Scancell Holdings plc, (‘Scancell’ or the ‘Company’) the developer of novel immunotherapies for the treatment of cancer, announces results for the year ended 30 April 2014.

Highlights during the period:

• Orphan drug designation granted by FDA for SCIB1 ImmunoBody® for the treatment of metastatic melanoma
• Positive data from Part 2 and an update from Part 1 of the on-going Phase 1/2 clinical trial with SCIB1 ImmunoBody® in patients with Stage III/IV melanoma
  • Melanoma-specific immune response seen in all Part 2 patients
  • Continuing positive survival trend in Part 1 subjects
  • No serious adverse events reported
  • Completion of patient dosing with 8mg of SCIB1 in Part 1 of on-going Phase 1/2 clinical trial in patients with Stage III/IV melanoma
• Planning for preclinical and clinical development of Modi-1, lead vaccine from Moditope® platform underway
  • Provisionally positioned as a novel immunotherapeutic for the treatment of lung, triple-negative breast cancer, ovarian and endometrial cancers
  • Continue to expect first-in-man clinical studies to start in 2016
• Publication of patent application underpinning the Company’s Moditope® platform
• Scancell granted an extension of the Option to commercialise Ichor’s proprietary Trigrid™ electroporation delivery system with SCIB1
• Loss for the year of £2,222,954 (2013: loss: £1,901,944)
• Group cash balance at 30 April 2014 was £5,566,234 (30 April 2013: £1,491,320). This increase in cash is attributable to the placing and open offer earlier in the financial year which raised £6.1m, net.

Post period highlights:

• New data demonstrates that a combination of SCIB1 and checkpoint inhibition showed enhanced tumour destruction and significantly longer survival times than when either treatment was used alone
• Patent granted in the United States for Scancell’s DNA ImmunoBody® platform technology, following the grant of counterparts in Australia, China and Japan
• Further positive results from the on-going Phase 1/2 clinical trial in patients with Stage III/IV melanoma treated with the SCIB1 ImmunoBody®
  • Survival times are highly encouraging in both Part 1 and Part 2 patient groups
  • Melanoma-specific immune responses in 24 of 28 (86%) patients
  • Reduction in the number and size of multiple lung metastases in two patients
  • No serious adverse events reported

Richard Goodfellow, Joint CEO of Scancell, said: “The cumulative results emerging from our ongoing Phase 1/2 SCIB1 clinical trial, including the destruction of lung metastases in two patients and the apparent prolongation of survival, continues to add to the evidence that SCIB1 has the potential to extend lives without the burden of serious side effects. The rationale for combining SCIB1 and PD-1 blockade, confirmed in recent animal studies, is also compelling.

“Our ongoing Moditope® research continues to be productive as we continue to prepare Modi-1, our lead vaccine from this platform, for clinical trials which are on schedule to start in 2016.

“Cancer immunotherapy is emerging as one of most exciting areas of pharmaceutical research and development. Scancell now has two innovative technology platforms in this emerging field, both of which are expected to be of substantial interest to the increasing number of pharmaceutical companies establishing R&D programmes in the area. The Board remains dedicated to realising value for our shareholders as we continue to build upon the excellent data garnered to date.”

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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 has a marked effect on tumour load, produces a melanoma-specific immune response and highly encouraging survival trend without serious side effects.

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.

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.