominant in the field in which research is proposed and have no more than 500 employees) which \"partner\" with a research institution in cooperative research and development.  At least 40 percent of the project is to be performed by the small business concern and at least 30 percent by the research institution. In both Phase I and Phase II, the research must be performed in the U.S. and its possessions.  To be eligible for funding, a grant application must be approved for scientific merit and program relevance by a scientific review group and a national advisory council.","beneficiary_eligibility":"Beneficiary eligibility is the same as applicant eligibility.\nAny nonprofit or for-profit organization, company, or institution engaged in biomedical research.","cfda_federal_agency":"NATIONAL INSTITUTES OF HEALTH, HEALTH AND HUMAN SERVICES, DEPARTMENT OF","cfda_number":"93.395","cfda_objectives":"To develop the means to cure as many cancer patients as possible and to control the disease in those patients who are not cured.  Cancer Treatment Research includes the development and evaluation of improved methods of cancer treatment through the support and performance of both fundamental and applied laboratory and clinical research.  Research is supported in the discovery, development, and clinical testing of all modes of therapy including: surgery, radiotherapy, chemotherapy, and biological therapy including molecularly targeted therapies, both individually and in combination.  In addition, research is carried out in areas of nutritional support, stem cell and bone marrow transplantation, image guided therapies and studies to reduce toxicity of cytotoxic therapies, and other methods of supportive care that may supplement and enhance primary treatment. Small Business Innovation Research (SBIR) program: To expand and improve the SBIR program; to increase private sector commercialization of innovations derived from Federal research and development; to increase small business  participation in Federal research and development; and to foster and encourage participation of socially and economically disadvantaged small business concerns and women-owned small business concerns in technological innovation.  Small Business Technology Transfer (STTR) program: To stimulate and foster scientific and technological innovation through cooperative research and development carried out between small business concerns and research institutions; to foster technology transfer between small business concerns and research institutions; to increase private sector commercialization of innovations derived from Federal research and development; and to foster and encourage participation of socially and economically disadvantaged small business concerns and women-owned small business concerns in technological innovation.","cfda_obligations":"(Cooperative Agreement) FY 24$427,927,639.00; FY 25$435,385,042.00; FY 26 est $305,362,778.00; - (Grant) FY 24$870,623,865.00; FY 25$979,580,392.00; FY 26 est $621,264,199.00; - ","cfda_popular_name":"Cancer Treatment Research","cfda_title":"Cancer Treatment Research","cfda_website":"http://www.cancer.gov/cancertopics/treatment","federal_action_obligation_amount":400000.0,"non_federal_funding_amount":0.0,"sam_website":"https://sam.gov/fal/ddc8ef4602064b7983b50206e31c99e1/view","total_funding_amount":400000.0}],"transaction_obligated_amount":400000.0,"funding_agency":{"id":830,"has_agency_page":true,"toptier_agency":{"name":"Department of Health and Human Services","code":"075","abbreviation":"HHS","slug":"department-of-health-and-human-services"},"subtier_agency":{"name":"National Institutes of Health","code":"7529","abbreviation":"NIH"},"office_agency_name":"NIH National Cancer Institute"},"awarding_agency":{"id":830,"has_agency_page":true,"toptier_agency":{"name":"Department of Health and Human Services","code":"075","abbreviation":"HHS","slug":"department-of-health-and-human-services"},"subtier_agency":{"name":"National Institutes of Health","code":"7529","abbreviation":"NIH"},"office_agency_name":"NIH National Cancer Institute"},"period_of_performance":{"start_date":"2025-09-18","end_date":"2026-08-31","last_modified_date":"2025-09-24"},"recipient":{"recipient_hash":"06ee66be-efd1-0fde-41e9-ee8d7fce0c8d-R","recipient_name":"AEROCYTEK, INC.","recipient_uei":"V1NAZKBGDEZ3","recipient_unique_id":null,"parent_recipient_hash":null,"parent_recipient_name":null,"parent_recipient_uei":null,"parent_recipient_unique_id":null,"business_categories":["Category Business","Small Business"],"location":{"location_country_code":"USA","country_name":"UNITED STATES","state_code":"CA","state_name":"CALIFORNIA","city_name":"SAN DIEGO","county_code":"073","county_name":"SAN DIEGO","address_line1":"17150 VIA DEL CAMPO STE 304","address_line2":null,"address_line3":null,"congressional_code":"50","zip4":"2139","zip5":"92127","foreign_postal_code":null,"foreign_province":null}},"executive_details":{"officers":[{"name":null,"amount":null},{"name":null,"amount":null},{"name":null,"amount":null},{"name":null,"amount":null},{"name":null,"amount":null}]},"place_of_performance":{"location_country_code":"USA","country_name":"UNITED STATES","county_code":null,"county_name":null,"city_name":null,"state_code":"CA","state_name":"CALIFORNIA","congressional_code":null,"zip4":null,"zip5":null,"address_line1":null,"address_line2":null,"address_line3":null,"foreign_province":null,"foreign_postal_code":null},"total_outlay":370000.0,"funding_opportunity":{"number":"PA-23-230","goals":"TO DEVELOP THE MEANS TO CURE AS MANY CANCER PATIENTS AS POSSIBLE AND TO CONTROL THE DISEASE IN THOSE PATIENTS WHO ARE NOT CURED.  CANCER TREATMENT RESEARCH INCLUDES THE DEVELOPMENT AND EVALUATION OF IMPROVED METHODS OF CANCER TREATMENT THROUGH THE SUPPORT AND PERFORMANCE OF BOTH FUNDAMENTAL AND APPLIED LABORATORY AND CLINICAL RESEARCH.  RESEARCH IS SUPPORTED IN THE DISCOVERY, DEVELOPMENT, AND CLINICAL TESTING OF ALL MODES OF THERAPY INCLUDING: SURGERY, RADIOTHERAPY, CHEMOTHERAPY, AND BIOLOGICAL THERAPY INCLUDING MOLECULARLY TARGETED THERAPIES, BOTH INDIVIDUALLY AND IN COMBINATION.  IN ADDITION, RESEARCH IS CARRIED OUT IN AREAS OF NUTRITIONAL SUPPORT, STEM CELL AND BONE MARROW TRANSPLANTATION, IMAGE GUIDED THERAPIES AND STUDIES TO REDUCE TOXICITY OF CYTOTOXIC THERAPIES, AND OTHER METHODS OF SUPPORTIVE CARE THAT MAY SUPPLEMENT AND ENHANCE PRIMARY TREATMENT. SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM: TO EXPAND AND IMPROVE THE SBIR PROGRAM, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, TO INCREASE SMALL BUSINESS  PARTICIPATION IN FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION.  SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM: TO STIMULATE AND FOSTER SCIENTIFIC AND TECHNOLOGICAL INNOVATION THROUGH COOPERATIVE RESEARCH AND DEVELOPMENT CARRIED OUT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO FOSTER TECHNOLOGY TRANSFER BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION."}}