TCBP's ACHIEVE Trial Completes First Full Dose Patient

TC BioPharm (Holdings) PLC, a clinical-stage biotechnology firm specializing in allogeneic gamma-delta T cell therapies for cancer, has reported significant progress in its ACHIEVE Phase 2b trial in the UK. The company announced that the first patient has successfully completed the full dosing regimen, receiving up to four doses of TCB008 without experiencing any drug-related adverse events. This milestone is a promising indicator of the safety and tolerability of TCB008.

The ACHIEVE trial aims to assess the efficacy and safety of TCB008 in patients with acute myeloid leukemia (AML) or myelodysplastic syndromes/acute myeloid leukemia (MDS/AML) who have either refractory or relapsed disease. The trial follows an open-label, phase II design and has initially enrolled 14 patients in Cohort A. An additional 10 patients are expected to join the cohort, bringing the total to 24 participants.

Preliminary safety data from the first fully dosed patient indicate that the 5mL dose of TCB008 is well-tolerated, with no adverse events related to the drug. This positive outcome supports the trial's safety objectives and endpoints. The company continues to identify, screen, and enroll new patients into the study, with expectations that three more patients will receive their fourth and final dose by the end of September.

TC BioPharm's Chief Executive Officer, Bryan Kobel, expressed satisfaction with the trial's progress. "We are extremely pleased to announce that the full dosing regimen has been completed by the first patient to receive the increased dose of TCB008 under the ACHIEVE trial. No drug-related adverse events have been observed in any of the restart patients," said Kobel. He further highlighted that the safety and tolerability data are encouraging and that efficacy data will be released after the cohort's completion and data cleaning, in compliance with regulatory mandates. Kobel also mentioned that strong recruitment and enrollment are ongoing at active sites, and the company expects to announce a comprehensive data set in the first half of 2025, inclusive of primary and secondary endpoints.

The ACHIEVE UK clinical trial is a significant step in evaluating TCB008's potential as a treatment option for patients with AML or MDS/AML. The trial's design and preliminary outcomes suggest that TCB008 could be a promising therapy for these challenging conditions. With no drug-related adverse events reported so far, the trial's safety objectives are being met, paving the way for further evaluation of the drug's efficacy.

TC BioPharm remains at the forefront of gamma-delta T cell therapy development, being the first company to conduct phase II/pivotal clinical studies in oncology using this innovative approach. The company's proprietary allogeneic CryoTC technology allows for the distribution of frozen gamma-delta T cell products to clinics globally, further solidifying its leadership in this field.

As the ACHIEVE trial progresses, TC BioPharm is poised to provide valuable insights into the safety and efficacy of TCB008, potentially offering a new therapeutic option for patients with AML or MDS/AML. The forthcoming data release in 2025 will be crucial in determining the drug's overall impact and future applications in oncology.