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TC BioPharm and the NIPRO Corporation Announce Strategic Programme Co-Developing a Novel Gamma-Delta CAR-T Product to Treat Cancer

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The NIPRO Corporation (TSE: 8086) and TC BioPharm Ltd (TCB), announced today that they have formed a strategic collaboration to co-develop a novel immunotherapy product using TCB’s safe CAR-T platform, based on unique properties of modified gamma delta (γδ) T cells to selectively target cancer whilst leaving healthy cells untouched. TCB intends to use this novel platform to develop new CAR-based immunotherapies, with the aim of treating a broad range of cancers and major viral disease.

TCB’s world-class GMP-compliant manufacturing facility and experienced in-house clinical team will allow us to leverage patient treatment at established cancer therapy centers throughout Europe”, said TCB’s Chief Operating Officer, Angela Scott, “since commencing operations in 2014, we have treated numerous cancer patients successfully with unmodified gamma-delta T cells and built sufficient infrastructure to progress our innovative proprietary next-generation CAR-T towards phase I studies during 2018.”

The NIPRO Corporation will provide non-dilutive funds in the form of up-front fees, milestone payments and research-support to progress elements of TCB’s CAR-T program to clinical studies. NIPRO cash will provide the Osaka-based company with an exclusive right to sell, and distribute CAR-T product worldwide.

TCB and NIPRO will co-develop an autologous gamma-delta CAR-T therapy directed against CD19, which is expressed in several B cell tumors such as multiple myeloma and lymphoma. Preclinical studies developing the product will be supported by a Scottish Enterprise ‘seek-and-solve’ grant which will provide £2.7m of additional non-dilutive funding. Commenting on both the grant and collaboration, Jim Watson, director of Innovation & Enterprise Services at Scottish Enterprise, said, “This particular grant is designed to encourage investment in R&D and inspire Scottish companies to partner with international players to expand market reach, it’s fantastic to see a pre-revenue company like TCB collaborating with NIPRO. TCB’s strong international mindset will help the company reap benefits of this collaboration – both in terms of financial support and the market knowledge that NIPRO brings to the table. The Seek and Solve project will allow TCB to accelerate route to market, meaning potentially quicker returns for the Scottish economy, helping establish TCB as a global leader in cancer-specific cell therapies.”

TCB’s proprietary ImmuniCAR® platform uses the innate ability of gamma-delta T cells to target cancer, this has allowed the Company develop a wide-range of innovative safe therapies designed to treat a variety of tumours without toxic side-effects seen in many current CAR-T products. NIPRO’s Managing Director, Toshiaki Masuda, said, “The collaboration with TC Biopharm - who has stand-alone technology in developing CAR-T products; and NIPRO - an experienced company in manufacturing cell culture products, will establish the safe and innovative cancer therapeutics for practical use in the global market.”

Head of the Department of Oncology at the University of Oxford, Professor Mark Middleton noted that, “the combination of gamma delta and CAR T cell therapy gives us the opportunity to test this promising new treatment in patients for the first time.’ He added that, ‘those of us who treat solid tumors have followed use of CAR T cells in hematological malignancy with great interest, this exciting collaboration between TCB and NIPRO has potential to overcome safety challenges when developing such treatments in patients with solid tumors”.

The collaboration with NIPRO is TCB’s first major pharma deal centred in Asia, and represents a strong endorsement of the therapeutic approach. Remarking on this significant milestone for the Company, Chief Executive Dr Michael Leek iterated that, “This commercial collaboration represents the cutting-edge of cell-based immunotherapy, providing clinicians and cancer patients access to next-generation, safe, innovative oncology products, we are privileged to be working alongside the NIPRO Corporation as they continue to build a formidable presence in the regenerative medicine sector “.

Chief Business Officer Dr Artin Moussavi added, “TCB has been very active over the last 12 months raising over $35m cash, sealing long-term commercial relationships with a potential combined pre-market income over $1bn. The NIPRO collaboration is our latest such deal, representing a joint-effort to build a significant immune-oncology business in Japan and Asia”.