Barzolvolimab

皮肤科 Dr 徐斌 医者丨跑者丨读者 一起做个有趣的人 “它不是过敏那么简单，也不是你太敏感；它是一种可以被理解、被分类、被精准治疗的免疫性皮肤病。”——摘自《过敏与临床免疫学杂志》2026年重磅综述 如果你或你的家人正在被反复发作的风团、剧烈瘙痒、甚至嘴唇或眼睑肿胀所困扰，吃抗过敏药效果越来越差，甚至医生也说“不太好控制”，那么今天的这篇文章，请你一定看完。 我结合全球顶级过敏与免疫学期刊《J Allergy Clin Immunol》2026年最新发表的权威综述，帮你用最通俗的语言，讲清楚你一直没搞懂的问题： 我得的到底是什么类型的“慢性荨麻疹”？ 为什么有人吃抗过敏药没用？ 有没有新的治疗办法？ 我还能不能恢复正常生活？一、你得的，可能是“慢性自发性荨麻疹” 慢性自发性荨麻疹（简称CSU）不是普通的过敏。它不是吃了某种东西、接触了某种东西才发，而是没有明确诱因地反复发作，持续超过6周。 它最常见的表现是：风团 ：突然冒出来，很痒，几小时内可以自己消退血管性水肿 ：嘴唇、眼皮、手脚甚至喉咙肿胀，不一定是风团夜间加重 ，影响睡眠和情绪 关键区别：还有一种病叫“遗传性血管性水肿”，它不痒、没有风团，治疗完全不同。所以明确诊断是第一位的。二、你不是“难治”，而是可能属于不同的“内型” 过去我们只知道“慢性荨麻疹”，现在医学已经把它分成了两种不同类型，治疗策略完全不同。 类型 通俗叫法 主要特点 治疗反应I型 过敏型 IgE抗体介导，像“假过敏” 抗组胺药、Omalizumab效果好IIb型 自身免疫型 IgG抗体攻击自身肥大细胞 对常规治疗反应差，需换用BTK抑制剂或环孢素 一个简单的判断线索：如果你总IgE很低、甲状腺抗体（TPO）升高，很可能属于IIb型，普通抗过敏药效果有限。三、治疗不是只能“硬扛”——这些新药已经来了 过去CSU的治疗流程是：抗组胺药 → 加量 → Omalizumab（抗IgE） → 环孢素（副作用大）。现在，多个新药已经获批或接近上市，效果更好、安全性更高。📌 慢性自发性荨麻疹新药一览表（患者友好版） 药物名称 类型 怎么用 适合谁 效果亮点Omalizumab 抗IgE单抗 每4周皮下注射 经典首选生物制剂 约60-70%有效Dupilumab 抗IL-4/13单抗 每2周皮下注射 抗组胺药无效者 对非过敏型也有效Remibrutinib BTK抑制剂（口服） 每天2次 难治性CSU 52周完全无风团率>50%Rilzabrutinib BTK抑制剂（口服） 每天3次 包括IIb型 20%完全无风团Barzolvolimab 抗c-KIT单抗 静脉注射 重度、难治性 可清除肥大细胞，效果持久YH35324 IgE陷阱融合蛋白 皮下注射 对抗IgE效果不佳者 8周效果优于Omalizumab环孢素 免疫抑制剂 口服 上述无效的最后选择 有效但需监测血压、肾功能 💡 一句话总结：如果你用Omalizumab效果不好，不要灰心，现在有BTK抑制剂、抗c-KIT抗体等多种新选择。四、作为患者，你可以做这三件事主动问医生 ：我属于哪一种CSU内型？要不要查IgE、TPO抗体？记录病情 ：用手机App（如CRUSE）或日记记录每天风团和瘙痒情况，这是医生调药的重要依据。不放弃新治疗 ：如果常规治疗失败，可以咨询是否适合BTK抑制剂或临床研究。五、Take Home Messages慢性自发性荨麻疹不是心理问题，也不是普通过敏，而是一种可以被分型、被精准治疗的免疫性疾病。抗过敏药无效 ≠ 无药可治。新型口服BTK抑制剂、抗c-KIT单抗等正在改变治疗格局。你不需要“硬扛”，主动与医生讨论内型和新药，完全有机会恢复正常生活。参考文献 Gandhi RS, Bruun TUJ, Bernstein JA. Hereditary angioedema and chronic spontaneous urticaria: Mechanisms, therapeutics, and the evolving landscape. J Allergy Clin Immunol. 2026;157(4):804-817.DOI: 10.1016/j.jaci.2026.01.027 声明： 本文内容基于2026年发表的权威医学综述，仅供科普参考，不替代专业诊疗建议。具体治疗方案请咨询正规医院皮肤科或过敏科医生。 往期精彩： 打疫苗就能预防“缠腰龙”？皮肤科医生教你最有效的一招！ 跑个马拉松，大脑“掉层皮”？顶级期刊《自然·代谢》科学家发现髓鞘可逆减少，揭示运动大脑的惊人智慧！ 脸上的小雀斑，哪种激光打起来更舒适更安全更有效？ 标个星，不走散 --- E N D --- 徐斌，常州一院皮肤科 副主任医师 专家门诊时间

Enrollment completed six months ahead of guidance in both barzolvolimab Phase 3 chronic spontaneous urticaria studies (EMBARQ-CSU 1 and 2); Topline data expected in Q4 26; BLA submission planned for 2027 Phase 3 barzolvolimab cold urticaria and symptomatic dermographism study (EMBARQ-ColdU and -SD) actively enrolling Phase 1 CDX-622 proof of mechanism study in asthma ongoing 2026 expected to deliver multiple key data readouts across the pipeline Raised $345 million in gross proceeds from a follow-on public offering, closed in April 2026 HAMPTON, N.J. , May 07, 2026 (GLOBE NEWSWIRE) -- Celldex (NASDAQ:CLDX) today reported financial results for the first quarter ended March 31, 2026 and provided a corporate update. "We began the year with a significant milestone - the early completion of enrollment in our Phase 3 CSU studies - and we have continued to build on that momentum over the quarter,” said Anthony Marucci , Co-founder, President and Chief Executive Officer of Celldex. “This spring, barzolvolimab was featured in five presentations at leading medical meetings, further reinforcing its potential as a first-in-class, best-in-disease therapy with the ability to transform the treatment landscape for patients in need of better options. This progress enabled the successful completion of a $345 million financing in early April, strengthening our balance sheet and supporting continued investments in our commercialization preparations and growing pipeline.” “As we look ahead, our focus remains on execution—driving strong enrollment across our Phase 3 study in ColdU and SD and advancing towards multiple important data readouts this year,” Mr. Marucci continued. “These include topline data from our Phase 3 barzolvolimab CSU studies, results from Phase 2 studies in prurigo nodularis and atopic dermatitis, and additional data from our novel bispecific program, CDX-622.” Recent Program Highlights Barzolvolimab - KIT Inhibitor Program Barzolvolimab is a humanized monoclonal antibody with a novel mechanism