Latest milestone for TC BioPharm
Cell therapy developer secures approval to treat cancer patients
The company, which recently took space at the Maxim Office Park in Lanarkshire, has secured a Clinical Trial Authorisation (CTA) by UK regulators for its lead product 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.
ImmuniCell uses patients’ own cells grown in culture to target a wide variety of different cancers. In addition to treating cancer, ImmuniCell has the potential to target major viral infections such as severe influenza, HIV and Ebola.
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.
The company has now gained all of the MHRA approvals required to begin patient treatment. Such rapid progress was assisted by TCB’s strategic partner, Medinet (Tokyo), 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 other clinical sites will join the study next year.
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 (pictured), 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.”
The 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. It has flexibility and capacity to treat individuals with cancer and those with major viral infections.