Jasper Shares Climb As FDA Grants Fast Track Status To Immunodeficiency Disease Candidate

Jasper Therapeutics JSPR announced that its lead asset JSP191 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.

JSP191 is currently being evaluated in four ongoing clinical studies in allogeneic hematopoietic stem cell transplant in patients with Acute Myeloid Leukemia (AML) / Myelodysplastic Syndromes (MDS), Severe combined immunodeficiency (SCID) , Fanconi anemia (FA) and Sickle Cell Disease (SCD).

JSP191 has been studied in 14 SCID patients in an ongoing multicenter clinical trial.

Ronald Martell, President and Chief Executive Officer, stated, "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. 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.”

“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.” Ronald Martell, added.

Jasper was previously granted Orphan and Rare Pediatric Disease by the regulatory agency for JSP191.

The company is on track to initiate a new study of JSP191 as a therapeutic in second-line therapy for patients with lower-risk MDS later this year.

The FDA designed the fast track process to facilitate the development and expedite the review of drugs to treat serious or life-threatening diseases or conditions and fill unmet medical needs.

Price Action : Jasper shares are trading around 12 percent higher at $1.49 on Thursday during pre-market session.