Business
Eurogentec manufacturing agreement
Eurogentec manufacturing agreement.
About this update from Scancell Holdings Plc
[{"type":"text","content":"\n \nRNS Number : 7970E Scancell Holdings Plc 21 July 2016 \n\n21 July 2016\n \nScancell Holdings Plc\n(\"Scancell\" or the \"Company\")\n \nLeading DNA plasmid manufacturer Eurogentec appointed to manufacture new SCIB1 material\n \nScancell 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® 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).\n \nEurogentec'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.\n \nDr Richard Goodfellow, CEO of Scancell, said: \n \n\"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.\n \n\"Access to Eurogentec's expertise and proprietary manufacturing processes has the potential to substantially increase the yields of ...