TC BioPharm Propels ACHIEVE Phase 2b Trial with New Progress

TC BioPharm Advances the ACHIEVE Phase 2b Trial

TC BioPharm (Holdings) PLC (NASDAQ: TCBP), a pioneering clinical-stage biotechnology company, is making remarkable progress in its ACHIEVE Phase 2b clinical trial. This trial focuses on developing allogeneic gamma-delta T cell therapies designed to combat cancer and other challenging indications. Recently, the company announced that three patients have successfully completed the full-dose regimen in this trial, and notably, no drug-related adverse events were reported amongst the restart patients.

Understanding the ACHIEVE Clinical Trial

The ACHIEVE UK clinical trial is an open-label, phase II study structured to examine the efficacy and effectiveness of TCB008 specifically in patients diagnosed with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS) who are either refractory or relapsed. This innovative trial aims to shed light on the potential of TCB008 as a viable treatment option for patients struggling with these aggressive conditions.

Patient Dosing and Recruitment Progress

As of now, ten patients have received their first dose, while nine have received their second dose. Four patients have now completed their third dose, and three have successfully completed their fourth and final dose. Out of the ten patients inducted to date, nine belong to Cohort A, which includes those who have struggled to achieve remission. One patient is included in Cohort B, consisting of individuals who managed to attain remission after previous treatment but still exhibit detectable residual disease. This patient enrolled in Cohort B received their final dose recently.

Safety Data and Patient Well-being

The preliminary safety data from the trial reveals that the 5mL dose of TCB008 is exceptionally well tolerated among patients, with no reported drug-related adverse events. This reassuring information aligns perfectly with TCB008's established safety profile, reinforcing the trial’s objectives and safety endpoints.

Success in Recruitment and Future Plans

According to Alison Bracchi, Executive Vice President of Clinical Operations, recruitment for the ACHIEVE trial has seen overwhelming success this year. Over half of Cohort A patients have already been recruited within a short timespan. The rapid pace of recruitment can be attributed to the dedicated efforts from the ACHIEVE Clinical sites and the whole TC BioPharm team. Both Bracchi and the team are enthusiastic about maintaining this momentum into the next year.

Strategic Focus on Cohort B

CEO Bryan Kobel highlighted that, as the trial progresses through Cohort B, there may be opportunities for expedited review should the patients' circumstances and disease expressions warrant it. The team is optimistic that minimal residual disease could present a significant opportunity for TCB008 to show impactful results. Although it is still too early to comment on efficacy due to regulatory constraints, the successful completion of dosing regimens without safety issues provides a strong foundation for future evaluations.

Collaboration and Recognition

TC BioPharm expresses gratitude towards King's College Hospital and the remarkable group of investigators, including Dr. Victoria Potter and Dr. Emma Nicholson. Their hard work has led to exceptional recruitment results, paving the way for continued collaboration as the study progresses into 2025.

About TC BioPharm (Holdings) PLC

TC BioPharm is at the forefront of developing innovative gamma-delta T-cell therapies aimed at treating various forms of cancer, with particular focus on acute myeloid leukemia. The company stands out as a leader in this field, undertaking pivotal phase II clinical studies in oncology.

Utilizing proprietary CryoTC technology, TC BioPharm aims to deliver unmodified gamma-delta T cell products to clinics worldwide, demonstrating the company's commitment to advancing healthcare and patient treatment options.

Frequently Asked Questions

What is the ACHIEVE Phase 2b trial?

The ACHIEVE Phase 2b trial is a clinical study evaluating the safety and efficacy of TCB008 in patients with AML or MDS/AML who are relapsed or refractory.

How many patients are currently involved in the trial?

Currently, ten patients have received their first dose, with ongoing recruitment aiming for a total of 48 patients across two cohorts.

What does the safety data indicate about TCB008?

The preliminary safety data reveal that TCB008 is well tolerated, with no drug-related adverse events reported among the participants.

Who is leading the trial?

The trial is being led by TC BioPharm, with significant contributions from collaborating clinical sites and dedicated investigators.

What future prospects exist for TCBP?

TC BioPharm aims to expedite recruitment and continue observing patient responses, with a focus on providing impactful treatments in 2025.

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