Celldex Therapeutics Presents Landmark 52 Week Results from Barzolvolimab Phase 2 Study in Chronic Spontaneous Urticaria at EADV 2024

About this update from Celldex Therapeutics, Inc.

- 71% of patients (150 mg Q4W) achieved complete response at Week 52 - - Rapid, profound and durable improvement in UAS7 as early as Week 1 with a deepening of response over 52 weeks - - Robust improvement across omalizumab-experienced/refractory/naïve disease - - Well tolerated through 52 weeks - - Enrollment to Global Phase 3 CSU trials underway - - Company to host webcast today at 12:00 pm ET / 6:00 pm CEST - HAMPTON, N.J. , Sept. 25, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced today new data demonstrating sustained and deepening disease efficacy and a well tolerated safety profile over a 52 week treatment period for barzolvolimab in chronic spontaneous urticaria (CSU), an immune-related condition driven by mast cell activation. Barzolvolimab specifically targets mast cells by binding the receptor tyrosine kinase KIT with high specificity and potently inhibiting its activity, which is required for mast cell function and survival. The data are bring presented today by Dr. Martin Metz , Professor of Dermatology and Allergy at Charité - Universitätsmedizin in Berlin in a late breaking oral presentation at the EADV Congress 2024. The Company previously announced that this Phase 2 study of barzolvolimab in patients with moderate to severe CSU refractory to antihistamines, including patients with biologic-refractory disease, met its primary endpoint—a significant improvement in UAS7 compared to placebo at 12 weeks—across all dose groups tested. “The barzolvolimab data reported today set a new bar for efficacy in CSU—demonstrating the highest rate of complete response observed in a well controlled study,” said Martin Metz , M.D. "By addressing the root driver of chronic spontaneous urticaria, the mast cell, barzolvolimab provides early, durable and, most importantly, the opportunity for complete symptom control for the many patients who do not see meaningful benefit from the current standard of care, including patients with omalizumab refractory disease. Importantly, barzolvolimab was also well tolerated across the 52 week treatment period further supporting barzolvolimab’s significant potential to become a transformative treatment option for patients suffering from this often very severe and debilitating disease." New long-term data from the Phase 2 study of barzolvolimab assessed at 52 weeks: Improvements in UAS7 (weekly urticaria activity score), previously shown to be statistically significantly vs placebo at Week 12, were noted as early as week 1 and were sustained or deepened at Week 52. At Week 16, patients receiving low dose barzolvolimab (75 mg) or placebo were transitioned to barzolvolimab 150 mg or 300 mg; after crossover, these patients experienced similar clinically meaningful disease response as the rest of the study population. 71% of patients treated with barzolvolimab 150 mg Q4W and 52% of patients treated with 300 mg Q8W had a complete response (no itch/hives; UAS7=0) at Week 52. These responses were observed early and sustained through 52 weeks. 74% of patients treated with barzolvolimab 150 mg Q4W and 68% of patients treated with 300 mg Q8W had well controlled (UAS7

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