Jasper Therapeutics’ JSP191, an anti-CD117 monoclonal antibody, has received fast track designation from the U.S. Food and Drug Administration (FDA) for the treatment of patients with severe combined immunodeficiency (SCID) undergoing allogeneic hematopoietic stem cell transplant.
To date, JSP191 has been studied in 14 SCID patients in an ongoing multicenter clinical trial with clinical outcome data presented at academic medical conferences.
“Patients born with SCID have a severely compromised immune system and need to rely on an allogeneic hematopoietic stem cell transplant to create the immune cells needed to fight infection,” said Ronald Martell, president and Chief Executive Officer of Jasper Therapeutics.
“Unfortunately many patients are too fragile to tolerate the toxic chemotherapy doses typically used in transplant, and may suffer severe side effects or fail transplant. Along with the FDA’s previous designations of Orphan and Rare Pediatric Disease for JSP191, this new Fast Track designation recognizes the potential role of JSP191 in improving clinical outcomes for these patients and will allow us to more closely work with the FDA in the upcoming months to determine a path toward a Biologics License Application (BLA) submission.”
The FDA’s Fast Track designation is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill unmet medical needs. The purpose is to accelerate the development of important new drugs for patients.
Drugs granted Fast Track designation are eligible for more frequent meetings with the FDA to discuss the drug’s development plan and ensure the collection of appropriate data needed to support approval, as well as eligibility for Accelerated Approval, Priority Review and Rolling Review if relevant criteria are met.