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Celldex’s KIT Inhibitor CDX-0159 Demonstrates Profound, Sustained Dose-dependent Reductions in Plasma Tryptase—an Indicator of Mast Cell Burden—and a Favorable Safety Profile
--Data strongly support expanding development into mast cell driven diseases----Data presented in a late-breaking session at EAACI Annual Congress 2020--
About this update from Celldex Therapeutics, Inc.
[{"type":"text","content":"--Data strongly support expanding development into mast cell driven diseases----Data presented in a late-breaking session at EAACI Annual Congress 2020--\n HAMPTON, N.J., June 06, 2020 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today announced results from the Company’s Phase 1 randomized, double-blind, placebo-controlled, dose escalation study of KIT inhibitor CDX-0159 in healthy subjects. Data (presentation #1829) were featured in a late breaking presentation today at the European Academy of Allergy and Clinical Immunology (EAACI) Annual Congress 2020. CDX-0159 demonstrated a favorable safety profile as well as profound and durable reductions of plasma tryptase, consistent with systemic mast cell suppression. A single dose of CDX-0159 induced dose-dependent tryptase reduction below the level of assay detection within days at doses as low as 1.0 mg/kg and maintained suppression for over two months at 3.0 mg/kg and above. Tryptase is an enzyme synthesized and secreted almost exclusively by mast cells and decreases in plasma tryptase levels are believed to reflect a systemic reduction in mast cell burden in both healthy volunteers and in disease, providing important proof of concept for the program. The data also support expansion of the program into mast cell driven diseases, including initially studies in forms of chronic urticaria (CU) given the central role mast cells are known to play in the etiology of CU. The data were presented by Dr. Marcus Maurer, Professor of Dermatology and Allergy and Director of Research at the Department of Dermatology and Allergy at the Allergie-Centrum-Charité of the Charité - Universitätsmedizin in Berlin. Dr. Maurer is also head of the Specialty Clinics for Urticaria, Mastocytosis, Pruritus and Angioedema and the Dermatological Allergology, and is a leading medical expert in urticaria whose research focuses on the physiological and pathological functions of mast cells. “The profound decreases in plasma tryptase coupled with the favorable safety profile observed in this study suggest that CDX-0159 has significant potential as a disease-modifying therapeutic for mast cell disorders driven by wild-type KIT,” said Dr. Maurer. “Chronic urticarias can have significant impact on quality of life, especially for patients with severe disease, where the intense itching can lead to insomn...