OSE Immunotherapeutics announced acceptance of the IND obtained by Veloxis Pharmaceuticals Inc. from the Food & Drug Administration for a clinical trial with VEL-101/FR104, a CD28 antagonist monoclonal antibody fragment. This trial will be sponsored and conducted by Veloxis Pharmaceuticals Inc. in the United States. This important milestone has been achieved by Veloxis Pharmaceuticals Inc. as part of the global license agreement signed in April 2021 under which Veloxis Pharmaceuticals Inc. obtained from OSE Immunotherapeutics worldwide rights to develop, manufacture and commercialize FR104, a CD28 antagonist monoclonal antibody fragment, for all transplant indications.

Under this agreement, acceptance of the US IND application has triggered a milestone payment of €5 million from Veloxis Pharmaceuticals Inc. to OSE Immunotherapeutics. In parallel, OSE Immunotherapeutics retains all product rights to develop FR104 in autoimmune diseases.