Scancell Holdings Regulatory News (SCLP)

1 October 2013

Scancell Holdings Plc

('Scancell')

Investor update showcases Moditope® platform and updates SCIB1 trial progress

Scancell Holdings Plc, (AIM:SCLP), the developer of novel immunotherapies for the treatment of cancer, will today hold an investor update. Following an introduction by Prof. Peter Stern, Institute of Cancer Sciences, University of Manchester, Dr Richard Goodfellow and Prof Lindy Durrant, Scancell's joint CEOs will present a business update as well an overview of the ImmunoBody® platform and SCIB1 clinical programme, including its current status. A detailed introduction to the new Moditope® platform will also be given for the first time.

Prof Durrant will review the SCIB1 clinical trial programme and confirm that the ongoing studies remain on track. Further results from this trial are expected by the end of 2013. SCIB1 is Scancell's first cancer immunotherapy and is a product of the Company's ImmunoBody® platform. It is being developed for the treatment of malignant melanoma and is currently in Phase 1/2 clinical trials.  Encouraging results from Part 1 of the study have previously been presented and provide the first clinical evidence that Scancell's ImmunoBody® immunotherapy approach is producing an immune response in cancer patients which may also be associated with clinical benefit. Prof Durrant will today add that four out of the six evaluable patients treated with either the 2mg or 4mg dose of SCIB1 still remain alive. The mean survival time in this group of five Stage IV and one Stage IIIb patients is currently 21 months from trial entry.

In view of the positive results and minimal side effects seen with the 4mg dose (Part 1) of the SCIB1 Phase 1/2 trial, the Company has initiated evaluation of an 8mg dose in up to six patients with measurable tumours. Five patients have been recruited to date: one patient will no longer be evaluable due to delivery of an incomplete dose of SCIB1 and a further patient was not able to complete dosing within the required timeframe. A safety review of the data from the 8 mg cohort in Part 1 will be conducted and, if adequate safety is demonstrated, Scancell plans to recruit a further 10 patients with measurable disease into Part 2 of the study. An amendment has been submitted to the appropriate regulatory authorities to request approval to treat these additional patients at the 8 mg dose.

Prof Lindy Durrant, the inventor of the Moditope® platform, will present a detailed overview of the technology and its potential. She will describe how the technology was used to generate the lead product, SCMod1. Planning is underway for the preclinical and clinical development of SCMod1 as an immunotherapeutic, provisionally for the treatment of triple-negative breast cancer, ovarian and endometrial cancers. First-in-man clinical studies are scheduled to start in 2016. Moditope® harnesses CD4+ T cells to eradicate tumours and represents a new class of immunotherapeutic agents.  The platform deploys citrullinated tumour-associated peptide epitopes to overcome self-tolerance and destroy tumour cells, with no requirement for blockade inhibitors (for example CTLA4 antibodies and PD-1 inhibitors). It can potentially be expanded to develop multiple immunotherapeutic agents for different cancers. A broad patent has been filed to protect this platform and covers the use of multiple tumour-associated modified epitopes for the treatment of cancer.

It will be recalled that the ImmunoBody® platform induces a high avidity CD8+ T cell response to tumour associated antigens. As the Moditope® platform stimulates a potent CD4+ T cell response to modified self-antigens both platforms are complementary relying on a response by different classes of T cell for their therapeutic effect. Thus, in principle, a combination of ImmunoBody® and Moditope® derived therapeutics may be a powerful approach to the treatment of both early and late stage cancers.

In the second part of the seminar, specialist guest speakers, led by Professor Karol Sikora, Dean of Medicine at University of Buckingham, Medical Director of CancerPartnersUK and honorary Consultant Oncologist at Hammersmith Hospital, will form an interactive panel to discuss the increasing importance of immunotherapy for the treatment of cancer and how Scancell's technology fits into this emerging landscape. 

Dr. Richard Goodfellow, joint CEO of Scancell, commented: "We welcome this opportunity to update investors following the recent successful fundraising completed in August. The SCIB1 clinical programme remains on track and further data is expected by the end of 2013. Having now filed and exemplified the patents covering our Moditope® technology, we can provide more detail on how this second platform technology has the potential to generate a completely new class of potent and selective immunotherapy agents and which could have a profound effect on the way that cancer immunotherapies are developed. In particular, the technology may overcome the immune suppression induced by tumours themselves without the need for checkpoint blockade inhibitors, thereby allowing activated T cells seek out and kill tumour cells that would otherwise be hidden from the immune system.

"In view of the short to medium term licensing and partnership potential that both the Moditope® and Immunobody® programmes now bring to the Company, our strategy requires a more flexible approach. Whilst we are still fully focused on securing a sale of the business at the earliest opportunity, we will now consider technology validating and revenue generating deals on each individual platform when and where appropriate in order to enhance the value of the Company when it is sold."

-ENDS-

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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 in Phase 1/2 clinical trials. Preliminary evidence from Part 1 of the study showing that SCIB1 produced an immune response which might be associated with clinical benefit in patients with malignant melanoma was released in December 2012.

Scancell's ImmunoBody® immunotherapies 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.

Scancell, Immunobody® and Moditope® are trade marks of Scancell Limited.