TC Biopharm advances ACHIEVE Phase 2b clinical trial

TC BioPharm (TCBP) announced 3 patients have now completed the full-dose regimen in the ACHIEVE Phase 2b trial in the UK with no drug-related Adverse Events seen in any of the restart patients. The ACHIEVE UK clinical trial is an open-label, phase II study designed to evaluate the efficacy and effectiveness of TCB008 in patients with AML or MDS/AML, with either refractory or relapsed disease. To date, 10 patients have received their first dose, 9 patients have received their second dose, 4 patients have received their third dose, and 3 patients have received their fourth and final dose. 9 out of 10 patients recruited to date are in Cohort A, representing relapsed/refractory patients who have been unable to attain remission. One patient has been enrolled into Cohort B, representing patients who have attained remission following prior treatment yet continue to have a detectable residual disease. The patient enrolled in Cohort B received their fourth and final dose in November 2024. Initially, 14 patients are planned to be recruited into Cohort A and Cohort B and, following confirmation of study endpoints, a further 10 patients will be recruited into each cohort, giving a total of 48 patients. The preliminary safety data shows that the 5mL dose of TCB008 is well tolerated, with no drug-related Adverse Events. These data outputs remain aligned with TCB008’s safety profile, in support of the ACHIEVE study safety objectives and endpoints.