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8/1/2013 8:10:42 AM
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Vienna, Austria and Laupheim, Germany, August 01, 2013 / B3C newswire / – APEIRON Biologics AG (Apeiron), a biotech company focused on immunologic and biologic therapies against cancer, and RENTSCHLER Biotechnologie GmbH (Rentschler), a full service biopharmaceutical contract manufacturer, jointly announce a partnership agreement to manufacture GMP material for various advanced clinical studies and later on for market supply of Apeiron’s lead program APN311.
APN311 is a chimeric antibody that targets the GD2 antigen which is abundantly expressed on neuroblastoma cells. The program is currently being evaluated in several clinical trials in patients with high-risk neuroblastoma in many European countries and other parts of the world. Neuroblastoma is the most common extracranial solid tumor seen in children. 50% of all cases are diagnosed within the first year after birth. To achieve a quick approval and make this therapy available to all patients as soon as possible, Apeiron is working closely with international regulatory authorities.
Decisive factors in Apeiron’s partnering selection were Rentschler’s ability to keep the very challenging project timelines and their technical and regulatory expertise in phase III and market projects. Apeiron receives access to experienced teams, appropriate mammalian cell culture capacity for clinical phase I to III and commercial production, fill and finish services as well as a scientific-driven and responsive project management. The partnership agreement includes the transfer of the manufacturing process to Rentschler, GMP manufacturing, and process validation in preparation of the MAA/BLA submission as well as future market supply.
Hans Loibner, Chief Executive Officer of Apeiron Biologics, mentioned: „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.” stated Frank Ternes, Chief Business Officer of 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.”
Apeiron is a primarily privately financed biotech company in Vienna, developing immunologic and biologic therapies against cancer. Its portfolio consists of five clinical projects and some preclinical approaches. In addition to the lead project APN311 Apeiron develops further clinical projects. APN301 is an immunocytokine and currently in a phase II in the US and Canada against neuroblastoma (relapsed/refractory patients) and in a separate trial against melanoma. The recombinant human Angiotensin Converting Enzyme 2 (GSK2586881, formerly APN01) was licensed to GlaxoSmithKline at the beginning of 2010 and is explored an ongoing phase II study in ARDS. Apeiron has been operational since 2006 and currently employs 23 people.
Rentschler is a biopharmaceutical CMO with over 35 years proven track record. Focused on the utilization of mammalian cell lines, Rentschler’s experience covers the development and production of recombinant proteins in compliance with international GMP standards. Rentschler’s customized solutions range from supporting drug candidate selection, cell line and process development capabilities, as well as GMP production to comprehensive analytics and fill & finish. Rentschler’s state-of-the-art manufacturing facility includes bioreactors up to 2,500 L and aseptic filling lines for vials (including lyophilization) and prefilled syringes. The long-term experience with international regulatory affairs and authorities complements the offerings. Rentschler’s full-service concept allows flexibility on the individual project requirements.
Apeiron Biologics GmbH
Dr. Hans Loibner, CEO
1030 Vienna, Austria
Tel. +43 1 865 65 77
Rentschler Biotechnologie GmbH
Dr. Marion Schrader, Senior Director Marketing
88471 Laupheim, Germany
Tel. +49 7392 701-491
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