Scancell Holdings Regulatory News (SCLP)

10 October 2016

Scancell Holdings Plc

("Scancell" or the "Company")

Scancell preparing SCIB2 for clinical study in lung cancer

· SCIB2 will be developed for the treatment of non-small cell lung cancer in combination with a checkpoint inhibitor

· Latest SCIB2 data published in peer-reviewed journal OncoImmunology confirms potent anti-tumour activity was further enhanced by checkpoint blockade

· Extension of clinical application from melanoma to lung cancer highlights potential of ImmunoBody® platform technology to target broad range of cancers

Scancell Holdings plc, ('Scancell' or the 'Company') the developer of novel immunotherapies for the treatment of cancer, today announces its intention to develop its SCIB2 ImmunoBody® for the treatment of non-small cell lung cancer (NSCLC) in combination with a checkpoint inhibitor. Scancell's Board approved the decision based on the outstanding results from the SCIB1 melanoma clinical trial which extended several years beyond the original completion date due to the unexpectedly long survival times. Planning for Phase I/II clinical trials in NSCLC is currently underway.

The latest data on SCIB2 has recently been published in OncoImmunology1, a highly regarded journal at the frontier between oncology and immunology. The results confirmed that SCIB2, an ImmunoBody® encoding NY-ESO-1 epitopes, induced potent anti-tumour immunity which was further enhanced by checkpoint blockade.

Prof Lindy Durrant, Chief Scientific Officer of Scancell, said: "Our clinical experience with the first ImmunoBody®, SCIB1, in the melanoma setting will greatly facilitate planning and execution of our planned lung cancer clinical trials with SCIB2. We believe that success with this clinical programme will highlight that ImmunoBody® has the potential to be applicable to cancers with very different characteristics and underlying genetics."

Dr Richard Goodfellow, Chief Executive Officer of Scancell, said: "It is recognised that the successful exploitation of novel therapeutic mechanisms, such as that underlying our ImmunoBody® platform, will be critical to further improving the poor mortality rates of patients with lung cancer. The data we have generated to date with the SCIB2 ImmunoBody® suggest that it should be well tolerated and be an ideal complement to existing and emerging portfolios of checkpoint inhibitor therapies in the treatment of NSCLC."

The Company will now begin to assemble a lung cancer investigator team in the United States to assist in finalising the clinical trial design.

Lung cancer remains one of the most prevalent and difficult to treat cancers in need of novel therapeutic approaches. According to the Bonnie Addario Lung Cancer Foundation, one of the largest philanthropic organisations targeting the disease, more than 228,000 people are diagnosed with lung cancer in the United States alone, and more 160,000 will go on to die. Lung cancer accounts for 27% of all cancer deaths, more than breast, prostate and colon cancers combined.2 ImmunoBody® is designed to be used to complement existing treatments in combination approaches, but may also be valuable where current treatments are either unsuitable or unavailable.

1 SCIB2, an antibody DNA vaccine encoding NY-ESO-1 epitopes, induces potent antitumor immunity which is further enhanced by checkpoint blockade. Xue W, Metheringham RL, Brentville VA, Gunn B, Symonds P, Yagita H, Ramage JM, Durrant LG. OncoImmunology. 2016 Apr 22;5(6):e1169353. doi: 10.1080/2162402X.2016.1169353. eCollection 2016 Jun. PMID: 27471648 

2 Bonnie J. Addario Lung Cancer Foundation (http://www.lungcancerfoundation.org/about-us/lung-cancer-facts/)

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Scancell Holdings Plc

About ImmunoBody®

ImmunoBody® is an injectable DNA based immunotherapy with a customizable targeting mechanism for multiple specific cancer types. Two additional major practical advantages of ImmunoBody® are a limited to a benign toxicity profile and a relatively low cost of manufacture.

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.

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's ImmunoBody® treatments 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.

Scancell has also identified and patented a series of modified epitopes that stimulate the production of killer CD4+ T cells that destroy tumours without toxicity. Add more information on lead product, Modi-1. The Directors believe that the Moditope® platform could play a major role in the development of safe and effective cancer immunotherapies in the future.