Scancell Holdings Regulatory News (SCLP)

20 May 2019

Scancell Holdings Plc

("Scancell" or the "Company")

Scancell and Cancer Research UK provide an update on the development of SCIB2, a novel cancer immunotherapy

 SCIB2 to be administered using new nanoparticle formulation in planned Phase 1/2 clinical trial

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 provide an update on their clinical development partnership* for the development of Scancell's ImmunoBody® vaccine, SCIB2, as a potential treatment for 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, oesophageal, ovarian, bladder and prostate cancers, neuroblastoma, melanoma and sarcoma.

Pre-clinical studies have demonstrated that administration of SCIB2 as a liposomal nanoparticle results in potent immune responses and prolonged survival. The nanoparticle technology utilises known lipid carriers that are optimised to deliver SCIB2 DNA to immune cells. The liposomal nanoparticles protect the DNA from degradation and facilitate efficient uptake, expression and T-cell activation against cancer cells. The nanoparticle delivery system provides an alternative approach to electroporation, which has been used to deliver other ImmunoBody® agents to patients. Cancer Research UK are now planning a clinical trial to investigate the safety and efficacy of the SCIB2-nanoparticle complex in patients with solid tumours.

Dr Cliff Holloway, Chief Executive Officer of Scancell, commented:

"We are delighted to announce this important milestone in our partnership with Cancer Research UK, which moves us one step closer to entering the clinic. This new nanoparticle approach to deliver SCIB2 is expected to achieve results that are as effective as, or even better than, electroporation. We believe SCIB2 has the potential to provide a much-needed treatment option for patients suffering from a range of common solid tumours including NSCLC, the most frequent cause of cancer death globally."

Dr Nigel Blackburn, Cancer Research UK's director of drug development, said:

"We're pleased to see advances in this innovative vaccine, which could bring about urgently needed improvements for some cancers. Our collaboration with Scancell, combining extensive expertise and experience in drug development, will help bring this treatment to the patients that need it sooner."

*Under the terms of the Clinical Development Partnership, Cancer Research UK will fund and sponsor a UK-based Phase 1/2 clinical trial; 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.

For Further Information:

About Scancell

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

ImmunoBody® vaccines target dendritic cells and stimulate both parts of the cellular immune system. They have the potential to be used as monotherapy or in combination with checkpoint inhibitors and other agents. This platform has the potential to enhance tumour destruction, prevent disease recurrence and extend survival.

· SCIB1, the lead programme, is being developed for the treatment of melanoma. A phase 1/2 clinical trial in patients with late stage metastatic melanoma has so far successfully demonstrated survival data of more than five years.

· SCIB2 is being developed for the treatment of non-small cell lung cancer and other solid tumours. Scancell has entered into a clinical development partnership with Cancer Research UK for SCIB2.

Moditope® represents a completely new class of potent and selective immunotherapy agents based on stress-induced post-translational modifications (siPTM). It stimulates the production of killer CD4 T cells which overcome the immune suppression induced by tumours, allowing activated T cells to seek out and kill tumour cells that would otherwise be hidden from the immune system. Moditope® alone, or in combination with other agents, has the potential to treat a wide variety of cancers.

· Modi-1 is being developed for the treatment of solid tumours including triple negative breast cancer, ovarian cancer and head and neck cancer.

For further details, please see the company website: www.scancell.co.uk

About Cancer Research UK's Clinical Development Partnerships

Clinical Development Partnership 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 more than 25 years, taking over 140 potential new anti-cancer agents into clinical trials in patients. Six of these new agents have made it to market including temozolomide for brain cancer, abiraterone for prostate cancer and rucaparib for ovarian cancer, and two other drugs are in late development Phase III trials. Cancer Research UK currently has a portfolio of around 30 new anti-cancer agents in preclinical development, Phase I or early Phase II clinical trials.

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.