Celldex Presents Data Demonstrating Barzolvolimab Improves Chronic Spontaneous Urticaria Independent of Baseline Immunoglobulin E levels in Phase 2 Study at EADV Congress 2025
Celldex (NASDAQ:CLDX) presented new Phase 2 data for barzolvolimab in chronic spontaneous urticaria (CSU) at EADV Congress 2025. The drug showed rapid and sustained efficacy regardless of patients' baseline immunoglobulin E (IgE) levels.
Key findings demonstrate that barzolvolimab achieved complete response rates of up to 51% at 12 weeks, increasing to 71% at 52 weeks. Notably, 41% of patients maintained complete response even 7 months after treatment completion. The drug works by targeting mast cells through the KIT receptor, showing particular promise for patients with low IgE levels who typically have more severe disease and respond poorly to existing treatments.
The company is currently conducting two global Phase 3 trials (EMBARQ-CSU1 and EMBARQ-CSU2) to further evaluate the drug's efficacy and safety in CSU patients who remain symptomatic despite antihistamine or biologic treatments.
Celldex (NASDAQ:CLDX) ha presentato nuovi dati di fase 2 per barzolvolimab nel CSU al Congresso EADV 2025. Il farmaco ha mostrato un’efficacia rapida e sostenuta indipendentemente dai livelli basali di IgE nei pazienti.
I risultati chiave indicano che barzolvolimab ha raggiunto tassi di risposta completa fino al 51% a 12 settimane, salendo al 71% a 52 settimane. Inoltre, il 41% dei pazienti ha conservato la risposta completa anche a 7 mesi dalla fine del trattamento. Il meccanismo d’azione mira alle cellule mastociti attraverso il recettore KIT, mostrando particolare potenziale nei pazienti con bassi livelli di IgE, che di solito hanno una malattia più grave e rispondono poco ai trattamenti esistenti.
L’azienda sta attualmente conducendo due studi globali di fase 3 (EMBARQ-CSU1 e EMBARQ-CSU2) per valutare ulteriormente l’efficacia e la sicurezza del farmaco in pazienti CSU che rimangono sintomatici nonostante antistaminici o terapie biologiche.
Celldex (NASDAQ:CLDX) presentó nuevos datos de fase 2 para barzolvolimab en la urticaria crónica espontánea (CSU) en el Congreso EADV 2025. El fármaco mostró una eficacia rápida y sostenida sin depender de los niveles basales de IgE de los pacientes.
Los hallazgos clave demuestran que barzolvolimab logró tasas de respuesta completa de hasta el 51% a las 12 semanas, aumentando al 71% a las 52 semanas. Cabe destacar que el 41% de los pacientes mantuvo la respuesta completa incluso 7 meses tras finalizar el tratamiento. El fármaco actúa dirigéndose a las células madre a través del receptor KIT, mostrando especial promesa en pacientes con niveles bajos de IgE, que suelen presentar una enfermedad más grave y responden peor a los tratamientos actuales.
La compañía está llevando a cabo dos ensayos globales de fase 3 (EMBARQ-CSU1 y EMBARQ-CSU2) para evaluar más a fondo la eficacia y seguridad del fármaco en pacientes con CSU que siguen sintomáticos a pesar de antihistamínicos o tratamientos biológicos.
Celldex (NASDAQ:CLDX)가 2025년 EADV 학회에서 만성 자연발진(CSU)을 대상으로 barzolvolimab의 새로운 2상 데이터를 발표했다. 이 약은 환자의 기저 IgE 수치에 관계없이 빠르고 지속적인 유효성을 보였다.
주요 결과에 따르면 barzolvolimab은 12주 차에 완전 반응 비율이 최대 51%에 달했고, 52주 차에는 71%로 증가했다. 특히 치료 종료 후 7개월까지도 환자의 41%가 완전 반응을 유지했다. 이 약물의 작용 기전은 KIT 수용체를 통해 비만세포를 표적으로 삼는 것으로, 보통 IgE 수치가 낮은 환자에서 더 심한 질환을 보이고 기존 치료에 덜 반응하는 경우에 특히 가능성이 크다.
회사는 현재 두 개의 전세계 3상 연구(EMBARQ-CSU1 및 EMBARQ-CSU2)를 진행 중이며, 항히스타민제나 생물학적 치료에 반응하지 않는 CSU 환자들에서 약물의 유효성 및 안전성을 추가로 평가하고 있다.
