OSE Immunotherapeutics and Nantes University Hospital Present Positive Interim Data Analysis from the FIRsT Phase 1/2 Study Evaluating FR104/VEL-101 Immunotherapy in Renal Transplant

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OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) (Paris:OSE) and Nantes University Hospital presented positive interim data analysis from first use of anti-CD28 FR104/VEL-101 in kidney transplantation at the Annual Meeting of the Francophone Society of Transplantation (SFT, Société Francophone de Transplantation) held in Brest, France (December 5 – 8, 2023).

The oral communication, entitled “First use of FR104, an anti-CD28 molecule in human kidney transplantation, interim analysis”, reported on the first data from the Phase 1/2 clinical trial FIRsT evaluating FR104/VEL-101(emerging locally from the ITUN/CR2TI*) 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.

Pr. Gilles Blancho, Head of the ITUN at the University Hospital in Nantes / Nantes University and Principal Investigator of the study commented: « We are very pleased to share interim data analysis on post-transplant immune response and one-year safety in patients treated with FR104/VEL-101 in the FIRsT study. There is a lot learned at this stage of the product’s clinical development as we did not observe acute rejection or safety alert after one year follow-up, both key therapeutic issues for patients undergoing renal transplant who require innovative solutions. The therapeutic approach based on selective CD28 blockage by FR104/VEL-101 might represent an effective immunomodulation strategy by reducing the activation of T lymphocytes, while sparing the activity of regulatory T lymphocytes. The exploration of FR104/VEL-101’s safety profile seems promising and encourages moving to a Phase 2 trial.”

Nicolas Poirier, Chief Executive Officer of OSE Immunotherapeutics, concluded: “We thank the University Hospital of Nantes for this major step which marks a key advancement in the clinical development towards a Phase 2 trial of CD28 antagonist FR104/VEL-101. A Phase 2 clinical trial of FR104/VEL-101 in patients undergoing kidney transplantation is under preparation by our partner Veloxis Pharmaceuticals.”

The purpose of the FIRsT 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 is performed one year after transplantation. One-year safety and efficacy of FR104/VEL-101 is evaluated in terms of renal function, incidence of rejection and suspected potential related adverse events.