OSE Immunotherapeutics Announced Acceptance of the US Investigational New Drug (IND) Application Obtained by Veloxis Pharmaceuticals, Inc., its Partner in Transplantation, for CD28 Antagonist VEL-101/FR104. Based on the global license agreement signed in April 2021, this first milestone triggers a €5 million payment from Veloxis Pharmaceuticals, Inc. to OSE Immunotherapeutics.
OSE Immunotherapeutics announced acceptance of the IND obtained by Veloxis Pharmaceuticals, Inc. from the Food & Drug Administration (FDA) 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.
Dominique Costantini, Chief Executive Officer of OSE Immunotherapeutics, comments: “We thank Veloxis Pharmaceuticals, Inc. for this first key achievement which demonstrates their commitment and strong belief in the potential of this first-in-class CD28 antagonist as an innovative immunosuppressive treatment and marks a major step in enlarging the product’s development in transplantation. The milestone payment, in line with our business model, will reinforce our cash position to advance our immuno-oncology and immunity & inflammatory pipeline.”