纪要涉及的公司和行业 - **公司**：Celldex Therapeutics（CLDX） - **行业**：制药行业，专注于慢性自发性荨麻疹（CSU）等疾病的药物研发 纪要提到的核心观点和论据 巴佐鲁单抗（Barzolumab）的研发进展 - **多适应症布局**：2020年展示了vargolumab项目数据，如今巴佐鲁单抗处于CSU的II期研究，还在慢性诱导性荨麻疹、嗜酸性食管炎、疣状苔藓和特应性皮炎等四个适应症进行II期开发 [7]。 - **CSU研究成果**：今年在AYAKE会议将展示已完成的CSU II期研究数据，该研究为76周大型随机II期研究，巴佐鲁单抗在各时间点均展现出该领域最高的完全缓解率，患者用药两周后即可快速完全缓解，缓解率在52周的积极治疗中持续保持 [8]。 巴佐鲁单抗的疗效优势 - **高完全缓解率**：76周研究中，治疗结束七个月后，高达41%的患者仍有完全缓解，且涵盖对奥马珠单抗无反应的患者，完全缓解与患者生活质量改善直接相关 [9]。 - **持续改善症状**：UAS 7评分在用药后迅速改善，至52周持续提升，76周时150毫克和300毫克组的基线UAS 7评分平均变化仍大于20分 [29]。 - **优于其他治疗**：完全缓解率高于许多患者接受其他治疗时的积极治疗阶段，且专家认为巴佐鲁单抗治疗后的影响和持久性明显优于该疾病的自发缓解 [31][32]。 巴佐鲁单抗的安全性 - **耐受性良好**：长期使用具有良好的安全性，风险获益比有利，随访期未发现新的安全信号，最常见事件轻微、可逆 [20]。 - **副作用轻微**：抑制KIT可能导致中性粒细胞计数减少和毛发、皮肤色素沉着变化，但均为轻度，无临床意义，不影响大多数患者，且可完全逆转 [21][24]。 巴佐鲁单抗的市场潜力 - **满足治疗需求**：CSU患者急需更有效的治疗方案，巴佐鲁单抗有望成为中重度CSU患者的首选药物 [8]。 - **医生认可度高**：调查显示医疗服务提供者在选择CSU治疗方法时，更看重疗效和生活质量相关特征，巴佐鲁单抗的数据得到医学界认可 [11]。 - **III期研究推进**：正在进行两项III期临床研究，计划在40个国家招募约915名患者，预计2026年夏季完成招募 [39]。 其他重要但是可能被忽略的内容 - **患者特征**：研究患者病情严重，70%的UAS 7评分大于28，血管性水肿发生率超70%，约20%接受过奥马珠单抗治疗，皮肤病生活质量指数平均得分15.7 - 17.4，表明CSU对生活质量影响大 [17]。 - **随访参与度**：161名患者完成52周治疗期，其中151名（94%）完成额外六个月随访期，数据可靠 [18]。 - **副作用细节**：中性粒细胞计数在随访期恢复到基线水平；毛发颜色变化中位发生时间为治疗后3.4个月，中位解决时间为5.6个月；皮肤色素沉着变化中位发生时间为8个月，中位解决时间为7.3个月 [22][25][55]。 - **治疗方案优化**：III期研究为300毫克剂量组增加负荷剂量，以实现更快速的反应和维持缓解，预计也会使150毫克剂量组受益 [94][96]。

Seven months after the completion of dosing: 41% of patients (150 mg Q4W) continue to experience complete response (UAS7=0)48% of patients (150 mg Q4W) report that CSU no longer impacts their quality of life (DLQI=0/1)KIT related tolerability events demonstrated to be reversible Enrollment to Phase 3 CSU trials ongoingCompany to host webcast today at 6:00 pm ET HAMPTON, N.J., June 12, 2025 (GLOBE NEWSWIRE) -- Celldex (NASDAQ:CLDX) announced today new data demonstrating profound, sustained complete response ...

Company to host webcast on Thursday, June 12 at 6:00 pm ETHAMPTON, N.J., June 10, 2025 (GLOBE NEWSWIRE) -- Celldex (NASDAQ:CLDX) announced today that data from the Company’s Phase 2 study of barzolvolimab in chronic spontaneous urticaria will be presented at the EAACI Congress 2025 being held in Glasgow, Scotland. Abstracts will be available on the meeting website Thursday, June 12th at 6:01 pm ET/ Friday, June 13th at 12:01 am CEST. Celldex will host a webcast on Thursday, June 12th at 6:00 pm ET to discus ...

