Jasper Therapeutics’ JSP191 Gains Fast Track Designation
Jasper Therapeutics’ investigational monoclonal antibody JSP191 has gained Fast Track status from the FDA for the treatment of patients with severe combined immunodeficiency (SCID) undergoing allogeneic hematopoietic stem cell transplant.
JSP191 is designed to block stem cell factor receptor signaling leading to the clearance of hematopoietic stem and progenitor cells from the bone marrow, said the company.
The antibody is under clinical development as a stem cell transplant conditioning agent where it helps create an empty space for donor or gene-corrected transplanted stem cells to engraft, the company said.
Jasper Therapeutics plans on working with the FDA to determine the feasibility of a path towards a Biologics License Application for JSP191. The agency previously gave JSP191 Orphan Drug and Rare Pediatric Disease designations.