Jasper Therapeutics Expands Clinical Program in Chronic Spontaneous Urticaria

REDWOOD CITY, Calif., Oct. 23, 2024 – Jasper Therapeutics, Inc. (Nasdaq: JSPR), a clinical-stage biotechnology firm, is advancing its development of briquilimab, an innovative antibody therapy targeting the c-Kit receptor (CD117), which is pivotal in treating mast cell-driven ailments such as chronic spontaneous urticaria (CSU), chronic inducible urticaria (CIndU), and asthma. The company recently announced the initiation of an open-label extension study for chronic urticarias, allowing patients from the BEACON and SPOTLIGHT studies to continue their participation following their initial follow-up period.

Jasper also revealed it has secured regulatory clearance in both the US and EU to broaden the BEACON study in CSU by incorporating a 360mg single-dose cohort, with participant enrollment already underway. The company plans to disclose initial data from all dosage levels up to 240mg in the BEACON study during the week of January 6th, 2025. Findings from the newly added 360mg single-dose cohort are expected in the first half of 2025.

Ronald Martell, President and Chief Executive Officer of Jasper, expressed satisfaction with the swift progress made by the clinical and regulatory teams. He emphasized that the addition of the 360mg single-dose cohort will help evaluate another potential loading dose, leveraging the ongoing clinical trial, while the rollover extension study will secure long-term safety and efficacy data for patients in both BEACON and SPOTLIGHT. The comprehensive clinical data in CSU and CindU is anticipated to guide optimal biologic dosing in upcoming registrational studies planned for the latter part of 2025.

Briquilimab functions as a targeted aglycosylated monoclonal antibody, preventing the stem cell factor from binding to the c-Kit receptor, effectively disrupting the signaling pathway. This inhibition results in the depletion of mast cells through apoptosis, thereby addressing the source of inflammatory responses in mast cell-driven diseases like chronic urticaria. Jasper is actively conducting clinical trials for briquilimab in patients with CSU, CIndU, and asthma. Additionally, it is exploring briquilimab’s potential in treating patients with lower-risk myelodysplastic syndromes (LR-MDS) and as a conditioning agent for cell therapies in rare diseases.

To date, briquilimab has shown promising efficacy and safety profiles in over 160 dosed participants and healthy volunteers. Clinical outcomes have been positive in CIndU and as a conditioning agent for severe combined immunodeficiency (SCID), acute myeloid leukemia (AML), myelodysplastic syndromes (MDS), Fanconi anemia (FA), and sickle cell disease (SCD).

Jasper Therapeutics is dedicated to advancing briquilimab, a monoclonal antibody targeting c-Kit (CD117), as a therapeutic solution for chronic mast and stem cell diseases such as chronic urticaria, asthma, and lower to intermediate-risk MDS. Moreover, briquilimab is being evaluated as a conditioning agent for stem cell transplants in rare diseases like SCD, FA, and SCID. The company continues to demonstrate the drug’s efficacy and safety in clinical trials involving more than 160 participants and healthy volunteers, with significant outcomes noted in CIndU and as a conditioning agent in SCID, AML, MDS, FA, and SCD.

Jasper Therapeutics remains focused on its clinical development plan, aiming to generate comprehensive data to support the optimal biologic dosing of briquilimab in its forthcoming registrational studies.