Celldex Therapeutics
🇺🇸United States
- Country
- 🇺🇸United States
- Ownership
- Public
- Established
- 1983-01-01
- Employees
- 160
- Market Cap
- $2.5B
- Website
- http://www.celldex.com
Dupilumab Shows Strong Efficacy in Chronic Spontaneous Urticaria Across All BMI Ranges
• Phase 3 LIBERTY-CSU CUPID trials demonstrate dupilumab's effectiveness in reducing itch and urticaria activity in patients unresponsive to H1-antihistamines.
• Clinical benefits of dupilumab were consistent across all BMI ranges, including patients in obese categories, providing important efficacy data for diverse patient populations.
• FDA review of dupilumab for chronic spontaneous urticaria is underway with a target action date of April 18, 2025, potentially offering a new treatment option for resistant cases.
Celldex Advances Barzolvolimab Phase 3 Program in Chronic Urticaria with Strong Pipeline Progress
• Celldex Therapeutics reports significant progress in Phase 3 trials of barzolvolimab for chronic spontaneous urticaria (CSU), with active enrollment ongoing across 40 countries and 500 sites.
• The company's Phase 2 CSU study demonstrated unprecedented efficacy with 71% of patients achieving complete response at Week 52, setting a new standard in disease treatment.
• Celldex expands its portfolio by initiating Phase 2 trials in atopic dermatitis and launching CDX-622, their first bispecific antibody targeting inflammatory diseases.
ACTG Launches ACACIA Trial in Africa to Evaluate HIV Cure Strategy
• The ACTG has initiated the ACACIA (A5417) study, a Phase 2 trial, to assess the safety and efficacy of broadly neutralizing antibodies (bNAbs) in HIV treatment.
• ACACIA will evaluate the combination of 3BNC117-LS and 10-1074-LS with antiretroviral therapy (ART) in adults living with HIV across four African countries.
• The trial includes an analytic treatment interruption (ATI) phase to determine if the intervention can control HIV in the absence of ART, a key step in HIV cure research.
• ACACIA aims to optimize the therapeutic benefit of bNAbs by administering them when viral load is high and assessing their long-lasting immunologic effects.
Ibrance Combo Extends Progression-Free Survival in HR+, HER2+ Metastatic Breast Cancer
• Pfizer's Ibrance, combined with anti-HER2 and endocrine therapies, significantly improved progression-free survival in HR+, HER2+ metastatic breast cancer patients.
• The Phase 3 PATINA trial showed a median PFS of 44.3 months with the Ibrance combination, compared to 29.1 months with anti-HER2 and endocrine therapies alone.
• The Ibrance combination demonstrated a manageable safety profile, with common adverse events including neutropenia, leukopenia, fatigue, stomatitis, and diarrhea.
• These findings suggest Ibrance may overcome resistance to existing therapies and could become a new standard of care for this specific breast cancer subtype.
Celldex Therapeutics Initiates Phase 2 Trial of Barzolvolimab for Atopic Dermatitis
• Celldex Therapeutics has begun a Phase 2 clinical trial to evaluate barzolvolimab for treating moderate to severe atopic dermatitis, a chronic inflammatory skin condition.
• Barzolvolimab, a humanized monoclonal antibody, targets mast cells implicated in atopic dermatitis, potentially offering a novel therapeutic approach.
• The randomized, double-blind, placebo-controlled study will assess the efficacy and safety of barzolvolimab, with primary endpoint focused on pruritus reduction.
• Positive clinical data from ongoing trials could position Celldex favorably in the dermatology market, addressing unmet needs in atopic dermatitis treatment.
Urticaria Clinical Trial Pipeline Heats Up with Novel Therapies in Development
• The urticaria treatment landscape is evolving, with over 20 companies developing more than 25 novel therapies to address unmet patient needs.
• Regeneron and Sanofi's Dupixent demonstrated positive Phase III results for chronic spontaneous urticaria, showing promise for biologic-naive patients.
• Evommune initiated a Phase II trial of EVO756 for chronic inducible urticaria, while Celldex Therapeutics reported positive Phase II data for barzolvolimab in chronic spontaneous urticaria.
• Emerging therapies target various mechanisms, including IgE, mast cells, and kinases, offering diverse approaches to urticaria management.
Evommune Secures $115 Million to Advance Clinical Trials for Chronic Immune Conditions
• Evommune has raised $115 million in Series C funding to support Phase 2 trials for EVO756 and EVO301, targeting chronic immune conditions like urticaria and atopic dermatitis.
