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OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) said it has received an announcement from its partner Veloxis Pharmaceuticals, Inc. that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to pegrizeprument (VEL-101) for the prophylaxis of heart allograft rejection in patients receiving a heart transplant. The designation follows an Orphan Drug Designation granted in January 2026 for prevention of organ rejection in patients receiving a liver transplant.
The FDA Orphan Drug Designation program grants orphan status to investigational drugs and biologics intended to prevent, diagnose or treat rare diseases and medical conditions affecting fewer than 200,000 people in the United States. The program is designed to encourage development of treatments for patients with rare conditions that are traditionally undertreated.
Pegrizeprument, also known as VEL-101, is a novel investigational immunomodulatory monoclonal monovalent antibody fragment. It was originally discovered and developed by OSE Immunotherapeutics and licensed to Veloxis in 2021 for all transplant-related indications. Veloxis is responsible for global development, manufacturing, and future commercialization.
The therapy is described as a pegylated monoclonal monovalent antibody fragment that binds to and blocks CD28-mediated effector-T cell costimulation, without blocking CTLA-4. The company states this is expected to support a dual mechanism of action: directly blocking CD28-mediated T cell activation and indirectly enabling CTLA-4 mediated immunosuppressive functions.
Pegrizeprument is currently being developed for the prevention of rejection in solid organ transplant recipients. It has also been referred to as FR104.
Pegrizeprument was licensed by Veloxis Pharmaceuticals, Inc. from OSE Immunotherapeutics in April 2021. Under the license agreement, Veloxis obtained worldwide rights to develop, manufacture, and commercialize pegrizeprument for all transplant indications.
OSE Immunotherapeutics is a biotech company focused on developing first-in-class assets in immuno-oncology (IO) and immuno-inflammation (I&I) addressing unmet patient needs. The company partners with academic institutions and biopharmaceutical companies to develop and bring to market medicines for people with serious diseases. OSE Immunotherapeutics is based between Nantes and Paris and is listed on Euronext.
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