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TC BioPharm Makes Progress in ACHIEVE Clinical Trial

On December 20, 2024, TC BioPharm (Holdings) PLC, a clinical-stage biotechnology firm traded on NASDAQ under the symbol TCBP, reported significant milestones regarding its ACHIEVE Phase 2b clinical trial conducted in the United Kingdom. The trial focuses on their innovative treatment, TCB008, designed for patients with Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS) complicated by leukemia. Recently, the company announced that three patients have successfully completed the full-dose regimen with TCB008, and notably, there were no adverse events linked to the medication in these participants.

The ACHIEVE clinical trial is classified as an open-label Phase II study aimed at investigating the efficacy and safety of TCB008 amongst individuals suffering from AML or MDS/AML. The trial specifically targets patients whose diseases are relapsed or refractory. As of now, nine out of the ten enrolled participants are in Cohort A, consisting of patients unable to achieve remission. One individual belongs to Cohort B, which encompasses patients who had previously attained remission but still exhibit detectable residual disease.

To date, the study has seen impressive engagement, with ten patients having received their initial doses, nine proceeding to their second dose, four advancing to their third dose, and three completing the four doses applicable in this study. The initial plans state that 14 patients were intended to be recruited per each cohort, allowing for a total of 48 patients upon completion of the study.

The preliminary safety results have shown promising outcomes for the 5mL dose of TCB008, indicating that participants tolerated the medication exceptionally well without any drug-related adverse effects. In light of these findings, key executives within TC BioPharm express confidence that they are on the right path to realizing the safety objectives of the ACHIEVE study.

Alison Bracchi, Executive Vice President of Clinical Operations, noted the remarkable success in recruitment throughout 2024, stating, "Recruitment into the ACHIEVE trial has been an overwhelming success in 2024... We're also thrilled to observe the progression of Cohort B." This optimistic outlook is supported by the quick accumulation of patient numbers within less than five months, thanks to the relentless efforts of the clinical sites involved in the trial, alongside the dedicated team at TC BioPharm.

Furthermore, Bryan Kobel, CEO of TC BioPharm, emphasized the potential for accelerated evaluations owing to the advanced stages of disease in patients from Cohort B. He indicated that managing minimal residual disease could enhance the therapeutic impact of TCB008. Although data collation is ongoing due to regulatory necessities, the company remains positive regarding the lack of safety issues and the successful completion of the dosing regimen by patients thus far.

As TC BioPharm looks toward 2025, their immediate goal is to focus on enhancing recruitment rates for Cohort B while wrapping up the current patient set for Cohort A. A collaborative effort with King's College Hospital and esteemed physicians involved in the trial, such as Dr. Victoria Potter and Dr. Emma Nicholson, has been pivotal in this achievement.

About TC BioPharm (Holdings) PLC

TC BioPharm is breaking new ground in the biopharmaceutical arena by developing and commercializing gamma-delta T-cell therapies aimed at treating various forms of cancer. Their expertise particularly extends into the realm of acute myeloid leukemia, showcasing the potential effectiveness of gamma-delta T cells, which originate naturally in the body and can discern healthy from diseased cells.

As pioneers in this field, TC BioPharm leads the way in conducting pivotal clinical trials for oncology, currently working on two studies involving their unique gamma-delta T cell product line through the proprietary CryoTC technology. This method allows for the preservation and delivery of frozen products to clinics worldwide, fundamentally changing how therapies can be administered in the future.

Forward-Looking Statements: This update may contain forward-looking statements dictated by the Private Securities Litigation Reform Act of 1995. These focus on anticipations regarding budgets, strategies, and clinical outcomes, which involve inherent risks and uncertainties. Consequently, actual results might differ significantly from predictions stated due to ongoing developments in life sciences and regulatory landscapes.

For more on TC BioPharm's achievements and their journey towards innovative cancer treatments, visit TC BioPharm's Investor Relations.