First Patient Dosed in Jasper Therapeutics' Phase 1b/2a ETESIAN Study of Briquilimab for Asthma

REDWOOD CITY, CA, USA I December 02, 2024 I Jasper Therapeutics, Inc. (Nasdaq: JSPR) (Jasper), a company dedicated to the development of briquilimab, an innovative antibody therapy targeting c-Kit (CD117) for tackling mast cell-related diseases like chronic spontaneous urticaria (CSU), chronic inducible urticaria (CIndU), and asthma, has announced the initiation of dosing for the first patient in their Phase 1b/2a clinical challenge study, ETESIAN. ETESIAN stands for Evaluating The Efficacy and Safety of briquilimab In participants with allergic asthma. This study is focused on assessing the effectiveness of a single administration of subcutaneous briquilimab in individuals with asthma.

According to Dr. Edwin Tucker, the Chief Medical Officer at Jasper, the first patient dosing in the ETESIAN study is a remarkable achievement and represents the third clinical study by Jasper to explore briquilimab in diseases caused by mast cell activity. After dose escalation in Part 2 of the BEACON study in CSU, Jasper received regulatory approval to proceed directly to a 180mg subcutaneous dose in the ETESIAN study. This dosage aims to significantly reduce mast cells in the airways, potentially offering long-lasting clinical benefits for asthma patients. Jasper intends to provide updates on patient enrollment throughout the study and aim to release initial data in the latter half of 2025.

The ETESIAN study, a Phase 1b/2a challenge, involves a single-dose, double-blind, placebo-controlled design. It expects to enroll approximately 30 patients across up to seven Canadian sites. The primary goal is to demonstrate proof-of-concept in asthma using a potential therapeutic dose that could guide future trials for a broader asthma patient population. The study will administer a 180mg dose of subcutaneous briquilimab, with key assessments including both early and late asthmatic responses, changes in airway hyperresponsiveness, mast cell depletion and recovery, and safety.

Dr. Paul O’Byrne, a Professor, Dean and Vice President of the Faculty of Health Sciences at McMaster University, believes that the inhibition of c-Kit as a means to deplete mast cells presents a novel approach that could benefit asthma patients who do not respond well to current therapies. He expressed optimism that briquilimab, as a potent and specific c-Kit inhibitor, could address the safety concerns that have impeded the progress of other c-Kit inhibitors and become a significant treatment option for asthma patients. Dr. O’Byrne is anticipating the enrollment of patients in the ETESIAN study.

Briquilimab is an aglycosylated monoclonal antibody designed to prevent stem cell factor from binding to the c-Kit receptor (CD117), thereby blocking the receptor's signaling. This blockage disrupts a vital survival signal, leading to the apoptosis of mast cells, thus eliminating the root cause of inflammation in mast cell-driven diseases like chronic urticaria and allergic asthma. Jasper is actively conducting clinical trials of briquilimab for treating patients with CSU, CIndU, or asthma. Thus far, briquilimab has shown an effective and safe profile in over 160 participants and healthy volunteers, with positive clinical outcomes in CIndU and as a conditioning agent in conditions like severe combined immunodeficiency (SCID), acute myeloid leukemia (AML), myelodysplastic syndromes (MDS), Fanconi anemia (FA), and sickle cell disease (SCD).

Jasper is a biotechnology company in the clinical stage, concentrating on developing briquilimab, which targets c-Kit (CD117) for treating chronic mast and stem cell diseases like chronic urticaria and asthma. To date, more than 160 participants and healthy volunteers have shown positive efficacy and safety profiles for briquilimab, with notable clinical outcomes in CIndU and other severe medical conditions.