HAMPTON, N.J., Nov. 06, 2025 (GLOBE NEWSWIRE) -- Celldex (NASDAQ:CLDX) announced today new data on exploratory endpoints (UCT7) further demonstrating barzolvolimab’s ability to improve urticaria control from the Company’s recently completed Phase 2 study in chronic spontaneous urticaria (CSU). The data (presentation #R080) are being presented at the American College of Allergy, Asthma & Immunology's Annual Scientific Meeting (ACAAI) in Orlando, Florida by Dr. Steven Greenberg, Vice President of Clinical Sci ...

Core Insights - Celldex announced positive data from the Phase 1 study of CDX-622, a bispecific antibody targeting inflammation and fibrosis pathways [1][2] - The study demonstrated good tolerability, a favorable pharmacokinetic profile, and significant reductions in serum tryptase levels, indicating effective mast cell inhibition [1][6] - The company plans to advance the study to the next phase, testing multiple ascending doses and initiating a Phase 1b study in asthma patients [2][4] Study Design and Results - The Phase 1 trial is a randomized, double-blind, placebo-controlled, dose escalation study assessing safety, pharmacokinetics, pharmacodynamics, and immunogenicity of CDX-622 [4][7] - Part 1 enrolled 32 participants across 4 cohorts, receiving single ascending intravenous doses of CDX-622 (0.3, 1.0, 3.0, and 9.0 mg/kg) over a 12-week observation period [4][6] - Data from Part 1 were presented, and enrollment for Part 2 is ongoing, with results from Parts 2 and 3 expected in Q3 2026 [4][6] Mechanism and Therapeutic Potential - CDX-622 targets two validated pathways: neutralizing TSLP and depleting mast cells via SCF starvation, potentially offering enhanced therapeutic benefits for inflammatory and fibrotic disorders [5][6] - The antibody showed a serum half-life of approximately 18 days at 9 mg/kg, with no evidence of immunogenicity or dose-limiting toxicities observed [6][2] - A single dose led to a rapid and sustained decrease of about 50% in circulating tryptase, consistent with systemic mast cell inhibition [6]

Core Viewpoint - Celldex Therapeutics, Inc. (NASDAQ:CLDX) is viewed as a small-cap stock with potential upside, but Barclays has initiated coverage with an Underweight rating and a $25 price target due to safety concerns and competitive pressures [1][3]. Group 1: Company Overview - Celldex Therapeutics, Inc. develops, manufactures, and commercializes novel therapeutics for human health care, with a pipeline that includes Varlilumab, CDX-1140, CDX-301, and CDX-3379 [3]. Group 2: Investment Analysis - Barclays highlighted that while there is binary risk associated with small and mid-cap biotechnology stocks, investments backed by de-risked mechanisms of action and prior clinical data present a favorable risk-reward profile [2]. - The firm noted that the market is currently favorable towards new mechanisms and modes of action that could enhance dosing frequency and patient compliance [2]. Group 3: Clinical Data and Market Position - Despite the encouraging clinical data for Celldex's lead molecule barzolvolimab, the shares are not expected to provide significant upside through 2026 due to safety liabilities and a competitive landscape [3].

Group 1 - Celldex Therapeutics, Inc. (NASDAQ: CLDX) shares have increased over 70% from their 60-month low in April 2025, which was attributed to high discontinuation rates for their lead asset, barzolvolimab [2] - The company is involved in mast cell therapy and has faced challenges with its primary asset, impacting its stock performance [2] - The Biotech Forum offers a model portfolio featuring 12-20 high upside biotech stocks, along with live discussions and weekly updates [2]

Core Insights - Celldex announced new data showing the efficacy of barzolvolimab in treating chronic spontaneous urticaria (CSU), demonstrating significant improvement regardless of baseline immunoglobulin E (IgE) levels [1][3][5] Group 1: Study Results - The Phase 2 study of barzolvolimab met its primary endpoint, showing a significant improvement in UAS7 (weekly urticaria activity score) compared to placebo at 12 weeks across all dose groups [5][9] - Complete response rates (UAS7=0) were observed in up to 51% of patients at 12 weeks, increasing to 71% at 52 weeks, with 41% of patients reporting a complete response at 76 weeks [5][8] - The study demonstrated similar efficacy in patients with low (<40) and normal/high (>40) IgE levels, reinforcing the role of mast cells in CSU [8][9] Group 2: Mechanism and Treatment Potential - Barzolvolimab targets mast cells by binding to the receptor tyrosine kinase KIT, inhibiting its activity, which is crucial for mast cell function and survival [1][7] - The drug shows promise as a treatment for all patients with moderate to severe CSU, particularly those with low IgE levels who typically respond poorly to existing therapies [3][8] Group 3: Ongoing Research and Development - Celldex is currently enrolling patients in a global Phase 3 program for barzolvolimab, consisting of two trials designed to establish its efficacy and safety in adult patients with CSU who remain symptomatic despite H1 antihistamine treatment [6][10] - The ongoing studies also include patients who have not responded to biologic treatments, indicating a broad potential application for barzolvolimab [6][10] Group 4: Background on CSU - Chronic spontaneous urticaria (CSU) is characterized by hives or wheals lasting for 6 weeks or longer without identifiable triggers, often leading to significant patient discomfort and reduced quality of life [11] - Current therapies provide only symptomatic relief for some patients, highlighting the need for more effective treatments like barzolvolimab [11]

