TC BioPharm Announces Launch of COVID-19 Phase I/II Human Trial

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Oct 13, 2021, 08:30 ET

EDINBURGH, Scotland, Oct. 13, 2021 /PRNewswire/ -- TC BioPharm LTD, a clinical stage biotechnology company developing an allogeneic gamma-delta T cell platform, today announces launch of a Phase I/II trial in COVID-19 infected patients in the UK.

The Company will utilize ImmuniStim®, its proprietary allogeneic gamma-delta T cell product in early-diagnosis COVID-19 patients. With recruitment initially commencing at the Newcastle upon Tyne Hospital under the leadership of Dr Brendon Payne, this is the first ICH-compliant application of an allogeneic gamma-delta product in a viral indication, an important milestone as TCB continues to expand its therapeutic pipeline.

ImmuniStim®, is derived from TCB's GMP-compliant allogenic cell banks using the Company's proprietary cell-expansion process and CryoTC® - an innovative freeze-thaw process allowing global shipping of cell-based product from cleanroom-to-clinic in a reproducible and cost-effective manner. Each of TCB's allogeneic cell banks have potential to treat many thousands of patients, creating a true "off the shelf" cell therapy for patients with severe viral infections such as early-diagnosis COVID-19.

Chief Executive Bryan Kobel commented, "In infected individuals, COVID-19 compromises immune function and some patients rapidly deteriorate, in many cases requiring hospitalization and constant oxygen support; boosting the immune system of affected patients with allogeneic gamma- delta T's could slow down disease progression, keeping patients out of overloaded ICUs."

Dr Brendan Payne, Consultant Virologist and Infectious Diseases Physician at Newcastle-upon-Tyne Hospitals, and Honorary Clinical Senior Lecturer at Newcastle University said, "I am very excited to be working with TC BioPharm to bring this potential new COVID-19 treatment to our patients. We already have treatments in our hospitals that can improve outcomes in the late stages of COVID-19 infection, such as dexamethasone or tocilizumab, but we don't yet have any treatments to give to patients with early infection to stop them from deteriorating. We hope that giving ImmuniStim® early in the course of a COVID-19 infection will give a boost to the patient's immune system and help them to recover more quickly. This is a new kind of approach to treating a viral infection. If successful, it could also point the way to new treatments for other viruses".

In previous clinical studies patients with late-stage blood cancer responded well to TCB's allogeneic gamma-delta T cell product 'OmnImune®'. Despite exhausting conventional cancer treatment options, some individuals exhibited complete responses with demonstrable increase in life-expectancy. Founder and Executive Chairman, Dr Michael Leek added, "Gamma-delta T cells have potential to cause disease-reduction in both cancer and severe viral infections such as COVID-19; future use of these cell-based products will represent a massive step-change in treatment options available to physicians, fulfilling our aim of improving patient health and quality of life."

About TC BioPharm, Ltd.

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 and viral infections 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 uses an allogeneic approach in both unmodified and CAR modified gamma delta t-cells to effectively identify, target and eradicate both liquid and solid tumors in cancer.

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 clinical trials for its unmodified gamma-delta T cell product ImmuniStim -a phase II/III pivotal trial in treatment of acute myeloid leukemia and a Phase I trial in treatment of COVID-19 patients. ImmuniStim uses the Company's proprietary allogenic CryoTC technology to provide frozen product to clinics worldwide. TC BioPharm also maintains a robust pipeline for future indications in solid tumors and other aggressive viral infections as well as a significant IP/patent portfolio in the use of CARs with gamma delta t-cells and owns our manufacturing facility to maintain cost and product quality controls. For more information, please visit www.tcbiopharm.com.

Forward Looking Statements

This press release may contain statements of a forward-looking nature relating to future events. These forward-looking statements are subject to the inherent uncertainties in predicting future results and conditions. These statements reflect our current beliefs, and a number of important factors could cause actual results to differ materially from those expressed in this press release. We undertake no obligation to revise or update any forward-looking statements, whether as a result of new information, future events or otherwise. The reference to the website of TC BioPharm has been provided as a convenience, and the information contained on such website is not incorporated by reference into this press release.

SOURCE TC BioPharm