REDWOOD CITY, Calif., June 22, 2023 (GLOBE NEWSWIRE) — Jasper Therapeutics, Inc. (Nasdaq: JSPR) (Jasper), a biotechnology company focused on the development of briquilimab, a novel antibody therapy targeting c-Kit (CD117) to address diseases such as chronic spontaneous urticaria, lower to intermediate risk myelodysplastic syndromes (LR-MDS) as well as novel stem cell transplant conditioning regimes, today announced that the first patient has been dosed in a Phase 1 trial evaluating briquilimab as second-line therapy in subjects with lower-risk myelodysplastic syndrome.
“The initiation of this trial in LR-MDS represents a significant milestone in our briquilimab development program,” said Ronald Martell, President and Chief Executive Officer of Jasper. “To date, the potential of briquilimab has been clinically assessed across five transplant indications and we are excited to explore its potential as a treatment option for a chronic disease such as LR-MDS. This trial underscores our commitment to improving outcomes and quality of life for patients with rare and chronic diseases driven by mast and stem cells.”
Jeffery Lancet, M.D., Chair of the Department of Malignant Hematology at Moffitt Cancer Center, where the Phase 1 trial is being conducted, added, “LR-MDS patients often face limited treatment options that primarily focus on increasing blood cell production and survival rather than restoring normal blood homeostasis. By directly targeting and depleting the diseased stem cells, briquilimab has the potential to restore bone marrow to a healthier and more functional state, with the ultimate goal of improved long-term outcomes and quality of life. We are excited to test briquilimab in the LR-MDS setting.”
Edwin J. Tucker, M.D., Chief Medical Officer of Jasper, stated, “There is a significant need for therapies for people living with LR-MDS. While certain treatments could be employed to manage the symptoms, they do not typically target diseased cells or offer a comprehensive therapeutic approach. With its compelling therapeutic potential in targeting c-Kit, briquilimab holds great promise in lower-risk MDS and could provide a profound benefit for patients in dire need of new therapies. We are excited to embark on this clinical journey and contribute to the advancement of treatment options for patients with chronic diseases.”
The open-label, single-arm Phase 1 trial will evaluate the safety and tolerability of briquilimab as a second-line therapy in subjects with LR-MDS. The trial will employ a 3+3 dose escalation design to identify the maximum tolerated dose or optimal biologic dose and recommended Phase 2 dose of briquilimab monotherapy as a chronic therapeutic for LR-MDS patients with documented cytopenia such as red blood cell transfusion dependence, thrombocytopenia or neutropenia. The trial will be conducted at Moffitt Cancer Center in Tampa, FL, and is expected to enroll up to 30 patients that will receive briquilimab every 56 days for 4 consecutive cycles.
For more information on the Phase 1 trial of briquilimab for the treatment of LR-MDS please visit clinicaltrials.gov and reference identifier: NCT05903274.
Jasper is a clinical-stage biotechnology company developing briquilimab, a monoclonal antibody targeting c-Kit (CD117) as a therapeutic for chronic mast and stem cell diseases such as chronic spontaneous urticaria and lower to intermediate risk myelodysplastic syndromes (MDS) and as a conditioning agent for stem cell transplants for rare diseases such as sickle cell disease (SCD), Fanconi anemia (FA) and severe combined immunodeficiency (SCID). To date, briquilimab has a demonstrated efficacy and safety profile in over 130 dosed subjects and healthy volunteers, with clinical outcomes as a conditioning agent in SCID, acute myeloid leukemia (AML), MDS, FA, and SCD. In addition, briquilimab is being advanced as a transformational non-genotoxic conditioning agent for gene therapy. For more information, please visit us at www.jaspertherapeutics.com.
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 briquilimab’s potential, including with respect to its potential to address diseases such as chronic spontaneous urticaria, lower to intermediate risk myelodysplastic syndromes as well as novel stem cell transplant conditioning regimes, its potential to restore bone marrow, its potential to improve long-term outcomes and quality of life, its therapeutic potential to target c-Kit, its potential profound benefit for patients in dire need of new therapies, its potential to contribute to the advancement of treatment options for patients with chronic diseases and its ability to target and deplete the diseased stem cells, the development of briquilimab, Jasper’s commitment to improving outcomes and quality of life for patients with rare and chronic diseases driven by mast and stem cells and Jasper’s expectations regarding the timing of, recruitment for and dosing in the clinical trial. 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. 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; 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 prior trial results may not be replicated; 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; 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, including its Annual Report on Form 10-K for the year ended December 31, 2022 and subsequent Quarterly Reports on Form 10-Q. 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.
John Mullaly (investors)
Jeet Mahal (investors)
Lauren Barbiero (media)