Jasper Therapeutics Gets Health Canada Approval for Briquilimab Asthma Study

On September 10, 2024, Jasper Therapeutics, Inc. (Nasdaq: JSPR), a biotechnology firm specializing in the development of briquilimab, announced Health Canada's approval of its Clinical Trial Application (CTA) for a Phase 1b/2a asthma challenge study. This study will evaluate briquilimab in asthma patients. Briquilimab is a novel antibody therapy targeting the c-Kit (CD117) receptor to treat diseases driven by mast cells, such as chronic spontaneous urticaria (CSU), chronic inducible urticaria (CIndU), and asthma.

Dr. Edwin Tucker, Jasper's Chief Medical Officer, expressed enthusiasm about Health Canada's no objection letter, which allows the company to proceed with its inaugural clinical trial of briquilimab for asthma. The company plans to begin enrolling patients soon. The study aims to provide proof of concept for using briquilimab to deplete mast cells effectively, which could lead to future studies involving a broader asthma patient population.

The Phase 1b/2a asthma study is designed as a single-dose, double-blind, placebo-controlled trial involving 30 patients across up to ten sites in Canada and the European Union. The primary goal is to demonstrate briquilimab's efficacy in treating asthma through mast cell depletion. The trial will use a single 180mg dose of subcutaneous briquilimab, with key assessments focusing on early and late asthmatic responses, changes in airway hyperresponsiveness, and safety. Jasper expects to start dosing patients in the fourth quarter of 2024 and plans to release initial data in the second half of 2025.

Ronald Martell, President and CEO of Jasper, highlighted the significance of the CTA clearance for the asthma study, marking a key milestone as the company expands its programs evaluating briquilimab for mast cell-driven diseases. He noted that the ability to use a 180mg dose directly, as determined by the BEACON study, is advantageous. Martell believes that a higher dose, which results in deep mast cell depletion in the airways, is crucial for demonstrating lasting clinical benefits for asthma patients.

Additionally, Jasper announced that the U.S. Patent and Trademark Office has granted a registered trademark for their proprietary Jasper c-Kit Mouse™ model. This model allows direct testing of c-Kit inhibitors for various diseases, overcoming the limitations of standard models. Wendy Pang, M.D., Ph.D., Jasper’s Senior Vice President of Research and Translational Medicine, emphasized the importance of this model in enabling preclinical studies with superior clinical translatability. This capability supports the clinical program's launch and expansion into additional indications.

Briquilimab, formerly known as JSP191, is a targeted monoclonal antibody that inhibits the stem cell factor from binding to the c-Kit receptor. This inhibition disrupts critical survival signals, leading to mast cell depletion and reducing the underlying inflammatory response in mast cell-driven diseases like chronic urticaria. Jasper is currently conducting clinical trials of briquilimab for CSU, CIndU, and plans to initiate a study for asthma. Briquilimab is also being tested in clinical studies for lower-risk myelodysplastic syndromes (LR-MDS) and as a conditioning agent for cell therapies in rare diseases. To date, briquilimab has shown efficacy and safety in over 145 participants, including healthy volunteers, and has demonstrated positive clinical outcomes in conditions such as severe combined immunodeficiency (SCID), acute myeloid leukemia (AML), myelodysplastic syndromes (MDS), Fanconi anemia (FA), and sickle cell disease (SCD).

Jasper Therapeutics is a clinical-stage biotechnology company focused on developing briquilimab, targeting c-Kit (CD117) for chronic mast and stem cell diseases like chronic urticaria, asthma, and MDS, as well as a conditioning agent for stem cell transplants for rare diseases such as SCID, FA, and SCD. The company continues to build its pipeline, aiming to provide innovative solutions for these challenging conditions.

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