On September 12, 2024 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 the first patient has completed the full dose regimen in the ACHIEVE Phase 2b trial ongoing in the UK with no drug related Adverse Events seen in any of the re start patients (Press release, TC Biopharm, SEP 12, 2024, https://www.prnewswire.com/news-releases/tcbp-announces-first-patient-completed-the-full-fose-regimen-in-achieve-clinical-trial-302246114.html [SID1234646544]). As previously stated, patients are eligible to receive up to 4 total doses of TCB under the ACHIEVE protocol. Based on the amended dosing, this patient received approximately one billion cells in the TCB008 dosing regimen.
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One patient in Cohort A has successfully completed the full dosing regimen having received all 4 doses. Preliminary safety data indicate the 5mL dose of TCB008 is well tolerated, with no TCB008-related Adverse Events. These data outputs are indicative of TCB008’s safety profile, in support of the ACHIEVE study safety objectives and endpoints. New patients will continue to be identified, screened, and enrolled into the study.
It’s expected that a further three patients will have received their 4th and final dose by the end of September. 14 patients in Cohort A are initially expected to receive TCB008 and, pending confirmation of primary endpoints, a further 10 patients will be recruited into the cohort for a total of 24 patients.
"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," said Bryan Kobel, Chief Executive Officer of TC BioPharm. "This initial feedback speaks to the safety and tolerability of TCBP’s drug. An additional three patients will receive their 4th and final dose by the end of September. While we are able to see safety and tolerability in the immediate aftermath of dosing for ACHIEVE to update investors, the measurement for efficacy and the release of that data will be after completion of the cohort and the data clean per regulatory mandate. 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"
The ACHIEVE UK clinical trial is an open-label, phase II study designed to evaluate the efficacy and effectiveness of TCB008 in patients with AML or MDS/AML, with either refractory or relapsed disease.