en.Wedoany.com Reported - U.S. biopharmaceutical company Celldex (NASDAQ: CLDX) presented positive results from a Phase 1 study of the bispecific antibody CDX-622 in healthy volunteers at the European Academy of Allergy and Clinical Immunology (EAACI) Annual Congress in Istanbul, Turkey. The antibody simultaneously targets soluble stem cell factor (SCF) and thymic stromal lymphopoietin (TSLP). Data showed that CDX-622 rapidly, durably, and dose-dependently reduced serum tryptase levels, indicating significant inhibition and depletion of tissue mast cells, and demonstrated good tolerability across all dose levels.
Dr. Tibor Keler, co-founder and Chief Scientific Officer of Celldex, stated that this is the first direct demonstration that neutralizing soluble SCF can selectively inhibit KIT signaling in mast cells, providing an anchoring mechanism for developing bispecific antibody combinations targeting multiple inflammatory diseases. Based on these results, the company plans to initiate further proof-of-concept studies in indications such as allergic rhinitis and food allergies. CDX-622 is engineered with disabled effector function (AQQ) and extended half-life (YTE) properties.
This Phase 1 trial was a randomized, double-blind, placebo-controlled, dose-escalation study designed to evaluate the safety, pharmacokinetics, pharmacodynamics, and immunogenicity of CDX-622 in healthy volunteers. Study data indicated that CDX-622 exhibited monoclonal antibody-like pharmacokinetic characteristics, with an extended half-life and good exposure following subcutaneous administration, consistent with favorable bioavailability. No evidence of immunogenicity was observed in any dose group.
In terms of safety, no dose-limiting toxicities or related serious adverse events occurred at any dose level. The most common adverse event was Grade 1 headache. No changes in hair or skin pigmentation were observed, and there were no significant effects on hematological parameters.
The company also presented preclinical data from non-human primates at the European Mast Cell and Basophil Research Network (EMBRN) Annual Meeting. The study showed that targeting soluble SCF to deplete mast cells produced effects similar to targeting membrane-bound SCF, but without significant impact on spermatogenesis or melanogenesis. These results support the potential of CDX-622, through combined TSLP neutralization and mast cell depletion, to produce broad efficacy in inflammatory diseases where both pathways play pathogenic roles.
Anthony Marucci, President and CEO of Celldex, stated that CDX-622 employs a different but highly synergistic platform approach compared to the company's other mast cell-targeting drug, Barzolvolimab. Barzolvolimab inhibits KIT receptor activity through high-specificity binding and is in Phase 3 studies for chronic spontaneous urticaria (CSU), cold urticaria (ColdU), and symptomatic dermographism (SD), and in Phase 2 studies for prurigo nodularis (PN) and atopic dermatitis (AD). CDX-622, by simultaneously neutralizing SCF and TSLP, aims to act by both reducing tissue mast cells and suppressing type 2 inflammation.
This article is compiled by Wedoany. All AI citations must indicate the source as "Wedoany". If there is any infringement or other issues, please notify us promptly, and we will modify or delete it accordingly. Email: news@wedoany.com
