OSE Immunotherapeutics and Nantes University Hospital Announce Completion of Patient Enrollment in the FIRsT Clinical Trial, a Phase 1/2 Study Evaluating FR104/VEL-101 Immunotherapy in Renal Transplantation

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OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) and Nantes University Hospital announced today the completion of patient enrollment in the FIRsT Study. This Phase 1/2 clinical trial is the first study to evaluate the immunotherapy FR104/VEL-101, a monoclonal antibody fragment CD28 antagonist, in patients undergoing renal transplant. This study is sponsored and conducted by the University Hospital of Nantes as part of a collaboration agreement with OSE Immunotherapeutics.

The purpose of this Phase 1/2 clinical trial is to investigate the safety, tolerability, and pharmacokinetics of FR104/VEL-101, a novel antagonist pegylated anti-CD28 Fab’ antibody fragment, as well as its potential clinical efficacy on acute rejection prophylaxis and renal function in a de novo renal transplant population receiving an allograft from standard criteria donors (NCT number: NCT04837092). A longer-term follow-up assessment will be performed one year after transplantation. One-year safety and efficacy of FR104/VEL-101 will be evaluated in terms of renal function, incidence of rejection and suspected potential related adverse events.

Pr. Gilles Blancho, Head of the ITUN (Institut de transplantation en urologie-néphrologie) in Nantes, commented: “Despite progress in immunosuppressive treatments, renal transplant recipients still need medical advances. The key issue in organ transplant remains to find efficient immunosuppressive treatments with minimal side effects, particularly on renal function in order to preserve patients’ quality of life, and long-term control of post-transplant immune reaction. Based on our previous preclinical and now clinical evaluation of FR104, we are hoping to contribute developing an innovative and promising immunotherapy for a patient population in need for lifelong immunosuppressor treatment.”

Nicolas Poirier, Chief Executive Officer of OSE Immunotherapeutics, concluded: “We are pleased to complete the enrollment for the Phase 1/2 evaluation of FR104/VEL-101, a key step in the product’s clinical development. We thank the University Hospital of Nantes and their team of excellence at the European Center for Transplantation and Immunotherapy Sciences (CESTI) for our long-standing collaboration and their commitment to tackle this therapeutic challenge. We are now looking forward to the results of the patients’ post-transplant immune response and the one-year safety and efficacy results of FR104/VEL-101 in the FIRsT Study. To continue the clinical development program initiated in Nantes, a larger Phase 2 clinical trial to evaluate FR104/VEL-101 in patients undergoing kidney transplantation will be initiated by our partner, Veloxis Pharmaceuticals.”