Jasper Therapeutics
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), SCID, Fanconi anemia and Sickle Cell Disease
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
REDWOOD CITY, Calif., Sept. 15, 2022 (GLOBE NEWSWIRE) -- Jasper Therapeutics, Inc. (Nasdaq: JSPR), a biotechnology company focused on developing multiple new therapies for the field of stem and cellular medicine, today announced that 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 FDAs 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 FDAs 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 drugs 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.
Story continues
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 create an empty space for donor or gene-corrected transplanted stem cells to engraft. While hematopoietic cell transplantation can 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 more than 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 transplant are currently ongoing. JSP191 is also planned to enter clinical development as a second-line therapeutic in transfusion-dependent, lower-risk MDS patients to preferentially drive recovery of healthy hematopoietic stem cells in order to help restore normal hematopoiesis.
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. Clinical study of JSP191 as a novel, disease-modifying, therapeutic for patients with lower risk MDS is also planned to begin in 2022. In parallel, Jasper Therapeutics is advancing its preclinical mRNA hematopoietic stem cell grafts 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 any potential benefits of the Fast Track Designation for JSP191, the potential for JSP191 to significantly improve clinical outcomes, the potential for JSP191 to address the limitations of transplant conditioning, the potential plans to initiate clinical development of JSP191 and any potential Biologics License Application for JSP191 and the expected timing for initiating clinical studies and trials. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of Jasper Therapeutics 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 Therapeutics. 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 Therapeutics 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 Therapeutics 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 Therapeutics will be unable to successfully market or gain market acceptance of its product candidates; the risk that prior study results may not be replicated; the risk that final study data may not be consistent with preliminary study data; the risk that Jasper Therapeutics product candidates may not be beneficial to patients or successfully commercialized; 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 these therapies; the effects of competition on Jasper Therapeutics business; the risk that third parties on which Jasper Therapeutics depends for laboratory, clinical development, manufacturing and other critical services will fail to perform satisfactorily; the risk that Jasper Therapeutics 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 Therapeutics 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 Therapeutics public filings with the SEC, including its Annual Report on Form 10-K for the year ended December 31, 2021 and subsequent Quarterly Reports on Form 10-Q. If any of these risks materialize or Jasper Therapeutics assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that Jasper Therapeutics does not presently know, or that Jasper Therapeutics currently believes are immaterial, that could also cause actual results to differ from those contained in the forward-looking statements. While Jasper Therapeutics may elect to update these forward-looking statements at some point in the future, Jasper Therapeutics specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Jasper Therapeutics 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 Advisors617-429-3548jmullaly@lifesciadvisors.com
Jeet Mahal (investors)Jasper Therapeutics650-549-1403jmahal@jaspertherapeutics.com
- Unable to find a partner for stem cell therapy, Gamida accepts sale to investment firm to survive - Fierce Biotech - March 28th, 2024
- Putting Stem Cell-Based Therapies in Context - National Institutes of ... - January 31st, 2024
- Global Stem Cell Therapy Industry Outlook to 2028, Driven by Therapeutic Innovations and Clinical Advancements ... - Yahoo Finance - January 31st, 2024
- Stem Cell Transplant and CAR T-cell Therapy: The Patient and Care Partner Experience | BMT Infonet - BMT Infonet | - January 31st, 2024
- New study on promising stem cell-based therapy for Crohn's disease - Medical Xpress - January 31st, 2024
