TC BioPharm Selected For EU Horizon 2020 Funding To Progress Novel, Mass-Market Cell Therapies To Clinical Trial

€4million grant would allow Scottish company to develop next-generation cancer therapies for multiple tumour types

Funding represents the largest EU-award to any UK company for development of a healthcare therapeutic product

SCOTLAND – 2 August 2017 –TC BioPharm (TCB) today announced it has been selected for funding from the European Union's Horizon 2020 (H2020) research and innovation programme. The biotechnology company has been awarded a €4million H2020 grant to progress its innovative GDT (gamma-delta T) cell therapy for treatment of cancer.

Funding will come from the SME instrument, the most competitive H2020 programme, where fewer than 4% of companies applying to phase 2 are selected (according to evaluation criteria related to scientific excellence, business impact and implementation quality). TCB was one of only 57 projects selected out of 1514 applications from the June cut-off.

TCB’s first-generation GDT cell product is an ‘autologous’ cell therapy formulated to treat patients with various tumours including malignant melanoma, kidney, and lung cancer. Autologous cell therapies use the patient’s own cells to treat their tumour which is a costly and logistically complex approach. The H2020 grant will allow TCB to develop a next-generation ‘allogeneic’ approach, meaning treatments can be manufactured using existing cells from donors, stored in a bio-bank. The technique is more scientifically complex because therapeutic cells will have been derived from a single donor to treat many people.

Allogenic ‘off-the-shelf’ approaches, however, have significant advantages over existing autologous treatments, as a larger target population of cancer sufferers can be treated with a more reproducible product which has been ‘campaign-manufactured’ in bulk to keep costs much lower.

Benefitting from H2020 support, TCB will manufacture allogeneic cell banks during 2017/8 with a view to treating first cancer patients with the novel approach early in 2019.

When coupled with TCB’s unique, proprietary CAR (Chimeric Antigen Receptor) platform which ‘supercharges’ GDT cells to attack specific tumour types, the company and its partners will move several steps ahead of current technology, as those active in CAR-based immunotherapy have recently iterated strong interest in a switch to allogeneic immunotherapy for cancer.

TCB’s €4million H2020 grant is the largest such EU-award to any UK company for development of a healthcare therapeutic product.

TC BioPharm is working with clinical centres of excellence to treat cancer patients in Glasgow, Edinburgh, Oxford, Southampton, London, Leeds, Cardiff, Manchester, Sheffield and Belfast. The company has raised over €25million in funding since commencing operations in February 2014. It has premises in Glasgow, Edinburgh and London, employing over 50 members of staff.

Seen as a means to drive economic growth and create jobs, Horizon 2020 has the political backing of Europe’s leaders and Members of the European Parliament. They agreed that research is an investment in the future and therefore put it at the heart of the EU’s blueprint for smart, sustainable and inclusive growth and jobs. By coupling research and innovation, H2020 is helping to achieve this with its emphasis on excellent science, industrial leadership and tackling societal challenges. The goal is to ensure Europe produces world-class science, removes barriers to innovation and makes it easier for the public and private sectors to work together in delivering innovation.

TCB’s chief operating officer, Angela Scott, said: “We are thrilled that H2020 funding has been awarded, allowing us to treat large numbers of cancer patients across the EU and in North America.”

Chief business officer, Dr Artin Moussavi, added: “I am excited at the prospect of combining allogeneic GDT cell therapy with our existing CAR platform; this will allow us to develop the next generation of safe, cost-effective immunotherapy for cancer.”

TCB’s chief executive, Dr Michael Leek, concluded: “With H2020 grant funding we remain steadfastly committed to working alongside our European clinical colleagues; we share a single goal of improving cancer patient health and quality of life across EU borders. I look forward to developing our novel allogeneic GDT cell therapies with clinical partners at trial sites in Prague, Madrid, Paris, Amsterdam and Brussels.”

ENDS

For more information regarding TC BioPharm, please contact Suzanne Clark-Amir or Fergus Reid at Smarts Communicate: suzanne.amir@smartscommunicate.com / 0141 222 2040 / 0797 083 4354 fergus.reid@smartscommunicate.com / 0141 222 2040 / 07971 583 535

Notes to editors:

Headquartered at the Pentlands Science Park outside Edinburgh, TCB is registered in Scotland (SC 453579). Becoming operational from February 2014, the company is developing ImmuniCell®, an autologous anti-cancer immunotherapy which involves expansion of gamma-delta T cells over several weeks - formulating a treatment for a wide-variety of different tumour types.

In January 2015, TCB’s cell therapy manufacturing facility at Maxim Office Park in Glasgow was awarded a Manufacturer's Authorisation for Investigational Medicinal Products MIA (IMP) which permits 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. Phase II/III clinical studies are ongoing throughout the UK.

Europe is experiencing an unprecedented cancer epidemic, driven by an ageing population. Traditional cancer treatments such as surgery, chemotherapy and radiation therapy have demonstrated very limited efficacy for patients with late-stage disease and often cause considerable side effects. Cell therapies are the next breakthrough in oncology, but autologous cells must be harvested from each patient, expanded for several weeks in vitro and re-administered to the same patient while hospitalised. TCB is developing a novel allogeneic gamma-delta T cell therapy (OmnImmune®) where T cells harvested from healthy donors are used to treat multiple recipients. OmnImmune® represents a truly disruptive, step-changing approach to the treatment of a wide variety of cancers. It has the potential to be manufactured for large market segments at a lower cost than competitors, and provide valuable increases to cancer patient quality of life.

This project has received funding from the European Union’s Horizon 2020 research and innovation under grant agreement No 783506.

This press release has been prepared by TC BioPharm Limited. The European Commission is not responsible for any information contained herein and any uses made of such information.

For more information on the EU’s H2020 programme, please visit: https://ec.europa.eu/programmes/horizon2020/en/what-horizon-2020

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