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Jasper Therapeutics Announces FDA Fast Track Designation

  • JSP191 is currently being evaluated in four ongoing clinical studies of allogeneic hematopoietic stem cell transplantation in patients with acute myeloid leukemia (AML)/myelodysplastic syndromes (MDS), SCID, Fanconi anemia and sickle cell disease
  • On track to initiate a new study of JSP191 as a second-line therapy for patients with low-risk MDS later this year

REDWOOD CITY, Calif., Sept. 15, 2022 (GLOBE NEWSWIRE) — Jasper Therapeutics, Inc. (Nasdaq: JSPR), a biotechnology company focused on developing several novel therapies for the field of stem and cell medicine, announced today that JSP191, an anti-CD117 monoclonal antibody, has received accelerated designation from the U.S. Food and Drug Administration (FDA) for the treatment of patients with severe combined immunodeficiency (SCID) undergoing allogeneic cell transplantation hematopoietic strains. To date, JSP191 has been studied in 14 SCID patients in an ongoing multicenter clinical trial with clinical outcome data presented at university medical conferences.

“Patients born with SCID have severely compromised immune systems and must rely on an allogeneic hematopoietic stem cell transplant to create the immune cells needed to fight infection,” said Ronald Martell, President and CEO of Jasper Therapeutics. “Unfortunately, many patients are too frail to tolerate the doses of toxic chemotherapy typically used in transplants, and may suffer serious side effects or fail the transplant. Along with previous FDA orphan and rare pediatric disease designations 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 work more closely with the FDA in the coming months to determine a path to a biologics license application submission. (BLA).

FDA Fast Track designation is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and address unmet medical needs. The goal is to accelerate the development of new drugs that are important to patients. Drugs with Fast Track designation are eligible for more frequent meetings with the FDA to discuss the drug’s development plan and ensure collection of appropriate data needed for approval, as well as eligibility for expedited approval. priority review and ongoing review if the relevant criteria are met. .

About JSP191

JSP191 is a humanized monoclonal antibody that blocks stem cell factor receptor signaling leading to the clearance of hematopoietic stem and progenitor cells from the bone marrow. JSP191 is in clinical development as a stem cell transplant conditioning agent where it helps to create a void space for the transplant of donor or gene-correction transplanted stem cells. While hematopoietic cell transplantation may be curative for patients, its use is limited because standard high-dose myeloablative conditioning is associated with severe toxicities and standard low-dose conditioning has limited efficacy. To date, JSP191 has been evaluated in over 110 healthy volunteers and patients. Four clinical trials for myelodysplastic syndromes (MDS)/acute myeloid leukemia (AML), severe combined immunodeficiency (SCID), Fanconi anemia (FA) and sickle cell disease undergoing allogeneic transplantation are currently underway. JSP191 is also expected to enter clinical development as a second-line therapy in low-risk, transfusion-dependent patients with MDS to preferentially promote recovery of healthy hematopoietic stem cells to help restore hematopoiesis. normal.

About Jasper Therapeutics

Jasper Therapeutics is a biotechnology company focused on developing novel curative therapies based on hematopoietic stem cell biology. The company is advancing two potentially game-changing programs. JSP191, an anti-CD117 monoclonal antibody, is in clinical development as a conditioning agent that eliminates hematopoietic stem cells from the bone marrow in patients undergoing hematopoietic cell transplantation. It is designed to enable safer and more effective curative allogeneic hematopoietic cell transplants and gene therapies. Clinical study of JSP191 as a new disease-modifying therapy for patients with low-risk MDS is also expected to begin in 2022. In parallel, Jasper Therapeutics is advancing its preclinical mRNA hematopoietic stem cell transplant platform, which is designed to overcome the main limitations of allogeneic and autologous genetically modified stem cell transplants. These two innovative programs have the potential to transform the field and expand hematopoietic stem cell therapy cures to more patients with life-threatening cancers, genetic diseases and autoimmune diseases than ever before. is possible today. For more information, visit us at jaspertherapeutics.com.

Forward-looking statements

Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements are sometimes accompanied by words such as “believe”, “may”, “will”, “estimate”, “continue”, “anticipate”, “intend”, “expect”, “should”, “would”, “plan”, “predict”, “potential”, “look”, “seek”, “future”, “outlook” and similar expressions which predict or indicate future events or trends or which are not statements of historical matters. include, but are not limited to, statements regarding the potential benefits of Fast Track designation for JSP191, the potential for JSP191 to significantly improve clinical outcomes, the potential for JSP191 to address limitations of graft conditioning, the potential plans to initiate clinical development of JSP191 and any potential biologics license application for JSP191 and the expected timing for the initiation of clinical studies and trials. These statements are based on various assumptions, whether or not identified in this press release, and Jasper Therapeutics’ current expectations and are not predictions of actual performance. These forward-looking statements are provided for informational purposes only and are not intended to serve as, and should not be relied upon by, any investor as a guarantee, assurance, prediction or definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from the assumptions. Many real events and circumstances are beyond the control of Jasper Therapeutics. These forward-looking statements are subject to a number of risks and uncertainties, including general economic, political and business conditions; the risk that potential product candidates developed by Jasper Therapeutics may not progress through clinical development or receive required regulatory approvals on schedule or at all; risks related to uncertainty regarding the regulatory path for Jasper Therapeutics’ product candidates; the risk that clinical trials may not confirm the safety, potency or other product characteristics described or implied in this press release; the risk that Jasper Therapeutics may not be able to successfully commercialize or achieve market acceptance of its product candidates; the risk that the results of previous studies will not be replicated; the risk that the final study data will not be consistent with the preliminary study data; the risk that Jasper Therapeutics’ product candidates may not benefit patients or be successfully marketed; the risk that Jasper Therapeutics has overestimated the size of the target patient population, their willingness to try new therapies and the willingness of physicians to prescribe such therapies; the effects of competition on the business of Jasper Therapeutics; the risk that third parties upon which Jasper Therapeutics depends for laboratory, clinical development, manufacturing and other essential services may not operate satisfactorily; the risk that Jasper Therapeutics’ business, operations, clinical development plans and schedules, and supply chain could be affected by the effects of health outbreaks, including the ongoing COVID-19 pandemic; the risk that Jasper Therapeutics may not be able to obtain and maintain sufficient intellectual property protection for its investigational products or infringe the intellectual property protection of others and other risks and uncertainties stated from time to time in Jasper Therapeutics’ public filings with the SEC, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2021 and subsequent quarterly reports on Form 10-Q. Should any of these risks materialize, or should Jasper Therapeutics’ assumptions prove incorrect, actual results could differ materially from the results implied by such forward-looking statements. There may be additional risks that Jasper Therapeutics is not currently aware of, or that Jasper Therapeutics currently believes are not material, that could also cause actual results to differ materially from those contained in the forward-looking statements. Although Jasper Therapeutics may choose to update these forward-looking statements at some time in the future, Jasper Therapeutics expressly disclaims any obligation to do so. These forward-looking statements should not be taken to represent Jasper Therapeutics’ assessments of any date subsequent to the date of this press release. Accordingly, undue reliance should not be placed on forward-looking statements.

contacts:

John Mullaly (investors)
LifeSci Advisors
617-429-3548
[email protected]

Jeet Mahal (investors)
Therapeutic Jasper
650-549-1403
[email protected]