Celldex Therapeutics Reports Major Advances in Chronic Urticaria Treatment

Celldex Therapeutics, Inc. has shared encouraging results from its Phase 2 studies of barzolvolimab, a monoclonal antibody designed to target mast cell activity in patients with chronic urticaria. Notably, in the chronic spontaneous urticaria (CSU) study, 82% of participants indicated that their symptoms ceased to affect their quality of life after 52 weeks. Furthermore, 60% of those suffering from chronic inducible urticaria (CIndU) experienced similar symptom relief at the 12-week mark. These findings, showcased at the AAAAI Annual Meeting, underscore the promise of barzolvolimab in transforming the treatment landscape for these chronic conditions. Given the limited options currently available for chronic urticaria, these results hold particular significance. Enrollment for global Phase 3 studies for CSU is ongoing, with plans to initiate CIndU Phase 3 studies in 2025.

Key Findings and Implications

• The Phase 2 studies revealed that 82% of CSU patients experienced substantial quality-of-life improvements, suggesting barzolvolimab’s strong efficacy.
• Many CSU patients showed complete symptom responses by Week 52, indicating barzolvolimab’s potential to shift treatment strategies for chronic urticaria.
• Progression to Phase 3 studies reflects the company’s seriousness about introducing a transformative therapy to patients in need.
• For CIndU patients, 60% reported improvements in their quality of life at Week 12, demonstrating the rapid effect of the treatment across different types of urticaria.

Challenges Ahead

• Celldex lacks extensive experience in advancing drug candidates through Phase 3 trials, which may affect the development and commercialization of barzolvolimab.
• There are concerns regarding the ability to secure necessary funding for long-term liquidity and the continuation of clinical trials.
• Potential regulatory hurdles could impede the approval and market entry of the drug candidates, raising further challenges.

Frequently Asked Questions

What are the benefits of barzolvolimab for CSU patients?

Barzolvolimab demonstrated that 82% of CSU patients saw their symptoms no longer impacting their quality of life after 52 weeks.

How did barzolvolimab perform in CIndU clinical trials?

In the CIndU trials, 60% of patients reported that their symptoms no longer affected their quality of life at Week 12.

What is the mechanism of action of barzolvolimab?

Barzolvolimab binds selectively to the KIT receptor, inhibiting mast cell function to promote better disease control in chronic urticaria.

What is the current status of the barzolvolimab trials?

Global Phase 3 studies for CSU are actively enrolling participants, with plans to move forward with CIndU Phase 3 studies in 2025.

What impact does CSU have on patients’ lives?

Patients suffering from CSU experience significant quality of life impairment that disrupts daily activities, work, sleep, and mental health.

Disclaimer: This article is based on a press release from GlobeNewswire. It is an AI-generated summary and may contain inaccuracies. Read the full release here.

Insider Trading Activity for $CLDX

Recently, insiders have traded $CLDX shares in the open market only once in the last six months. Of these transactions, one was a purchase while there were no sales.

Here’s a brief overview of the recent insider trading activity for $CLDX:

• ANTHONY S MARUCCI (PRESIDENT & CEO) purchased 11,500 shares totaling approximately $308,430.

For further details on insider transactions, visit Quiver Quantitative’s trading dashboard.

Institutional Activity Regarding $CLDX

In the latest quarter, 92 institutional investors have added shares of $CLDX, while 104 have decreased their positions.

Some of the most significant recent activities include:

• JEFFERIES FINANCIAL GROUP INC. added 2,369,398 shares (+11282.8%) in Q4 2024, valued at approximately $59,874,687.
• COMMODORE CAPITAL LP removed 1,618,937 shares (-100.0%) in Q4 2024, worth around $40,910,537.
• KYNAM CAPITAL MANAGEMENT, LP added 1,605,598 shares (+46.4%) in Q4 2024 for an estimated $40,573,461.
• DEEP TRACK CAPITAL, LP added 1,540,132 shares in Q4 2024, valued at about $38,919,135.
• JENNISON ASSOCIATES LLC removed 1,324,410 shares (-100.0%) in Q4 2024 for around $33,467,840.
• FMR LLC reduced holdings by 1,166,748 shares (-19.4%) in Q4 2024, valued at approximately $29,483,721.
• POLAR CAPITAL HOLDINGS PLC removed 1,155,046 shares (-42.5%) in Q4 2024, worth about $29,188,012.

