On January 7, 2018 Shanghai Sinobioway Sunterra Biotechnology (SSSB) and F1 Oncology reported the signing of new development, manufacturing, and supply agreements with plans to complete a new cGMP manufacturing facility in Shenzhen in support of large scale lentivirus contract manufacturing (Press release, EXUMA Biotechnology, JAN 7, 2018, View Source [SID1234619679]). The new facility, Shenzhen Biowit, which will expand from the current clinical production staff and site in Shenzhen, is scheduled for completion in 2018 and will utilize F1 Oncology’s chemically defined suspension-based lentivirus manufacturing technology and processes. The Shenzhen Biowit facility, 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.
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The new collaboration agreements between F1 Oncology’s international affiliates and Sinobioway Sunterra Biotechnology will facilitate clinical development and commercialization 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. F1 Oncology will be responsible for lead generation, preclinical safety assessment and clinical virus manufacturing costs. Sinobioway Sunterra Biotechnology will be responsible for cGMP cell processing, clinical development, regulatory approval, and commercialization in the defined territories.
The agreement 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. 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.
"Biowit, a subsidiary of SSSB, has been providing the majority of cell therapy research institutions in China with virus products service over the past 7 years. Today, the introduction of F1 Oncology’s chemically defined suspension-based lentivirus manufacturing technology marks a new stage of China clinical virus manufacturing. Through our one year-old collaboration, Sunterra is leveraging the value of F1 Oncology’s CAB-CAR-T technology and proprietary industrial manufacturing processes to begin novel CAR-T clinical trials in China. We are confident that F1 Oncology’s differentiating technologies will allow us to stand out from other players in the CAR-T solid tumor space." Stated Mr. Wu Zili, Board Director and founder of SSSB.
"Reliable supply of viral gene vectors for cell and gene therapy programs is a current and growing challenge for the commercial biotechnology industry, and generally requires a different facility configuration to those used for traditional biologics" stated Tim Mayall, Ph.D. Head of Process Development at F1 Oncology. "Our early investments in the generation of serum-free well-characterized cell substrates capable of suspension-based lentivirus production supports a scalability that we believe will be beneficial from first in human through commercialization."