TC BioPharm's IND Application For TCB-008 In Acute Myeloid Leukemia Gets FDA Clearance

(RTTNews) - TC BioPharm (Holdings) Plc. (TCBP) Monday announced that the FDA provided clearance on an investigational new drug application for a Phase 1B study in relapse/refractory Acute Myeloid Leukemia.

The Open-label, multi-center ACHIEVE2 Phase 1B study will be a 9-patient, dose-escalating study. The study will evaluate the safety, persistence/expansion, and preliminary efficacy of single and multiple IV doses of TCB008 in patients with Acute Myeloid Leukemia.

The clinical-stage biotechnology company said it will be continuing the UK ACHIEVE trial in AML, expecting to submit amendments to the protocol.

TCB008 or OmnImmune is an allogeneic unmodified cell therapy consisting of activated and expanded gamma delta T cells.