OSE Immuno: FDA green light for Veloxis Pharmaceuticals


(CercleFinance.com) – OSE Immunotherapeutics announces that the United States Food & Drug Administration (FDA) has accepted the Investigational New Drug (IND) application formulated by Veloxis Pharmaceuticals for a clinical trial involving VEL-101/FR104 .

This milestone was achieved by Veloxis Pharmaceuticals under the global licensing agreement signed in April 2021 whereby OSE Immunotherapeutics granted Veloxis Pharmaceuticals the worldwide rights to develop, manufacture and register FR104, a monoclonal antibody fragment antagonist of CD28, in all transplantation indications.

According to this agreement, the acceptance of the application for IND in the United States triggers the payment of a milestone payment of 5 million euros from Veloxis Pharmaceuticals to OSE Immunotherapeutics.

In parallel, OSE Immunotherapeutics retains all rights to develop FR104 in autoimmune diseases.

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