TC BioPharm (Holdings) PLC (NASDAQ: TCBP) a UK-based clinical stage biotechnology company, announced on Monday that on 16 July it dosed its sixth patient in its ACHIEVE (UK) clinical trial of TCB-008.

This is the first patient treated with a higher dose of TCB-008 post the amendment approved by the MHRA on 22 Feb 2024.

The ACHIEVE UK clinical trial is an open-label, phase II study designed to evaluate the efficacy and effectiveness of TCB-008 in patients with AML or MDS/AML, with either refractory or relapsed disease. ACHIEVE is comprised of two cohorts representing separate disease states. The protocol allows for either cohort to be advanced as an independent Phase III Pivotal Trial upon completion of the cohort, presuming the primary efficacy endpoints is met.

Cohort A represents relapsed/refractory patients who have been unable to attain remission and are in palliative care as they are unable to tolerate further chemotherapy. Initially, 5 patients were treated at the lower dose. Up to 14 patients may be recruited into this cohort at the higher dose. Pending confirmation of the primary endpoints, a further 10 patients may be recruited into Cohort A for a total of 24 patients.

Cohort B represents patients who have attained remission following prior treatment, however, continue to have a detectable residual disease.

Enrolled patients will be treated with an increased dose of TCB-008, containing up to 230,000,000 cells per dose compared to the previous dose of 35,000,000.