Glasgow, UK – 22 January, 2019 – TC BioPharm (TCB), a developer of CAR-T immuno-oncology products, including Gamma Delta T (GDT) cell therapies, today announced it has completed formulation of its first allogeneic GDT cell banks. The T cell banks provide TCB with core technology to develop a deep portfolio of next-generation CAR-T products directed against a wide variety of different cancer types, both hematological and solid tumors. The project was supported by funding from the European Union’s Horizon 2020 (H2020) Research and Innovation program via a €4million grant, the largest such EU award to any UK company for development of a healthcare therapeutic product.

The GDT cell banks are collected and stored from healthy donors, providing a source for TCB to manufacture next-generation ‘off-the-shelf’ GDT cell therapies for future clinical product development. Using allogeneic material from healthy donors offers several advantages over conventional autologous CAR-T therapies, which use the patient’s own cells to treat their tumor, as TCB’s proprietary allogeneic CAR-T cells are not prone to ‘on-target, off-tumor’ toxicities. Additionally, a larger population of cancer patients can be treated with a single reproducible product, ‘campaign-manufactured’ in bulk to keep costs lower, consequently increasing accessibility and reducing financial burden for healthcare systems.

Benefitting from H2020 support, TCB is rapidly progressing its clinical evaluation of allogeneic therapies. Having recently demonstrated safety and efficacy of large-dose autologous gamma-delta T cells in cancer patients, TCB is commencing treatment of cancer patients with an allogeneic variant. By building on its exclusive CAR-T platform, the company also plans to treat leukemia patients with an allogeneic CD19-directed GDT CAR-T product.

Angela Scott, Co-Founder and Chief Operating Officer, TCB, said: “I am delighted we have completed manufacture of our first allogeneic cell banks. By combining allogeneic GDT therapy with our unique CAR-T platform it will allow us to develop the next generation of safe, cost-effective immunotherapy for cancer, improving patient outcomes and quality of life.”

Dr Michael Leek, Co-Founder and Chief Executive, TCB, commented: “Availability of clinical-grade allogeneic GDT cell banks is an important commercial milestone for TCB. This allows us to transition our therapeutic approach from expensive and complex personalized therapy using patient’s own cells, to a more cost-effective ‘pharmaceuticalized’ approach.”

This project has received funding from the European Union’s Horizon 2020 Research and Innovation program.

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About TC BioPharm www.tcbiopharm.com

TC BioPharm is a biotechnology company developing a platform of CAR-T immuno-oncology products which involve expansion of gamma-delta T cells to formulate treatments for a wide variety of hematological and solid tumor types. The company aims to develop and commercialize innovative cell-based products to tackle disease, improve patient quality of life. Commencing operations in 2014, TCB has grown rapidly due to extensive, unrivaled cell therapy experience leveraged by its two founders, Dr Michael Leek and Angela Scott. Active in the regenerative medicine sector since 1989, Dr Leek has taken ten different cell therapies to the clinic including the first allogeneic therapy to undergo multinational phase III clinical evaluation. Angela Scott has an equally impressive pedigree as one of the pioneering scientists that created ‘Dolly the Sheep’ in 1996, she was also part of the team that clinically developed the world’s first-in-man allogeneic stem cell treatment for stroke patients.

TC BioPharm works with clinical centers of excellence to treat cancer patients in the UK and continental Europe. Employing over 80 members of staff, the UK-based company has premises in Glasgow, Edinburgh and Japan. Clinical-grade product is manufactured in-house from TCB’s GMP-compliant cell and gene processing unit in Scotland.

TCB is registered in Scotland (SC 453579). In January 2015, TCB’s cell therapy manufacturing facility at Maxim Park, Glasgow was awarded a Manufacturer’s Authorisation for Investigational Medicinal Products MIA (IMP) which permits GMP manufacture and release of Advanced Therapy Medicinal Products (ATMPs) for use in clinical trials. Further to obtaining an MHRA manufacturing license, TCB was granted a Clinical Trial Authorisation (CTA) by the MHRA in September 2015 to commence clinical evaluation of gamma-delta T cell therapies.

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