Scancell Holdings Plc Eurogentec manufacturing agreement (7970E)
21 July 2016 - 4:00PM
UK Regulatory
TIDMSCLP
RNS Number : 7970E
Scancell Holdings Plc
21 July 2016
21 July 2016
Scancell Holdings Plc
("Scancell" or the "Company")
Leading DNA plasmid manufacturer Eurogentec appointed to
manufacture new SCIB1 material
Scancell Holdings plc, ('Scancell' or the 'Company') the
developer of novel immunotherapies for the treatment of cancer,
today announces an agreement with Eurogentec S.A, an FDA inspected
CMO specialised in the GMP production of plasmid DNA and
recombinant proteins, for the manufacture of new supplies of
Scancell's SCIB1 ImmunoBody(R) vaccine for use in the US clinical
study of SCIB1 in combination with a checkpoint inhibitor, expected
to commence in 2017. Upon completion and once fully evaluated,
which is expected to take approximately 9-12 months, this clinical
trial material will also be available to recommence dosing of
patients in the Company's long-term extension of the Phase 1/2
SCIB1 clinical study in malignant melanoma (subject to regulatory
approval).
Eurogentec's biologics division produces clinical trial and
commercial biopharmaceutical material compliant with current Good
Manufacturing Practice (cGMP) for all major markets according to US
Food and Drug Administration (FDA) and the European Medicines
Agency (EMA) requirements. The company is FDA inspected (2011,
2013, 2014) and currently manufactures a biopharmaceutical marketed
in the US. In the field of plasmid DNA, Eurogentec is a recognised
leading CMO having recently manufactured 150g of plasmid DNA
material for a major pharmaceutical company with plans to scale the
process to commercial requirements.
Dr Richard Goodfellow, CEO of Scancell, said:
"We are delighted to be working with Eurogentec, a world class
manufacturer, to provide the new batch of SCIB1 material. As can be
seen from the latest data from our Phase 1/2 clinical trial, SCIB1
continues to deliver compelling survival data in patients with
resected stage III/IV melanoma. This new supply will not only be
used in our upcoming US checkpoint inhibitor combination trial, but
also enable us to recommence treating patients in the long-term
extension of the Phase 1/2 study.
"Access to Eurogentec's expertise and proprietary manufacturing
processes has the potential to substantially increase the yields of
SCIB1 and fast-track the scale-up that will be required for future
Phase III and commercial supply."
For Further Information:
Scancell Holdings Plc
Dr John Chiplin, Executive
Chairman +1 858 900 2646
Dr Richard Goodfellow, Scancell Holdings +44 (0) 20 3727
CEO Plc 1000
Freddy Crossley (Corporate +44 (0) 20 7886
Finance) 2500
Tom Salvesen (Corporate Panmure Gordon +44 (0) 20 7886
Broking) & Co 2500
+44 (0) 20 3727
Mo Noonan/Simon Conway FTI Consulting 1000
About Scancell
Scancell is developing novel immunotherapies for the treatment
of cancer based on its ImmunoBody(R) and Moditope(R) technology
platforms.
Scancell's first ImmunoBody(R), SCIB1 is being developed for the
treatment of melanoma. Data from thePhase 1/2 clinical 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(R) 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(R) platform could play a major role in the development of
safe and effective cancer immunotherapies in the future.
About Eurogentec
Eurogentec S.A., part of Kaneka Corporation, is a leading global
supplier of innovative reagents, kits, specialty products and
custom services. Through its three inter-related business units,
the company provides high quality products to scientists involved
in the life science, biotechnology, diagnostic and pharmaceutical
markets. Eurogentec is fully ISO 9001, ISO 13485 certified, cGMP
accredited by the Belgian Ministry of Health and approved by the US
FDA for the commercial manufacturing of a biologic marketed in the
US. www.eurogentec.com
This information is provided by RNS
The company news service from the London Stock Exchange
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