OSE Immunotherapeutics and Veloxis Pharmaceuticals Enter Into Global License Agreement to Develop, Manufacture, and Commercialize FR104, a CD28 Antagonist, in the Organ Transplantation Market

• Agreement expands Veloxis’ product portfolio and the continued commitment to improving the lives of transplant patients.
  
• OSE Immunotherapeutics to receive up to €315 million in potential milestones, including a €7 million upfront, and tiered royalties on sales.

NANTES, France and CARY, N.C. , April 26, 2021 (GLOBE NEWSWIRE) -- OSE Immunotherapeutics (ISIN: FR0012127173; Mnemo: OSE) and Veloxis Pharmaceuticals Inc., a subsidiary of Asahi Kasei, today announced a global license agreement granting Veloxis Pharmaceuticals worldwide rights to develop, manufacture and commercialize FR104, a CD28 antagonist monoclonal antibody fragment, for all transplant indications. In parallel, OSE Immunotherapeutics retains all product rights to develop FR104 in autoimmune diseases. Through this license agreement, Veloxis plans to develop FR104 to provide a new therapeutic option for prophylaxis of organ rejection in patients receiving a solid organ transplant.

According to the agreement, OSE Immunotherapeutics will receive up to €315 million in potential milestones from Veloxis, including a €7 million upfront payment; development, registration and commercialization milestone payments; as well as additional tiered royalties on potential future sales. Veloxis will assume all production, development and commercialization costs in the transplant indications for FR104.

Alexis Peyroles, Chief Executive Officer of OSE Immunotherapeutics, comments: “We are excited to begin this collaboration with Veloxis, a leading transplantation company, and the perfect partner for clinical advancement of FR104 in this field. This partnership demonstrates the outstanding value and great potential of our clinical stage product to meet patients and physicians’ needs in transplantation.”

Ulf Meier-Kriesche MD, Chief Scientific Officer of Veloxis, a board-certified Nephrologist with over 20 years of practical clinical experience in transplantation, comments: “We are very excited about the opportunity to develop this new molecular entity as a potential alternative to CNI’s in the immunosuppressive regimen following kidney transplantation. The range of successful non-clinical pharmacologic, mechanistic and toxicology studies already conducted with FR-104 as well as the first-in-man data that have been generated provide us a good foundation to advance the product development. We believe this is a significant step towards addressing some of the critical unmet medical needs in transplantation. It also reinforces our commitment to our patients and the transplant community we serve.”