Business
Celldex Reports 80% Complete Response Rate in Interim Data Update from Phase 1b study of CDX-0159 in Chronic Inducible Urticaria
--CDX-0159 generally well tolerated to date----Conference call to be held at 7:45 a.m. ET today-- HAMPTON, N.J., March 29, 2021 (GLOBE NEWSWIRE) -- Celldex
About this update from Celldex Therapeutics, Inc.
[{"type":"text","content":"--CDX-0159 generally well tolerated to date----Conference call to be held at 7:45 a.m. ET today-- HAMPTON, N.J., March 29, 2021 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today reported interim data from the Company’s ongoing, open label clinical trial of CDX-0159 in patients with antihistamine refractory cold contact urticaria (ColdU) and symptomatic dermographism (SD), the two most common forms of chronic inducible urticaria (CIndU). In all patients treated and assessed for at least 15 days after treatment (n=10), 8 of 10 patients (80%) experienced a complete response (CR) to provocation testing post-treatment and one patient experienced a partial response (PR). CDX-0159 was generally well tolerated. CDX-0159 is a humanized monoclonal antibody developed by Celldex that binds the KIT receptor with high specificity and potently inhibits its activity. The KIT receptor tyrosine kinase is expressed in a variety of cells, including mast cells, which mediate inflammatory responses such as hypersensitivity and allergic reactions. Enrollment is currently being completed in the ColdU and SD cohorts (10 per cohort; 20 total). Based on these compelling results, the study will be expanded to also include 10 patients with cholinergic urticaria. The Company will host a conference call at 7:45 am ET today to discuss results and will be joined by Dr. Marcus Maurer, Professor of Dermatology and Allergy at Charité - Universitätsmedizin in Berlin, who is conducting the study. “CDX-0159 is having a profound, beneficial impact for patients in this study, all of whom entered with significant disease which was refractory to antihistamines,” said Dr. Maurer. “As a physician, it is exciting to see such high complete response rates, which are made even more noteworthy by the fact that the responses are developing rapidly after treatment and are coupled with a well-tolerated safety profile to date. Inducible urticarias can significantly impact a patient’s quality of life, and this is especially true for cold contact urticaria and symptomatic dermographism, as avoiding the triggers for these diseases is extremely difficult. CDX-0159 through its unique ability to impact mast cells is demonstrating great potential and could be a much-needed addition to the treatment landscape.” Data Summary:Fifteen out of 20 planned patients with antihista...