#United Kingdom #Edinburgh #TC BioPharm #ACHIEVE Trial #TCB008

TC BioPharm's Recent Progress in Clinical Trials

TC BioPharm (Holdings) PLC, a prominent name in the biotechnology sector focused on innovative cancer therapies, has recently celebrated an important milestone in its clinical research. The company announced that the first patient in Cohort B of its ACHIEVE clinical trial has successfully completed dosing. This pivotal trial seeks to evaluate the efficacy and safety of TCB008, a groundbreaking therapy targeted specifically at treating Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS/AML).

The ACHIEVE trial, which is presently in Phase 2B in the UK, is an open-label study intended to assess how effective and tolerable the TCB008 treatment is for patients suffering from AML, particularly those who exhibit complications from previous treatments. Patients who have previously reached remission but have detectable minimal residual disease (MRD) are recruited for Cohort B in this study. As part of this cohort, the first patient received four doses of TCB008, amounting to approximately 819 million gamma-delta T cells. An additional fifth dose is planned to further evaluate treatment outcomes.

Recruitment for Cohort B commenced in the final quarter of 2024, ahead of the company’s intended schedule, showcasing the rapid advancement of the study. By October 2024, the first patient had begun the dosing regimen, and the enrollment of a second patient is underway to continue the momentum of the trial.

The primary safety objectives of the ACHIEVE trial include monitoring patient responses to TCB008, with careful observation of adverse events, cytokine release syndrome, and possible neurotoxicity. Preliminary assessments have revealed no adverse drug-related events following the cumulative doses of TCB008, reinforcing the therapy's promising safety profile. As reported by Alison Bracchi, the Executive Vice President of Clinical Operations, the progress made in just under six months has been remarkable, reflecting both the commitment of the TC BioPharm team and the clinical sites involved. Initial data suggest a positive safety outcome and potential efficacy signals, demonstrating cellular recovery and diminished inflammation in AML patients receiving the treatment.

Bryan Kobel, CEO of TC BioPharm, expressed optimism about the development of TCB008, noting that it represents a significant step toward addressing large unmet needs within the AML patient community. The results thus far indicate that the therapy is well-tolerated, showing no unexpected incidents or toxicities, and some patients are already demonstrating promising efficacy. The second cohort presents a unique opportunity, with patients possessing a more robust immune system to potentially enhance the effects of TCB008.

Looking ahead, TC BioPharm expects to finalize recruitment for the second cohort in the first half of 2025, and they anticipate reporting further data later in the year. Their commitment to advancing novel gamma-delta T cell therapies in oncology places them at the forefront of biopharmaceutical development in this crucial area of need, positioning TC BioPharm as a leader in innovative cancer treatment research.

About TC BioPharm

TC BioPharm specializes in the research and development of gamma-delta T cell therapies aimed at treating various cancers. With a focus on human efficacy data in acute myeloid leukemia, the company is a pioneer in conducting clinical trials utilizing gamma-delta T cells. These immune cells possess properties that enable them to differentiate between healthy and diseased tissues, making them a powerful tool in cancer therapy.

As TC BioPharm progresses through its ambitious clinical trials, stakeholders eagerly await further updates that could revolutionize treatment approaches for patients suffering from challenging types of cancer such as AML.