Date: 2013-08-01
Type of information: Production agreement
Compound: APN311
Company: Apeiron Biologics (Austria) Rentschler Biotechnologie (Germany)
Therapeutic area: Cancer - Oncology
Type agreement: manufacturing
production
Action mechanism: APN311 is a chimeric antibody that targets the GD2 antigen which is abundantly expressed on neuroblastoma cells.
Disease: neuroblastoma
Details: * On August 1, 2013, Apeiron Biologics, a biotech company focused on immunologic and biologic therapies against cancer, and Rentschler Biotechnologie, 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. 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.
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.
Financial terms:
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