HAMPTON, N.J., June 06, 2025 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today announced that Denice M. Torres has been elected to the company’s Board of Directors. "We are excited to welcome Denice to the Celldex Board of Directors," said Anthony Marucci, Co-founder, President and Chief Executive Officer of Celldex. "Denice’s extensive leadership experience across both the pharmaceutical and consumer healthcare sectors brings a deep operational and commercial perspective to our team. Her t ...

Celldex Therapeutics (CLDX) came out with a quarterly loss of $0.81 per share versus the Zacks Consensus Estimate of a loss of $0.75. This compares to loss of $0.56 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -8%. A quarter ago, it was expected that this biopharmaceutical company would post a loss of $0.75 per share when it actually produced a loss of $0.71, delivering a surprise of 5.33%.Over the last four quarters, the c ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number: 000-15006 CELLDEX THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware No. 13-3191702 (I.R.S. Employer Identification No.) (State or other jurisdiction of incorporation or organization) Perryville III Building, 53 Frontage Road, Suite 220, Hampton, New Jersey 08827 ☒ ...

HAMPTON, N.J., May 08, 2025 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today reported financial results for the first quarter ended March 31, 2025 and provided a corporate update. "In the first quarter of 2025, we presented data from our Phase 2 studies in chronic spontaneous and chronic inducible urticaria that demonstrated that barzolvolimab greatly improved quality of life for patients," said Anthony Marucci, Co-founder, President and Chief Executive Officer of Celldex Therapeutics. "Ba ...

Strong execution and progress across pipeline with multiple key data read outs expected in 2025Late breaking oral presentation on Phase 2 CSU program at EAACI 2025 in JunePhase 3 barzolvolimab CSU studies enrollment ongoing; Phase 3 program in CIndU under developmentPhase 2 EOE study enrollment complete; ongoing enrollment in Phase 2 PN and AD studiesCelldex’s first bispecific for inflammatory diseases, CDX-622, Phase 1 study ongoing HAMPTON, N.J., May 08, 2025 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. ...

HAMPTON, N.J., May 05, 2025 (GLOBE NEWSWIRE) -- Celldex announced today the presentation of histology data from the Company’s ongoing Phase 2 study of barzolvolimab in eosinophilic esophagitis (EoE). Biopsies taken during screening demonstrate the presence of high numbers of intraepithelial mast cells in participants with active EoE and correlate with eosinophil counts, supporting the hypothesis that treating EoE with barzolvolimab—a mast cell depleting agent—could provide promising therapeutic benefit. The ...

文章核心观点 - 公司公布CDX - 622积极临床前数据，其双靶点中和作用或为炎症和纤维化疾病患者带来临床益处，1期健康志愿者研究已启动 [1][2][3] CDX - 622介绍 - CDX - 622是双特异性抗体，靶向驱动慢性炎症的两条互补途径，中和TSLP并通过SCF饥饿耗竭肥大细胞，有望减少组织肥大细胞和抑制2型炎症反应 [5] - 1期随机、双盲、安慰剂对照、剂量递增研究正在招募最多56名健康参与者，评估单升剂量和多升剂量的安全性、药代动力学和药效学 [5] 临床前研究结果 - CDX - 622在体外抑制TSLP和SCF依赖性活动的效力与亲本单克隆抗体、tezepelumab和barzolvolimab相似 [8] - 优先抑制可溶性SCF而非膜形式SCF，可能对KIT依赖性过程产生不同影响 [8] - 在人体皮肤外植体模型中抑制SCF和TSLP依赖性炎症特征 [8] - 表现出单克隆抗体样药代动力学特性，显著减少皮肤肥大细胞特征 [8] - 在GLP毒理学研究中各剂量水平耐受性良好，无观察到的不良反应水平，导致多个组织中肥大细胞大量耗竭 [8] 公司介绍 - 公司是临床阶段生物技术公司，处于肥大细胞生物学和变革性疗法开发的前沿，管线包括基于抗体的疗法 [6]