TCBP Announces Site Opening of Guys and St. Thomas Hospital

Rhea-AI Summary

TC BioPharm (NASDAQ: TCBP) has announced the opening of a new site for its ACHIEVE UK Trial at Guys and St. Thomas Hospital in London. This leading hospital, known for its extensive experience in cell therapy and oncology trials, will contribute to increasing enrollment velocity for the study. Dr. Hugues de Lavallade, a consultant hematologist with over 10 years of experience in myeloid disorders, will serve as the Principal Investigator.

The ACHIEVE clinical trial, which is evaluating TCB008 in patients with AML or MDS/AML, has been progressing positively since a dose increase earlier this year. The company reports strong enrollment and remains on schedule for data release in the first half of 2025. TC BioPharm's Executive VP of Clinical, Alison Bracchi, expressed enthusiasm about the positive feedback from clinicians and the AML community as they continue to activate new sites for this phase II, open-label study.

Positive

• New site opening at Guys and St. Thomas Hospital expected to increase enrollment velocity
• ACHIEVE clinical trial progressing positively with strong enrollment
• On schedule for data release in the first half of 2025
• Positive feedback from clinicians and AML community

Negative

• None.

• Additional London-based clinic to increase enrolment velocity
• Leading hospital with extensive cell therapy and oncology trial experience

EDINBURGH, Scotland, Sept. 25, 2024 /PRNewswire/ -- 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, today announced new site opening of Guys and St. Thomas Hospital in the ACHIEVE UK Trial.

Guys and St. Thomas is a London-based hospital with a leading oncology clinic and cell therapy clinical team. Dr. Hugues de Lavallade is the Principal Investigator on the trial, having over 10 years of experience as a consultant hematologist with a special interest in myeloid disorders. This new site was opened in September 2024, facilitating the expedited progression of the ACHIEVE clinical trial timelines using Dr. de Lavallade's experience working with AML patients with measurable residual disease.

"The progression of the ACHIEVE clinical trial since the dose increase earlier this year continues to be very positive with strong enrolment and remains on schedule for data in the first half of 2025," said Alison Bracchi, Executive Vice President of Clinical at TC BioPharm. "We are thrilled with the positive feedback from Clinicians and the wider AML community as we continue recruitment and activate new sites for this important trial, and we feel fortunate to be partnering with several centers of excellence to help us deliver on our goal of offering new hope and an alternative treatment of seriously ill AML patients."

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.

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 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.

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SOURCE TC BioPharm

FAQ

What is the purpose of TC BioPharm's ACHIEVE UK Trial?

The ACHIEVE UK Trial is a phase II study designed to evaluate the efficacy and effectiveness of TCB008 in patients with AML or MDS/AML who have either refractory or relapsed disease.

Who is the Principal Investigator for the ACHIEVE UK Trial at Guys and St. Thomas Hospital?

Dr. Hugues de Lavallade, a consultant hematologist with over 10 years of experience in myeloid disorders, is the Principal Investigator for the ACHIEVE UK Trial at Guys and St. Thomas Hospital.

When does TC BioPharm (TCBP) expect to release data from the ACHIEVE clinical trial?

TC BioPharm expects to release data from the ACHIEVE clinical trial in the first half of 2025.

How has the enrollment been for TC BioPharm's (TCBP) ACHIEVE clinical trial?

According to the company, enrollment for the ACHIEVE clinical trial has been strong, especially since a dose increase earlier in the year.