Celldex (NASDAQ:CLDX) a présenté de nouveaux données de phase 2 pour barzolvolimab dans l’urticaire chronique spontanée (UCS) au Congrès EADV 2025. Le médicament a démontré une efficacité rapide et durable indépendamment des niveaux initiaux d’IgE des patients.
Les résultats clés montrent que barzolvolimab a atteint des taux de réponse complète allant jusqu’à 51% à 12 semaines, augmentant à 71% à 52 semaines. Fait notable, 41% des patients ont maintenu une réponse complète même 7 mois après l’arrêt du traitement. Le médicament agit en ciblant les mastocytes via le récepteur KIT, montrant un potentiel particulier chez les patients avec de faibles niveaux d’IgE, qui présentent généralement une maladie plus grave et répondent mal aux traitements actuels.
L’entreprise mène actuellement deux essais mondiaux de phase 3 (EMBARQ-CSU1 et EMBARQ-CSU2) afin d’évaluer plus en détail l’efficacité et la sécurité du médicament chez les patients CSU qui demeurent symptomatiques malgré les antihistaminiques ou les traitements biologiques.
Celldex (NASDAQ:CLDX) präsentierte neue Phase-2-Daten zu barzolvolimab bei der chronischen spontan auftretenden Urtikaria (CSU) auf dem EADV-Kongress 2025. Das Medikament zeigte eine schnelle und anhaltende Wirksamkeit, unabhängig von den Baseline-IgE-Werten der Patienten.
Zentrale Befunde zeigen, dass barzolvolimab vollständige Ansprechraten von bis zu 51% nach 12 Wochen erreichte und bis auf 71% nach 52 Wochen anstieg. Bemerkenswert ist, dass 41% der Patienten auch 7 Monate nach Beendigung der Behandlung eine vollständige Reaktion aufrechterhielten. Das Wirkprinzip zielt über den KIT-Rezeptor auf Mastzellen ab und verspricht insbesondere bei Patienten mit niedrigem IgE-Wert, die typischerweise eine schwerere Erkrankung haben und schlechter auf bestehende Therapien ansprechen, große Fortschritte.
Das Unternehmen führt derzeit zwei globale Phasen-3-Studien (EMBARQ-CSU1 und EMBARQ-CSU2) durch, um die Wirksamkeit und Sicherheit des Medikaments bei CSU-Patienten weiter zu bewerten, die trotz Antihistaminika oder Biologika symptomatisch bleiben.
Celldex (NASDAQ:CLDX) قدمت بيانات جديدة من المرحلة الثانية لـ barzolvolimab في الحَسْسِية المزمنة العفوية (CSU) في مؤتمر EADV 2025. الدواء أظهر فعالية سريعة ومستدامة بغض النظر عن مستويات IgE الأساسية لدى المرضى.
تشير النتائج الرئيسية إلى أن barzolvolimab حقّق نسب استجابة كاملة حتى 51% عند 12 أسبوعًا، وتزايدت إلى 71% عند 52 أسبوعًا. ومن الجدير بالذكر أن 41% من المرضى حافظوا على الاستجابة الكاملة حتى 7 أشهر بعد انتهاء العلاج. يعمل الدواء من خلال استهداف الخلايا البدينة عبر مستقبل KIT، وهو ما يعطي أملاً خاصاً للمرضى ذوي مستويات IgE المنخفضة الذين عادةً ما تكون حالتهم أكثر حدة ويستجيبون بشكل ضعيف للعلاجات الحالية.
تجري الشركة حالياً تجربتين عالميتين من المرحلة 3 (EMBARQ-CSU1 و EMBARQ-CSU2) لتقييم فاعلية وسلامة الدواء بشكل أوسع لدى مرضى CSU الذين ما زالوا يعانون من الأعراض رغم استخدام مضادات الهستامين أو العلاجات البيولوجية.
