Shanghai, PRC and West Palm Beach, FL – January 7th, 2018 – F1 Oncology, Inc., a biotechnology company discovering and developing adoptive cellular therapies (ACTs) for solid tumors, today announced receipt of a $10 million equity investment from its current investors upon ethics committee approval of a novel precision medicine-directed trial sponsored by Shanghai Sinobioway Sunterra Biotechnology and its hospital collaborators for two novel chimeric antigen receptor T cell (CAR-T) products for the treatment of metastatic renal cell carcinoma (mRCC).
The two conditionally active CAR-T cellular products targeting AXL and ROR2 will be tested in subjects with refractory, advanced stage mRCC. CCT301-38 AXL and CCT301-59 ROR2 were evolved and molecularly engineered into CAR-T products to provide tumor microenvironment (TME) control over CAR-T receptor ligand binding, cytokine release, and cell lysis. Each cellular product additionally contains a cell removal epitope for antibody mediated removal. Both cellular products are processed using a 3rd generation suspension-based lentiviral system and proprietary T cell closed cell processing system developed by F1 Oncology.
The precision medicine-driven clinical trial will enroll patients with multi-organ, recurrent/refractory metastatic renal cell carcinoma based on expression of the AXL or ROR2 targets in tumor biopsy. Eligible subjects will be assigned to one of two arms via immunohistochemistry (IHC) analysis of AXL and ROR2 expression in a parallel dose escalation design in Stage A followed by cohort expansion in Stage B after data safety monitoring board review. Safety, cellular kinetics, and objective response by RECIST 1.1 with central radiology review will be performed on subjects enrolled in each arm of the study. Study results for each arm will be reported at the completion of Stage A and the completion of Stage B, including interim follow-up findings for durability of response, cellular persistence, and safety.
“Our appreciation for the unique technologies at F1 Oncology has been validated by the close working collaboration between the two organizations,” stated Wu Zili, Director and founder of Shanghai Sinobioway Sunterra Biotechnology. “The future potential benefit to many Chinese patients from this work is a continuous motivation.”
“We look forward to reviewing the outcome of this innovative clinical approach with two CAR-T products against a single malignancy in a target-driven trial,” stated Gregory Frost, Ph.D. Chairman & CEO of F1 Oncology. “The clinical investigation of these first tumor microenvironment-controlled CAR-T products, each with unique targets and activating domains and properties, will advance the field towards the objective of making CAR-T more broadly applicable to patients suffering from solid tumor malignancies”.
F1 Oncology combines its US partner, BioAtla LLC’s, CAB technology with F1 Oncology’s proprietary technologies to develop and commercialize CAB-CAR-T therapies and other ACTs for the treatment of solid tumor malignancies. CAB-CAR-T cell therapies are designed to be conditionally active only in the tumor microenvironment, and may therefore help reduce potential adverse events associated with on-target, off-tumor effects of CAR-T therapies.
About F1 Oncology, Inc.
F1 Oncology, Inc. is a private Delaware corporation formed in November 2015 with operations in West Palm Beach, Florida, San Diego, California and international affiliates in George Town, Cayman Islands, Hong Kong, and Shanghai, China. F1 Oncology leverages its globally integrated science, development and informatics teams located across multiple time zones to accelerate the design, high-throughput screening, discovery and development of adoptive cellular therapy (ACT) 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. Learn more at www.f1oncology.com.
About Shanghai Sinobioway Sunterra Biotechnology
Shanghai Sinobioway Sunterra Biotechnology (“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. Learn more at www.sunterra-bio.com.
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|Lingchen Yan, Ph. D.
Shanghai Sinobioway Sunterra
Biotechnology Co., Ltd
|Alissa Kerner, Ph.D.
F1 Oncology, Inc.