REDWOOD CITY, Calif.--(BUSINESS WIRE)--Jasper Therapeutics, Inc., a biotechnology company focused on hematopoietic cell transplant therapies, today announced positive preliminary findings from its ongoing multicenter Phase 1 clinical trial of JSP191, a first-in-class anti-CD117 (stem cell factor receptor) monoclonal antibody, as a conditioning agent in older patients with myelodysplastic syndromes (MDS) or acute myeloid leukemia (AML) undergoing hematopoietic (blood) cell transplantation.
Data from the first six patients who received a single dose of JSP191 prior to transplantation showed successful engraftment in all six patients. Complete donor myeloid chimerism (equal or greater than 95%) was observed in five of six evaluable patients at 28 days, and all three evaluable patients had total donor chimerism equal or greater than 95% observed at day 90. In addition, at 28 days, three of five evaluable patients showed complete eradication of measurable residual disease (MRD) as measured by next-generation sequencing. Two of the five evaluable patients showed substantial reductions in MRD. No treatment-related serious adverse events were reported.
The findings were presented by lead investigator Lori Muffly, M.D., M.S., Assistant Professor of Medicine (Blood and Bone Marrow Transplantation) at Stanford Medicine, as a late-breaking abstract at the 2021 Transplantation & Cellular Therapy (TCT) Meetings of the American Society for Transplantation and Cellular Therapy (ASTCT) and the Center for International Blood & Marrow Transplant Research (CIBMTR).
These early clinical results are the first to demonstrate that JSP191 administered in combination with a standard non-myeloablative regimen of low-dose radiation and fludarabine is well tolerated and can clear measurable residual disease in older adults with MDS or AML undergoing hematopoietic cell transplantation a patient population with historically few options, said Kevin N. Heller, M.D., Executive Vice President, Research and Development, of Jasper Therapeutics. These patients could be cured by hematopoietic cell transplantation, but the standard-of-care myeloablative conditioning regimens used today are highly toxic and associated with high rates of morbidity and mortality particularly in older adults. Traditional lower intensity transplant conditioning regimens are better tolerated in older adults, but are associated with higher rates of relapse in MDS/AML patients with measurable residual disease. JSP191, a well-tolerated biologic conditioning agent that targets and depletes both normal hematopoietic stem cells and those that initiate MDS and AML, has the potential to be a curative option for these patients.
The open-label, multicenter Phase 1 study (JSP-CP-003) is evaluating the safety, tolerability and efficacy of adding JSP191 to the standard conditioning regimen of low-dose radiation and fludarabine among patients age 65 to 74 years with MDS or AML undergoing hematopoietic cell transplantation. Patients were ineligible for full myeloablative conditioning. The primary outcome measure of the study is the safety and tolerability of JSP191 as a conditioning regimen up to one year following a donor cell transplant.
We designed JSP191 to be given as outpatient conditioning and to have both the efficacy and safety profile required for use in newborn patients and older patients for successful outcomes, said Wendy Pang, M.D., Ph.D. Executive Director, Research and Translational Medicine, of Jasper Therapeutics. We are enthusiastic about the reduction of measurable residual disease seen in these patients, especially given that it is associated with improved relapse-free survival. We are excited to continue our research in MDS/AML, with plans for an expanded study. We are evaluating JSP191, the only antibody of its kind, in two ongoing clinical studies and are encouraged by the positive clinical data seen to date.
About MDS and AML
Myelodysplastic syndromes (MDS) are a group of disorders in which immature blood-forming cells in the bone marrow become abnormal and do not make new blood cells or make defective blood cells, leading to low numbers of normal blood cells, especially red blood cells.1 In about one in three patients, MDS can progress to acute myeloid leukemia (AML), a rapidly progressing cancer of the bone marrow cells.1 Both are diseases of the elderly with high mortality. Each year, about 5,000 patients with MDS and 8,000 people with AML in the G7 countries receive hematopoietic cell transplants. These transplants are curative but are underused due to the toxicity of the current high-intensity conditioning regimen, which includes the chemotherapy agents busulfan and fludarabine.
JSP191 (formerly AMG 191) is a first-in-class humanized monoclonal antibody in clinical development as a conditioning agent that clears hematopoietic stem cells from bone marrow. JSP191 binds to human CD117, a receptor for stem cell factor (SCF) that is expressed on the surface of hematopoietic stem and progenitor cells. The interaction of SCF and CD117 is required for stem cells to survive. JSP191 blocks SCF from binding to CD117 and disrupts critical survival signals, causing the stem cells to undergo cell death and creating an empty space in the bone marrow for donor or gene-corrected transplanted stem cells to engraft.
