Announcement • Jun 15

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Celldex Presents Long-Term Barzolvolimab Results Demonstrating Sustained Off-Treatment Improvement in Angioedema in Patients with CSU

Celldex announced the presentation of long-term results from the Phase 2 study of barzolvolimab in a flash talk session at the European Academy of Allergy and Clinical Immunology Annual Meeting in Istanbul, Türkiye. The data presented demonstrated that barzolvolimab treatment results in rapid, significant, and durable improvements in angioedema in patients with chronic spontaneous urticaria (CSU) refractory to antihistamines. These results were sustained off-treatment, seven months after completion of barzolvolimab dosing (Week 76). Barzolvolimab has potential to shift treatment goals from symptom control to disease modification. Results continue to support ongoing Phase 3 trials of barzolvolimab in CSU; topline data expected in Fourth Quarter 2026. Angioedema occurs in 55% of people with CSU and patients report a mean of 7.7 angioedema episodes annually. Patients with CSU-related angioedema report significantly worse physical and mental health outcomes, lower health related quality of life, a higher percentage of anxiety and depression, along with significantly increased emergency room visits and hospitalizations compared to patients without angioedema in the United States. Similarly, these patients report significantly higher work and activity impairment than those without angioedema. Both patients and physicians report being free of angioedema as an important treatment goal in CSU. As previously reported, data from the Phase 2b trial showed that treatment with barzolvolimab resulted in rapid, significant, and durable improvements in angioedema. Relief from angioedema symptoms began as early as Week 1 and deepened over 52 weeks of treatment. Furthermore, newly presented data show that barzolvolimab treatment led to robust and sustained reductions in angioedema symptoms at Week 76, demonstrating prolonged off-treatment benefits. Up to 64% of patients who had angioedema at baseline were angioedema-free 7 months after the last dose. Two Phase 3 trials of barzolvolimab in CSU are ongoing and enrollment is complete. 1,939 patients were enrolled, the largest program conducted in antihistamine-refractory CSU, including patients with advanced therapy experienced/refractory CSU. The studies included 43 countries across 500 sites. Topline data are anticipated in Fourth Quarter 2026, supporting a planned BLA submission in 2027. Barzolvolimab is a humanized monoclonal antibody with a novel mechanism of action that targets mast cells by binding with high specificity to a unique part of the KIT receptor and potently inhibiting its activity. The KIT receptor is abundantly expressed by mast cells and critical for their function and survival. Mast cells are drivers of inflammatory responses such as hypersensitivity and allergic reactions and, in certain inflammatory diseases, such as chronic urticarias, mast cell activation plays a central role in the onset and progression of the disease. Based on data from robust, randomized, placebo controlled Phase 2 studies, barzolvolimab has significant potential as a first-in-class and best-in-disease treatment option for patients with chronic spontaneous urticaria (CSU), cold urticaria (ColdU) and symptomatic dermographism (SD). Barzolvolimab is currently being studied in Phase 3 studies in CSU and ColdU/SD and Phase 2 studies in prurigo nodularis (PN) and atopic dermatitis (AD), with additional indications planned for the future. The randomized, double-blind, placebo-controlled, parallel group Phase 2 study evaluated the efficacy and safety profile of multiple dose regimens of barzolvolimab in patients with CSU who remain symptomatic despite antihistamine therapy, to determine the optimal dosing strategy. 208 patients were randomly assigned on a 1:1:1:1 ratio to receive subcutaneous injections of barzolvolimab at 75 mg every 4 weeks, 150 mg every 4 weeks, 300 mg every 8 weeks or placebo during a 16-week placebo-controlled treatment period. After 16 weeks, patients then entered a 36-week active treatment period, in which patients receiving placebo or the 75 mg dose were randomized to receive barzolvolimab 150 mg every 4 weeks or 300 mg every 8 weeks; patients already randomized to the 150 mg and 300 mg treatment arms remained on the same regimen as during the placebo-controlled treatment period. After 52 weeks, patients entered a follow-up period for an additional 24 weeks. Barzolvolimab achieved the primary efficacy endpoint of the study—a statistically significant mean change from baseline to Week 12 in UAS7 (weekly urticaria activity score) compared to placebo at all dose levels.

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