Scancell Holdings Regulatory News (SCLP)

14 December 2017

Scancell Holdings Plc

("Scancell" or the "Company")

Scancell and Cancer Research UK collaborate to advance novel cancer immunotherapy into

clinical trials

Cancer Research UK to progress SCIB2 into a Phase 1/2 study for patients with a range of solid tumours

Scancell Holdings PLC, a developer of novel immunotherapies for the treatment of cancer, and Cancer Research UK, the world's leading cancer charity dedicated to saving lives through research, are pleased to announce that they have entered into a Clinical Development Partnership to develop Scancell's ImmunoBody® vaccine, SCIB2, for the treatment of patients with solid tumours, including non-small cell lung cancer (NSCLC).

Scancell's ImmunoBody® immunotherapy platform activates the body's immune system by enhancing the uptake and presentation of cancer antigens to help target and eliminate cancer cells. SCIB2, Scancell's second ImmunoBody® therapy, targets an antigen called NY-ESO-1, which is expressed on a range of solid tumours, including NSCLC and oesophageal, ovarian, bladder and prostate cancers, as well as neuroblastoma, melanoma and sarcoma.

Under the terms of the Clinical Development Partnership, Cancer Research UK will fund and sponsor a UK-based Phase 1/2 clinical trial of SCIB2 in combination with a checkpoint inhibitor in patients with solid tumours, focusing on NSCLC in the first instance. The charity's Centre for Drug Development (CDD) will be responsible for manufacturing the clinical trial supplies of SCIB2, conducting pre-clinical testing, sponsoring and managing the clinical trial, including the clinical trial timelines.

Following completion of the Phase 1/2 clinical trial, Scancell will have the option to acquire the rights to the data to support further development of SCIB2 itself. If Scancell elects not to exercise the option, Cancer Research UK will retain the right to take the SCIB2 programme forward in all indications.

Professor Lindy Durrant, Chief Scientific Officer of Scancell, commented: "We are delighted to announce this partnership with Cancer Research UK, which is a significant endorsement for our ImmunoBody® technology. The charity's world-renowned expertise will no doubt be invaluable as we progress SCIB2 through the clinic. In pre-clinical studies, we have shown that a combination of SCIB2 and checkpoint inhibition produces enhanced tumour destruction and significantly longer survival times than when either treatment was used alone. We believe SCIB2 has the potential to provide a much needed treatment option for patients suffering from a range of common solid tumours."

Dr Nigel Blackburn, Cancer Research UK's director of drug development, said: "We're excited to be giving our extensive expertise and experience in drug development to move this immunotherapy treatment into the clinic.

"This collaboration will ensure that this innovative vaccine reaches patients sooner and could bring about urgently needed improvements for some cancers which can be hard to treat, including lung cancer - a disease where survival rates remain stubbornly low."

This announcement contains insider information for the purposes of Article 7 of Regulatory (EU) No596/2014.

For Further Information:

About Scancell

Scancell is developing novel immunotherapies for the treatment of cancer based on its ImmunoBody® and Moditope® technology platforms.

Scancell's first ImmunoBody®, SCIB1 is being developed for the treatment of melanoma. Data from the Phase 1/2 clinical trial demonstrate that SCIB1, when used as monotherapy, has a marked effect on tumour load, produces a melanoma-specific immune response and highly encouraging survival trend without serious side effects. In patients with resected disease there is increasing evidence to suggest that SCIB1 may delay or prevent disease recurrence.

Scancell's ImmunoBody® vaccines target dendritic cells and stimulate both parts of the cellular immune system: the helper cell system where inflammation is stimulated at the tumour site, and the cytotoxic T-lymphocyte or CTL response where immune system cells are primed to recognise and kill specific cells.

Pre-clinical data on a combination of SCIB1 or SCIB2 and checkpoint inhibition (blockade of the PD-1 or CTLA-4 immune checkpoint pathways) have shown enhanced tumour destruction and significantly longer survival times than when either treatment was used alone.

Scancell has also identified and patented a series of modified epitopes that stimulate the production of killer CD4+ T cells that have the ability to destroy tumours with minimal toxicity. The Directors believe that the Moditope® platform could play a major role in the development of safe and effective cancer immunotherapies in the future.

About Cancer Research UK's Clinical Development Partnerships

CDP is a Cancer Research UK initiative that aims to develop promising anti-cancer agents from companies that are not able to take them through early phase clinical trials themselves. Under the scheme, Cancer Research UK sponsors and funds early clinical development, while companies retain all underlying rights to their programmes. At the end of the study, companies can decide if they wish to develop the drug further based on the clinical trial results. If they choose not to, the charity may secure an alternative partner and ensure the drug has every possible chance of reaching patients, with a share of future income returned to Cancer Research UK.

About Cancer Research UK's Centre for Drug Development

Cancer Research UK has an impressive record of developing novel treatments for cancer. The Cancer Research UK Centre for Drug Development, formerly the Drug Development Office, has been pioneering the development of new cancer treatments for 25 years, taking over 140 potential new anti-cancer agents into clinical trials in patients. It currently has a portfolio of around 30 new anti-cancer agents in preclinical development, Phase I or early Phase II clinical trials. Six of these new agents have made it to market including temozolomide for brain cancer, abiraterone for prostate cancer and rucaparib for ovarian cancer. Two other drugs are in late development Phase III trials. This rate of success is comparable to that of any pharmaceutical company.

About Cancer Research UK

· Cancer Research UK is the world's leading cancer charity dedicated to saving lives through research.

· Cancer Research UK's pioneering work into the prevention, diagnosis and treatment of cancer has helped save millions of lives.

· Cancer Research UK receives no government funding for its life-saving research. Every step it makes towards beating cancer relies on vital donations from the public.

· Cancer Research UK has been at the heart of the progress that has already seen survival in the UK double in the last 40 years.

· Today, 2 in 4 people survive their cancer for at least 10 years. Cancer Research UK's ambition is to accelerate progress so that by 2034, 3 in 4 people will survive their cancer for at least 10 years.

· Cancer Research UK supports research into all aspects of cancer through the work of over 4,000 scientists, doctors and nurses.

· Together with its partners and supporters, Cancer Research UK's vision is to bring forward the day when all cancers are cured.

For further information about Cancer Research UK's work or to find out how to support the charity, please call 0300 123 1022 or visit www.cancerresearchuk.org. Follow us on Twitter and Facebook.