Jasper Therapeutics Announces First Patient Dosed in a Phase 1 Trial of Briquilimab in Lower-Risk Myelodysplastic Syndrome
“The initiation of this trial in LR-MDS represents a significant milestone in our briquilimab development program,” said
Jeffery Lancet, M.D., Chair of the
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
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
Source: Jasper Therapeutics