Jasper Therapeutics, Inc., a clinical-stage biotechnology firm, announced its progress in developing briquilimab, a promising antibody therapy aimed at treating mast cell-driven diseases such as chronic spontaneous urticaria (CSU), chronic inducible urticaria (CIndU), and asthma. The company's BEACON and SPOTLIGHT studies have advanced significantly, experiencing faster-than-expected patient enrollment rates.
President and CEO Ronald Martell highlighted the accelerated patient enrollment in both studies, allowing the inclusion of additional cohorts in the initial CSU data readout. Martell also revealed that Jasper plans to present results from dosing cohorts up to 240mg in the fourth quarter of this year. Rapid enrollment has enabled the study's expansion to include a dosing cohort of 180mg administered every 8 weeks (Q8W), which will help generate a more robust dataset for future registrational trials in CSU without affecting the timeline.
Chief Medical Officer Dr. Edwin Tucker praised the progress, noting that the BEACON study has moved swiftly through dose escalation and is now enrolling patients at the 240mg level. He emphasized that this rapid progress, combined with approval from the Independent Data Monitoring Committee (IDMC), allows for a broader understanding of briquilimab's potential benefits for CSU patients without delaying the program. Initial data from both the BEACON and SPOTLIGHT studies are expected later this year, with full study reports planned for early 2025.
Key updates for the second quarter of 2024 include the completion of enrollment in various dosing cohorts of the BEACON study, with the 240mg single-dose cohort actively enrolling patients. Jasper has opened 31 clinical sites across the U.S. and EU for the BEACON study, and due to favorable enrollment rates, the company plans to report data from all dosing cohorts in the fourth quarter of 2024. Endpoints for the initial data readout will include UAS7 scores, UCT scores, serum tryptase, and adverse events. The study remains blinded to efficacy data until the interim analysis.
The BEACON study evaluates subcutaneous briquilimab in adult CSU patients who remain symptomatic after or cannot tolerate omalizumab. Parts 2 and 3 of the study are double-blind and placebo-controlled, with Jasper remaining blinded to efficacy data until the initial analysis.
Enrollment in the 120mg cohort of the SPOTLIGHT study, which evaluates briquilimab for treating cold urticaria (ColdU) or symptomatic dermographism (SD), is ongoing. Initial data from the SPOTLIGHT study is anticipated in the fourth quarter of 2024.
Jasper also announced the expansion of its mast cell portfolio with a new development program in asthma, expecting to begin enrolling patients in a Phase 1b/2a study in the fourth quarter of 2024. The company also appointed Svetlana Lucas, Ph.D., to its Board of Directors, bringing expertise in strategic planning and business development.
Preclinical data presented at the European Hematology Association (EHA) Hybrid Congress demonstrated briquilimab's effect on hematopoietic stem cells, indicating that blocking SCF/c-Kit signaling does not cause apoptosis of HSCs. Additionally, Jasper presented data at the EAACI Congress 2024, showing briquilimab's potential in treating asthma and atopic dermatitis (AD). These studies used Jasper’s proprietary c-Kit Mouse™, demonstrating briquilimab's ability to deplete mast cells and improve lung function in an allergen-induced asthma model and reduce dermal mast cells and inflammatory leukocytes in AD.
Financially, Jasper's cash and cash equivalents totaled $106.8 million as of June 30, 2024. Research and development expenses for the quarter were $11.3 million, while general and administrative expenses were $4.7 million. The company reported a net loss of $15.0 million for the quarter.
Overall, Jasper Therapeutics continues to make significant strides in developing briquilimab, with promising advancements in clinical studies and new developments in treating mast cell-driven diseases and asthma.
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