TC BioPharm's TCB008 Shows Promise in Phase 2b ACHIEVE Trial for Acute Myeloid Leukemia
Key Insights
TC BioPharm's ACHIEVE Phase 2b trial evaluates TCB008 for acute myeloid leukemia (search) (AML (search)) and myelodysplastic syndromes (search) (MDS/AML).
The trial's Cohort A, focusing on relapsed/refractory AML (search) patients, has completed dosing with a favorable safety profile and some achieving stable disease.
Cohort B, involving patients in remission with minimal residual disease, has seen its first patient complete dosing, with recruitment ongoing.
TC BioPharm (TCBP) is making strides in its Phase 2b ACHIEVE clinical trial, evaluating TCB008, an allogeneic gamma-delta T cell therapy, for the treatment of acute myeloid leukemia (search) (AML (search)) and myelodysplastic syndromes (search) (MDS/AML). The open-label study is designed to assess the safety and efficacy of TCB008 in patients with relapsed or refractory AML (Cohort A) and those in remission but with minimal residual disease (Cohort B).
ACHIEVE Trial Updates
TC BioPharm recently announced the completion of dosing in Cohort A. The available data indicates a favorable safety and efficacy response in Cohort A patients, with no drug-related adverse events and some patients achieving stable disease following multiple infusions of TCB008. Recruitment for Cohort A was re-initiated in July 2024 using higher doses of TCB008, containing up to one billion gamma-delta T cells.
In parallel, the first patient in Cohort B has completed the full dosing regimen of TCB008, receiving four doses of approximately 819 million gamma-delta T cells. This patient is expected to receive an additional fifth dose. Enrollment of a second Cohort B patient has also been initiated. Recruitment into Cohort B was initiated ahead of schedule in the fourth quarter of 2024.
Safety and Efficacy Signals
Preliminary data from the ACHIEVE trial indicates a positive safety profile for TCB008, with no drug-related adverse events reported following cumulative infusions containing up to one billion cells. The trial's safety objectives include monitoring adverse events, cytokine release syndrome, and neurotoxicity.
Alison Bracchi, EVP of Clinical Operations, noted the rapid progress of the ACHIEVE study and the encouraging safety profile and efficacy signals, including cellular recovery and reduced inflammation in AML (search) patients.
TCB008 and Gamma-Delta T Cell Therapy
TCB008 is an allogeneic unmodified gamma-delta T cell therapy. Gamma-delta T cells possess characteristics of both innate and adaptive immune systems, enabling them to differentiate between healthy and diseased tissue. TC BioPharm is focused on developing these therapies for cancer treatment.
Future Directions
TC BioPharm anticipates completing enrollment in Cohort B in the first half of 2025, with a data readout expected later in the year. The company believes that minimal residual disease represents a significant opportunity for TCB008 to be impactful. CEO Bryan Kobel expressed optimism about the potential for an expedited review of Cohort B data, given the patients' disease stage and expression.