TCBP Announces Successful Completion of Initial Cohort B Patient Dosing in the ACHIEVE Clinical Trial

Core Viewpoint - TC BioPharm has announced the completion of the full dosing regimen for the first patient in Cohort B of the ACHIEVE Phase 2B clinical trial, which evaluates the efficacy and safety of TCB008 in treating Acute Myeloid Leukemia (AML) [1][3]. Group 1: Clinical Trial Details - The ACHIEVE trial is an open-label Phase II study focused on the efficacy and safety of TCB008 for patients with AML and myelodysplastic syndromes (MDS/AML), particularly those with refractory or relapsed conditions [2]. - Recruitment for Cohort B began in Q4 2024, ahead of schedule, with the first patient receiving their dose in October 2024 and completing all four planned doses [3][9]. - A second patient has also been enrolled in Cohort B, which targets patients who have achieved remission but still have detectable minimal residual disease (MRD) [2][3]. Group 2: Safety and Efficacy - The safety objectives of the ACHIEVE trial include evaluating patient responses to TCB008, grading adverse events, and monitoring for cytokine release syndrome and neurotoxicity [4]. - Preliminary data indicates no drug-related adverse events after cumulative infusions of TCB008, which contains up to approximately 1 billion cells [4][9]. - Initial data reviews suggest a positive safety profile and promising efficacy signals, including cellular recovery and reduced inflammation in AML patients [5]. Group 3: Company Insights and Future Plans - The rapid progress of the ACHIEVE study is attributed to the dedication of the TC BioPharm team and clinical sites, achieving significant milestones in under six months [5]. - The CEO of TC BioPharm expressed optimism about TCB008's potential as an effective treatment for AML patients with unmet needs, highlighting the well-tolerated nature of the therapy and the compelling patient population in Cohort B [5]. - Enrollment for the second cohort is expected to be completed in the first half of 2025, with data readout anticipated later in the year [5].