TCBP Provides Quarterly Update on the ACHIEVE (UK) Clinical Trial
Rhea-AI Summary
TC BioPharm (NASDAQ: TCBP) provided an update on its ACHIEVE UK Trial for TCB008, a gamma-delta T cell therapy. Over half of Cohort A patients in Stage One have received treatment, showing positive safety signals at the 5mL dose (230 million Gamma Delta T-Cells) with no serious adverse events reported.
The company plans to increase dosage up to 819 million cells to identify optimal levels. Currently, 4 UK clinical sites are recruiting patients, with 2 more sites expected in H1 2025. The trial includes two patient groups: Cohort A (failed standard treatments) and Cohort B (residual disease after initial remission). The company plans to implement increased TCB008 doses alongside a scaled-up manufacturing process in 2025.
Positive
- Positive safety data with no serious adverse events reported
- Trial expansion planned with 2 additional clinical sites in H1 2025
- Manufacturing process improvements planned for 2025 to increase yields and economic efficiency
Negative
- Current trial to relatively low dose (230 million cells) requiring dose escalation studies
News Market Reaction – TCBP
On the day this news was published, TCBP gained 5.83%, reflecting a notable positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
- 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
"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."
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 December 31, 2023, and our other reports filed with the SEC, all of which is available on the Company's Investor Relations website at www.tcbiopharm.com and on the SEC website at www.sec.gov. All forward-looking statements reflect the Company's beliefs and assumptions only as of the date of this Current Report on Form 8-K. The Company undertakes no obligation to update forward-looking statements to reflect future events or circumstances.
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.
Contact:
Chris Camarra
EVP Communications
c.camarra@tcbiopharm.com
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SOURCE TC BioPharm
FAQ
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