Eurogentec specialises in the cGMP manufacture of plasmid DNA and recombinant proteins
Scancell Holdings, a UK-based developer of immunotherapies for the treatment of cancer, has agreed that Eurogentec will manufacture new supplies of the firm's SCIB1 ImmunoBody vaccine.
In June, Scancell suspended dosing with clinical supplies of SCIB1, some of which had been stored for seven years, following discussion with the MHRA Clinical Trials Unit. The company concluded that these supplies were no longer suitable for use, although no new side-effects had emerged.
Eurogentec, a Belgian FDA inspected contract manufacturing organisation which specialises in the manufacture of plasmid DNA and recombinant proteins, will manufacture new supplies of SCIB1 for its use in a US clinical study in combination with a checkpoint inhibitor, which is expected to start 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 FDA and EMA 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 I/II 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 will also enable us to recommence treating patients in the long-term extension of the Phase I/II 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.'