Jasper Therapeutics announces EMA ODD for briquilimab

Jasper Therapeutics announced that the European Medicines Agency, EMA, Committee for Orphan Medicinal Products, COMP, has granted orphan drug designation, ODD, to briquilimab, formerly known as JSP191, a monoclonal antibody targeting the CD117, receptor, for conditioning treatment prior to HCT. Previously, the U.S. Food and Drug Administration granted orphan drug designation to briquilimab in HCT, as well as rare pediatric disease designation for the treatment of severe combined immunodeficiency. "The EMA’s decision to grant orphan drug designation to briquilimab highlights the clear need for non-genotoxic, targeted conditioning for patients receiving hematopoietic stem cell transplant," said Ronald Martell, President and Chief Executive Officer of Jasper Therapeutics. "Transplants have the potential to cure several hematologic cancers and genetically inherited diseases. However, the toxicities associated with genotoxic conditioning needed to prepare patients for these procedures often limit their use. We believe that briquilimab has the potential to fill this gap, effectively expanding access to curative stem cell transplant across a range of indications. With the orphan designation, the EMA has demonstrated support of briquilimab in Europe and Jasper is committed to advancing this therapy globally."