Preclinical studies have shown that JSP191 as a single agent safely depletes normal and diseased hematopoietic stem cells, including in animal models of SCID, myelodysplastic syndromes (MDS) and sickle cell disease (SCD). Treatment with JSP191 creates the space needed for transplanted normal donor or gene-corrected hematopoietic stem cells to successfully engraft in the host bone marrow. To date, JSP191 has been evaluated in more than 90 healthy volunteers and patients.
JSP191 is currently being evaluated in two separate clinical studies in hematopoietic cell transplantation. A Phase 1/2 dose-escalation and expansion trial is evaluating JSP191 as a sole conditioning agent to achieve donor stem cell engraftment in patients undergoing hematopoietic cell transplantation for severe combined immunodeficiency (SCID), which is potentially curable only by this type of treatment. Data presented at the 62nd American Society of Hematology (ASH) Annual Meeting showed that a single dose of JSP191 administered prior to stem cell transplantation in a 6-month-old infant was effective in establishing sustained donor chimerism followed by development of B, T and NK immune cells. No treatment-related adverse events were reported. A Phase 1 clinical study is evaluating JSP191 in combination with another low-intensity conditioning regimen in patients with MDS or AML undergoing hematopoietic cell transplantation. For more information about the design of these two ongoing clinical trials, visit http://www.clinicaltrials.gov (NCT02963064 and NCT04429191).
Additional studies are planned to advance JSP191 as a conditioning agent for patients with other rare and ultra-rare monogenic disorders and autoimmune diseases.
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 companys lead compound, JSP191, is in clinical development as a conditioning antibody that clears hematopoietic stem cells from bone marrow in patients undergoing a hematopoietic cell transplant. This first-in-class conditioning antibody is designed to enable safer and more effective curative hematopoietic cell transplants and gene therapies. For more information, please visit us at jaspertherapeutics.com.
- Researchers investigate whether stem cell therapy is safe and effective for treatment-resistant bipolar disease - Newswise - April 18th, 2021
- Stem Cell and Regenerative Therapy Market: Cell Therapy Segment to Dominate Global Market - BioSpace - April 18th, 2021
- First in the nation, FDA-approved Phase II mesenchymal stem cell therapy for Parkinson's disease begins - Newswise - April 18th, 2021
- Cellino Biotech developing tech to help scale stem cell therapies - MedCity News - April 18th, 2021
- Stem cell treatment needed to fight the good fight - Victoria Lookout - April 18th, 2021
- Being bionic: the future of regenerative medicine - Toronto Star - April 18th, 2021
- Treating chronic myeloid leukemia (CML): By phase and more - Medical News Today - April 18th, 2021
- Chemical conversion of human epidermal stem cells into intestinal goblet cells for modeling mucus-microbe interaction and therapy - Science Advances - April 18th, 2021
- Andres Isaias Combining Innovation and Excellence - Influencive - April 18th, 2021
- A Massive New Gene Editing Project Is Out to Crush Alzheimer's - Singularity Hub - April 18th, 2021
- Antibiotic Use Prior to Allogeneic Stem Cell Transplantation May Be Linked to Graft Vs Host Disease - Hematology Advisor - April 18th, 2021
- Mucopolysaccharidosis (MPS) Treatment Market Is Rising With Post COVID-19 Impact Analysis, Development, CAGR - Global Banking And Finance Review - April 18th, 2021
- The Recovery Room: News beyond the pandemic April 16 - Medical News Today - April 18th, 2021
- The Governments Watchful Eye on Fraud Stemming from Stem Cell Therapy - JD Supra - April 4th, 2021
- Uprooting Cancer: Innovative Hydrogel Rapidly Reverts Cancer Cells Back to Cancer Stem Cells - SciTechDaily - April 4th, 2021
- Multiple sclerosis: Recent research on causes and treatments - Medical News Today - April 4th, 2021
- First CAR T-Cell Therapy for Multiple Myeloma: Abecma - Medscape - April 4th, 2021
- Vitro Biopharma Retains Leading Health Care Executive as Acting Director of Regulatory Affairs & Director - Benzinga - April 4th, 2021
