TC BioPharm Ltd (TCB) has today announced it has been granted a Clinical Trial Authorisation (CTA) by UK regulators to treat cancer patients with its novel cell therapy – ImmuniCell®.
TCB’s successful regulatory submission to the UK Medicines and Healthcare Regulatory Agency (MHRA) comprised two main components – the Clinical Protocol detailing exactly how cancer patients will be treated, and the Investigational Medicinal Product Dossier, which summarised drug-product manufacture, mechanism of action and safety.
TCB’s lead product, ImmuniCell®, uses patients’ own cells grown in culture to target a wide-variety of different cancers. In addition to treating cancer, ImmuniCell® has platform potential to target major viral infections such as severe influenza, HIV and Ebola. In designing the adaptive phase II/III clinical trial, TCB worked closely with the MHRA, through its Protocol Advice service, to establish a pragmatic treatment framework which focuses on patient safety whilst maximising the potential for an efficacious outcome.
The ground-breaking clinical trial design allows patients with melanoma, kidney and lung cancer to be treated in a single study – maximising the potential to establish how three different cancer types respond to TCB’s innovative immunotherapeutic approach.
Following receipt of a Manufacturer’s Licence for its state-of-the-art cell therapy facility in January 2015, TC BioPharm has now gained all of the MHRA approvals required to commence patient treatment. Such rapid progress was assisted by TCB’s strategic partner, Medinet (Yokohama), which has established a safe history of use in Japan, and facilitated transfer of a proven cell therapy from its Shin-Yokohama facility to TCB’s cleanrooms in Scotland.
The first cancer patients will be treated at the Beatson West of Scotland Cancer Centre in Glasgow under the expert guidance of chief investigator, Professor Jeff Evans. Subsequent trial sites will recruit patients at cancer centres of excellence in Southampton and Edinburgh.
Several additional clinical sites will join the study during 2016 - potentially including London, Manchester, Swansea, Newcastle, Leeds, Oxford and Cambridge.
Dr Karen Williams, TCB’s director of Clinical Studies, said: “MHRA approval of our Clinical Trial Authorisation is an important milestone for TC BioPharm – we can now realise our goal of treating cancer patients with the aim of significantly improving their health and quality of life.”
Dr Michael Leek, TCB’s chief executive, said: “Regulatory approval to commence phase II/III clinical studies in melanoma, kidney and lung cancer catapults TC BioPharm to the forefront of UK cell therapy. This is largely due to the expertise, loyalty and passion of our dedicated staff; and sustained, unwavering support from Scottish Enterprise, without whom we could not have progressed so rapidly to clinic.”
ImmuniCell® is manufactured by TCB at its multi-million pound cleanrooms just outside Glasgow, Scotland. The GMP-compliant (Good Manufacturing Practice) facility at Maxim Park houses TCB’s 25 staff, and is primed to become a hub for immuno-cell therapy, benefitting cancer patients in the UK and Europe. The facility has flexibility and capacity to treat both individuals with cancer and those with major viral infections, potentially allowing large patient numbers to benefit from TCB’s versatile therapeutic platform.
For more information regarding TC BioPharm see http://www.tcbiopharm.com or contact:
t: 0141 222 2040 / 07970 834354