Clinical Trial Progress - The ACHIEVE UK clinical trial is a phase II study evaluating the efficacy of TCB008 in patients with AML or MDS/AML, focusing on refractory or relapsed disease [1] - Preliminary safety data shows the 5mL dose of TCB008 is well tolerated with no drug-related Adverse Events, aligning with the safety profile [2] - 3 patients have completed the full-dose regimen in the ACHIEVE Phase 2b trial with no drug-related Adverse Events observed [5] - 10 patients have received their first dose, 9 their second dose, 4 their third dose, and 3 their fourth and final dose [9] - 9 out of 10 recruited patients are in Cohort A (relapsed/refractory), while 1 patient is in Cohort B (remission with residual disease) [9] - Recruitment for the ACHIEVE trial has been successful, with over half of Cohort A patients recruited in less than 5 months [10] Company Overview - TC BioPharm is a clinical-stage biopharmaceutical company developing gamma-delta T cell therapies for cancer treatment [3][11] - The company is the first to conduct phase II/pivotal clinical studies in oncology using gamma-delta T cell therapies [3] - TC BioPharm is conducting two investigator-initiated clinical trials, including a Phase 2b/3 pivotal trial for acute myeloid leukemia using its proprietary CryoTC technology [3] Future Plans and Expectations - The company plans to recruit 14 patients initially into Cohort A and B, with an additional 10 patients per cohort after confirming study endpoints, totaling 48 patients [9] - The immediate clinical focus is on high recruitment for Cohort B in 2025 and completing data review for Cohort A [6] - The CEO highlighted the potential for an expedited review due to the patients' stage and disease expression, with minimal residual disease representing a high opportunity for TCB008 [6]
TCBP Advances ACHIEVE Phase 2b Clinical Trial with Final Dosing of 3 Patients