TC BioPharm, a clinical-stage biotechnology company, announced a fundamental shift in the development and manufacture of its lead product, TCB-008, an allogeneic gamma-delta T cell therapy for cancer. The company intends to pursue exclusive partnerships for test research and combination trials using allogeneic gamma-delta T-cells, subvariant 2 (“GDT v2s”) that will add value to its therapies and expand its operations into CAR Therapy with a focus on binder B7H3 for the treatment of ovarian cancer.
The shift will enable the company to maximize the potential of its therapies and increase the value of its assets and the company. Bryan Kobel, CEO of TC BioPharm, said that TCB-008 is an extremely promising therapeutic in cancer, and given its versatility, its mechanism of action, and the numerous arenas where other companies are attempting to activate or interact with gamma-delta t-cells to tumors, they believe TCB-008 will be a best-in-class asset for these companies to partner with in the future.
TCB-008 is currently scheduled for the FDA IND filing in Q3 of 2023 and the final monotherapy trial for TCB-008. The company has executed three research collaborations around TCB-008 in combination with complementary approaches and expects to finalize a partnership from one of these collaborations in 2023 for trial in 2024.
A collaborative integration of TC BioPharm’s primary asset, TCB-008, will further enable the company to expand operations into CAR Therapy with a focus on binder B7H3 for the treatment of ovarian cancer. The current target indication will be Ovarian cancer, with more than 313,000 new cases of ovarian cancer in 2020. The Five-year Relative Survival rate is 49.7%.
Clinical development to-date has enabled the company to pivot to a more agile clinical strategy towards US FDA trials for TCB-008 for Acute Myeloid Leukemia (AML). TCBP became the leader in the allogeneic gamma-delta space by completing dosing of the safety cohort.
TCBP will review external assets with pre-clinical packages/early data Cell therapies across the spectrum including TCR/CAR/Other immunotherapy opportunities and other areas where TCB-008 might be effective. Potential near-term collaborations could include fungal infection therapies in Rare Disease indications and combination research to assist private companies seeking capital where it can leverage equity capital to stockpile assets.
Kobel said that prioritizing partnerships as they head towards US trials realigns them with their long-term goal of becoming a leading commercial-stage company. These partnerships will expand the data set on TCB-008, give them more knowledge around both the product and GDTs, and provide investors with multiple shots on goal and additional inflection points at a lower cash expenditure. The company firmly believes in the potential of TCB-008 and will position the company to be more economically efficient.
TC BioPharm is a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of gamma-delta T-cell therapies for the treatment of cancer. Gamma-delta T cells are naturally occurring immune cells that embody properties of both the innate and adaptive immune systems and can intrinsically differentiate between healthy and diseased tissue. TC BioPharm uses an allogeneic approach in both unmodified and CAR modified gamma-delta T cells to effectively identify, target, and eradicate both liquid and solid tumors in cancer.
TC BioPharm is the first company to conduct phase II/pivotal clinical studies in oncology and is conducting two investigator-initiated clinical trials for its unmodified gamma-delta T cell product line – Phase 2b/3 pivotal trial for OmnImmune® in the treatment of acute myeloid leukemia using the company’s proprietary allogenic CryoTC technology to provide frozen product to clinics worldwide. TC BioPharm maintains a robust pipeline for future indications in solid tumors as well as a significant IP/patent portfolio in the use of CARs with gamma-delta T cells and owns its manufacturing facility to maintain cost and product quality controls.
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