Policy & Regulation
F1 Oncology, SSSB Partner to Complete New cGMP Lentivirus Manufacturing Facility in Shenzhen
11 January 2018 - - Shenzhen, Shanghai, and Hong Kong, China- and Grand Cayman, Grand Cayman Island-based F1 Oncology's Hong Kong affiliate has signed new development, manufacturing, and supply agreements with Shanghai Sinobioway Sunterra Biotechnology (SSSB) for plans to complete a new cGMP manufacturing facility in Shenzhen in support of large scale lentivirus contract manufacturing, the company said.
The new facility, Shenzhen Biowit, will utilize F1 Oncology's chemically defined suspension-based lentivirus manufacturing technology and processes, and, in collaboration with F1 Oncology's Hong Kong affiliate, will support future China gene therapy markets with clinical and commercial cGMP lentivirus for CAR-T and other gene therapies.
The new collaboration agreements between F1 Oncology's international affiliates and SSSB will facilitate clinical development and commercialisation of F1 Oncology's CCT3-based conditionally active biologic chimeric antigen receptor T cell (CAB-CAR-T) products in China, Hong Kong, Macau, and Taiwan.
F1 Oncology retains rights to CCT3 products in all other territories and exclusive responsibility for global manufacturing and supply of certain product classes.
Upon SSSB's closing of certain financing activities, SSSB will issue to F1 Oncology 20% equity plus 5% warrants. The agreement also provides for certain licensing fees to be paid by SSSB upon nomination of new CAR-T products with preclinical packages delivered to SSSB for commercialization.
F1 Oncology will be responsible for lead generation, preclinical safety assessment and clinical virus manufacturing costs. SSSB will be responsible for cGMP cell processing, clinical development, regulatory approval, and commercialisation in the defined territories.
The agreement further provides for processing of raw materials provided by F1 Oncology's international affiliates and production to supply commercial products to the China markets.
SSSB was formed by Sinobioway Group, Sunterra Capital, and F1 Oncology for the express purpose of developing novel CAB-CAR-T therapies for solid tumor malignancies in China. SSSB's GMP cell processing facilities in Shanghai have been developed to support clinical research through key academic collaborations.
F1 Oncology, with operations in West Palm Beach, Florida, San Diego, California and international affiliates in George Town, Cayman Islands, Hong Kong, and Shanghai, China, leverages its globally integrated science, development, and informatics teams to accelerate the design, high-throughput screening, discovery, and development of adoptive cellular therapy candidates.
The company is developing two CAB-based ACT platforms to develop TME-restricted CAR-T therapies for solid tumors, as well as developing highly scalable systems for global deployment, beginning in Asia.
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