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

OSE Immunotherapeutics and Nantes University Hospital announced 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.