• EVO756, an oral small molecule, is being developed as a potential first-in-class treatment for mast cell-driven conditions by blocking the MRGPRX2 receptor.
• EVO301, a fusion protein targeting IL-18, is under evaluation for atopic dermatitis, showcasing a compelling clinical profile with convenient dosing intervals in Phase 1 testing.
• The funding will support multiple data readouts with potential for an IPO, as the company advances its pipeline for inflammatory diseases.
Barzolvolimab Achieves Primary and Secondary Endpoints in Phase 2 Trial for Chronic Inducible Urticaria
• Celldex's barzolvolimab met all primary and secondary endpoints in a Phase 2 trial for chronic inducible urticaria (CIndU) with high statistical significance.
• The trial demonstrated complete response rates of up to 53.1% in cold urticaria and 57.6% in symptomatic dermographism patients unresponsive to antihistamines.
• Barzolvolimab exhibited a favorable safety profile, with mostly Grade 1 adverse events, and Celldex plans to advance to Phase 3 development in 2025.
• Rapid disease improvement was observed as early as two weeks after the initial dose, with a high patient retention rate of 90% through 12 weeks.
Barzolvolimab Achieves Primary and Secondary Endpoints in Chronic Inducible Urticaria Phase 2 Trial
• Celldex Therapeutics' barzolvolimab demonstrates clinical benefit in chronic inducible urticaria (CIndU) patients in a randomized, placebo-controlled study.
• The Phase 2 trial met all primary and secondary endpoints with high statistical significance, showing improvements in cold urticaria and symptomatic dermographism.
• Barzolvolimab exhibited a favorable safety and tolerability profile, supporting its potential as a novel treatment for CIndU.
• Celldex plans to advance barzolvolimab into Phase 3 development in 2025, aiming to provide a new medicine for patients with inducible urticaria.
Barzolvolimab Achieves Primary and Secondary Endpoints in Phase 2 CIndU Trial
• Celldex's barzolvolimab demonstrated clinical benefit in patients with chronic inducible urticaria (CIndU) in a randomized, placebo-controlled Phase 2 study.
• The study achieved statistically significant and clinically meaningful improvements across all primary and secondary endpoints, with a favorable safety profile.
• Celldex plans to advance barzolvolimab into Phase 3 development for CIndU in 2025, offering a potential new treatment option for patients.
• Barzolvolimab rapidly improved disease symptoms, with reductions in critical temperature and friction thresholds observed as early as two weeks after the initial dose.
Barzolvolimab Achieves Primary and Secondary Endpoints in Phase 2 CIndU Trial
• Celldex's barzolvolimab demonstrated significant clinical benefit in patients with chronic inducible urticaria (CIndU) in a randomized, placebo-controlled Phase 2 study.
• The trial met all primary and secondary endpoints with high statistical significance, showing improvements in trigger thresholds for cold urticaria and symptomatic dermographism.
• Barzolvolimab exhibited a favorable safety and tolerability profile, supporting its potential as a novel treatment for CIndU.
• Celldex plans to advance barzolvolimab into Phase 3 development in 2025, aiming to provide a new medicine for patients with CIndU.
Barzolvolimab Achieves Primary and Secondary Endpoints in Phase 2 Trial for Chronic Inducible Urticaria
• Celldex Therapeutics' barzolvolimab met all primary and secondary endpoints in a Phase 2 trial for chronic inducible urticaria (CIndU).
• The study included patients with cold urticaria and symptomatic dermographism who remained symptomatic despite antihistamine treatment.
• Barzolvolimab significantly improved trigger thresholds, enabling patients to regain control of their lives, with Phase 3 development planned for 2025.
• The drug was well-tolerated, with a favorable safety profile, and demonstrated rapid disease improvement as early as two weeks after the initial dose.
Dupixent Shows Promise in Phase 3 Trial for Chronic Spontaneous Urticaria
• Dupixent met primary and key secondary endpoints in a Phase 3 trial for chronic spontaneous urticaria (CSU) patients uncontrolled on antihistamines.
• The LIBERTY-CUPID Study C demonstrated a nearly 50% reduction in itch and urticaria activity scores compared to placebo.
• Sanofi and Regeneron plan to resubmit data to the FDA, potentially making Dupixent the first targeted CSU therapy in a decade if approved.
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