Celldex (NASDAQ:CLDX) 在EADV大会2025上公布了用于慢性自发性荨麻疹（CSU）的<barzolvolimab的二期数据。该药物显示出<快速且持续的疗效，与患者的基线IgE水平无关。
关键发现显示，barzolvolimab在12周时达到的<完全反应率高达51%，在52周时上升至<71%。值得注意的是，有41%的患者在停药后7个月仍维持完全反应。该药通过KIT受体作用于肥大细胞，尤其在IgE水平较低、病情通常更严重且对现有治疗反应较差的患者中显示出希望。
公司目前正在进行两项全球性III期试验（EMBARQ-CSU1和EMBARQ-CSU2），以进一步评估该药在对抗仍有症状的CSU患者中的疗效和安全性。
- Achieved up to 71% complete response rate at 52 weeks of treatment
- Demonstrated efficacy in both low and normal/high IgE level patients
- Maintained 41% complete response rate 7 months post-treatment
- Well-tolerated safety profile throughout the study
- Successfully met primary endpoint across all dose groups
- None.
Insights
Celldex's barzolvolimab shows strong efficacy for all CSU patients regardless of IgE levels, addressing an unmet need for difficult-to-treat cases.
Celldex's barzolvolimab data presentation demonstrates a significant therapeutic breakthrough for chronic spontaneous urticaria (CSU) treatment. The drug's novel mechanism targeting KIT receptor on mast cells has shown efficacy independent of baseline IgE levels - a crucial differentiator from existing therapies like omalizumab that primarily target IgE-mediated pathways.
This is particularly important because patients with low IgE levels typically have more severe disease and respond poorly to current IgE-targeted treatments. Barzolvolimab addresses this unmet clinical need by directly targeting the mast cells themselves rather than just the IgE pathway.
The data demonstrates impressive complete response rates of up to 51% at 12 weeks, which deepened to 71% at 52 weeks. Even more compelling is the durability of response, with 41% of patients maintaining complete responses 7 months after treatment cessation.
The drug's consistent efficacy across both low and normal/high IgE subgroups validates Celldex's approach of targeting the underlying cellular mechanism rather than downstream mediators. With the Phase 3 EMBARQ-CSU trials currently enrolling, these results suggest barzolvolimab could potentially become a first-line biologic therapy for CSU patients, particularly those who don't respond to current treatments.
This data strengthens Celldex's position in the competitive immunology space and highlights a potential expansion of the addressable market to include difficult-to-treat CSU patients with low IgE levels.
Rapid and sustained efficacy regardless of baseline IgE levels in patients with CSU
HAMPTON, N.J., Sept. 17, 2025 (GLOBE NEWSWIRE) -- Celldex (NASDAQ:CLDX) announced today new data demonstrating rapid and strong efficacy regardless of baseline immunoglobulin E (IgE) levels in patients with chronic spontaneous urticaria (CSU), an immune-related condition driven by mast cell activation. Barzolvolimab specifically targets mast cells by binding the receptor tyrosine kinase KIT with high specificity and potently inhibiting its activity, which is required for mast cell function and survival.
The data were presented in an oral e-poster presentation (EPS02.09) at the EADV Congress 2025 by Martin Metz, M.D., Professor, Department of Dermatology and Allergy, Head of Translation Research and Deputy Head of Clinical Trials at Charité – Universitätsmedizin in Berlin and the lead investigator of the study.
“These data reinforce that mast cells are important drivers of CSU and that barzolvolimab, with its novel mechanism of action, has significant potential to be a meaningful treatment for all patients with CSU, regardless of underlying disease endotype,” said Diane C. Young, MD, Senior Vice President and Chief Medical Officer of Celldex. “This is especially important for patients with low IgE levels, who typically have more severe disease and are less likely to respond to IgE targeted therapies, including omalizumab.”
Key data highlights:
- Barzolvolimab demonstrated rapid and sustained efficacy in patients with CSU with both low (<40) and normal/high (>40) IgE levels.
- Similar improvement in weekly urticaria activity scores (UAS7; mean change from baseline) were observed across both IgE low and IgE normal/high subgroups at Weeks 12 and 52.
- Similar rates of well-controlled disease (UAS7<6) and complete disease control (both UAS7=0) were also observed across both IgE normal/high and IgE low subgroups at Weeks 12 and 52.
- Similar rates of well-controlled disease (UCT7>12) and complete disease control (UCT7=16) were also observed across both IgE normal/high and IgE low subgroups at Weeks 12 and 52.
- Data reinforce that mast cells are important drivers of CSU regardless of the underlying endotype and are consistent with the novel mechanism of action of barzolvolimab.
- Barzolvolimab is a promising therapy for all patients with moderate to severe CSU, regardless of underlying endotype.
