High hopes for immunotherapy candidate in renal transplant


OSE Immunotherapeutics and Nantes University Hospital have revealed positive interim data analysis from the FIRsT Phase I/II study evaluating FR104/VEL-101 immunotherapy in renal transplants.

The data was presented the Annual Meeting of the Francophone Society of Transplantation (SFT, Société Francophone de Transplantation) held in Brest, France.

Professor Gilles Blancho, Head of the ITUN at the University Hospital in Nantes / Nantes University and Principal Investigator of the study, commented: “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 II trial.”

A Phase II clinical trial of FR104/VEL-101 in patients undergoing kidney transplantation is under preparation by OSE’s partner Veloxis Pharmaceuticals.

In the FIRsT Phase I/II clinical trial, seven patients completed one-year treatment with FR104/VEL-101 and one is ongoing (Month 4). At this interim analysis, no safety alert was detected for FR104/VEL-101. Adverse events were those conventionally observed in kidney transplantation.

Pharmacological monitoring made it possible to optimise exposure to FR104/VEL-101 and to maintain high receptor occupancy during the one-year follow-up. No acute rejection under FR104/VEL-101 was observed.

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