APEIRON Biologics AG (Apeiron) and RENTSCHLER Biotechnologie GmbH (Rentschler) have jointly announced 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.
Ternes continued, “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.”