TCBP Provides Quarterly Update on the ACHIEVE (UK) Clinical Trial
- Positive safety data, allowing for exploration of higher TCB008 doses
- 4
UK -based clinical sites recruiting patients, with a further 2 sites expected in H1 2025
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
“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
The increased TCB008 dose will be implemented concurrently to the scaled-up manufacturing process, developed by Dr.
“The operational teams at TC BioPharm are incredibly resourceful,” said
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this Current Report on Form 8-K that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding the Company’s intent or ability to affect any budget savings or execute on any M&A or capital raising strategy. These statements are based on management’s current assumptions and are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause the Company’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. For other important factors that could cause actual results to differ materially from the forward-looking statements in this Current Report on Form 8-K, please see the risks and uncertainties identified under the heading “Risk Factors” in our Annual Report on Form 10-K for the year ended
About TC BioPharm (Holdings) PLC
TC BioPharm is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of gamma-delta T cell therapies for the treatment of cancer with human efficacy data in acute myeloid leukemia. Gamma-delta T cells are naturally occurring immune cells that embody properties of both the innate and adaptive immune systems and can intrinsically differentiate between healthy and diseased tissue.
TC BioPharm is the leader in developing gamma-delta T cell therapies, and the first company to conduct phase II/pivotal clinical studies in oncology. The Company is conducting two investigator-initiated clinical trials for its unmodified gamma-delta T cell product line – Phase 2b/3 pivotal trial in treatment of acute myeloid leukemia using the Company’s proprietary allogeneic CryoTC technology to provide frozen product to clinics worldwide.
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