OSE Immunotherapeutics and Nantes University Hospital Reveal Positive Phase 1/2 Study on FR104/VEL-101 Immunotherapy in Renal Transplant

June 5, 2024, Nantes, France - OSE Immunotherapeutics SA and Nantes University Hospital have announced encouraging findings from their Phase 1/2 study on the use of FR104/VEL-101, an anti-CD28 immunotherapy, in kidney transplantation. These results were presented during three oral sessions at the American Transplant Congress (ATC) held from June 1-5, 2024, in Philadelphia.

Study Background and Presentations

The first presentation, led by Professor Gilles Blancho, head of the Urology and Nephrology Transplant Institute (ITUN) at Nantes University Hospital, detailed the initial clinical use of FR104/VEL-101 in renal transplantation. This study, named FIRsT, evaluated the immunotherapy in patients receiving kidney transplants and reported promising safety and efficacy results.

The second presentation, conducted by Veloxis Pharmaceuticals, focused on the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of subcutaneous administration of FR104/VEL-101 in healthy individuals. This Phase 1 clinical trial also highlighted the tolerability and pharmacological behavior of the drug at different doses.

The third presentation, by Professor Richard Pierson's team from Massachusetts General Hospital, discussed preclinical data on the combined blockade of CD154 and CD28 pathways. This approach showed positive effects on heart allograft survival in cynomolgus monkeys, suggesting potential for broader applications of FR104/VEL-101 in transplantation.

Clinical Trial Results

The Phase 1/2 FIRsT clinical trial aimed to assess the safety, tolerability, and pharmacokinetics of FR104/VEL-101 in kidney transplant patients. The study involved ten low-risk patients, with eight successfully completing the one-year follow-up. The primary outcomes were renal function, incidence of acute rejection, and adverse events.

Key results indicated that no acute rejection episodes occurred during the one-year period, even after the withdrawal of tacrolimus, a commonly used immunosuppressant. Additionally, no immunization against the donor organs was detected, further supporting the safety profile of FR104/VEL-101. The study underscored the potential of this therapy as an alternative to calcineurin inhibitors, aiming to reduce side effects and improve long-term patient outcomes.

Comments from Key Stakeholders

Nicolas Poirier, CEO of OSE Immunotherapeutics, expressed gratitude to Nantes University Hospital for this significant milestone. He highlighted the positive results from the subcutaneous Phase 1 trial by Veloxis Pharmaceuticals, which will guide dose selection for the upcoming Phase 2 study in kidney transplant recipients. Poirier also emphasized the promising preclinical cardiac transplantation results, enhancing the future market potential of FR104/VEL-101.

Professor Gilles Blancho, the principal investigator of the FIRsT study, shared his satisfaction with the one-year safety and efficacy data. He noted the absence of acute rejection episodes and the promising safety profile, encouraging the progression to Phase 2 trials for renal transplant patients seeking innovative immunosuppressive solutions.

Future Directions

The ongoing assessment of FR104/VEL-101 aims to explore its full potential in transplant immunotherapy. The next phase will focus on further evaluating its efficacy and safety in a larger patient population. Researchers and collaborators anticipate that FR104/VEL-101 could offer a new approach to immunosuppression with fewer adverse effects, ultimately improving the quality of life and long-term outcomes for transplant recipients.

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