Scancell Holdings Regulatory News (SCLP)

09 July 2015

Scancell Holdings Plc

Patient recruitment completed for SCIB1 Phase 1/2 clinical trial

SCIB1 continues to deliver strong survival data in resected melanoma patients with Stage III/IV disease

Scancell Holdings plc ('Scancell' or the 'Company'), the developer of novel immunotherapies for the treatment of cancer, today announces that it has closed patient recruitment for its SCIB1 ImmunoBody® Phase 1/2 clinical trial in patients with Stage III/IV melanoma.

The Phase 1/2 clinical trial, conducted across five UK centres, is an open label, non-randomised study to determine the safety and tolerability of SCIB1 administered intramuscularly using an electroporation device (TriGrid Delivery System, manufactured by Ichor Medical Systems, USA). Part 1 was a dose-escalation designed trial to determine the dose for Part 2. While the primary objective of the study is to access safety and tolerability, the study is also assessing immune response and anti-tumour activity, and the ability of SCIB1 to delay or prevent disease recurrence in patients with resected disease.

In total, 35 patients have now been treated with SCIB1, including ten patients at the higher 8mg dose. Six patients remain on long-term treatment and have received between one and nine additional 4mg or 8mg doses of SCIB1 every three to six months.

As with previously reported data, SCIB1 continues to be a safe and well tolerated treatment with no withdrawals from the study due to drug-related adverse events. All 20 patients with resected disease remain alive including the four patients on the 8mg dose. The median survival time in the 16 patients with resected disease who received 2-4 mg doses of SCIB1 is now 35 months.

The last patient in the formal six month study will be dosed in October this year after which the Company will analyse the data and prepare a clinical study report. Patients on long-term continuation treatment will continue to be dosed for up to five years from the start of their treatment regime.

Dr Richard Goodfellow, Joint Chief Executive Officer of Scancell, said: "With the recruitment of the SCIB1 Phase 1/2 melanoma trial coming to a close, we continue to see highly encouraging survival times and melanoma-specific immune responses in patients, especially those with resected tumours. We believe that our ImmunoBody® platform offers melanoma patients a new treatment option that has the potential to extend life expectancy and improve their quality of life. We look forward to reporting the final results of the study in due course."

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Notes to Editors

SCIB1 mechanism of action

SCIB1 is a DNA ImmunoBody® immunotherapy encoding a human IgG1 antibody, with three epitopes from gp100 and one from TRP-2 engineered into its CDR regions. This immuno-stimulatory antibody targets dendritic cells in vivo via the high affinity Fc receptor, CD64, and stimulates high avidity T cells. Extensive research studies suggest SCIB1 ImmunoBody® has a dual mechanism of action that combines cross-presentation with direct-presentation. This results in amplification of the immune response to induce high frequency, high avidity T cells which translates into a potent anti-tumour response.

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 and is being evaluated in a Phase 1/2 clinical trial. Data from the 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 destroy tumours without 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.