TCB's chief operating officer, Angela Scott, said: "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. 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 blood cancers 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 a 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 to develop a wide-range of innovative and 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, which 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: "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. 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, TCB's chief executive Dr Michael Leek added: "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 it continues to build a formidable presence in the regenerative medicine sector."
Chief business officer Dr Artin Moussavi concluded: "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 of 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."
About TC BioPharm Ltd (TCB)Headquartered at the Pentlands Science Park outside Edinburgh, TCB is registered in Scotland (SC 453579). Becoming operational in February 2014, the Company is developing ImmuniCell and ImmuniCAR an autologous anti-cancer immunotherapies which involve 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 Park, 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) for ImmuniCell by the MHRA in September 2015, phase IIb clinical studies are ongoing throughout the UK.
About NIPRO CorporationSince its founding in 1954, NIPRO Corporation (Osaka, Japan) has strived to realize its management philosophy of contributing to society through its business activities. The Company has expanded the scope of its business from medical glass products to medical devices and pharmaceutical products. Leveraging the technologies and expertise accumulated over many years, the Company now offers products and technologies that meet the needs of patients and medical professionals in a wide range of fields, such as artificial organs, circulatory organs, test/diagnostic agents, cell culture, injection/infusion solutions, ethical pharmaceuticals, and pharma-packaging products.
About Scottish EnterpriseScottish Enterprise is Scotland's main economic development agency and aims to deliver a significant, lasting effect on the Scottish economy. Our role is to help identify and exploit the best opportunities for economic growth. SE supports ambitious Scottish companies to compete within the global marketplace and help build Scotland's globally competitive sectors. We also work with a range of partners in the public and private sectors to attract new investment to Scotland and to help create a world-class business environment.