Rentschler To Produce Apeiron Antibody

APEIRON Biologics AG and RENTSCHLER Biotechnologie GmbH have entered a partnership agreement for the manufacture of GMP material for advanced clinical studies, as well as market supply of Apeiron’s lead program APN311. 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.

APN311 is a chimeric antibody that targets the GD2 antigen, which is abundantly expressed on neuroblastoma cells. The program is currently in several clinical trials in patients with high-risk neuroblastoma, the most common extracranial solid tumor seen in children.
 
Hans Loibner, chief executive officer 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 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.”