[Shanghai /Florida] Shanghai EXUMA Biotechnology to Develop Novel Solid Tumor CAR-T Programs Under Centralized Regulatory Pathway from Investigator-Initiated Studies Currently Underway in Shanghai. F1 Oncology, a biotechnology company discovering and developing adoptive cellular therapies (ACTs) for solid tumors, announced on November 13 that its international affiliate, EXUMA Biotechnology Hong Kong, has formed Shanghai EXUMA Biotechnology Co., Ltd., a wholly foreign-owned enterprise (WFOE), to acquire all rights to novel chimeric antigen receptor T (CAR-T) cell therapy and manufacturing assets in Shanghai and Shenzhen for the development and commercialization of cellular therapies in Greater China to be used in the treatment of solid tumor malignancies.
Shanghai EXUMA will develop these clinical programs into multicenter trials under a centralized regulatory pathway based on the results of investigator-initiated trials (IITs) of CAR-T therapies for the treatment of metastatic renal cell carcinoma (mRCC) and other solid tumor malignancies. Shanghai EXUMA will be expanding its CAR-T cell processing capabilities at its new facility in the Shanghai International Medical Zone within Zhangjiang Innopark in Shanghai's Pudong district and its viral manufacturing capabilities at its newly constructed Shenzhen facility.
"The treatment of cancer is advancing at unprecedented speed, and we are pleased to be playing a role in this rapid and positive evolution, of which the formation of Shanghai EXUMA Biotechnology is an important component," said Gregory Frost, Ph.D., Chairman and CEO of F1 Oncology. "The decision to integrate these programs and processes into EXUMA was driven by the favorable early clinical profile, and we are excited to support their advancement toward multicenter trials next year. By turning a hostile tumor microenvironment (TME) into an activating signal for CAR-T cells, this platform could open the therapeutic window of CAR-T to many solid tumors."
EXUMA Biotech integrates BioAtla's conditionally active biologic (CAB) protein therapeutic technology with F1 Oncology's proprietary CAR-T technologies to develop and commercialize CAB-CAR-T therapies and other ACTs for the treatment of solid tumor malignancies. CAB-CAR-T cellular therapies are designed to be conditionally active only in the TME and may therefore help reduce potential adverse events associated with on-target, off-tumor effects of CAR-T therapies in solid tumors. While BioAtla's option to purchase F1 Oncology expired in May 2018, F1 Oncology retains an exclusive global license to discover and develop CAB-based ACTs.