On December 4, 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 an update on the progression of the ACHIEVE UK Trial (Press release, TC Biopharm, DEC 4, 2024, View Source [SID1234648810]).
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As of this week, over half of the Cohort A patients in Stage One of the ACHIEVE study have received TCB008. These patients have an unmet clinical need, as they have been unable to attain remission with the existing Standard of Care, other treatments, or tolerate further chemotherapy. Data evaluated at this milestone demonstrate positive safety signals for the 5mL dose of TCB008, as no Serious Adverse Events have been attributed to the TCB008 drug product. The Company intends to use this data to justify further increases in the TCB008 dose, from 230 million Gamma Delta T-Cells up to 819 million Gamma Delta T-Cells, to identify the optimal dose for Cohort A patients.
Cohort B patients with residual disease after initially achieving remission with existing available treatment continue to be actively recruited into the ACHIEVE study at the current TCB008 dose of 230 million Gamma Delta T-Cells. These patients will be recruited at 1 of the 4 active clinical trial sites. Each site, including Guy’s and St. Thomas, is led by a Principal Investigator, who are experienced hematologists who oversee the use of TCB008 as an experimental acute myeloid leukemia treatment. Two more sites will be onboarded in the first half of 2025 for 6 recruiting sites in the United Kingdom.
"Medicinal products cannot be effective if they are not safe, and it’s clear from these initial data that TCB008 is safe for our patients," said Alison Bracchi, Executive Vice President of Clinical Operations. "Our priority now, for Cohort A, is to find the optimal biologically effective dose for patients that have exhausted all other treatments to drive a long term response. We look forward to completing the recruitment of Cohort B patients, and are planning to evaluate these data in the first half of 2025."
The increased TCB008 dose will be implemented concurrently to the scaled-up manufacturing process, developed by Dr. Lauren Bor’s team, in 2025.
"The operational teams at TC BioPharm are incredibly resourceful," said Callum Fiske, Head of Operations. "Cross-functional collaboration is ongoing to deliver improvements to the manufacturing process as soon as possible, enabling increased yields that will expedite TCB008 delivery from cleanroom to clinic, and drive economic efficiencies to the commercial cost, in 2025."