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news.US-based ImmunoCellular Therapeutics has entered into an agreement with Dutch contract manufacturing organisation (CMO) PharmaCell to offer contract manufacturing services for the European production of a dendritic cell-based cancer immunotherapy, ICT-107, being developed as a potential treatment for glioblastoma (GBM).
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The deal focuses on the production of human cell therapy products and is designed to allow The US firm to access Phase III supplies of ICT-107, manufactured with its commercial-ready production process.
In 2015, ImmunoCellular plans to begin a Phase III registrational program for ICT-107 in the US and in Europe.
ImmunoCellular chief executive officer Andrew Gengos said: "Securing high quality ICT-107 manufacturing in Europe is a key milestone on our way to initiating a Phase III registrational trial later this year, and helps to lay the groundwork for seeking EMA regulatory approval, assuming a positive outcome to the phase III program and favorable regulatory review.
"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."
Additionally, ImmunoCellular intends to begin a technology transfer process from its North American manufacturer to complement the EU and US methods of production of ICT-107 for the planned Phase III registration trial.
PharmaCell chief executive officer Alexander Vos 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."