TC BioPharm (Holdings) PLC (NASDAQ: TCBP), a clinical-stage biotechnology company specializing in allogeneic gamma-delta T cell therapies, has made notable progress in its ACHIEVE Phase 2b clinical trial. The company recently announced that three patients have successfully completed the full-dose regimen of TCB008, a promising treatment for Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS), without any drug-related adverse events.
The ACHIEVE trial is an open-label, Phase 2 study designed to assess the efficacy and safety of TCB008 in patients suffering from refractory or relapsed AML or MDS/AML. The trial’s current enrollment statistics reveal that out of the ten patients treated so far, nine have received their second dose, four have completed their third dose, and three have finished the full course of four doses. This includes nine patients in Cohort A, which comprises those who are relapsed or refractory and have not achieved remission. Additionally, one patient has been enrolled into Cohort B, which targets individuals who have achieved remission but still exhibit detectable residual disease.
Initially, the trial plans to recruit 14 patients for each cohort, with a potential expansion to include an additional ten patients per cohort, culminating in a total of 48 participants. This structured approach allows for an adaptive trial design that can respond to emerging data and patient needs.
Preliminary safety data from the trial indicates that the 5mL dose of TCB008 is well tolerated among participants. Notably, there have been no reported drug-related adverse events, aligning with TCB008’s established safety profile. This positive outcome supports the study’s safety objectives and enhances confidence in the therapy’s potential effectiveness.
Alison Bracchi, Executive Vice President of Clinical Operations at TC BioPharm, expressed enthusiasm regarding recruitment efforts for the ACHIEVE trial. “Recruitment into the ACHIEVE trial has been an overwhelming success in 2024,” she stated. “More than half of the patients in Cohort A have been recruited in less than five months, thanks to the dedication of our clinical sites and team.”
Looking ahead, TC BioPharm is optimistic about the potential for expedited review processes as Cohort B progresses. CEO Bryan Kobel emphasized that minimal residual disease presents a significant opportunity for TCB008 to demonstrate its impact. While specific efficacy data is still being collated due to regulatory requirements, Kobel noted that the successful completion of dosing regimens without safety issues is encouraging.
The company’s immediate focus will be on enhancing recruitment efforts for Cohort B throughout 2025 while completing patient enrollment for Cohort A. Kobel acknowledged the contributions of King’s College Hospital and the investigator team led by Dr. Victoria Potter and Dr. Emma Nicholson in achieving these recruitment milestones.
TC BioPharm is at the forefront of developing gamma-delta T cell therapies aimed at treating various cancers. The company’s innovative approach utilizes naturally occurring immune cells that can differentiate between healthy and diseased tissues, potentially offering new therapeutic options for patients with challenging conditions like AML.
