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Clinical trial of pioneering T Cell Therapy for COVID-19 patients in Edinburgh

An award-winning Glasgow-based biotechnology company TC BioPharm today confirmed that it is commencing initial clinical trials anticipated to be at the Edinburgh Royal Infirmary. The company has submitted documents to UK regulators to start safety trials on an experimental therapy designed to kill COVID-19 infected cells.

Established in 2014, TCB is the leader in clinical use of gamma-delta T cells (GDTs) which are the first line of defence in viral infection and are pre-programmed to target a wide range of diseases including many cancer types. TCB is a pioneer of the first scalable allogeneic gamma delta T cell therapy platform.

Having previously demonstrated safety of GDT’s in late-stage cancer patients, TCB has been in discussion with the UK regulatory body (Medicines and Healthcare products Regulatory Agency – MHRA) and now the Company has recently gained approval to treat patients hospitalised with COVID-19. Subsequent to such regulatory approval, TCB aims to commence clinical safety studies in the next few weeks.

The initial clinical trial site is anticipated to be the Edinburgh Royal Infirmary. COVID-19 patients will be treated under the supervision of Chief Investigator Dr Nik Hirani. Hospitalised patients will receive treatment following confirmation of COVID-19 infection, with the intention of preventing their need for intensive care. Several scientific publications have highlighted that those patients at greatest risk from COVID-19 are deficient in GDT cells and so may be unable to fight the infection. The latest data has shown that patients with severe infection exhibit a deficiency of these important virus killing cells. It is hoped that by donating these immune privileged cells which are banked from healthy volunteers that the immune system can fight the infection.

Regarded as the leader in gamma-delta T cell therapy TC BioPharm was the first company to treat cancer patients using allogeneic (donated) GDT cell banks in an ICH-compliant clinical study. The Company has demonstrated in late-stage patients with acute myeloid leukaemia that GDTs are safe and well-tolerated with a significant reduction in tumour burden within 14 days of commencing treatment. The benefit of this donation from healthy volunteers is the number of patients who could benefit is unlimited and TCB can scale-up significant amounts of therapeutic product at a cost-effective pricing.

TCB employs over 80 staff to manufacture large banks of these killer cells which can be shipped to the hospital as cryopreserved product, ready for use as patients develop severe symptoms following COVID-19 infection.

Scottish Government Trade Minister Ivan McKee said:

“TC Biopharm are one of the most innovative and impressive companies operating in Scotland’s world-leading life sciences sector. They are always at the forefront of innovation and it’s fantastic that we’re able to utilise their globally-renowned expertise in the fight against COVID-19.

“I am incredibly proud that so many Scottish companies like TCB have contributed to the fight against the coronavirus pandemic, and we will continue to support them and others to ensure that we beat the virus as soon as possible.”

Dr Nik Hirani, Chief Investigator (University of Edinburgh and Edinburgh Royal Infirmary) commented:

“Harnessing the immune system to effectively and safely kill virus-infected cells is an extremely attractive strategy. GDTs are a potent component of the normal host defence system and seem to be deficient in patients with Covid. For a clinician that sees the consequences of Covid lung injury for patients, the opportunity to test the idea that donor GDTs can be safely infused into infected patients is very exciting.”

Dr Mike Leek, TCB’s Chief Executive added: “having initially built TCBs cell therapy platform for treatment of cancer patients, it’s a unique and exciting opportunity for the company to treat individuals stricken by this terrible pandemic. Our focus has always been to treat patients and we are encouraged by the response of renowned clinicians, leading scientists and our investor base. We are pleased by the constructive support from Scottish Enterprise and the Royal Bank of Scotland.”