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Celldex Therapeutics, Inc. reports developments as a clinical-stage biotechnology company focused on mast cell biology and antibody-based therapeutics for allergic, inflammatory, autoimmune and other mast cell-mediated diseases. Company updates center on barzolvolimab, a humanized monoclonal antibody being studied across chronic spontaneous urticaria, cold urticaria and symptomatic dermographism, as well as pipeline work that includes CDX-622 in asthma.
Recurring news themes include clinical data presentations at allergy and dermatology meetings, financial results, corporate updates and capital actions. Celldex also reports financing activity tied to its common stock and development priorities for its antibody-based immunology pipeline.
Celldex Therapeutics (NASDAQ:CLDX) announced significant improvements in angioedema in patients with chronic spontaneous urticaria (CSU) during a Phase 2 trial of barzolvolimab. Data revealed a rapid onset of relief within 2 weeks, sustained through 12 weeks, across various dose groups. The study included 208 participants and demonstrated clinically meaningful and statistically significant advancements in AAS7 scores, with improvements seen in patients regardless of their prior omalizumab status. The 300 mg cohort showed the highest efficacy, with a 25.32 LS mean difference from placebo. The findings, presented at the EAACI Congress 2024, suggest barzolvolimab could become an effective treatment for CSU, leading to the initiation of Phase 3 studies this summer.
Celldex Therapeutics announced the dosing of the first patient in its Phase 2 study of barzolvolimab for treating prurigo nodularis (PN). This humanized monoclonal antibody targets the KIT receptor tyrosine kinase, important for mast cell function, believed to drive chronic itch and neuroinflammation in PN. Earlier Phase 1b results showed significant clinical benefits with barzolvolimab, prompting this larger, double-blind, placebo-controlled study. The trial will assess the efficacy and safety of two dosing regimens in about 120 patients over 40 weeks, aiming to evaluate itch improvement and lesion healing. The study involves 50 global centers, including the U.S.
Celldex Therapeutics, Inc. (NASDAQ:CLDX) reported Q1 2024 financial results and a corporate update. Phase 3 CSU studies to start in summer 2024. Positive Phase 2 CSU 12-week data presented at AAAAI 2024, with 52-week data to follow later. Phase 2 CIndU study enrollment completed, with Phase 2 PN study ongoing. Atopic dermatitis selected for Phase 2 study by YE 2024. Cash position at $823.8 million. Total revenue at $0.2 million. R&D expenses at $31.7 million. G&A expenses at $9.1 million. Net loss at $32.8 million.
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