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Celldex Announces First Patient Dosed in Phase 1 Healthy Volunteer Study of CDX-622, a Bispecific Antibody, for the Treatment of Inflammatory Diseases
HAMPTON, N.J., Nov. 20, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today announced that the first patient has been dosed in the
About this update from Celldex Therapeutics, Inc.
[{"type":"text","content":"HAMPTON, N.J., Nov. 20, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today announced that the first patient has been dosed in the Company’s Phase 1a study of CDX-622 in healthy volunteers. CDX-622 is a bispecific antibody that targets two complementary pathways that drive chronic inflammation, potently neutralizing the alarmin thymic stromal lymphopoietin (TSLP) and depleting mast cells via stem cell factor (SCF) starvation. “The introduction of our first bispecific candidate for inflammatory diseases, CDX-622, builds on our leadership in mast cell biology,” said Anthony Marucci, Co-founder, President and Chief Executive Officer of Celldex Therapeutics. “CDX-622 combines mast cell depletion with inhibition of Type 2 inflammatory responses and could be broadly applicable across a wide range of respiratory and dermatological disorders. Upon successful completion of this study in healthy volunteers, we look forward to building a robust pipeline beginning initially with a study in asthma. Importantly, we believe CDX-622 complements our barzolvolimab program, further strengthening our existing pipeline which is now advancing across five diseases.” TSLP has been directly implicated in several respiratory and dermatological disorders, such as asthma, chronic obstructive pulmonary disease, eosinophilic esophagitis, atopic dermatitis and chronic spontaneous urticaria, and in fibrotic diseases such as systemic sclerosis and idiopathic pulmonary fibrosis. In these disorders, TSLP is often upregulated and associated with disease severity. Similarly, mast cells drive or contribute to the pathophysiology of allergic, inflammatory, autoimmune and fibrotic disorders and CDX-622 contains a unique SCF neutralizing function that is expected to inhibit and deplete mast cells. Combined neutralization of SCF and TSLP with CDX-622 is expected to simultaneously reduce tissue mast cells and inhibit Type 2 inflammatory responses to potentially offer enhanced therapeutic benefit in inflammatory and fibrotic disorders. The Phase 1a clinical trial is a two-part, randomized, double-blind, placebo-controlled, dose escalation study designed to assess the safety, pharmacokinetics, and pharmacodynamics ofof single ascending doses (Part 1) and multiple ascending doses (Part 2) of CDX-622 in up to 56 healthy participants. A single dose of CDX-...