The Company previously announced that this Phase 2 study of barzolvolimab in patients with moderate to severe CSU refractory to antihistamines, including patients with biologic-refractory disease, met its primary endpoint—a significant improvement in UAS7 compared to placebo at 12 weeks—across all dose groups tested. Barzolvolimab also demonstrated rapid, profound complete response rates (UAS7=0; no itch/no hives) in up to
The Company is currently enrolling patients in a global Phase 3 Program for barzolvolimab in CSU, consisting of two Phase 3 trials (EMBARQ-CSU1; NCT06445023 and EMBARQ-CSU2; NCT06455202) designed to establish the efficacy and safety of barzolvolimab in adult patients with CSU who remain symptomatic despite H1 antihistamine treatment. The studies also include patients who remain symptomatic after treatment with biologics.
About Barzolvolimab
Barzolvolimab is a humanized monoclonal antibody that binds the receptor tyrosine kinase KIT with high specificity and potently inhibits its activity. KIT is expressed in a variety of cells, including mast cells, which mediate inflammatory responses such as hypersensitivity and allergic reactions. KIT signaling controls the differentiation, tissue recruitment, survival and activity of mast cells. In certain inflammatory diseases, such as chronic urticaria, mast cell activation plays a central role in the onset and progression of the disease. Barzolvolimab is currently being studied in chronic spontaneous urticaria (CSU), two forms of chronic inducible urticaria (CIndU) – cold urticaria (ColdU) and symptomatic dermographism (SD), prurigo nodularis (PN) and atopic dermatitis (AD), with additional indications planned for the future.
About the Phase 2 CSU Study
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 remained 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. For additional information on this trial (NCT05368285), please visit www.clinicaltrials.gov.
About the Phase 3 Program
Celldex is currently conducting a global Phase 3 Program for barzolvolimab in CSU, consisting of two Phase 3 trials (EMBARQ-CSU1; NCT06445023 and EMBARQ-CSU2; NCT06455202) designed to establish the efficacy and safety of barzolvolimab in adult patients with CSU who remain symptomatic despite H1 antihistamine treatment. The studies also include patients who remain symptomatic after treatment with biologics. Enrollment is underway.
About Chronic Spontaneous Urticaria (CSU)
CSU is characterized by the occurrence of hives or wheals for 6 weeks or longer without identifiable specific triggers or causes. The activation of the mast cells in the skin (release of histamines, leukotrienes, chemokines) results in episodes of itchy hives, swelling and inflammation of the skin that can go on for years or even decades. Current therapies provide symptomatic relief only in some patients.
About Celldex
Celldex is pioneering new horizons in immunology to deliver life-changing therapies. We are relentless in our pursuit of novel antibody-based treatments that engage the human immune system and directly affect critical pathways to improve the lives of patients with allergic, inflammatory and autoimmune disorders.
Visit www.celldex.com.
Forward Looking Statement
This release contains "forward-looking statements" made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements are typically preceded by words such as "believes," "expects," "anticipates," "intends," "will," "may," "should," or similar expressions. These forward-looking statements reflect management's current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct or that those goals will be achieved, and you should be aware that actual results could differ materially from those contained in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, our ability to successfully complete research and further development and commercialization of Company drug candidates, including barzolvolimab (also referred to as CDX-0159), in current or future indications; the uncertainties inherent in clinical testing and accruing patients for clinical trials; our limited experience in bringing programs through Phase 3 clinical trials; our ability to manage and successfully complete multiple clinical trials and the research and development efforts for our multiple products at varying stages of development; the availability, cost, delivery and quality of clinical materials produced by our own manufacturing facility or supplied by contract manufacturers, who may be our sole source of supply; the timing, cost and uncertainty of obtaining regulatory approvals; the failure of the market for the Company's programs to continue to develop; our ability to protect the Company's intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company's products; our ability to continue to obtain capital to meet our long-term liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials that we have initiated or plan to initiate; and other factors listed under "Risk Factors" in our annual report on Form 10-K and quarterly reports on Form 10-Q.
All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. We have no obligation, and expressly disclaim any obligation, to update, revise or correct any of the forward-looking statements, whether as a result of new information, future events or otherwise.
Company Contact
Sarah Cavanaugh
Senior Vice President, Corporate Affairs & Administration
(508) 864-8337
scavanaugh@celldex.com
Patrick Till
Meru Advisors
(484) 788-8560
ptill@meruadvisors.com
FAQ
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