Core Insights - Celldex announced new data showing rapid and strong efficacy of barzolvolimab in treating chronic spontaneous urticaria (CSU), regardless of baseline immunoglobulin E (IgE) levels [1][3][8] Study Results - The Phase 2 study of barzolvolimab met its primary endpoint, showing significant improvement in UAS7 (weekly urticaria activity score) compared to placebo at 12 weeks across all dose groups [5][9] - At 12 weeks, up to 51% of patients achieved a complete response (UAS7=0), which increased to 71% at 52 weeks; 41% of patients reported a complete response at 76 weeks [5][8] - The study demonstrated a well-tolerated safety profile throughout the treatment period [5] Mechanism of Action - Barzolvolimab targets mast cells by binding to the receptor tyrosine kinase KIT, inhibiting its activity, which is crucial for mast cell function and survival [1][7] - The data reinforces the role of mast cells as key drivers of CSU, indicating that barzolvolimab could be a meaningful treatment for all patients, including those with low IgE levels [3][8] Ongoing Research - Celldex is currently enrolling patients in a global Phase 3 Program for barzolvolimab, consisting of two trials designed to establish its efficacy and safety in adult patients with CSU who remain symptomatic despite H1 antihistamine treatment [6][10] About Chronic Spontaneous Urticaria (CSU) - CSU is characterized by hives or wheals lasting 6 weeks or longer without identifiable triggers, often resulting from mast cell activation [11]

Core Viewpoint - The session at the Morgan Stanley Global Healthcare Conference features the Celldex team, focusing on their company background and lead asset [1][2]. Company Background - Celldex is being introduced to attendees who may not be familiar with the company and its operations [2]. Lead Asset - The discussion will include details about Celldex's lead asset, which is a significant focus for the company [2].

Group 1 - The session is part of the Morgan Stanley Global Healthcare Conference, focusing on the biotech sector [1] - Judah Frommer serves as an equity analyst specializing in SMid biotech [1] - The Celldex team is being welcomed to present their company and lead asset [2] Group 2 - The conference aims to provide insights for those less familiar with Celldex and its offerings [2]

Summary of Celldex Therapeutics FY Conference Call Company Overview - **Company**: Celldex Therapeutics (NasdaqCM:CLDX) - **Industry**: Biotech, specifically in immunoinflammatory diseases - **Lead Asset**: Barzolvolimab (CDX-0159), an antibody targeting KIT (CD117) [2][4] Key Points and Arguments Clinical Development - **Current Studies**: - Two Phase III studies in Chronic Spontaneous Urticaria (CSU) with 1,830 patients across 480 sites in over 40 countries [2] - Two indications in urticaria: cold urticaria and symptomatic dermographism, with 12-week data meeting all endpoints [2][3] - Upcoming 20-week data readout expected in Q4 2025 and 44-week data in early 2026 [3] - Phase II studies ongoing for Prurigo Nodularis (PN) and atopic dermatitis [3][4] Efficacy and Safety Data - **76-week Data**: 41% of patients had a sustained complete response seven months after stopping Barzolvolimab, significantly higher than the expected <10% spontaneous remission rate [8][10] - **Safety Profile**: Adverse events (AEs) related to KIT were reversible, with no long-term clinical impact observed [10][17] - **KOL Reactions**: Positive feedback from Key Opinion Leaders (KOLs) regarding the long-term efficacy and safety data [14][15] Market Positioning - **Market Opportunity**: Barzolvolimab is positioned to treat a wide range of patients, including those refractory to antihistamines and those with varying IgE levels [30][31] - **Competition**: Focus on standard of care rather than competing with other KIT programs, as Barzolvolimab is in Phase III while competitors are further behind [41] Financials and Runway - **Cash Position**: $630 million at the end of the quarter, expected to last through 2027 and into 2028 [47] - **Upcoming Milestones**: Key readouts include Phase III for CSU, Sindu study, and Phase II studies for AV and PN [47] Additional Insights - **Mast Cell Role**: The importance of mast cells in various indications is being validated, particularly in chronic itch and atopic dermatitis [6][7] - **Bispecific Pipeline**: CDX-622, a bispecific targeting TSLP and stem cell factor, is in early studies with potential applications in asthma and other pulmonary conditions [42][43] - **Regulatory Environment**: No significant changes noted with the FDA; however, the company is monitoring potential impacts from tariffs and pricing strategies [56][60] Conclusion Celldex Therapeutics is advancing its lead asset, Barzolvolimab, through critical clinical trials with promising efficacy and safety data. The company is well-positioned in the market with a strong cash runway and a focus on expanding its therapeutic pipeline.

HAMPTON, N.J., Sept. 09, 2025 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced that management will participate in a fireside chat today, September 9th, 2025, at the Morgan Stanley 23rd Annual Global Healthcare Conference at 3:20 pm ET. A live webcast of the presentation will be available on the "Events & Presentations” page of the "Investors" section of the Celldex website. A replay will be available for 90 days following the event. About CelldexCelldex is pioneering new horizons in i ...