- Allogeneic hematopoietic stem cell transplantation for therapy-related myeloid neoplasms following treatment of a lymphoid malignancy - DocWire News - April 4th, 2021
- Orca-T Offers an Alternative to HSCT With Improved Patient Experience - OncLive - April 4th, 2021
- Russell Health Highlighted in the Silicon Review's '50 Leading Companies of the Year 2021' - PRNewswire - April 4th, 2021
- Gracell Biotechnologies Announces Enrollment of First Patient in Registrational Phase 1/2 Clinical Study for GC007g, an Allogeneic CAR-T Cell Therapy... - April 4th, 2021
- LGL Leukemia: Overview, Symptoms, and Treatment - Healthline - April 4th, 2021
- Funding the Next Generation of Cancer Therapies - Genetic Engineering & Biotechnology News - April 4th, 2021
- RenovaCare Announces Organizational Changes and Appointment of New Officers - GlobeNewswire - April 4th, 2021
- Stem Cell Therapy Market expected to reach USD 16.51 Billion by 2025 KSU | The Sentinel Newspaper - KSU | The Sentinel Newspaper - March 8th, 2021
- Creative Medical Technology Holdings Publishes Efficacy in Pain Reduction and Mobility in Patients with Disc Degenerative Disc Using StemSpine... - March 8th, 2021
- New Controversy for Stem Cell Therapy That Repairs Spinal Cords - The Great Courses Daily News - March 8th, 2021
- Cell Therapy for Cartilage Regeneration Gets a Boost With Hyaluronic Acid Enriched Chondrocytes in a 3D Tissue Engineering Platform - Business Wire - March 8th, 2021
- Scar-Forming Cells Switch to Producing New Neurons that Promote Functional Recovery in Mice after Spinal Cord Injury - Genetic Engineering &... - March 8th, 2021
- Moderna Hires Harvard Stem Cell Researcher Jonathan Hoggatt as Director of Hematology: What You Need to Know - Yahoo Finance - March 8th, 2021
- Stem Cell Banking Market Report 2021 | Growth and Opportunities Analysis - BioSpace - February 19th, 2021
- Global Cell Therapy Biomanufacturing Market (2020 to 2025) - Featuring Lonza Group, Merck & Novartis Among Others - ResearchAndMarkets.com -... - February 19th, 2021
- Off-the-Shelf NK Immunotherapy Is Safe and Promising in B-Cell NHL With Chemotherapy and Transplant - Targeted Oncology - February 17th, 2021
- Braunschweig Makes the Case for Earlier Use of CAR T-Cell Therapy in DLBCL - OncLive - February 17th, 2021
- Creative Medical Technology Holdings Files Patent on Prevention of Organ Transplant Rejection using ImmCelz - PRNewswire - February 17th, 2021
- Lineage to Host Virtual OPC1 Investor & Analyst Day on February 22, 2021 - Business Wire - February 17th, 2021
- Novartis, Gates Foundation pursue a simpler gene therapy for sickle cell - STAT - February 17th, 2021
- CRISPR Therapeutics Provides Business Update and Reports Fourth Quarter and Full Year 2020 Financial Results - GlobeNewswire - February 17th, 2021
- Equillium Presents Positive Interim Clinical Data of Itolizumab in First-line Treatment of Acute Graft-Versus-Host Disease at the 2021 Transplantation... - February 14th, 2021
- Zebrafish reveal regenerative protein that could inspire new treatments for muscle-wasting diseases and aging - FierceBiotech - February 11th, 2021
- Stem cell study illuminates the cause of an inherited heart disorder | Penn Today - Penn Today - February 11th, 2021
- Neurons from patient blood cells enable researchers to test treatments for genetic brain disease - Brown University - February 11th, 2021
- Therapeutic Solutions International Acquires Stem Cell Therapy That Successfully Completed FDA Double Blind Placebo Controlled Efficacy Study for Lung... - February 11th, 2021
- The Role and Activation Mechanism of TAZ in Hierarchical Microgroove/N | IJN - Dove Medical Press - February 11th, 2021
- Stem Cell Therapy Market: Top 5 trends fueling the industry revenue through 2025 - BioSpace - February 9th, 2021
- Magenta Therapeutics to Present Additional Data from Phase 1 MGTA-145 Stem Cell Mobilization Program and Preclinical Updates on Targeting Conditioning... - February 9th, 2021
- Gamida Cell Presents Efficacy and Safety Results of Phase 3 Study of Omidubicel in Patients with Hematologic Malignancies at the 2021 TCT Meetings of... - February 9th, 2021
- Creative Medical Technology Holdings Recruits Internationally Renowned Kidney Expert to Scientific Advisory Board - PRNewswire - February 9th, 2021
