On February 13, 2025 TC BioPharm (Holdings) PLC ("TC BioPharm" or the "Company") (NASDAQ: TCBP) a clinical-stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer and other indications, reported that it has concluded dosing of Cohort A patients in the ACHIEVE Phase 2B UK clinical trial (Press release, TC Biopharm, FEB 13, 2025, View Source [SID1234650269]).
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The available data show a favorable safety and efficacy response in Cohort A patients, patients with relapse or refractory AML. No patients have experienced any drug-related adverse event, and preliminary efficacy data demonstrate a number of patients attaining stable disease following multiple infusions of TCB008.
"We’re thrilled to be sharing these preliminary results," stated Alison Bracchi, EVP of Clinical Operations. "These early data points pave the way for future clinical studies, as we consider how the therapeutic effect of TCB008 can be prolonged or enhanced to reverse the disease state in these incredibly sick patient populations. We have additional data review to complete, which will further define our next steps with TCB008, including as a potential bridge to transplant or other combination efforts."
The ACHIEVE trial is an open-label Phase II study dedicated to evaluating the efficacy and safety of TCB008. This trial is focused on assessing the treatment’s effectiveness and tolerability in patients suffering from acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS/AML). Cohort A targeted patients who were ineligible for, or had exhausted all, available therapies, as they were unable to achieve remission or had subsequently relapsed following remission.
Cohort A recruitment was re-initiated in July 2024 using higher doses of TCB008 that contained a cumulative dose of up to a billion Gamma Delta T-Cells. Investigator and patient interest in the ACHIEVE trial has allowed the Company to expedite recruitment; as such, enrolment into Cohort A has concluded. Recruitment into Cohort B continues.
"This early safety and efficacy data, obtained in patients with significant unmet clinical need, reiterates our confidence in our lead candidate, TCB008," said Bryan Kobel, CEO of TC BioPharm. "We’re seeing the expedited delivery of data, six months after study re-initiation, signalling a positive safety and efficacy profile for TCB008. This data will shape our approach to clinical development as we continue to investigate how stable disease can be sustained, both to prevent relapse and to progress patients to additional treatment options in conjunction wth TCB008."