Celldex Presents Long-Term Barzolvolimab Results Demonstrating Sustained Off-Treatment Improvement in Angioedema in Patients with CSU at the European Academy of Allergy and Clinical Immunology Annual Meeting

• Remedy with barzolvolimab resulted in speedy, important, and sturdy enhancements in angioedema in sufferers with average to extreme CSU
• Seven months after the completion of dosing (Week 76), as much as 64% of sufferers handled with barzolvolimab who had angioedema at baseline remained angioedema-free
• Barzolvolimab has potential to shift remedy targets from symptom management to illness modification
• Results proceed to assist ongoing Part 3 trials of barzolvolimab in CSU; topline knowledge anticipated in This autumn 2026

HAMPTON, N.J., June 14, 2026 (GLOBE NEWSWIRE) — Celldex (NASDAQ:CLDX) introduced at the moment the presentation of long-term outcomes from the Part 2 research of barzolvolimab in a flash discuss session at the European Academy of Allergy and Clinical Immunology (EAACI) Annual Meeting in Istanbul, Türkiye. The info offered demonstrated that barzolvolimab remedy outcomes in speedy, important, and sturdy enhancements in angioedema in sufferers with power spontaneous urticaria (CSU) refractory to antihistamines. These outcomes had been sustained off-treatment, seven months after completion of barzolvolimab dosing (Week 76). The info proceed to display barzolvolimab’s potential to shift the objective of CSU remedy from symptom management to illness modification and additional assist the ongoing Part 3 trials of barzolvolimab in CSU.

“Angioedema performs a serious function in the bodily and psychological well being of the majority of individuals residing with CSU, inflicting extraordinarily painful swelling and disfigurement that dramatically impacts high quality of life,” mentioned Diane C. Younger, MD, Senior Vice President and Chief Medical Officer of Celldex Therapeutics. “Barzolvolimab has persistently proven profound, lasting outcomes together with excessive charges of full response, outlined as full absence of itch and hives, and dramatic enhancements in high quality of life and angioedema management by way of 52 weeks of remedy and now seven months after the final dose, demonstrating its potential for illness modification and the potential to vary how CSU sufferers dwell their lives.”

Angioedema happens in 55% of individuals with CSU¹ and sufferers report a imply of 7.7 angioedema episodes yearly.² Patients with CSU-related angioedema report considerably worse bodily and psychological well being outcomes, decrease well being associated high quality of life, a better proportion of nervousness and melancholy, alongside with considerably elevated emergency room visits and hospitalizations in comparison with sufferers with out angioedema in the United States.^3,4 Equally, these sufferers report considerably increased work and exercise impairment than these with out angioedema.⁵ Each sufferers and physicians report being free of angioedema as an vital remedy objective in CSU.⁶

As beforehand reported, knowledge from the Part 2b trial confirmed that remedy with barzolvolimab resulted in speedy, important, and sturdy enhancements in angioedema. Aid from angioedema signs started as early as Week 1 and deepened over 52 weeks of remedy. Moreover, newly offered knowledge present that barzolvolimab remedy led to sturdy and sustained reductions in angioedema signs at Week 76, demonstrating extended off-treatment advantages. As much as 64% of sufferers who had angioedema at baseline had been angioedema-free 7 months after the final dose.

Two Part 3 trials of barzolvolimab in CSU are ongoing and enrollment is full. 1,939 sufferers had been enrolled, the largest program performed in antihistamine-refractory CSU, together with sufferers with superior remedy skilled/refractory CSU. The research included 43 nations throughout 500 websites. Topline knowledge are anticipated in This autumn 2026, supporting a deliberate BLA submission in 2027.

¹Kolkhir P, et al. Nat Rev Dis Primers. 2022 Sep 15;8(1):61 ²Weller, et al. Dermatol Ther, 2025. ³Balp M, et al. Burden of angioedema in sufferers with power spontaneous urticaria in EU5 and US, EADV Congress 2023. ⁴Balp M, et al. Characterization of power spontaneous urticaria amongst sufferers in EU5, US and Japan. EADV Congress 2023. ⁵Soong W, et al. World Allergy Organ J. 2025. ⁶Bernstein J, et al. Frequency of angioedema in power spontaneous urticaria sufferers: Report from the Urticaria Voices research, GA²LEN World Urticaria Discussion board 2024.

