SHANGHAI and WEST PALM BEACH, Fla., Jan. 7, 2018 /PRNewswire/ — F1 Oncology, Inc., a biotechnology company discovering and developing adoptive cellular therapies (ACTs) for solid tumors, today announced receipt of a $10 millionequity 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 3^rd 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 inAsia. 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.

SOURCE F1 Oncology

Related story:

F1 Oncology’s International Affiliates And Sinobioway Sunterra Biotechnology Announce New Development, Manufacturing, And Supply Agreements To Support cGMP Lentivirus Supply

New Shenzhen facility, in collaboration with F1 Oncology’s Hong Kong affiliate, to support future China gene therapy markets with clinical and commercial cGMP lentivirus for CAR-T and other gene therapies

Jan 07, 2018, 11:32 ET from F1 Oncology

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SHENZHEN, China and SHANGHAI and HONG KONG and GRAND CAYMAN, Grand Cayman Island, Jan. 7, 2018 /PRNewswire/ — Shanghai Sinobioway Sunterra Biotechnology (SSSB) and F1 Oncology today announced 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. 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.

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.”

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

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.