- The Trouble With Stem Cell Therapy - Consumer Reports - December 20th, 2023
- Stem Cell Therapy Boosts Quality of Life for People With Advanced Heart Failure - MedicineNet - December 20th, 2023
- The stem cell therapy project Blue4Therapy brought to a highly successful close - Marketscreener.com - April 7th, 2023
- Stem Cell Therapy for Spinal Cord Injury - PubMed - December 27th, 2022
- How much does stem cell therapy cost in 2022? - The Niche - December 18th, 2022
- How Does Stem Cell Therapy Work and What Are the Risks? | ISCRM - December 18th, 2022
- Ethical issues in stem cell research and therapy - December 10th, 2022
- EdiGene to Present Preliminary Safety and Efficacy Results of an Investigator Initiated Trial for ET-01, its Investigational Gene Editing... - November 6th, 2022
- Global Stem Cell Umbilical Cord Blood (UCB) Market Report 2022-2026: Increased Federal Investment in Stem Cell Therapy, and the Advent of Cord Blood... - October 21st, 2022
- Global Cell Culture Protein Surface Coating Market to Grow at a CAGR of 13.82% During 2022-2031; Market to Expand on the Back of the Technological... - October 21st, 2022
- Stem Cell Therapy for Knees - thriveMD Denver & Vail, CO - October 13th, 2022
- Stem cell therapy and autism | Raising Children Network - October 13th, 2022
- Cellectis Presents Data on Two TALEN-based Gene Therapy Preclinical Programs for Patients with ... - The Bakersfield Californian - October 13th, 2022
- Global Nerve Repair and Regeneration Devices Market to Reach $12.9 Billion by 2027 - Yahoo Finance - October 13th, 2022
- 2023 to be highly lucrative for drug developers across therapeutic areas: Report - BSI bureau - October 13th, 2022
- Stem Cell Therapy in Heart Diseases - Cell Types, Mechanisms and ... - October 4th, 2022
- Long-Term Data from Omidubicel Phase 3 Trial Demonstrates Overall Survival and Sustainable Durable Outcomes for Patients with Blood Cancers at the... - October 4th, 2022
- Innovative Imaging Techniques to Accelerate the Discovery of New... - Healthcare Tech Outlook - October 4th, 2022
- Celtic-mad dad left unable to talk after horror attack as family fundraise for stem cell therapy... - The Scottish Sun - September 25th, 2022
- Stem Cell Therapy Market worth $558 million by 2027 Exclusive Report by MarketsandMarkets - Benzinga - September 16th, 2022
- Stem Cell Therapy Market worth $558 million by 2027 Exclusive Report by MarketsandMarkets - GlobeNewswire - September 16th, 2022
- Radical lupus treatment uses CAR T-cell therapy developed for cancer - New Scientist - September 16th, 2022
- T-Cell Redirection Therapy Shows Promise As Salvage Therapy in R/R Multiple Myeloma - Targeted Oncology - September 16th, 2022
- Orca Bio expands manufacturing capabilities to take cell therapies through to commercialization - BioPharma-Reporter.com - September 16th, 2022
- BioRestorative Therapies : BRTX Presentation September 2022 - Marketscreener.com - September 16th, 2022
- Advanced cellular therapy brings hope to KSA cancer patients - Omnia Health Insights - September 16th, 2022
- IN8bio Partners with the Dunbar CAR T-Cell Program at the University of Louisville as the Manufacturing Center for INB-400 - BioSpace - September 16th, 2022
- The five hottest private biotech companies in India - Labiotech.eu - September 16th, 2022
- Be The Match and William G. Pomeroy Foundation Announce $500k Gift and Matching Campaign - PR Newswire - September 16th, 2022
- California man appears to be another person cured of HIV after a stem cell transplant - aidsmap - August 5th, 2022
- Poseida Therapeutics Announces Strategic Global Collaboration with Roche Focused on Allogeneic CAR-T Cell Therapies for Hematologic Malignancies - PR... - August 5th, 2022
- Induced Pluripotent Stem Cell (iPSC) Global Market to Reach $3.57 Billion by 2026 - Benzinga - August 5th, 2022
- The Role of Cell Banking Outsourcing Market Industry Growth, Competitors Analysis, New Technology, Trends and Forecast 2020 2030 - Digital Journal - August 5th, 2022
- World to Witness Surging Use of Neurostimulation & Neuromodulation Devices for Nerve Repair and Regeneration, Predicts Fact.MR - GlobeNewswire - August 5th, 2022
- Dr. Owhofasa Agbedia Honored With The 2022 ASH-CIBMTR-ASTCT Career Development Award - Business Wire - August 5th, 2022
- Novel Drug-Chemotherapy Combo After Stem Cell Transplant Associated With 'Favorable Survival Outcomes' in Group of Rare Blood Cancers - Curetoday.com - July 27th, 2022
- Broadening access to cancer fighting therapy led by UH researcher | University of Hawaii System News - University of Hawaii - July 27th, 2022
- Petition calling for 'life-changing' MS treatment funding handed to Parliament - Stuff - July 27th, 2022
