TC BioPharm (Holdings) PLC announced that the first patient has completed the full dose regimen in the ACHIEVE Phase 2b trial of TCB008, an allogeneic gamma-delta T cell therapy, without any drug-related adverse events. The ACHIEVE trial is currently ongoing in the UK.
The open-label Phase 2b trial is designed to assess the efficacy and safety of TCB008 in patients with acute myeloid leukemia (AML) or myelodysplastic syndrome/AML (MDS/AML) who have either refractory or relapsed disease. Patients in the trial are eligible to receive up to four doses of TCB008.
Safety and Tolerability
According to TC BioPharm, the first patient in Cohort A received all four doses of TCB008, totaling approximately one billion cells. Preliminary safety data indicates that the 5mL dose of TCB008 was well tolerated, with no TCB008-related adverse events observed. These initial findings support the safety profile of TCB008, aligning with the ACHIEVE study's safety objectives.
Bryan Kobel, Chief Executive Officer of TC BioPharm, stated, "We are extremely pleased to announce that the full dosing regimen is completed by the first patient to receive the increased dose of TCB008 under the ACHIEVE trial. Including the fully-dosed first patient in the ACHIEVE Phase 2b trial, we have observed no drug related Adverse Events in any of the restart patients. This initial feedback speaks to the safety and tolerability of TCBP's drug."
Trial Enrollment and Future Data Release
TC BioPharm expects that three additional patients will receive their fourth and final dose by the end of September. The initial cohort (Cohort A) is expected to enroll 14 patients, with a potential expansion to 24 patients pending confirmation of primary endpoints. The company anticipates releasing a full data set, inclusive of primary and secondary endpoints, in the first half of 2025.
"We are seeing strong recruitment and enrollment at our active sites and expect to be able to announce a full data set in the first half of 2025 inclusive of primary and secondary endpoints," added Kobel.
