20 October 2015
Scancell Holdings Plc
("Scancell" or the "Company")
Translating innovative science into ground-breaking new products
Scancell Holdings Plc, (AIM:SCLP), the developer of novel immunotherapies for the treatment of cancer, will today provide a business and R&D update following the Company's AGM. Dr Richard Goodfellow and Prof Lindy Durrant, Scancell's joint CEOs, will present a summary of the latest available data from the SCIB1 Phase 1/2 clinical trial in malignant melanoma, the lead programme from the Company's ImmunoBodyÒ platform. The Company will also provide an update on the latest data and plans for the ModitopeÒ platform.
Highlights
· Maturing survival and safety data from Phase 1/2 clinical trial continues to suggest that SCIB1 has the potential to become the first effective stand-alone adjuvant treatment for early stage metastatic melanoma, a billion US dollar market opportunity
o All 20 patients with resected tumours at study entry remain alive
§ Of the 16 patients who received 2-4mg doses of SCIB1
· Median survival since entry is 39 months or 44 months since first diagnosis of metastatic disease
· Only five patients have progressed
§ Of the four patients who received an 8mg dose (recruited after lower dose cohorts)
· None have progressed
· Median survival since entry is 7 months to date
o Final Clinical Study Report for trial expected H1 2016
· Further animal data has confirmed that SCIB1 offers the potential to be combined with checkpoint inhibition thereby increasing response rates beyond the 25-30% of patients responding to checkpoint inhibitors alone
· Progress in pre-clinical development of Modi-1, lead pipeline candidate from Moditope® platform
o Modi-1 peptide components broadened to include additional enolase peptide
§ Significantly extends tumour coverage and patient eligibility in triple negative breast and ovarian cancer patient populations
§ First in Man studies in these settings provisionally targeted for Q4 2016
· Roadmap for further clinical development of Immunobody® and Moditope® assets outlined
· Continuing to explore various options for the Company consistent with maximising shareholder value
Prof Lindy Durrant, Joint CEO of Scancell, said: "We continue to be excited by the compelling data emerging from our Phase 1/2 clinical trial in metastatic melanoma with SCIB1, the lead pipeline candidate from our ImmunoBody® platform. In particular the encouraging survival data in patients with resected disease continues to support its potential to become the first effective, stand-alone adjuvant treatment for early stage metastatic melanoma. We have also continued to progress the pre-clinical development of Modi-1, the lead candidate from our second platform technology, Moditope®. The product has been further improved to be potentially effective in up to 95% of patients with triple negative breast and ovarian cancers. We look forward to progressing Modi-1 into the clinic in these indications towards the end of 2016."
Dr Richard Goodfellow, Joint CEO of Scancell, added: "The commercial launch of the first cancer immunotherapies has cemented the importance of this approach in the treatment of cancer. We continue to believe that Scancell has a complementary and potentially valuable pipeline of immuno-oncology assets that is underpinned by two differentiated technology platforms.
"We look forward to communicating the findings from the final Clinical Study Report from our SCIB1 Phase 1/2 trial during the first half of 2016 and to progressing Modi-1 into the clinic towards the end of that year. While we continue to refine our roadmap for the future development of assets from both our platforms, we also continue to explore various options for the Company that are consistent with maximising shareholder value."
David Evans, Non-Executive Chairman of Scancell, commented: "Given the strength of the clinical data and product pipeline, the Board believes that investment in further focused clinical studies on both SCIB1 and Moditope® could add significant value to the Company and is actively evaluating the possibility of conducting one or more of these studies on its own behalf alongside other strategic opportunities for realising shareholder value. The Company is poised for an exciting future as one of the leaders in immuno-oncology and we anticipate strengthening both the Board and management as the Company evolves into a later stage development business."
-ENDS-
For Further Information:
Dr Richard Goodfellow, Joint CEO Professor Lindy Durrant, Joint CEO |
Scancell Holdings Plc |
+ 44 (0) 20 3727 1000 |
Rob Naylor (Corporate Finance) Maisie Atkinson (Sales) |
Panmure Gordon & Co |
+44 (0) 20 7886 2714 +44 (0) 20 7886 2905 |
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Mo Noonan/Simon Conway |
FTI Consulting |
+ 44 (0) 20 3727 1000 |
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.
