Sixteen months after moving into an empty space in the Eurocentral business park in Lanarkshire, outside Glasgow, Dr Michael Leek, Chief Executive Officer, TC Biopharm (TCB) and his team have received all approvals from the UK regulator to move their first product, ImmuniCell, into phase II/III trials in October.
The Beatson West of Scotland Cancer Centre in Glasgow will be the first site to recruit cancer patients for this trial, followed by cancer centres of excellence in Southampton and Edinburgh. Additional clinical sites, possibly in London, Manchester, Swansea, Newcastle, Leeds, Oxford and Cambridge will join the study during 2016.
In collaboration with Japanese immuno-therapy company Medinet, TCB has an exclusive license to take the product through clinical development in the UK, European and North American markets. While Medinet clinicians have already proved that the process of using cancer patients’ white blood corpuscles (more specifically the gamma delta T cells) is safe, the Scottish company will scale up the process and take it through all clinical development phases, to get evidence-based data necessary for approval in the UK, EU and the US.
The company got Medicines and Healthcare Products Regulatory Agency (MHRA) approval to produce human cell therapy products at its clinical manufacturing facility in Lanarkshire this January. More recently on September 9, TCB announced that it had received Clinical Trial Authorisation (CTA) from the MHRA. This 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 adaptive phase II/III clinical trial for this product is considered groundbreaking because it allows patients with three different types of cancer — melanoma, kidney and lung — to be treated simultaneously in a single study. The company reportedly worked closely with MHRA’s Protocol Advice service to ‘ establish a pragmatic treatment framework which focuses on patient safety whilst maximising the potential for an efficacious outcome,’ according to a press release from Scottish Enterprise, one of TCB’s funding agencies.
The TCB team
Speaking to journalists on a recent media tour organised by Scottish Development International, Leek said, “We expect to start studies in blood cancer next year but this platform technology has the potential to treat not just cancer but also be effective in viral infections like HIV, severe influenza and Ebola.”
ImmuniCell is a concentrated infusion of cancer patients’ gamma delta T cells. The multi-step process involves collection of samples, screening/activation and growth of gamma delta T cells in a culture medium for two/three weeks in TCB’s MHRA approved GMP compliant facility in Lanarkshire. The end result is an infusion of highly concentrated gamma delta T cells which are then infused back into the patient, where they recognise and target specific structures present on the surface of cancerous cells, and cells that have been virally infected. This triggers the release of a potent toxin (granzyme) into the cancerous cell which results in cell death.
The therapy complements ‘new’ antibody-based cancer treatments such as CTLA-4 and PDL-1 inhibitors and TCB is hence attracting a lot of interest from pharma companies, according to Leek. Seen as a strong future acquisition target, with an attractive valuation with significant uplift potential,’ TCB is backed by experienced team members like Angela Scott, Operations and Site Director -GMP manufacture and facilities, who has 32 years in oncology research and regenerative medicine. Leek jokingly referred to Scott as the ‘mother of Dolly the sheep’, as she was part of the team that cloned Dolly, a project that came to embody Scotland’s prowess in this field. Leek, a self professed ‘cell therapy junkie’, has taken 10 cell-based products from laboratory into clinic while Dr Karen Williams, Director of Clinical Studies, has had stints in Novartis and Pfizer.
Funding cancer therapy
TCB managed to raise £3.3 million in seed funding and grants over the past 16 months, from investors like Scotland’s only female angel investment group Investing Women (£1.18 million in equity and grant funding in August this year) supported by a grant award of approximately £500,000 from Scottish Enterprise’s SMART:SCOTLAND programme.
Congratulating TCB for reaching this significant milestone of receiving all approvals from the UK regulator to move their first product into phase II/II trials Sharon McKendry, international sector head, life sciences, Scottish Development International, said, “Along with our partners, we have worked closely with TCB over the last three years to provide an integrated package of support that includes account management, international market support, assistance from our High Growth Start Up Unit and investment from SMART: SCOTLAND and the Scottish Investment Bank. We are pleased to be able to work with a company that is addressing significant public health issues and manufacturing a leading edge product in Scotland. We look forward to continuing to work with the company to help realise its ambitious growth plans.”
Commenting that commercialisation of this groundbreaking cancer therapy in Scotland further cements the country’s global reputation for regenerative medicine and stratified medicine, she pointed out that there is a clear and growing demand for improved cancer treatments, with the worldwide market for cell and tissue products forecast to almost $10 billion by 2017. According to her, over the last decade, Scotland has established the regulatory, manufacturing and clinical expertise to lead the world in developing new cell therapies to treat unmet medical needs and is well placed to maximise future opportunities.
Given that TCB’s product has already been ‘de-risked’ to some extent by the initial work done by Medinet, which has a significant shareholding in TCB, a clear route to exit by 2016/17 does seem plausible. Provided of course, all goes as per plan in the clinical studies.
