Jasper Therapeutics Showcases Achievements and Future Milestones

Jasper Therapeutics, a biotechnology firm specializing in the development of briquilimab, a novel antibody therapy aimed at c-Kit (CD117) for treating mast cell-related diseases, recently announced significant milestones and outlined its goals for 2024. Briquilimab targets chronic spontaneous urticaria (CSU), chronic inducible urticaria (CIndU), and lower to intermediate-risk myelodysplastic syndromes (LR-MDS), and is also being explored as a conditioning regimen for stem cell transplants.

The European Medicines Agency (EMA) has approved Jasper's Clinical Trial Applications (CTA) for Phase 1b/2a trials of briquilimab designed to treat CIndU and CSU. The upcoming study, termed SPOTLIGHT, will explore the efficacy of briquilimab in patients diagnosed with cold urticaria or symptomatic dermographism by administering single doses of the antibody subcutaneously.

Ronald Martell, President and CEO of Jasper, emphasized that 2023 was pivotal for the company as they secured crucial IND clearance and CTA authorizations for the Phase 1b/2a BEACON study in CSU and successfully dosed their first patient. They also disclosed encouraging data from early-phase trials of briquilimab in treating Fanconi Anemia (FA) and finalized results for the Phase 1 study on acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) in patients undergoing hematopoietic cell transplants. Additionally, Jasper initiated the Phase 1b trial for LR-MDS and strengthened its leadership team.

Jasper expects a transformative year in 2024 with multiple pivotal clinical milestones across various indications. They aim to present preliminary data from the BEACON study by mid-2024, offering insights into briquilimab's therapeutic potential. Initial data from the SPOTLIGHT study on CIndU is anticipated in the latter half of the year, following the CTA approval, with patient enrollment starting in early 2024. Results from the Phase 1b LR-MDS study are also expected in the first half of 2024.

Recent and forthcoming milestones include securing IND and CTA authorizations for the BEACON study, enrolling approximately 40 patients in the US and EU, and expected initial data on various cohorts by mid-2024. The CTA approval for the SPOTLIGHT study, planning to enroll about 15 patients in the EU, with initial data expected in the latter half of 2024, is another key milestone.

Additionally, Jasper hosted a webinar featuring key opinion leaders discussing briquilimab’s potential as a therapeutic option for chronic urticaria, the existing treatment landscape, and unmet needs. They also launched a Phase 1 study exploring briquilimab as a second-line treatment for LR-MDS, with anticipated data in early 2024. Positive results for briquilimab combined with fludarabine and low-dose irradiation (Flu/TBI) in AML patients were presented at the American Society of Hematology (ASH) 2023 Annual Meeting. The European Union granted Orphan Drug Designation for briquilimab for conditioning treatments before stem cell transplants.

Jasper has also reinforced its team with notable leadership appointments, including Thomas Wiggans as Chairperson of the Board, Scott Brun, M.D., as Director, Herb Cross as CFO, Edwin J. Tucker, M.D., as CMO, and Patricia Carlos as SVP of Regulatory Affairs & Quality.

Briquilimab works by blocking stem cell factor from the c-Kit receptor, leading to mast cell depletion and mitigating inflammatory responses. Its efficacy and safety have been demonstrated in over 145 participants, showing potential in conditions like SCID, AML, MDS, FA, and sickle cell disease (SCD).

Jasper is committed to advancing briquilimab as a treatment for chronic urticaria, LR-MDS, and as a conditioning agent for rare diseases. The company continues to demonstrate its dedication through ongoing clinical trials and substantial progress in its research and development efforts.