To track institutional holdings, explore Quiver Quantitative’s dashboard.

Summary of Findings

– Significant patient quality of life improvements reported in CSU and CIndU patients –

– 82% of CSU patients no longer report affected quality of life at Week 52 –

– 60% of CIndU patients report no impact on quality of life at Week 12 –

HAMPTON, N.J., March 1, 2025 (GLOBE NEWSWIRE) — Celldex Therapeutics, Inc. (NASDAQ:CLDX) disclosed positive data on disease control and quality of life improvements from its Phase 2 studies of barzolvolimab in chronic urticaria patients. Barzolvolimab is a humanized monoclonal antibody with a high specificity for the receptor tyrosine kinase KIT, effectively inhibiting its activity essential for mast cell function and survival.

In the Phase 2 studies, both the chronic spontaneous urticaria (CSU) (52-week analysis) and chronic inducible urticaria (CIndU) (12-week analysis) demonstrated rapid and sustained improvements, significantly impacting patient quality of life as measured by both the Urticaria Control Test
¹ and Dermatology Life Quality Index
². These results were presented by Martin Metz, M.D., Deputy Director and Head of Translational Research at Charité – Universitätsmedizin Berlin, during poster sessions (CSU #L11, CIndU #183) at the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting 2025.

“Chronic urticaria can severely disrupt daily life, often for years or decades, with limited treatment options currently available,” stated Martin Metz, MD, emphasizing the urgent need for effective therapies in this area.

Barzolvolimab Shows Promise in Treating Chronic Urticaria Disorders

Research conducted at Charité – Universitätsmedizin Berlin highlights that barzolvolimab has the potential to revolutionize treatment approaches for chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIndU). “We are especially excited to see these meaningful improvements consistently across patients in large clinical studies,” said the research team.

Patients suffering from CSU experience significant quality of life impairment affecting daily activities, work performance, sleep quality, and social interactions. This can lead to mental health issues, including depression and anxiety, manifested in some cases as suicidal thoughts.
^3,4
A recent international patient survey revealed that most respondents reported a moderate to high impact from CSU on their everyday lives.
⁵
Current clinical guidelines suggest achieving complete disease control should be the primary treatment objective.
⁶
Several studies have shown that patients who reach complete disease control experience minimal disruption to their quality of life.
^7,8

Phase 2 CSU Trial Results: Disease Control and Quality of Life Metrics

• Up to 71% of patients with CSU achieved a complete response (UAS7 = 0) at Week 52—the highest rate recorded in a well-controlled study.
• Patients refractory to antihistamines demonstrated rapid and sustained improvement in urticaria control (UCT) and quality of life (DLQI).
• At Week 52, 82% of patients reported that CSU symptoms ceased to impact their quality of life.
• 95% of patients noted meaningful quality of life improvements based on DLQI metrics by Week 52.
• 82% of participants reported well-controlled urticaria based on UCT, with nearly half experiencing complete control at Week 52.

Phase 2 CIndU Trial Results: Disease Control and Quality of Life Metrics

• 53% of ColdU and 58% of SD patients achieved complete response (negative provocation test)—a landmark randomized, placebo-controlled study confirming clinical benefit in CIndU patients.
• Significant and swift improvements in UCT and DLQI were observed in patients with ColdU and SD, sustained throughout the 12-week study period.
• 60% of patients indicated that CIndU symptoms no longer impacted their quality of life at Week 12.
• 69% of patients reported well-controlled urticaria based on UCT at Week 12.

Global Phase 3 studies (EMBARQ-CSU1 and EMBARQ-CSU2) are currently enrolling participants for barzolvolimab in CSU cases. Celldex plans to progress barzolvolimab into Phase 3 development for CIndU by 2025.

References:

¹Urticaria Control Test (UCT) includes four questions (0-4 scale; total 0-16) that assess symptoms, treatment effectiveness, and overall disease control in chronic urticaria. UCT≥12 indicates well-controlled, while UCT=16 signifies complete control.

²Dermatology Life Quality Index (DLQI) comprises ten questions (0–3 scale, total 0–30) evaluating skin disease’s impact on quality of life, including daily activities and personal relationships. A score of 0–1 indicates no life effect.

