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Jasper Therapeutics Announces Plans for Registrational Study of JSP191 in Older Patients with Myelodysplastic Syndromes or Acute Myeloid Leukemia Undergoing Hematopoietic Cell Transplantation after Type C FDA Meeting
Based on positive feedback provided by FDA on key clinical design details Jasper plans to initiate registrational studies in AML and MDS patients REDWOOD
About this update from Jasper Therapeutics, Inc.
[{"type":"text","content":"Based on positive feedback provided by FDA on key clinical design details Jasper plans to initiate registrational studies in AML and MDS patients\nREDWOOD CITY, Calif., April 28, 2022 (GLOBE NEWSWIRE) -- Jasper Therapeutics, Inc., (NASDAQ: JSPR) a biotechnology company focused on hematopoietic stem cell therapies, today announced that after discussion with the FDA the company plans to initiate a registrational study of JSP191 as a targeted, non-toxic conditioning agent in older patients with myelodysplastic syndromes (MDS) or acute myeloid leukemia (AML) undergoing allogeneic hematopoietic (blood) cell transplantation. The recent discussion with the FDA included review of the trial comparator arm, population, size, statistical assumptions and primary endpoints. The company agreed with the FDA to submit a trial protocol which is currently being finalized based on agency input. No additional studies were identified as needed prior to start of a potential registrational studies in either MDS or AML patients. “We would like to thank the FDA for recognizing the need to develop new conditioning regimens with minimal toxicities and enhanced disease control for the growing population of older patients with AML or MDS undergoing transplant,” said Ronald Martell, President and CEO of Jasper Therapeutics. “Given the JSP191 clinical data in AML and MDS patients recently presented at the 2022 Transplantation & Cellular Therapy (TCT) Meeting, we believe that JSP191 has the potential to significantly improve transplantation for patients ineligible for intensive myeloablative conditioning. We are looking forward to completing the study protocol for review with the FDA and launching the registrational study early next year.” Updated data presented at the 2022 TCT Meeting showed that conditioning with a single dose of JSP191 0.6 mg/kg prior to low dose radiation and fludarabine in preparation for transplantation was well tolerated and led to successful engraftment as evidenced by primary neutrophil recovery and full donor myeloid chimerism in twenty-four older patients (aged 62-79) with AML in complete response (CR) or MDS. Twenty patients were determined to be free from morphological relapse or disease progression at last follow up and four patients were off study due to relapse or progression. Clearance of measurable residual disease (MRD) was ...