- USC scientist Ya-Wen Chen receives American Lung Association grant to advance stem cell-based lung therapies - USC News - February 9th, 2021
- [Full text] Successful Use of Nivolumab in a Patient with Head and Neck Cancer Aft | OTT - Dove Medical Press - February 9th, 2021
- Responses to Liso-Cel Not Influenced by Prior Treatment With Anti-CD19 Agents in R/R Large B-Cell Lymphoma - Targeted Oncology - February 9th, 2021
- Drugs that trip cellular alarm could help clear out hibernating HIV - New Atlas - February 9th, 2021
- Leukemia in children: Symptoms, causes, treatment, outlook, and more - Medical News Today - February 6th, 2021
- Stem Cell Study Illuminates the Cause of a Devastating Inherited Heart Disorder - Newswise - February 4th, 2021
- iSpecimen expands offerings to support regenerative medicine, adding cryopreserved stem and immune cells to existing biospecimens available through... - February 4th, 2021
- CU Researchers Win Prize from National Eye Institute - CU Anschutz Today - February 4th, 2021
- Leading Urologist Doubles Down on CaverStem Regenerative Stem Cell Procedure for Treatment of Erectile Dysfunction in Men - BioSpace - January 25th, 2021
- Research Assistant - Department of Obstetrics and Gynaecology job with NATIONAL UNIVERSITY OF SINGAPORE | 239606 - Times Higher Education (THE) - December 24th, 2020
- Getting to the root of why hair goes gray - messenger-inquirer - December 24th, 2020
- How the COVID Virus Induces Inflammation, Cytokine Storm and Stress in Infected Lung Cells - SciTechDaily - December 24th, 2020
- Medicine by Design symposium highlights importance of convergence in regenerative medicine and human health - News@UofT - December 22nd, 2020
- 2020 in Neuroscience, Longevity, and AIand What's to Come - Singularity Hub - December 22nd, 2020
- Updated Findings Show Continued Efficacy for CAR T-Cell Therapy in Heavily Pretreated Myeloma - Targeted Oncology - December 14th, 2020
- Cell Isolation/ Separation Market worth $15.0 billion by 2025 - Exclusive Report by MarketsandMarkets - PRNewswire - December 14th, 2020
- Cord blood banks sell parents on promising stem cell research, but with no guarantees - The Arizona Republic - December 8th, 2020
- Procyon Technologies LLC and Novo Nordisk A/S to Collaborate on the Development of a Stem-Cell Based Therapy for Type 1 Diabetes - PRNewswire - December 8th, 2020
- Genetic engineering transformed stem cells into working mini-livers that extended the life of mice with liver disease - The Conversation US - December 8th, 2020
- Hadassah Medical Center and Neurogenesis Announce Groundbreaking Results from a Phase 2 Study in Progressive Multiple Sclerosis treated with NG-01... - December 8th, 2020
- Worldwide Cell Culture Industry to 2025 - Featuring Thermo Fisher Scientific, Corning Incorporated and Eppendorf Among Others - GlobeNewswire - December 8th, 2020
- The cell culturemarket is projected to reach USD 33.1 billion by 2025 from USD 19.0 billion in 2020, at a CAGR of 11.8% - GlobeNewswire - December 8th, 2020
- Treatment with Investigational LentiGlobin Gene Therapy for Sickle Cell Disease (bb1111) Results in Complete Elimination of SCD-Related Severe... - December 8th, 2020
- New DARZALEX (daratumumab) Data from GRIFFIN Study Show Deeper and Longer Responses in Patients with Newly Diagnosed Multiple Myeloma - BioSpace - December 8th, 2020
- Anatomy of a vaccine: What it takes to create a safe, effective COVID shot - University of California - December 8th, 2020
- Development of New Stem Cell Type May Lead to Advances In Regenerative Medicine - Newswise - December 3rd, 2020
- UCLA receives $7.3 million grant to build state-of-the-art facility for developing gene, cell therapies - UCLA Newsroom - December 3rd, 2020
- Human Embryonic Stem Cells Market in Global : Current and the Future Trends: Astellas Pharma Inc/ Ocata Therapeutics, Stemcell Technologies Inc - The... - December 3rd, 2020
- Possible Role for Comprehensive Molecular ProfilingBased Treatment Selection in Newly Diagnosed AML, Study Suggests - Cancer Therapy Advisor - December 3rd, 2020
- Nobel Prize history from the year you were born - Herald & Review - December 3rd, 2020
- 4D hires a trio of area heads as it ramps up its gene therapy pipeline - FierceBiotech - December 3rd, 2020