OSE Immunotherapeutics Welcomes FDA Orphan Drug Designation Granted to Pegrizeprument (VEL-101)

Core Insights - OSE Immunotherapeutics acknowledges the FDA's Orphan Drug Designation for pegrizeprument (VEL-101), aimed at preventing organ rejection in liver transplant patients [1][3] Group 1: Product Development - Pegrizeprument is a novel investigational immunomodulatory monoclonal antibody fragment, originally developed by OSE Immunotherapeutics and licensed to Veloxis Pharmaceuticals in 2021 for all transplant-related indications [2][6] - The drug is designed to block CD28-mediated T cell activation while allowing CTLA-4 mediated immunosuppressive functions, indicating a dual mechanism of action [5] Group 2: Market Implications - The Orphan Drug Designation highlights the need for improved treatment options in solid organ transplantation, marking a significant milestone in the development of pegrizeprument [3][4] - Veloxis Pharmaceuticals is responsible for the global development, manufacturing, and commercialization of pegrizeprument, which is currently being developed for kidney transplantation [2][6] Group 3: Company Overview - OSE Immunotherapeutics is a biotech company focused on developing first-in-class assets in immuno-oncology and immuno-inflammation, partnering with leading institutions to address unmet patient needs [7]