Policy & Regulation
TC BioPharm's TCB008 IND application for Phase 1B study in relapse/refractory Acute Myeloid Leukaemia receives US FDA approval
28 November 2023 -

TC BioPharm (Holdings) PLC (NASDAQ: TCBP), a UK-based clinical stage biotechnology company, announced on Monday that it has received approval from the US FDA for the company's investigational new drug (IND) application for a Phase 1B study in relapse/refractory Acute Myeloid Leukaemia (AML).

The Phase 1B study is named ACHIEVE2 and will be a nine patient, dose escalating study assessing safety and dose optimisation. The Open-label, multi-centre study will be carried out in two parts (dose escalation followed by dose expansion) and will assess safety, persistence/expansion, and preliminary efficacy of single and multiple IV doses of TCB008 in patients with AML or MDS/AML. Patients are expected to be reinfused with TCB008 up to three times subsequent to initial infusion as deemed appropriate by the investigator or designee if protocol specified criteria are met.

The firm will also be continuing with the UK ACHIEVE trial in AML and is expected to submit amendments to the protocol prior to year-end to align the dosing and other criteria with the ACHIEVE2 trial of TCBP's lead product.

TCB008 is an allogeneic unmodified cell therapy that consists of activated and expanded gamma delta T cells.