ImmunoCellular Therapeutics, Ltd. ("ImmunoCellular") (NYSE MKT: IMUC) today announced the establishment of an agreement with PharmaCell B.V. to provide contract manufacturing services for the European production of ICT-107, a dendritic cell-based cancer immunotherapy in development as a potential treatment for glioblastoma (GBM). This agreement with PharmaCell, a leading European contract manufacturing organization focuses on the production of human cell therapy products, and is designed to enable ImmunoCellular to access phase 3 supplies of ICT-107, manufactured with ImmunoCellular's commercial-ready production process. ImmunoCellular intends to initiate a Phase 3 registrational program for ICT-107 in the US and in Europe in 2015.
"Securing high quality ICT-107 manufacturing in Europe is a key milestone on our way to initiating a phase 3 registrational trial later this year, and helps to lay the groundwork for seeking EMA regulatory approval, assuming a positive outcome to the phase 3 program and favorable regulatory review," said Andrew Gengos, ImmunoCellular Chief Executive Officer. "PharmaCell has an excellent reputation as a high-quality, full-service GMP manufacturer, with unique expertise in cancer immunotherapy products manufactured for the EU market. We believe that the start of this trial will bring us closer to our goal of building a leading cancer immunotherapy company."
Alexander Vos, Chief Executive Officer of PharmaCell BV, said: "We are excited that ImmunoCellular Therapeutics, a global leader in cancer immunotherapy, has decided to work with us. Their decision confirms that our new Geleen facility is indeed viewed by industry experts as meeting the requirements and client expectations for late clinical stage and commercial manufacturing for ATMPs. We look forward to supporting ImmunoCellular in its effort to develop ICT-107 for the benefit of European patients."
ImmunoCellular plans to initiate a technology transfer process from its North American manufacturer to harmonize the EU and US methods of production of ICT-107 for the planned phase 3 registration trial. The technology transfer process is anticipated to begin as soon as practicable.
Stem-cell implants restore vision in patients with corneal stem cell deficiency