Scancell Holdings Regulatory News (SCLP)

12 January 2015

Scancell Holdings Plc

Scancell to provide positive SCIB1 Phase 1/2 clinical trial update during corporate presentations 12-15 January, San Francisco

Part 2 patients have median survival time of 28 months since study entry

All resected patients are still alive with median survival time of 30 months and 27 months for Stage III and IV patients, respectively

Scancell Holdings plc, ('Scancell' or the 'Company') the developer of novel immunotherapies for the treatment of cancer, announces that Joint CEOs Dr Richard Goodfellow and Professor Lindy Durrant will be making corporate presentations 12-15 January 2015, coincident with JP Morgan's 33rd Annual Healthcare Conference, San Francisco, CA, USA.

A very encouraging update on clinical outcomes in the Company's on-going Phase 1/2 clinical trial in patients with Stage III/IV melanoma treated with the SCIB1 ImmunoBody® will be given as part of these presentations. It will be reported that the overall median survival of Part 1 patients with tumour present at trial entry and who received at least three doses of 2-8mg of SCIB1 is 24 months. This compares favourably with first line untreated Stage IV disease where patients with no visceral disease had a median survival of 11 months and patients with visceral disease had a median survival of six months (Sosman et al., 2011 Cancer 117:4740-4706). The status of the patients with resected tumours at study entry is equally promising. The 14 patients in Part 2 of the trial have been on study for 23-32 months (median 28 months) and only three have evidence of disease progression. Of particular note, all resected patients (n=16; two from Part 1 and 14 from Part 2) are still alive and only four have progressed. The median recurrence-free survival (when 50% of patients have died) has not been reached; these resected patients have a median survival time of 30 months for Stage III patients (n=9) and 27 months for Stage IV patients (n=7). This compares very favourably with reported data from a peptide vaccine trial following two years of treatment, in which 50% of Stage III patients had disease progression and 19% had died; while 52% of Stage IV patients had disease progression and 33% had died (Slingluff et al., 2011 J Clin Oncol 29:2924-2932).

Richard Goodfellow, Joint CEO of Scancell, said: "The maturing clinical data from our lead ImmunoBody®, SCIB1, continues to enhance our confidence in the clinical value of SCIB1 as monotherapy, especially in the adjuvant setting, a huge and relatively untapped market." 

-ENDS-

For Further Information:

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.

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 and checkpoint inhibition (blockade of the PD-1 immune checkpoint pathway) has 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.