Pharma Focus Europe

TC BioPharm Receives FDA Clearance for Phase 1B Investigational New Drug (IND) TCB-008 in Acute Myeloid Leukemia

Tuesday, November 28, 2023

TC BioPharm (Holdings) PLC, a biotechnology company focused on developing allogeneic gamma-delta T cell therapies for cancer (NASDAQ: TCBP), has received clearance from the FDA for its investigational new drug (IND) application for a Phase 1B study targeting relapse/refractory Acute Myeloid Leukemia (AML).

The Phase 1B study, named ACHIEVE2, is set to include nine patients in a dose-escalating approach to assess safety and optimize dosage. The study, an open-label, multi-center initiative conducted in two stages (dose escalation followed by dose expansion), will evaluate the safety, persistence/expansion, and preliminary efficacy of single and multiple intravenous doses of TCB008 in AML or MDS/AML patients. Reinfusion of TCB008, up to three times, may occur following the initial infusion based on protocol-specific criteria.

Bryan Kobel, CEO of TC BioPharm, described the acceptance of the TCB-008 IND as a significant milestone, reflecting the execution of their strategic plan outlined to shareholders in April. The company aims to establish TCB008 as the standard of care for individuals globally suffering from blood and bone marrow cancer, with the ultimate goal of improving their quality of life and extending remission.

The company will also continue its UK ACHIEVE trial in AML, planning to submit protocol amendments before year-end to align dosing and other criteria with the ACHIEVE2 trial of TCBP's lead product.

Kobel emphasized TCB-008's promising results in late-stage AML patients and its potential as a therapeutic option for various blood-related cancers. Looking ahead to 2024, TC BioPharm anticipates achieving significant milestones in both the US and ongoing ACHIEVE trials, as well as in platform expansion. The company remains committed to executing its refocused strategy, expanding its platform, and generating robust clinical data as a leader in the gamma delta space.

TCB008, also known as OmnImmune®, is an allogeneic unmodified cell therapy that utilizes activated and expanded gamma-delta T cells. The therapy, designed for patients with relapse/refractory AML, involves GDT cells sourced from healthy donors, expanded, activated, purified, and formulated for infusion. OmnImmune® is a frozen and thawed product, now "banked" from donor-derived cells.



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