First patient dosed in trial of novel T-cell therapy for leukaemia Milestone for Cell Therapy Catapult, UCL Business & Imperial Innovations partnership

17 December 2014

The first acute myeloid leukaemia patient has been dosed in a Phase I/ll cell therapy trial1 being undertaken by Catapult Therapy TCR Ltd, a partnership established in July 2014 to accelerate development of a novel T cell receptor (TCR) therapy. The trial is expected to involve five centres in the UK, and is to assess the safety and efficacy of the therapy, which targets diseases associated with overexpression of the WT1 antigen. Catapult Therapy TCR Ltd is an innovative partnership between the Cell Therapy Catapult, which is focused on the development of the UK cell therapy industry to increase the nation’s health and wealth, UCL Business (UCLB) and Imperial Innovations.

The new therapy was developed initially at Imperial College London and then at UCL by scientists funded by the charity Leukaemia & Lymphoma Research. Using TCR gene-modified T cells to target WT1-overexpressing cells, it shows potential in disorders such as acute myeloid leukaemia and myelodysplastic syndrome. The treatment involves modification by gene therapy of the patient’s own T cells, so that they may recognise and destroy WT1-expressing cells when infused back into the body.

Following promising initial preclinical work on the therapy, Catapult Therapy TCR Limited was established to progress it through Phase II clinical trials and manufacturing process development. A second trial involving the therapy, in myelodysplastic syndrome, is expected to start in 2015.

Dr Emma Morris, UCL clinical academic, Chief Investigator & co-inventor, said, ‘We’re really excited to have dosed the first patient in our trial for acute myeloid leukaemia, an area of high unmet medical need. While recognising that we are at the start of the process of testing this product in trials, the partners are pleased with the progress made so far and are committed to working together to accelerate the delivery of safe and effective therapies to patients.

Dr Barny Cox, Senior Business Manager at UCLB said: ‘This therapy is a great example of the wealth of opportunity that lies within UCL’s research base and the important role UCLB plays in helping to bring innovative ideas from laboratory to market. It’s hugely rewarding to be part of a project like this, which promises to bring real benefit to patients.

Professor Chris Bunce, Research Director at Leukaemia & Lymphoma Research, said, ‘Survival rates for acute myeloid leukaemia are currently unacceptable and many patients do not respond to or eventually relapse after traditional treatment. The early success of this exciting trial is very promising for patients who desperately need new treatment options.

Keith Thompson, CEO of the Cell Therapy Catapult, said, ‘The dosing of the initial patient in this study of a novel T cell therapy marks an important milestone for us, as it is the first clinical trial for which the Cell Therapy Catapult has been the sponsor. We look forward to continued working with our partners in Catapult Therapy TCR to advance this product, as well as helping other companies and academics move their programmes through the clinic.

1 More detail at http://clinicaltrials.gov, identifier NCT01621724

For further information about this technology, please contact Dr Barny Cox b.cox@uclb.com

About the Cell Therapy Catapult
The Cell Therapy Catapult is a centre of translational excellence for cell therapy and regenerative medicine. Its vision is for the UK to be a global leader in the development, delivery and commercialisation of cell therapy, making it a location for business start-up and growth. Based in London at Guy’s Hospital, the centre takes products into early clinical trials, providing clinical, technical, manufacturing and regulatory expertise and access to the NHS. There is a focus on collaboration and lowering barriers to investment and funding, and operations have grown rapidly since inception. UK Trade & Investment has valued the global regenerative medicine industry at just over £500 million, and estimates that it will be generating revenues of over £5 billion by 2021. For more information go to ct.catapult.org.uk

About Catapults
Catapult centres are being established and overseen by Innovate UK as a new addition to its range of programmes to stimulate innovation. They are places where the best of the UK’s innovative businesses and researchers work together to bring new products and services more quickly to commercialisation. Focusing on areas with great market potential, Catapults will open up global opportunities for the UK and generate economic growth for the future.

For more information, please visit: www.catapult.org.uk

About Innovate UK
Innovate UK is the new name for the Technology Strategy Board – the UK’s innovation agency. Taking a new idea to market is a challenge. Innovate UK funds, supports and connects innovative businesses through a unique mix of people and programmes to accelerate sustainable economic growth.

For further information, visit: www.innovateuk.org

About Imperial Innovations – www.imperialinnovations.co.uk
Imperial Innovations creates, builds and invests in pioneering technologies developed from the academic research of the UK’s four leading Universities. The Group supports scientists and entrepreneurs in the commercialisation of their ideas and intellectual property by leading the formation of new companies, providing facilities in the early stages, providing investment and encouraging co-investment to accelerate development, providing operational expertise and recruiting high-calibre management teams. It also runs an Incubator in London that is the initial home for many of its technology spin-outs. Originally formed as the Technology Transfer office for Imperial College – a role it still carries out today, Innovations also invests in opportunities arising from intellectual property developed at, or associated with, Cambridge University, Oxford University and University College London.  These are the top four research intensive universities in Europe with a research income of over £1.4 billion per annum. Innovations invests in the most promising opportunities from whichever technology sector they arise, but has built particular expertise in the key sectors of: therapeutics, medtech, engineering and materials, and ICT. Since listing in 2006, Innovations has invested a total of £176.0 million across its portfolio companies, which have raised collectively investment of over £822.5 million. Innovations’ largest holding is in Circassia Pharmaceuticals, which listed on the London Stock Exchange main market in March 2014 with a market capitalisation of £581.0 million.

About UCL Business PLC
UCL Business PLC (UCLB) is a leading technology transfer company that supports and commercialises research and innovations arising from UCL, one of the UK’s top research-led universities. UCLB has a successful track record and a strong reputation for identifying and protecting promising new technologies and innovations from UCL academics. UCLB has a strong track record in commercialising medical technologies and provides technology transfer services to UCL’s associated hospitals; University College London Hospitals, Moorfields Eye Hospital, Great Ormond Street Hospital for Children and the Royal Free London Hospital. It invests directly in development projects to maximise the potential of the research and manages the commercialisation process of technologies from laboratory to market.

For further information, please visit: www.uclb.com

About Leukaemia & Lymphoma Research
Leukaemia & Lymphoma Research is a leading UK charity dedicated to improving the lives of patients with all types of blood cancer, including leukaemia, lymphoma and myeloma. Its life-saving work is focused on finding causes, improving diagnosis and treatments, and running groundbreaking clinical trials for all blood cancer patients. The charity champions patients’ needs by influencing relevant policy and decision makers. Its communities give blood cancer patients and their families a place where they can find support and information and share their journey with other people who can relate to what they are going through. Around 30,000 people of all ages, from children to adults, are diagnosed with blood cancer every year in the UK.

For more information, visit: beatingbloodcancers.org.uk