³Maurer et al. The burden of chronic spontaneous urticaria is substantial: Real-world evidence from ASSURE-CSU. Allergy, 2017.

⁴Kolkhir P et al. Mortality in adult patients with chronic spontaneous urticaria: A real-world cohort study. Journal of Allergy and Clinical Immunology, 2025.

⁵Winders TA et al. Impact of Chronic Spontaneous Urticaria on Health-related quality of life domains: Data from the Urticaria Voices study. EADV 2024.

⁶Zuberbier T et al. The international EAACI/GA2LEN/EuroGuiDerm/APAAACI guideline for urticaria management. Allergy, 2022.

⁷Kolkhir P et al. The Benefit of Complete Response to Treatment in Patients With Chronic Spontaneous Urticaria: CURE Results. Journal of Allergy and Clinical Immunology Practice, 2023.

⁸Bernstein J et al. Why a Complete Response is the Treatment Aim in Chronic Spontaneous Urticaria. Journal of Clinical Medicine, 2023.

About Chronic Spontaneous Urticaria (CSU)

CSU manifests as hives or wheals lasting six weeks or longer without identifiable triggers. Skin mast cell activation releases histamines that cause episodes of hives, swelling, and inflammation, which can persist for years. Existing treatments provide variable symptomatic relief.

About Chronic Inducible Urticaria (CIndU)

CIndU involves hives or wheals triggered by specific stimuli. For instance, ColdU occurs with exposure to cold temperatures, while symptoms of SD arise from skin manipulation like stroking or scratching. Current management options are limited primarily to antihistamines, with patients often trying to avoid known triggers.

About Barzolvolimab

Barzolvolimab is a humanized monoclonal antibody specifically targeting the KIT receptor tyrosine kinase, crucial for mast cell activity and inflammatory response. It is being studied for its potential across multiple conditions, including chronic urticaria, prurigo nodularis, eosinophilic esophagitis, and atopic dermatitis. Further indications are being explored.

About Celldex Therapeutics, Inc.

Celldex is a clinical-stage biotechnology company devoted to advancing therapeutics focused on mast cell biology. Their antibody-based treatments aim to engage the immune system and target pathways crucial for alleviating severe inflammatory and autoimmune diseases.

Celldex Therapeutics Discusses Forward-Looking Statements and Risks

For more information, visit www.celldex.com.

Forward Looking Statement

This release contains “forward-looking statements” as defined by the Private Securities Litigation Reform Act of 1995. These statements generally include terms like “believes,” “expects,” “anticipates,” “intends,” “will,” “may,” “should,” or similar expressions. They reflect management’s current knowledge, assumptions, judgments, and expectations about future performance or events.

Management considers these expectations reasonable; however, there is no guarantee that they will be accurate or that the anticipated goals will be met. It’s important to recognize that actual outcomes may differ significantly from the scenarios described in these forward-looking statements. Several risks and uncertainties could impact results, including:

• Our ability to successfully advance research and commercialization of drug candidates like barzolvolimab (also known as CDX-0159).
• Uncertainties associated with clinical testing and patient recruitment for trials.
• Limited experience in conducting Phase 3 clinical trials.
• Challenges in managing and completing multiple clinical trials and diverse product development efforts.
• Factors affecting the availability, cost, and quality of clinical materials from in-house production or third-party manufacturers.
• Uncertainties regarding obtaining regulatory approvals.
• Market developments impacting the Company’s programs.
• Our capacity to safeguard intellectual property.
• The potential loss of key personnel or consultants.
• Increased competition and possible changes in regulatory conditions.
• Our ability to secure necessary capital to sustain long-term liquidity.
• Other risks detailed in our annual Form 10-K and quarterly Form 10-Q reports.

All forward-looking statements are qualified entirely by this cautionary notice. Readers should not place excessive reliance on these statements, which reflect conditions only as of the release date. We disclaim any obligation to update, revise, or correct forward-looking statements based on new information or future events.

Company Contact

For inquiries, please contact:

Sarah Cavanaugh
Senior Vice President, Corporate Affairs & Administration
(508) 864-8337
[email protected]

Patrick Till
Meru Advisors
(484) 788-8560
[email protected]

This article was originally published on Quiver News; read the full story.

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