Jasper Therapeutics Announces Treatment of First Patient in Study of JSP191 Conditioning in Patients with Fanconi Anemia

Rhea-AI Summary

Jasper Therapeutics, Inc. (NASDAQ: JSPR) has initiated a Phase 1/2 clinical trial at Stanford University to evaluate JSP191 as a conditioning agent for patients with Fanconi Anemia requiring bone marrow transplants. This research aims to improve donor stem cell engraftment while reducing toxicity. The trial is led by Dr. Rajni Agarwal and focuses on assessing treatment-emergent adverse events among participants. JSP191, previously tested in over 100 patients, is designed to facilitate safer allogeneic transplants. Jasper also plans further clinical trials expanding JSP191's applications.

Positive

• Initiation of Phase 1/2 clinical trial for JSP191 at Stanford.
• JSP191 aims to enhance donor stem cell engraftment with reduced toxicity.
• Previous evaluation of JSP191 in over 100 healthy volunteers and patients.
• Potential expansion of JSP191's application in future clinical trials.

Negative

• None.

REDWOOD CITY, Calif., May 17, 2022 (GLOBE NEWSWIRE) -- Jasper Therapeutics, Inc. (NASDAQ: JSPR), a biotechnology company focused on hematopoietic cell transplant therapies, today announced the dosing of the first patient in the Company’s sponsored research of the Center for Definitive and Curative Medicine (CDCM) at the Stanford University School of Medicine for the study of JPS191 as a conditioning agent in the treatment of Fanconi Anemia. In accordance with the sponsored research agreement, Stanford Medicine is conducting a Phase 1/2 clinical trial (NCT04784052) utilizing JSP191 to treat Fanconi Anemia patients in bone marrow failure requiring allogeneic transplant with non-sibling donors.

Fanconi Anemia (FA) is a rare but serious blood disorder that prevents the bone marrow from making sufficient new red blood cells. The disorder can also cause the bone marrow to make abnormal blood cells. FA typically presents at birth or early in childhood between five and ten years of age. Ultimately it can lead to serious complications, including bone marrow failure and severe aplastic anemia. Cancers such as AML and MDS are other possible complications. Treatment may include blood transfusions or medicine to create more red blood cells, but hematopoietic stem cell transplant (HSCT) is the only cure.

The objective of the study is to develop a cell therapy for FA which enables enhanced donor hematopoietic and immune reconstitution with decreased toxicity by transplanting depleted stem cells from a donor, after using JSP191 as a part of conditioning. Primary outcome measures include the number of patients without treatment emergent adverse events following administration of JSP191. The principal investigator is Rajni Agarwal, MD, Professor of Pediatrics, Stanford University School of Medicine.

“There is a compelling need in this patient population for a non-toxic conditioning regimen, and we are very pleased to support this effort to seek therapeutic advances for these patients,” said Ronald Martell, President and CEO of Jasper Therapeutics. “We look forward to continuing our collaboration and advancing the study of JSP191 to the next phase of development.”

About JSP191
JSP191 is a humanized monoclonal antibody in clinical development as a conditioning agent that blocks stem cell factor receptor signaling leading to clearance of hematopoietic stem cells from bone marrow, creating an empty space for donor or genetically modified transplanted stem cells to engraft. To date, JSP191 has been evaluated in more than 100 healthy volunteers and patients. Three clinical trials for myelodysplastic syndromes (MDS)/acute myeloid leukemia (AML), severe combined immunodeficiency (SCID) and Fanconi anemia are currently enrolling. The Company plans a new study of JSP191 as a second-line therapeutic in lower risk MDS patients in 2022 as well as the registrational study in MDS/AML transplant in early 2023. Enrollment in additional studies are planned in patients with sickle cell disease, chronic granulomatous disease and GATA2 MDS who are undergoing hematopoietic cell transplantation.

About Jasper Therapeutics
Jasper Therapeutics is a biotechnology company focused on the development of novel curative therapies based on the biology of the hematopoietic stem cell. The company is advancing two potentially groundbreaking programs. JSP191, an anti-CD117 monoclonal antibody, is in clinical development as a conditioning agent that clears hematopoietic stem cells from 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. In parallel, Jasper Therapeutics is advancing its preclinical mRNA engineered hematopoietic stem cell (eHSC) platform, which is designed to overcome key limitations of allogeneic and autologous gene-edited stem cell grafts. Both innovative programs have the potential to transform the field and expand hematopoietic stem cell therapy cures to a greater number of patients with life-threatening cancers, genetic diseases and autoimmune diseases than is possible today. For more information, please 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,” “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding the potential long-term benefits of hematopoietic stem cells (HSC) engraftment following targeted single-agent JSP191 conditioning in the treatment of severe combined immunodeficiency (SCID) and Jasper’s ability to potentially deliver a targeted non-genotoxic conditioning agent to patients with SCID. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of Jasper and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, an assurance, a prediction or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond the control of Jasper. These forward-looking statements are subject to a number of risks and uncertainties, including general economic, political and business conditions; the risk that the potential product candidates that Jasper develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; risks relating to uncertainty regarding the regulatory pathway for Jasper’s product candidates; the risk that clinical trials may not confirm any safety, potency or other product characteristics described or assumed in this press release; the risk that Jasper will be unable to successfully market or gain market acceptance of its product candidates; the risk that Jasper’s product candidates may not be beneficial to patients or successfully commercialized; patients’ willingness to try new therapies and the willingness of physicians to prescribe these therapies; the effects of competition on Jasper’s business; the risk that third parties on which Jasper depends for laboratory, clinical development, manufacturing and other critical services will fail to perform satisfactorily; the risk that Jasper’s business, operations, clinical development plans and timelines, and supply chain could be adversely affected by the effects of health epidemics, including the ongoing COVID-19 pandemic; the risk that Jasper will be unable to obtain and maintain sufficient intellectual property protection for its investigational products or will infringe the intellectual property protection of others; and other risks and uncertainties indicated from time to time in Jasper’s filings with the SEC. If any of these risks materialize or Jasper’s assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. While Jasper may elect to update these forward-looking statements at some point in the future, Jasper specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Jasper’s assessments of any date subsequent to the date of this press release. Accordingly, undue reliance should not be placed upon the forward-looking statements.

Contacts:
John Mullaly (investors)
LifeSci Advisors
617-429-3548
jmullaly@lifesciadvisors.com

Jeet Mahal (investors)
Jasper Therapeutics
650-549-1403
jmahal@jaspertherapeutics.com

FAQ

What is the significance of the JSP191 clinical trial announced by Jasper Therapeutics?

The JSP191 clinical trial aims to evaluate its effectiveness as a conditioning agent for treating Fanconi Anemia, potentially improving patient outcomes during bone marrow transplants.

When did Jasper Therapeutics announce the dosing of the first patient in the JSP191 study?

Jasper Therapeutics announced the dosing of the first patient on May 17, 2022.

What are the primary goals of the JSP191 clinical trial?

The primary goals include assessing the safety of JSP191 and its ability to enhance donor stem cell engraftment while minimizing treatment-related adverse events.

Who is leading the JSP191 clinical trial for Fanconi Anemia?

Dr. Rajni Agarwal, a Professor of Pediatrics at Stanford University School of Medicine, is the principal investigator leading the trial.

What is Fanconi Anemia and how does it relate to the JSP191 trial?

Fanconi Anemia is a serious blood disorder that can lead to bone marrow failure. The JSP191 trial seeks to develop treatments that improve outcomes for patients with this condition.