TCBP Announces H5N1 Proof of Concept Studies Intention

EDINBURGH, Scotland, Jan. 15, 2025 /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 that it intends to begin Proof of Concept preclinical studies for its lead therapeutic TCB008, for treatment in H5N1, commonly known as "Bird Flu." The Company is currently approaching potential university partners to expedite the preclinical work required for a Phase I study.

H5N1 is a viral infection often contracted by contact with sick birds, yet it can also be passed from person to person. Symptoms begin within two to eight days and can seem like the common flu, causing cough, fever, sore throat, muscle aches, headache, and shortness of breath. The disease can carry a high mortality in humans. Some antiviral drugs, if taken within two days of symptoms, may help. Last week, the Louisiana Department of Health recently reported the first U.S. death from H5N1.

TCB008 is an allogeneic, unmodified cell therapy made up of activated and expanded gamma delta T (GDT) cells, which the company expects will have applications in treating the emerging avian bird flu epidemic. Due to the highly infectious nature of H5N1, TC BioPharm's goal would be to partner with a leading Infectious Disease Center or University to advance the Proof-of-Concept and pre-clinical studies.

"As we have continually noted, we believe that our lead therapeutic TCB008 has tremendous potential in treating a host of diseases and infections due to its function within the immune system," said Bryan Kobel, CEO of TC BioPharm. "This endeavor further marks TCBP's intent to expand into indications in the Infectious Disease vertical, with several Proof of Concept studies planned in multiple infectious diseases. With the U.S. already incurring its first fatality and additional cases now confirmed, we want to be aggressive in working towards a treatment."

About TC BioPharm (Holdings) PLC

TC BioPharm is a clinical-stage biopharmaceutical company focused on discovering, developing, and commercializing gamma-delta T-cell therapies for cancer treatment 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 the treatment of acute myeloid leukemia using the Company's proprietary allogeneic CryoTC technology to provide frozen product to clinics worldwide.

Forward-Looking Statements for TC BioPharm

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.

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SOURCE TC BioPharm