Core Insights - Celldex Therapeutics, Inc. announced topline results from its Phase 2 study of barzolvolimab for eosinophilic esophagitis (EoE), meeting the primary endpoint of mast cell depletion but failing to show clinical improvement in symptoms [1][2][6] Study Results - The study aimed to assess the effect of barzolvolimab on intraepithelial mast cells and clinical outcomes in EoE [1] - The primary endpoint was met with a significant reduction in peak esophageal intraepithelial mast cell count, showing an absolute change from baseline of -36.0 for barzolvolimab compared to -2.7 for placebo at Week 12 [5][6] - Despite the significant mast cell depletion, no improvement in EoE symptoms was observed, with p-values of 0.33 for the Dysphagia Symptom Questionnaire and 0.95 for endoscopic scoring [6][7] Safety Profile - Barzolvolimab exhibited a favorable safety and tolerability profile consistent with previous studies [2][7] - The dosing regimen of 300 mg Q4W was well-tolerated, showing no significant adverse effects compared to less frequent dosing in earlier studies [7] Future Directions - Following these results, Celldex will not pursue further development of barzolvolimab for EoE but will continue to advance its pipeline, including ongoing studies in chronic spontaneous urticaria and plans for a Phase 3 program in inducible urticaria [3][4]

Core Insights - Celldex Therapeutics reported topline results from a Phase 2 study of barzolvolimab in eosinophilic esophagitis (EoE), indicating that while the primary endpoint of mast cell depletion was met, there was no improvement in EoE symptoms or endoscopic assessments compared to placebo [1][4][5] - The company will not pursue further development of barzolvolimab for EoE but will continue to explore its potential in other gastrointestinal indications [1][2] Study Design and Results - The Phase 2 study was a randomized, double-blind, placebo-controlled trial involving 65 patients with moderate to severe EoE, assessing the efficacy and safety of subcutaneous barzolvolimab [4][6] - The primary endpoint was the reduction in peak esophageal intraepithelial mast cell count at 12 weeks, which was achieved with a significant reduction of -36.0 in the barzolvolimab group compared to -2.7 in the placebo group (p=<0.0001) [5][6] - Despite the significant mast cell depletion, no clinical improvement was observed in EoE symptoms (p=0.33) or endoscopic scoring (p=0.95) [5][6] Safety Profile - Barzolvolimab demonstrated a favorable safety profile at the 300 mg Q4 weekly dosing regimen, consistent with previous studies [5][6] - An unblinded review of data through the full treatment period (28 weeks) showed consistent clinical and safety outcomes [5] Future Development Plans - Celldex is focusing on advancing barzolvolimab's pipeline, with ongoing enrollment in four studies, including two Phase 3 studies in chronic spontaneous urticaria and Phase 2 studies in atopic dermatitis and prurigo nodularis [2][8] - Plans are also being finalized to initiate a Phase 3 program in inducible urticaria, which will include cold urticaria and symptomatic dermographism [2][8]

Core Insights - Celldex Therapeutics announced that barzolvolimab significantly improves angioedema in chronic spontaneous urticaria (CSU) patients after 52 weeks of treatment [1][2][3] Group 1: Clinical Trial Results - The Phase 2 clinical trial met primary and secondary endpoints at 12 weeks, showing significant decreases in UAS7 scores compared to placebo [2][5] - At Week 52, an 86% mean reduction in angioedema activity was reported for the 150 mg Q4W group, and an 82% reduction for the 300 mg Q8W group [6] - 77% of patients treated with barzolvolimab who had angioedema at baseline were angioedema-free at Week 52 [5][6] Group 2: Patient Impact - The majority of patients with severe CSU experience painful angioedema, which significantly affects their quality of life [3][6] - 87% of patients reported clinically meaningful improvement in angioedema activity scores at Week 52 [6] Group 3: Drug Mechanism and Future Studies - Barzolvolimab is a humanized monoclonal antibody that targets the receptor tyrosine kinase KIT, which is involved in mast cell activation [4] - Celldex is conducting a global Phase 3 program for barzolvolimab in CSU, with enrollment currently underway [8]

Core Insights - Celldex announced new data showing significant and sustained complete response in chronic spontaneous urticaria (CSU) patients treated with barzolvolimab, with improvements in quality of life observed at 76 weeks post-treatment [1][2][3] Efficacy Data - The Phase 2 study met its primary endpoint, showing a significant improvement in UAS7 (weekly urticaria activity score) compared to placebo at 12 weeks across all dose groups [2][11] - At 12 weeks, up to 51% of patients achieved a complete response (UAS7=0), which increased to 71% at 52 weeks, and 41% maintained this response at 76 weeks [2][6] - 48% of patients reported that CSU no longer impacted their quality of life at 76 weeks, as measured by the Dermatology Life Quality Index (DLQI) [5][6] Safety Profile - Barzolvolimab demonstrated a well-tolerated safety profile throughout the study, with the most common adverse events being mild and reversible [7][3] - No new safety signals were identified, and neutropenia events resolved rapidly without association to infections [7][3] Future Developments - Enrollment for Phase 3 trials of barzolvolimab in CSU is ongoing, with two global Phase 3 trials designed to establish efficacy and safety in patients who remain symptomatic despite antihistamine treatment [12][11] - The company is focused on executing clinical trials to bring this potential new treatment to patients suffering from CSU [8][14]

