TC BioPharm Limited

 

TC BioPharm (TCB) is developing a clinical therapy called ImmuniCell® which harnesses the body’s own immune system to fight cancerous tumours.

TCB completed its SyndicateRoom round in May 2016, raising a total of £1,205,625.

 

 

The story

Every person has gamma-delta T cells as part of their immune system – they’re one of the key powerhouses that help fight illness. Using a proprietary process, TCB isolates and expands patients’ own gamma-delta T cells to better attack tumours. Existing data has evidenced the method’s safety and efficacy.

TCB anticipates that ImmuniCell® will significantly improve patient quality of life and extend progression-free survival and overall survival rates for patients, while reducing unwanted and potentially serious side-effects experienced with current standards of care.

 

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Whilst the current ImmuniCell® treatment is a patient-specific ‘personalised medicine’, TCB has a pipeline of second-generation products with the potential to treat larger numbers of cancer patients. This pipeline provides a cost-effective way for TCB to partner with pharmaceutical companies to target significant patient populations.

TCB-sponsored clinical studies have already commenced at cancer ‘centres of excellence’ in Glasgow, Edinburgh and Southampton, with further sites in the EU and USA scheduled to commence trials in late 2016 – maximising opportunities to generate robust clinical data to support efficacy targets.

Dr Michael Leek, CEO TC Biopharm

TC Biopharm CEO Dr Michael Leek has 25 years’ experience in regenerative medicine, during which he progressed nine different cell-based products from laboratory into clinic. He has extensive GMP manufacture, clinical, regulatory and logistic expertise, and has directly raised more than £30m equity funding and £8m grant funding.

Funds from this round will be used to facilitate a strategic Series A round and complete TCB’s Phase IIa trials for ImmuniCell®. Existing data has allowed TCB to bypass Phase I clinical studies and move straight to Phase II/III studies, thereby removing a significant amount of clinical and commercial risk.

 

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The lead investor

Narec Capital (NCL) invested £500,000 in TC Biopharm. NCL is a specialist investment company that acts as a Commercialisation Engine for disruptive component technologies and associated novel projects.

NCL provides a seamless, integrated approach by deploying the relevant commercial, technical and financial skills that can surround an SME, or project developer, with the talent required to guide and accelerate their concept through to commercial reality.

 

 

Where are they now?

 

20 April 2016: Angel group backs TCB

Investing Women, a growing community of women angel investors who believe in a 'more than the money' approach to investing, has chosen to invest into TCB. As reasons for investing, the angels cited both the potential investment return and the privilege of working with a team whose drive and objective was ultimately to successfully treat disease.

‘Investing Women were thrilled to invest in TCB which allows the first treatment of cancer patients using ImmuniCell® therapy. It has been an exciting journey, and this is just the start. The team at TCB are at the top of their game, and we have absolute confidence in their ability to deliver amazing results as well as their utter dedication to saving lives.’

– Jackie Waring, CEO of Investing Women

 

21 April 2016: Specials licence granted

TCB announced that its Scottish clinical manufacturing facility has been licensed for the production of human cell therapy products under a ‘Specials’ licence. The Specials framework is a unique EU regulatory structure which allows individual patients with specific clinical requirements to be treated with GMP-grade* products under the guidance and responsibility of their doctor. Manufacture of products under a ‘Specials’ licence will allow TCB to work closely with clinical colleagues across the UK to treat small numbers of cancer patients who have limited therapeutic options.

'Having a Specials licence allows oncologists to prescribe novel immunotherapies for individuals who are not able to join ongoing clinical trials; this is good for patients, and meets our aim of helping people with different forms of cancer.'

– Dr Karen Williams, clinical director at TC BioPharm

 

January 2017: TCB wins £6.25m+ of investment

TC BioPharm Limited announced a fundraising in excess of £6.25m.

Funds were provided predominately by the NIPRO Corporation (Osaka, Japan) and the Scottish Investment Bank, augmented by several family-based investment sources. Much of the funds will be used to move TCB’s lead product, ImmuniCell®, towards Phase III multinational clinical studies in the UK/EU and US.

Data emerging from ongoing Phase II studies is encouraging: initial patients are responding well, with an absence of treatment-related toxicity or side-effects. TCB will progress the Phase IIb clinical phase during 2017, with a transition to phase III studies towards year end.

‘The company has raised almost £9m over the last 12 months. This places TC BioPharm in a strong position to commence confirmatory studies late 2017, moving towards marketing authorisation as efficacy data emerges in cancer patients.'

– Dr Artin Moussavi, TCB Chairman

Series-A funds will also be used to develop the next generation of safe CAR-T immuno-oncology products via TCB’s ImmuniCAR® platform.

Remarking on this significant inward investment for TCB and Scotland, Chief Executive Dr Michael Leek iterated that, ‘TC BioPharm and NIPRO share the same top-level goals to develop innovative therapies with potential to dramatically improve patient health and quality of life, I’m delighted to be working alongside like-minded individuals who place patient well-being at the forefront of our collective vision.'