- How effective is stem cell therapy for liver cirrhosis? - Times of India - July 27th, 2022
- Kite's CAR T-cell Therapy Tecartus Receives Positive CHMP Opinion in Relapsed or Refractory Acute Lymphoblastic Leukemia (r/r ALL) - Gilead Sciences - July 27th, 2022
- S'porean doctor, a sought-after top expert in cell therapy, appointed to WHO expert panel - The Straits Times - July 27th, 2022
- Top 10 Advances in Large B-Cell Lymphomas in the Past 10 Years - Targeted Oncology - July 27th, 2022
- Stem Cell Therapy Market Emerging Trends to Make Driving Growth on Key Players Status - Taiwan News - July 19th, 2022
- PROMISING STEM CELL THERAPY IN THE MANAGEMENT OF HIV & AIDS | BTT - Dove Medical Press - July 11th, 2022
- Global Stem Cell Manufacturing Market Value Projected To Reach USD 21.71 Billion By 2029, Registering A CAGR Of 9.1% - Digital Journal - July 11th, 2022
- Diabetic foot treatment: Here's all you need to know about stem cell therapy - Hindustan Times - July 11th, 2022
- Every 5 minutes someone in India is diagnosed with blood cancer or a blood disorder: Patrick Paul, CEO, DKMS BMST Foundation India - The Financial... - July 11th, 2022
- Growing Prevalence & Recurrence Of Rheumatoid Arthritis Is Expected To Growth Of The Rheumatoid Arthritis Stem Cell Therapy Market Designer Women... - July 11th, 2022
- New sickle cell disease gene therapies depend on getting the right mouse - EurekAlert - July 11th, 2022
- Market Share, Supply, Analysis and Forecast of Human Insulin Drugs and Delivery Devices to 2026 Designer Women - Designer Women - July 3rd, 2022
- Gamida Cell Submits Biologics License Application for Omidubicel to the FDA - Pharmacy Times - June 22nd, 2022
- Global Rheumatoid Arthritis Stem Cell Therapy Market 2022 Swot Analysis by Top Key Vendors, Demand And Forecast Research to 2028 Designer Women -... - June 22nd, 2022
- Stem Cell Therapy in Jacksonville at Pangenics Regenerative Center - June 13th, 2022
- Stem-Cell Based Therapy Shows Promise in Treating High-Risk Type 1 Diabetes - Newswise - June 13th, 2022
- What Is Myelofibrosis? Symptoms, Causes, Diagnosis, Treatment, and Prevention - Everyday Health - June 13th, 2022
- European Commission Approves Mosunetuzumab for Patients with R/R Follicular Lymphoma - Targeted Oncology - June 13th, 2022
- Global Human Embryonic Stem Cell Market To Be Driven By The Rapid Technological Advancements In The Forecast Period Of 2022-2027 The Greater... - June 4th, 2022
- Pancreatic Cancer Therapy Experiment Saves Woman; Is It A Breakthrough? - Kaiser Health News - June 4th, 2022
- Dedication, Achievement and Grace in Cancer Care - Curetoday.com - June 4th, 2022
- Nerve Repair and Regeneration Market worth $11.6 billion by 2027 - Exclusive Report by MarketsandMarkets - Yahoo Finance - June 4th, 2022
- Efficacy and Safety of MSC Cell Therapies for Hospitalized Patients with COVID-19: A Systematic Review and Meta-Analysis - DocWire News - June 4th, 2022
- CPX-351 in Treatment of AML and Clinical Considerations - OncLive - June 4th, 2022
- High Economic Burden of MM, Particularly Within 1 Year of Diagnosis, Says French Study - AJMC.com Managed Markets Network - June 4th, 2022
- JASPER THERAPEUTICS, INC. Management's Discussion and Analysis of Financial Condition and Results of Operations (form 10-Q) - Marketscreener.com - May 15th, 2022
- Cell Culture Market to Gain US$ 27.6 Bn by 2031, Burgeoning Demand for Biosimilars and Biologic Therapeutics Fueling Market Growth - BioSpace - May 15th, 2022
- Pilot Study Shows Promising Results With CPX-351 in Relapsed/Refractory ALL - OncLive - May 15th, 2022
- Primary Cell Culture Market Mechanical Separation Segment Is Expected To Witness A Lucrative CAGR Of 11.7 - Benzinga - May 15th, 2022
- Vale man with MS needs 50,000 for treatment in Mexico - Evesham Journal - May 2nd, 2022
- Kala Pharmaceuticals to Present Clinical Data for KPI-012, its Mesenchymal Stem Cell Secretome Product, for the Treatment of PCED at the 2022 ARVO... - May 2nd, 2022
- Long-Term Axi-Cel Data 'May Be Suggestive of a Cure' in Patients With Large B-Cell Lymphoma - Curetoday.com - May 2nd, 2022
- Billy Connolly donates painting to Glasgow woman diagnosed with cancer five times - Glasgow Times - May 2nd, 2022
- The Progress Made in Stem Cell Therapy, Regenerative Medicine: Peter J. McAllister, MD, FAAN - Neurology Live - April 19th, 2022
- AACR: Resistance Mechanisms to CAR-T Cell Therapy ID'd in ALL - HealthDay News - April 19th, 2022
- 2022-04-18 | NDAQ:BRTX | Press Release | BioRestorative Therapies Inc - Stockhouse - April 19th, 2022
- First Patient With Lymphoma Receives Novel Cell Therapy in Large-Scale Trial - Curetoday.com - April 6th, 2022