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European Partners Combine to Bring Therapeutic Antibody to Market

By BiotechDaily International staff writers
Posted on 15 Aug 2013
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Two European biotechnology companies have agreed to collaborate to complete development and commence marketing of a novel therapeutic antibody that targets the GD2 antigen, which is abundantly expressed on neuroblastoma cells.

Neuroblastoma is a cancer of the sympathetic nervous system that accounts for about 7% of all childhood cancers and 10% to 15% of all childhood cancer deaths.

Apeiron Biologics AG (Vienna, Austria), a biotech company focused on immunologic and biologic therapies against cancer, has agreed to a joint project with Rentschler Biotechnologie GmbH (Laupheim, Germany), a full service biopharmaceutical contract manufacturer, to complete development of the chimeric APN311 antibody for advanced clinical studies and then to manufacture it under full GMP compliance.

Per the agreement, Apeiron will receive access to experienced teams, appropriate mammalian cell culture capacity for clinical phase I to III trials, commercial production, fill and finish services as well as a scientifically driven, and responsive project management. The manufacturing process, validation, and regulatory affairs will be transferred to Rentschler.

Hans Loibner, CEO of Apeiron Biologics, said, "We are happy to have identified Rentschler as a professional contract manufacturer and consider this collaboration as a distinct value increase for our project APN311, which is also acknowledged in discussions with existing and potential partners. This decision resolved a significant hurdle in our effort to make this therapy available as soon as possible. I am very much looking forward to a fruitful collaboration."

"We are very excited to contribute our expertise to meet the truly challenging timeline of this project which is so very important for children suffering from this life threatening disease," said Frank Ternes, chief business officer at Rentschler. "We are confident that this cooperative atmosphere will continue to grow and mature over the course of the entire project, and ensure the success of this partnership."

Related Links:
Apeiron Biologics AG
Rentschler Biotechnologie GmbH

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