TCBP Completes Final Dosing in ACHIEVE Phase 2b Trial

EDINBURGH, Scotland, Dec. 20, 2024 – TC BioPharm (Holdings) PLC, a biotechnology company specializing in developing gamma-delta T cell therapies, recently announced progress in its ACHIEVE Phase 2b clinical trial in the UK. This trial is focused on assessing the treatment's effectiveness on patients suffering from acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS/AML) with challenging cases such as refractory or relapsed conditions. The company reported that three patients have successfully completed the full-dose regimen without experiencing any drug-related adverse events.

The ACHIEVE trial is an open-label Phase II study dedicated to evaluating the efficacy of their treatment, TCB008. As of now, ten patients have received their first dose, nine have had a second dose, four a third dose, and three patients their fourth and final dosage. Among these participants, nine belong to Cohort A, comprising patients who have failed to achieve remission, while one patient in Cohort B has reached remission but still has detectable disease. This sole participant in Cohort B received their final dose in November 2024.

Initially, the trial plans to enroll 14 patients in both Cohort A and Cohort B. Following the confirmation of study endpoints, an additional 10 patients will be recruited for each cohort, culminating in a total of 48 participants. Early safety results indicate that the 5mL dose of TCB008 is well-tolerated, aligning with the treatment’s safety objectives.

Alison Bracchi, Executive Vice President of Clinical Operations, expressed optimism about the trial's recruitment progress, highlighting that more than half of the initial patients for Cohort A have been enrolled. She praised the rapid recruitment achieved in under five months, attributing this success to the dedication of ACHIEVE’s clinical sites and the TCBP team. She anticipates continued success with the study into 2025.

CEO Bryan Kobel remarked on the promising potential of the ongoing work with Cohort B, suggesting that the minimal residual disease represents a significant opportunity for TCB008's impact. He mentioned the possibility of observing a notable response in fewer patients than initially estimated. Although specific details on efficacy are not yet available, the company is collecting data and sees it as encouraging that patients are completing the dosage regimen without safety concerns. The focus will remain on Cohort B recruitment and finalizing Cohort A for data assessment.

TC BioPharm is esteemed for its pioneering work in gamma-delta T cell therapies, especially in oncology. The company has been leading efforts in this field and has launched significant clinical trials, including a Phase 2b/3 pivotal trial using its proprietary CryoTC technology, which allows for the global distribution of frozen therapeutic products.

By spearheading research and innovation, TC BioPharm aims to make substantial advancements in cancer treatment, leveraging the unique capabilities of gamma-delta T cells. These naturally occurring immune cells play a dual role, capable of distinguishing between healthy and diseased tissues, thus offering a promising avenue for therapeutic development in oncology.