of action that targets mast cells by binding with high specificity to a unique part of the KIT receptor and potently inhibiting its activity. The KIT receptor is abundantly expressed by mast cells and critical for their function and survival. Mast cells are drivers of inflammatory responses such as hypersensitivity and allergic reactions and, in certain inflammatory diseases, such as chronic urticarias, mast cell activation plays a central role in the onset and progression of the disease. Chronic Urticarias Enrollment was completed six months ahead of guidance in the global Phase 3 program in chronic spontaneous urticaria (CSU)—demonstrating strong interest in barzolvolimab. The Phase 3 program consists of two trials—EMBARQ-CSU1 and EMBARQ-CSU2. 1,939 patients were enrolled—the largest program conducted in antihistamine refractory CSU, including patients with advanced therapy experienced/refractory CSU. The studies included 43 countries and over 500 sites. EMBARQ-CSU1 and EMBARQ-CSU2 are designed to establish the efficacy and safety of barzolvolimab in adult patients with CSU who remain symptomatic despite H1 antihistamine treatment and also include patients who remain symptomatic after treatment with advanced therapies. Topline data are anticipated in Q4 2026, supporting a planned BLA filing in 2027. In December 2025 , Celldex initiated a global Phase 3 study in cold urticaria (ColdU) and symptomatic dermographism (SD)—EMBARQ-ColdU and -SD. Barzolvolimab is the first drug in development to demonstrate clinical benefit in patients with ColdU and SD in a large, randomized, placebo-controlled study. In the recently completed Phase 2 study, all primary and secondary endpoints were met with high statistical significance at 12 weeks and sustained through the end of the treatment period (20 weeks). Data from the Phase 2 studies of barzolvolimab in both CSU and ColdU/SD were presented at the 2026 AAAAI Annual Meeting ( February 27 – March 2 ) and the 2026 AAD Annual Meeting (March 27 – 31) further demonstrating a first-in-class and best-in-disease profile. Key highlights include: Barzolvolimab retreatment achieves similar profound efficacy to first exposure in patients with ColdU and SD; ability to retreat facilitates a real-world paradigm in which treatment may be intermittent for patients with ColdU and SD Sustained off-treatment efficacy despite barzolvolimab clearance and normalization of tryptase, suggesting disease modification in patients with CSU treated for full 52 weeks Greatly improved quality of life and reduced disease impact for patients with ColdU/SD at Week 20 Greatly improved quality of life and reduced disease impact for patients with CSU, ColdU and SD across all measured domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships and treatment Barzolvolimab retreatment achieves similar profound efficacy to first exposure in patients with ColdU and SD; ability to retreat facilitates a real-world paradigm in which treatment may be intermittent for patients with ColdU and SD Sustained off-treatment efficacy despite barzolvolimab clearance and normalization of tryptase, suggesting disease modification in patients with CSU treated for full 52 weeks Greatly improved quality of life and reduced disease impact for patients with ColdU/SD at Week 20 Greatly improved quality of life and reduced disease impact for patients with CSU, ColdU and SD across all measured domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships and treatment Prurigo Nodularis and Atopic Dermatitis Enrollment is complete in the Phase 2 study in prurigo nodularis (PN). This randomized, double-blind, placebo-controlled, parallel group study is evaluating the efficacy and safety profile of barzolvolimab in patients with moderate to severe PN. Topline data from this study are expected to be presented in the summer of 2026. Enrollment is complete in the Phase 2 study in atopic dermatitis (AD). This randomized, double-blind, placebo-controlled, parallel group study is evaluating