About Barzolvolimab
Barzolvolimab is a humanized monoclonal antibody with a novel mechanism of motion that targets mast cells by binding with excessive specificity to a singular half of the KIT receptor and potently inhibiting its exercise. The KIT receptor is abundantly expressed by mast cells and essential for his or her perform and survival. Mast cells are drivers of inflammatory responses equivalent to hypersensitivity and allergic reactions and, in sure inflammatory ailments, equivalent to power urticarias, mast cell activation performs a central function in the onset and development of the illness. Based mostly on knowledge from sturdy, randomized, placebo managed Part 2 research, barzolvolimab has important potential as a first-in-class and best-in-disease remedy possibility for sufferers with power spontaneous urticaria (CSU), chilly urticaria (ColdU) and symptomatic dermographism (SD). Barzolvolimab is at present being studied in Part 3 research in CSU and ColdU/SD and Part 2 research in prurigo nodularis (PN) and atopic dermatitis (AD), with further indications deliberate for the future.

About the Part 2 CSU Examine
The randomized, double-blind, placebo-controlled, parallel group Part 2 research evaluated the efficacy and security profile of a number of dose regimens of barzolvolimab in sufferers with CSU who stay symptomatic regardless of antihistamine remedy, to find out the optimum dosing technique. 208 sufferers had been randomly assigned on a 1:1:1:1 ratio to obtain subcutaneous injections of barzolvolimab at 75 mg each 4 weeks, 150 mg each 4 weeks, 300 mg each 8 weeks or placebo throughout a 16-week placebo-controlled remedy interval. After 16 weeks, sufferers then entered a 36-week lively remedy interval, in which sufferers receiving placebo or the 75 mg dose had been randomized to obtain barzolvolimab 150 mg each 4 weeks or 300 mg each 8 weeks; sufferers already randomized to the 150 mg and 300 mg remedy arms remained on the identical routine as throughout the placebo-controlled remedy interval. After 52 weeks, sufferers entered a follow-up interval for a further 24 weeks. Barzolvolimab achieved the major efficacy endpoint of the research—a statistically important imply change from baseline to Week 12 in UAS7 (weekly urticaria exercise rating) in comparison with placebo at all dose ranges. For added info on this trial (NCT05368285), please go to www.clinicaltrials.gov.

About Celldex
Celldex is pioneering new horizons in immunology to ship life-changing therapies. We’re relentless in our pursuit of novel antibody-based therapies that have interaction the human immune system and immediately have an effect on essential pathways to enhance the lives of sufferers with allergic, inflammatory and autoimmune issues. Go to www.celldex.com.

Ahead Trying Assertion
This launch incorporates “forward-looking statements” made pursuant to the secure harbor provisions of the Personal Securities Litigation Reform Act of 1995. These statements are usually preceded by phrases equivalent to “believes,” “expects,” “anticipates,” “intends,” “will,” “might,” “ought to,” or comparable expressions. These forward-looking statements replicate administration’s present data, assumptions, judgment and expectations relating to future efficiency or occasions. Though administration believes that the expectations mirrored in such statements are cheap, they offer no assurance that such expectations will show to be right or that these targets will likely be achieved, and you need to be conscious that precise outcomes may differ materially from these contained in the forward-looking statements. Ahead-looking statements are topic to a quantity of dangers and uncertainties, together with, however not restricted to, our potential to efficiently full analysis and additional growth and commercialization of Firm drug candidates, together with barzolvolimab (additionally known as CDX-0159) and CDX-622, in present or future indications; the uncertainties inherent in medical testing and accruing sufferers for medical trials; our restricted expertise in bringing applications by way of Part 3 medical trials; our potential to handle and efficiently full a number of medical trials and the analysis and growth efforts for our a number of merchandise at various levels of growth; the availability, price, supply and high quality of medical supplies produced by our personal manufacturing facility or provided by contract producers, who could also be our sole supply of provide; the timing, price and uncertainty of acquiring regulatory approvals; the failure of the marketplace for the Firm’s applications to proceed to develop; our potential to guard the Firm’s mental property; the loss of any government officers or key personnel or consultants; competitors; modifications in the regulatory panorama or the imposition of rules that have an effect on the Firm’s merchandise; our potential to proceed to acquire capital to fulfill our long-term liquidity wants on acceptable phrases, or at all, together with the further capital which will likely be obligatory to finish the medical trials that we now have initiated or plan to provoke; and different components listed underneath “Threat Components“ in our annual report on Kind 10-Okay and quarterly stories on Kind 10-Q.

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Firm Contacts
Sarah Cavanaugh
Senior Vice President, Company Affairs & Administration
(508) 864-8337
scavanaugh@celldex.com

Elizabeth Higgins
Government Director, Investor Relations & Company Communications
(857) 404-2088
ehiggins@celldex.com