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TC BioPharm Files Investigational New Drug (IND) Application with U.S. FDA for the Treatment of Relapse/Refractory AML

Tuesday, October 24, 2023

TC BioPharm (Holdings) PLC, trading under the symbol TCBP on NASDAQ, is a biotechnology company in the clinical development stage, focusing on the creation of allogeneic gamma-delta T cell therapies for cancer treatment. Today, the company officially submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for TCB-008. This application seeks approval for the utilization of TCB-008 in the treatment of patients with relapse/refractory Acute Myeloid Leukemia (AML).

TCB-008 serves as the company's flagship product, comprising unmodified allogeneic gamma delta T-cells. Currently, TCB-008 is undergoing Phase 2b clinical trials in the United Kingdom for the treatment of AML.

The IND application is built on innovative research into the potential use of gamma-delta T cells for managing relapse/refractory AML. It's important to note that TCB-008 has previously received Orphan Drug Status for AML treatment.

TC BioPharm, remarked, "The submission of the IND for TCB-008 represents a significant milestone in the clinical progression of this product and aligns with our strategic shift, announced in the second quarter of this year, to focus on our clinical strategy with an eye toward future trials in the United States. This IND application draws upon supporting clinical data from ongoing AML studies and reflects the substantial pre-clinical work conducted by the TCB team over the past six months. I want to express my appreciation to our dedicated team, who have put in tireless efforts to accomplish the company's inaugural filing for a U.S. FDA trial. We eagerly anticipate collaborating with the FDA for the IND's acceptance in the next 30 days and the progression of our lead candidate through the clinical development stages."

It's important to note that the FDA will review this application and assess the data's suitability before TC BioPharm can initiate its first clinical trial for TCB-008. The FDA might also request additional information during the review process.

As for OmnImmune®, it's an allogeneic unmodified cell therapy that comprises activated and expanded gamma delta T cells. This therapy is intended for patients dealing with relapse/refractory AML. It involves the use of GDT cells obtained from healthy donors, which are then expanded and activated in substantial quantities. Subsequently, these cells are purified and prepared for infusion into patients. OmnImmune® is stored as a frozen product, derived from donor cells and kept in a bank for future use.




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