First Patient Dosed in Phase 2 Trial for Pegrizeprument

Nantes, France, September 9, 2026 /CourierPR/ -- OSE Immunotherapeutics is celebrating a significant milestone as its licensee, Veloxis Pharmaceuticals, Inc., announced the dosing of the first patient in the Phase 2 RENGEVITY-201 clinical trial. This trial is evaluating pegrizeprument (VEL-101), an innovative monoclonal antibody fragment, for the prevention of organ rejection in kidney transplant recipients.

Pegrizeprument, also known as VEL-101, is a novel immunomodulatory drug originally developed by OSE Immunotherapeutics. It was licensed to Veloxis in April 2021 for all transplant-related indications. Veloxis is responsible for the development, manufacturing, and future commercialization of the product.

This phase of the clinical trial aims to assess the efficacy of pegrizeprument in preventing organ rejection, a critical challenge in kidney transplant patients. The drug works by binding to and blocking CD28-mediated effector-T cell costimulation, a process that is crucial for the immune response. Unlike traditional therapies, pegrizeprument is designed to block CD28-mediated T cell activation while still allowing for CTLA-4 mediated immunosuppressive functions, creating a dual mechanism of action.

The U.S. Food and Drug Administration (FDA) has already granted Orphan Drug Designation to pegrizeprument for the prevention of organ rejection in liver transplant recipients, effective as of December 2025. This designation also covers heart transplant recipients, effective as of March 2026, underscoring the drug's potential to address a significant unmet medical need.

OSE Immunotherapeutics, a biotech company dedicated to developing first-in-class assets in immuno-oncology and immuno-inflammation, is excited about the progress. "We are pleased to see the RENGEVITY-201 trial taking its first step," said a spokesperson for OSE Immunotherapeutics. "This trial is a crucial step towards bringing pegrizeprument to the market, potentially offering a new, effective solution for kidney transplant recipients."

The company's focus on addressing unmet patient needs through innovative therapies is a core part of its mission. "Pegrizeprument represents a promising advancement in the field of transplant immunology," continued the spokesperson. "We are committed to advancing this treatment to provide better outcomes for patients."