OSE Immunotherapeutics Announces Dosing of the First Participant in a Phase 1 Study of VEL-101/FR104, a Novel Investigational Drug for Kidney Transplant Immunosuppression

Regulatory News:

OSE Immunotherapeutics SA (Paris:OSE) (ISIN: FR0012127173; Mnemo: OSE) today announced that the first participant has been dosed in a Phase 1 Study of VEL-101/FR104 [NCT05238493], a study sponsored and conducted by its partner in transplantation, Veloxis Pharmaceuticals, Inc., an Asahi Kasei company.

VEL-101/FR104 is a novel investigational maintenance immunosuppressive agent being developed for prevention of acute rejection in kidney transplant recipients.

“Dosing our first participant in this study is a monumental step for Veloxis and our growth as a global pharmaceutical development company” said Mark Hensley, chief executive officer of Veloxis. “This milestone demonstrates how our relationship with the Asahi Kasei Group is enabling us to deliver on our promise to improve the lives of transplant patients by developing innovative therapeutics.”

Dominique Costantini, chief executive officer of OSE Immunotherapeutics, comments: “We thank Veloxis for this new step which marks a key advancement in the clinical development of CD28 antagonist VEL-101/FR104 and promising innovative immunosuppressive treatment addressing a key therapeutic challenge. To complement Veloxis’ efforts, an investigator-initiated clinical trial* to evaluate VEL-101/FR104 in patients undergoing renal transplantation is being conducted at University Hospital of Nantes.”

The Veloxis study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of single ascending doses of VEL-101 or placebo when administered subcutaneously (SC) or intravenously (IV). Approximately 56 healthy participants will be enrolled and will undergo monitoring for 50 days.

VEL-101/FR104’s prior Phase 1, randomized, double-blind, placebo-controlled study evaluated single and multiple ascending IV doses of VEL-101/FR104 in healthy participants. The current Phase 1 study will provide important data following SC administration before proceeding to studies in the kidney transplant population. A SC route of administration is being studied to potentially support self-administration at home.

“We are excited to initiate the development of VEL-101 with this study in healthy participants in the United States. The Phase 1 study will primarily provide data on the safety and tolerability of the investigational drug when administered using a subcutaneous route of administration and in a non-weight based fixed dose format”, says Tunde Otulana MD, chief medical officer of Veloxis. “The study will also generate data to support the selection of an appropriate dose-range to incorporate into the next study, which will be a Phase 2 proof of concept study in de novo kidney transplant patients.”