Celldex Therapeutics(US:CLDX) Newsfilter·2025-03-03 13:01Core Insights - Celldex Therapeutics announced positive preclinical data for CDX-622, a bispecific antibody targeting TSLP and SCF pathways involved in inflammation and fibrosis [1][2][3] Group 1: CDX-622 Mechanism and Efficacy - CDX-622 neutralizes both SCF and TSLP, leading to reduced tissue mast cells and inhibition of Type 2 inflammatory responses, suggesting enhanced clinical activity compared to single-target therapies [2][5] - The bispecific antibody is designed to simultaneously reduce tissue mast cells and inhibit Type 2 inflammatory responses, potentially offering significant therapeutic benefits in inflammatory and fibrotic disorders [5][8] Group 2: Clinical Development - A Phase 1 randomized, double-blind, placebo-controlled study is currently ongoing to assess the safety, pharmacokinetics, and pharmacodynamics of CDX-622 in up to 56 healthy participants [5][3] - Initial data from the Phase 1 study is expected to be presented later this year, following the initiation of the study in November [3][5] Group 3: Preclinical Findings - Preclinical studies show that CDX-622 exhibits similar potency to its parental monoclonal antibodies and other treatments like tezepelumab and barzolvolimab [8] - The antibody preferentially inhibits the soluble form of SCF, which may have a differential impact on KIT-dependent processes [8] - CDX-622 was well tolerated in a GLP toxicology study at all dose levels, including the highest tested dose of 75 mg/kg, resulting in significant mast cell depletion in various tissues [8]