CLDX News & Events

Celldex announced the initiation of its global Phase 3 trial designed to establish the efficacy and safety of barzolvolimab in adult patients with cold urticaria, ColdU, and symptomatic dermographism, SD, who remain symptomatic despite H1 antihistamine treatment. ColdU and SD are characterized by the occurrence of hives or wheals that have an attributable trigger associated with them-exposure to cold temperatures in ColdU and scratching/rubbing of the skin in SD. Mast cell activation is known to be a critical driver in ColdU and SD. Barzolvolimab is a humanized monoclonal antibody that specifically binds the receptor tyrosine kinase KIT with high specificity and potently inhibits its activity, which is required for mast cell function and survival.

"This quarter, Celldex continued to demonstrate our leadership in the field of mast cell biology, presenting exciting data across our pipeline programs," said Anthony Marucci, co-founder, president and CEO of Celldex. "Barzolvolimab is the first in the field to demonstrate clinical benefit in a large, randomized, placebo-controlled study of cold urticaria and symptomatic dermographism, and we were also pleased to report additional endpoints from our Phase 2 CSU study and promising data from CDX-622, the first stem cell factor neutralizing bispecific antibody to be studied in humans, which we designed to also target TSLP."