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Jasper Therapeutics’ JSP191 Gains Fast Track Designation

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.

Jasper Therapeutics

Jasper is a biotechnology company focused on enabling cures with hematopoietic stem cell therapies. Our mission is to make safer and potentially curative therapy possible for more patients in need. We are bringing together a team of biotech veterans, leading academic institutions and a strong syndicate of healthcare-focused investors to achieve our vision of developing an improved end-to-end stem cell transplantation process and associated therapies, starting with safer and more effective conditioning agents and engineered stem cell therapies.

September 16, 2022

https://www.fdanews.com/


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