the efficacy and safety profile of barzolvolimab in patients with moderate to severe AD. Topline data from this study are expected to be presented in late 2026. Novel Bispecific Antibody Platform CDX-622 – Bispecific SCF & TSLP CDX-622 targets two complementary pathways that drive chronic inflammation, potently neutralizing the alarmin thymic stromal lymphopoietin (TSLP) and depleting mast cells via stem cell factor (SCF) starvation. Combined neutralization of SCF and TSLP with CDX-622 is expected to simultaneously reduce tissue mast cells and inhibit Type 2 inflammatory responses to potentially offer enhanced therapeutic benefit in inflammatory and fibrotic disorders. CDX-622 has been engineered to disable effector function (AQQ) and enhance half-life (YTE). Enrollment is complete in the multi-part Phase 1 study in healthy volunteers. Positive data from the single ascending dose portion of the study was presented in October 2025 . Data from the multiple ascending dose portion of the study and SubQ administration are anticipated in the third quarter of 2026. The pharmacodynamic biomarkers from blood and skin will be highly informative on the ability of CDX-622 to engage and neutralize SCF and TSLP. In January 2026 , we initiated an open-label, single-dose Phase 1 proof of mechanism (POM) study to assess the safety, pharmacodynamics, and pharmacokinetics of CDX-622 in adults with mild to moderate asthma. Participants will receive a single IV infusion of CDX-622 and be followed for 12 weeks. PD effects of CDX-622 on fractional exhaled nitric oxide (FeNO), absolute eosinophil count (AEC) and serum biomarkers, including TSLP- and SCF-related biomarkers, will be evaluated. First Quarter 2026 Financial Highlights and 2026 Guidance Cash Position: Cash, cash equivalents and marketable securities as of March 31, 2026 were $451.5 million compared to $518.6 million as of December 31, 2025 . The decrease was primarily driven by first quarter cash used in operating activities of $65.6 million . At March 31, 2026 , Celldex had 66.6 million shares outstanding. In April 2026 , the Company issued 11,896,750 shares of its common stock in an underwritten public offering, resulting in gross proceeds to the Company of $345.0 million . Revenues: Total revenue was $0.0 million in the first quarter of 2026, compared to $0.7 million for the comparable period in 2025. The decrease in revenue was primarily due to a decrease in services performed under our manufacturing and research and development agreements with Rockefeller University . R&D Expenses: Research and development (R&D) expenses were $73.0 million in the first quarter of 2026, compared to $52.6 million for the comparable period in 2025. The increase in R&D expenses was primarily due to an increase in barzolvolimab clinical trial and contract manufacturing expenses and an increase in employee headcount. G&A Expenses: General and administrative (G&A) expenses were $11.4 million in the first quarter of 2026, compared to $10.8 million for the comparable period in 2025. The increase in G&A expenses was primarily due to an increase in barzolvolimab commercial planning expenses. Net Loss: Net loss was $78.7 million , or ( $1.18 ) per share, for the first quarter of 2026, compared to a net loss of $53.8 million , or ( $0.81 ) per share, for the comparable period in 2025. Financial Guidance: Celldex believes that the cash, cash equivalents and marketable securities at March 31, 2026 , along with the approximately $323.9 million in net proceeds from our April 2026 underwritten public offering, are sufficient to meet estimated working capital requirements and fund current planned operations through 2028. About CelldexCelldex 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 StatementThis 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) and CDX-622, 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) 864-8337scavanaugh@celldex.com Patrick Till Meru Advisors (484) 788-8560ptill@meruadvisors.com Source: Celldex Therapeutics, Inc.