TCBP Doses 6th Patient in ACHIEVE AML Study

TC BioPharm (Holdings) PLC, a biotechnology firm listed on NASDAQ, announced a significant milestone in its ACHIEVE UK clinical trial on July 22, 2024. The ACHIEVE trial, aimed at evaluating the efficacy of the TCB-008 therapy in patients with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS/AML), treated its sixth patient on July 16, 2024. This patient is the first to receive the higher dose of TCB-008 following an amendment approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in February 2024.

The ACHIEVE trial is a phase II, open-label study designed to test the effectiveness of TCB-008 in two distinct patient cohorts. The first cohort (Cohort A) includes patients with relapsed or refractory AML who have not achieved remission and are receiving palliative care due to their inability to tolerate further chemotherapy. Initially, five patients were treated with a lower dose, and up to 14 patients can be treated with the higher dose. If primary efficacy endpoints are confirmed, an additional 10 patients may be added, bringing the total to 24 patients in Cohort A.

The second cohort (Cohort B) consists of patients who have achieved remission following prior treatment but still show detectable residual disease. Similar to Cohort A, up to 14 patients may receive the higher dose, with the potential to recruit an additional 10 patients upon confirmation of primary endpoints, resulting in a total of 24 patients in Cohort B.

The study's protocol allows for either cohort to advance independently to a Phase III Pivotal Trial upon completion, provided the primary efficacy endpoints are met. Importantly, interim data reviews are not contingent upon the completion of both cohorts, meaning the company can proceed to a Phase III study in one or both cohorts simultaneously.

Patients enrolled in the trial will receive the increased dose of TCB-008, which contains up to 230,000,000 cells per dose, significantly higher than the previous dose of 35,000,000 cells. This increased dosage aligns with the medium dose cohort proposed for the company’s FDA trial in AML. Eligible patients will receive up to three additional infusions of TCB-008, administered every 14 days after the previous dose, totaling four doses or approximately 1,000,000,000 cells.

Bryan Kobel, CEO of TC BioPharm, expressed optimism about the trial’s progress. He highlighted that the dosing and restart of ACHIEVE mark an essential step towards gathering Phase 2b efficacy data in AML. An interim data announcement is expected within the next six to nine months. Kobel also noted that the company has screened and enrolled additional patients into the trial and plans to dose up to 10 more patients in 2024. Furthermore, TC BioPharm aims to open at least one additional clinical trial site in the third quarter.

Kobel emphasized the company’s accomplishments in navigating the regulatory and clinical trial environments and refining TCB-008 over the last six months. Given the significant clinical safety and efficacy data accumulated, along with encouraging results from the initial five-patient safety cohort in ACHIEVE, Kobel is confident in TCB-008's potential as a monotherapy and is actively pursuing partnerships for combination therapies.

TC BioPharm continues to lead in the development of gamma-delta T cell therapies for cancer treatment. The company's proprietary allogeneic CryoTC technology enables the provision of frozen gamma-delta T cell products to clinics worldwide. The ongoing Phase 2b/3 pivotal trial for OmnImmune® in treating acute myeloid leukemia underscores TC BioPharm's commitment to advancing innovative therapies for cancer.