Core Insights - Celldex will present data from its Phase 2 study of barzolvolimab for chronic spontaneous urticaria at the EAACI Congress 2025 in Glasgow, Scotland [1][2] - A webcast will be hosted by Celldex on June 12 at 6:00 pm ET to discuss the study data [1][2] - Key presentations include sustained disease control following withdrawal of barzolvolimab and improvement in angioedema in CSU patients [3] Company Information - Celldex is focused on developing novel antibody-based therapies that engage the human immune system to treat allergic, inflammatory, and autoimmune disorders [4] - The company emphasizes its commitment to pioneering advancements in immunology to improve patient outcomes [4] Event Details - The EAACI presentation session for the late-breaking oral presentation will occur on June 13 at 9:12 am BST [3] - The oral presentation on angioedema data will take place on June 14 at 3:48 pm BST [3] - The webcast will be accessible through the Investor Relations page of Celldex's website [2]

Core Viewpoint - Celldex Therapeutics reported positive Phase 2 study results for barzolvolimab, indicating significant improvements in the quality of life for patients with chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIndU) [2][14] Financial Highlights - As of March 31, 2025, the company had cash, cash equivalents, and marketable securities totaling $673.3 million, down from $725.3 million at the end of 2024, primarily due to $54.4 million used in operating activities during the first quarter [10][15] - Total revenue for the first quarter of 2025 was $0.7 million, an increase from $0.2 million in the same period of 2024, attributed to increased services under manufacturing and research agreements [11] - Research and development expenses rose to $52.6 million in Q1 2025 from $31.7 million in Q1 2024, mainly due to costs associated with barzolvolimab clinical trials [12] - General and administrative expenses increased to $10.8 million in Q1 2025 from $9.1 million in Q1 2024, primarily due to higher stock-based compensation [13] - The net loss for the first quarter of 2025 was $53.8 million, or ($0.81) per share, compared to a net loss of $32.8 million, or ($0.56) per share, in the same period of 2024 [15] Pipeline and Clinical Development - Barzolvolimab is a humanized monoclonal antibody targeting the KIT receptor, showing best-in-class efficacy in chronic urticaria with high complete response rates [3][2] - A global Phase 3 program for CSU is ongoing, with two trials (EMBARQ-CSU1 and EMBARQ-CSU2) enrolling approximately 915 patients each across 40 countries [7] - The company is planning a global Phase 3 program for chronic inducible urticaria (CIndU) expected to start in 2025 [7] - Data from the Phase 2 CSU study, including 76-week follow-up results, will be presented at the EAACI Congress 2025 [6][7] Additional Indications and Studies - Enrollment is complete for the Phase 2 study in eosinophilic esophagitis (EoE), with data expected in 2025 [14] - Ongoing enrollment in Phase 2 studies for prurigo nodularis (PN) and atopic dermatitis (AD) [14] - CDX-622, a bispecific antibody targeting SCF and TSLP, is in Phase 1 study with data expected in 2025 [9]

Core Insights - Celldex announced histology data from its ongoing Phase 2 study of barzolvolimab in eosinophilic esophagitis (EoE), indicating a potential therapeutic benefit due to the correlation between intraepithelial mast cells and eosinophil counts [1][2] - The Phase 2 "EvolvE" study aims to test the hypothesis that barzolvolimab can deplete esophageal mast cells and lead to clinical improvement in EoE, a condition with limited treatment options [3][5] Study Details - The ongoing 28-week, randomized, double-blind, placebo-controlled study evaluates 300 mg of barzolvolimab or placebo administered every 4 weeks to participants with known EoE [3] - The primary endpoint is the reduction in peak esophageal epithelial mast cell count at 12 weeks, with key secondary endpoints including reduction in peak eosinophil count and dysphagia symptom scores [3] - Screening data from 151 participants show high numbers of intraepithelial mast cells in active EoE cases, correlating with eosinophil counts [3] Eosinophilic Esophagitis (EoE) Overview - EoE is characterized by chronic inflammation of the esophagus due to eosinophil infiltration, leading to symptoms such as difficulty swallowing and chest pain [5] - Current treatment options for EoE are limited, highlighting the importance of developing effective therapies like barzolvolimab [5] Barzolvolimab Profile - Barzolvolimab is a humanized monoclonal antibody targeting the receptor tyrosine kinase KIT, which is involved in mast cell activity and inflammatory responses [6] - The drug is also being studied for other conditions, including chronic spontaneous urticaria and atopic dermatitis, indicating its broader therapeutic potential [6] Company Background - Celldex Therapeutics is a clinical-stage biotechnology company focused on developing therapeutics that engage the immune system and target critical pathways for severe inflammatory and allergic diseases [7]