The National Cancer Center (President: Hitoshi Nakagama, “NCC”) and Asahi Kasei Corp. (President: Koshiro Kudo, “Asahi Kasei”) have signed a joint research agreement to develop cellular immunotherapies utilizing the chimeric antigen receptor T cell (CAR-T cell1) format. This alliance will drive CAR-T cell pipelines established at National Cancer Center Research Institute (Director: Hiroyuki Mano) Division of Cancer Immunology (Chief: Hiroyoshi Nishikawa) towards clinical implementation targeting patients having T cell malignancies with unfavorable prognoses, and those having solid tumors that are resistant against standard immunotherapies.
NCC currently has three preclinical CAR-T cell pipelines to T cell malignances or solid tumors with definitive proof of concept data, one of which is under preparation for a first-in-human clinical trial. NCC has established procedures of vector production T cell expansion and analytical methods for the CAR-T cells. NCC will transfer its techniques to Asahi Kasei, which will work to establish the process of GMP/GCTP2 CAR-T cell production/qualification for clinical trials, and to further advance development for CDMO3 production in the future commercial phase. As a longer-term goal, the Asahi Kasei–NCC alliance aims to become a global hub for research, development, GMP/GCTP production, and supply of cellar therapy products.
The Asahi Kasei Group has a proven track record in the development and marketing of biopharmaceutical products, as well as manufacturing technologies for regenerative medicine products. Asahi Kasei will promote this joint research with NCC by leveraging its knowledge and experience, and contribute to the establishment of manufacturing technology for the practical application of CAR-T cell therapy.
- CAR-T cell (chimeric antigen receptor T cell). A T cell that is genetically modified to express CAR to redirect T cells to and attack tumors. Several types of CAR-T cell products are approved for B cell malignancies such as malignant lymphoma, acute lymphoblastic leukemia, and myeloma.
- GMP/GCTP (Good Manufacturing Practice/Good Gene, Cellular, and Tissue-based Products Manufacturing Practice). GMP/GCTP is a system for ensuring that products are consistently produced and controlled according to quality standards. Either investigational or commercialized CAR-T cell process must be produced and supplied under the GMP/GCTP condition.
- CDMO (Contract Development and Manufacturing Organization). A company or institute that supplies services in drug development and manufacturing for pharmaceutical companies including cell manufacturing and qualification of the drug.