Business
Celldex Initiates Phase 1 Study of KIT Inhibitor CDX-0159
CDX-0159 to be studied in chronic idiopathic urticaria after completing healthy volunteer study HAMPTON, N.J., Nov. 18, 2019 (GLOBE NEWSWIRE) -- Celldex
About this update from Celldex Therapeutics, Inc.
[{"type":"text","content":"CDX-0159 to be studied in chronic idiopathic urticaria after completing healthy volunteer study\nHAMPTON, N.J., Nov. 18, 2019 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (Nasdaq:CLDX) announced today that a Phase 1a study of CDX-0159 has initiated in healthy volunteers. CDX-0159 is a humanized monoclonal antibody that specifically binds the KIT receptor and potently inhibits its activity. The KIT receptor tyrosine kinase is expressed in a variety of cells, including mast cells. In certain inflammatory diseases, such as chronic idiopathic urticaria (CIU), also known as chronic spontaneous urticaria (CSU), mast cell degranulation plays a central role in the onset and progression of the disease. Following completion of the study in healthy volunteers, Celldex plans to further study CDX-0159 in CIU.\n “CDX-0159 is a potent KIT inhibitor that we believe has significant potential in diseases driven by mast cells via KIT,” said Diane C. Young, MD, Senior Vice President and Chief Medical Officer. “We look forward to completing this study in healthy volunteers and moving into chronic idiopathic urticaria, an indication where mast cells play a central role in disease pathophysiology and which we believe offers a rapid development pathway.” This first in-human study is a randomized, double-blind, placebo-controlled, Phase 1 study designed to evaluate the safety of single ascending doses in up to 32 healthy subjects. Secondary objectives of the study include analyses of pharmacokinetic and pharmacodynamics, as assessed by measuring changes in stem cell factor and tryptase, and assessments of the immunogenicity of CDX-0159. More information about this study is available on www.clinicaltrials.gov (Identifier: NCT04146129). A review of the CDX-0159 early development program was presented at the American College of Allergy, Asthma & Immunology Annual Scientific Meeting on November 9, 2019 in the Distinguished Industry Oral Abstract Session. About CDX-0159CDX-0159 is a humanized monoclonal antibody that specifically binds the receptor tyrosine kinase KIT and potently inhibits its activity. KIT is expressed in a variety of cells, including mast cells, and its activation by its ligand SCF regulates mast cell functions including activation and survival. In certain inflammatory diseases, such as chronic idiopathic urticaria (CIU), also known as c...