OSE Immunotherapeutics and Nantes University Hospital Announce Initiation of a Phase 1/2 Clinical Trial to Evaluate CD28 Antagonist FR104 in Patients Undergoing Renal Transplantation

• University Hospital of Nantes will sponsor and conduct the clinical trial
  
  
• OSE Immunotherapeutics will provide its FR104 product
  
  
• Post-transplant immune response is a key therapeutic issue for patients and a new development indication for FR104
  

NANTES, France, Dec. 03, 2020 (GLOBE NEWSWIRE) -- OSE Immunotherapeutics (ISIN: FR0012127173; Mnémo: OSE), and Nantes University Hospital (CHU de Nantes) today announced that the French National Agency for Medicines and Health Products Safety (ANSM) and the French Central Ethics Committee (CPP) approved the initiation of a Phase 1/2 trial evaluating first administration of FR104, a monoclonal antibody CD28 antagonist, in patients undergoing renal transplant. This study will be conducted as part of a collaboration agreement between OSE Immunotherapeutics and the University Hospital of Nantes.

Alexis Peyroles, Chief Executive Officer of OSE Immunotherapeutics, comments: “We are very pleased to be collaborating with the University Hospital of Nantes and the ITUN, a very high-level clinical investigation center, with a team of excellence in renal graft at European level. The initiation of a first clinical trial of FR104 in renal transplantation is a key step in the product’s development. Since graft rejection is a major issue for patients that results in need for lifelong immunosuppressive treatment, the evaluation of FR104 immunotherapy in the long-term control of post-transplant immune reaction addresses a key therapeutic challenge that requires innovative solutions. OSE Immunotherapeutics is also working on a new Phase 2 clinical trial with FR104 in a niche indication in autoimmune diseases as the product has showcased a strong development potential in a number of indications.”

The purpose of this Phase 1/2 clinical trial is to investigate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of FR104 in renal transplant patients.

A long-term follow up assessment will be performed one year after the end of the study. Long term safety and efficacy will be evaluated in terms of renal function, incidence of rejection and all suspected FR104 related adverse events. 

The study will be conducted under the sponsorship of Nantes University Hospital. Pr. Gilles Blancho, Head of the ITUN (Institute of Urology and Nephrology Transplantation) within the University Hospital, will serve as the coordinating investigator. OSE Immunotherapeutics will provide its product FR104 and a financial support.