IMG-007

贝壳社 7月24日，赛诺菲宣布终止amlitelimab在中重度特应性皮炎（AD）的临床开发，不再向全球任何监管机构递交上市申请。 在Dupixent（度普利尤单抗）专利到期倒计时的节点上，赛诺菲又少了一个潜在的接力者。 01 数据并不难看 amlitelimab是全球首个且目前唯一进入临床III期阶段的OX40L单抗，在早期的III期研究（COAST 1、COAST 2、SHORE）及II期延伸研究（ATLANTIS）中，amlitelimab均表现出疗效随治疗时间持续改善、无平台期，且部分患者在停药后仍能维持较好疗效的趋势。III期长期延伸研究ESTUARY则显示，患者在持续治疗后能够维持临床应答且不复发，安全性数据与既往研究一致。 从纯数据角度看，amlitelimab并非无效。它确实展现了优于安慰剂的疗效，长期用药也维持了应答。但赛诺菲的判断是："从既往研究的安全性数据来看，amlitelimab不足以成为特应性皮炎患者的更好的标准治疗选择。" 在Dupixent占据AD市场领先份额，且部分长期或深度缓解数据表现优异的市场里，一个比安慰剂好但未必比现有疗法好的药物，商业生存空间有限。 Dupixent在2025年的全球销售额约为178亿美元（约157亿欧元），其中特应性皮炎适应症贡献了约128亿美元，占总收入的近七成。这个产品已经从一个自免新药成长为赛诺菲的营收基石，一个产品撑起公司约36%的总收入。 但Dupixent也面临着专利悬崖，核心化合物专利预计在2031年前后到期。这意味着赛诺菲需要在大约5年内找到能部分替代Dupixent营收的产品或管线。amlitelimab原本是这条赛道上最被看好的候选者之一，同样是免疫学机制、同样聚焦皮肤炎症，如果成功，几乎是天衣无缝的接力方案。 现在这个方案被砍掉了。 2025年底，赛诺菲经历了CEO更替，任期六年的Paul Hudson离任，曾在默克任职15年并担任CEO的Belén Garijo回归掌舵。Garijo上任后的核心任务之一，就是对管线进行效率审计，把资源集中在真正有差异化潜力的候选者身上。 amlitelimab在AD的出局，或许正是基于这一战略的调整。 02 OX40L通路 OX40是一种主要表达在活化T细胞表面的受体，当它与配体OX40L结合时，产生的共刺激信号支持多种T细胞亚型的活化、扩增和存活。与dupixent从下游阻断IL-4/IL-13信号不同，amlitelimab试图在更上游的位置进行干预，即在炎症启动的前阶段就截断T细胞过度活化的信号，同时保留促炎性T细胞和调节性T细胞之间的平衡，而非简单地耗竭T细胞。 这种调节而非耗竭的理念在学术上很有吸引力，也是赛诺菲当初以11亿美元收购Kymab获得这一管线的动力。 值得注意的是，赛诺菲在终止AD适应症的同时，保留了amlitelimab在乳糜泻（celiac disease）领域的II期临床开发，预计2026年下半年读出数据。 amlitelimab退场的同时，AD赛道的竞争仍在加剧。在生物制剂领域，康诺亚的司普奇拜单抗作为国产首个IL-4Rα单抗，已经在AD市场快速放量。其III期52周数据显示，EASI-75和EASI-90应答率分别达到92.5%和77.1%，在数据层面与Dupixent形成直接竞争。此外，康悦达的定价（约1039元/针）低于Dupixent（约1508元/针），2026年7月已正式纳入国家基药目录。 礼来的来瑞组单抗（lebrikizumab/Ebglyss）作为高选择性IL-13靶向药物，2026年6月获FDA新批了每8周一次的超长效维持方案，全年仅需6次注射，使其成为给药最便利的AD生物制剂之一。礼来的来瑞组单抗已在国内提交上市申请。 JAK抑制剂方面，口服给药的便利性优势渐显。强生的口服银屑病药Icotyde上市首个完整季度处方量即突破1.8万张，验证了口服在自免领域的巨大潜力。 更值得关注的是STAT6靶点，作为IL-4/IL-13通路下游的核心转录因子，被称为Th2型炎症的"总开关"。2026年6月，Kymera的口服STAT6降解剂KT-621的IIb期临床完成入组，顶线数据预计年底读出，消息当天股价暴涨超16%，市值逼近百亿美元。 与此同时，OX40/OX40L通路中，信达生物的IBI356是国内首款申报临床的OX40L单抗，目前正在进行中重度特应性皮炎的II/III期临床研究，采用皮下注射或静脉输注给药。创响生物的IMG-007（anti-OX40单抗）在中重度特应性皮炎患者中的Phase 2b ADAPTIVE研究，预计顶线结果将于2026年第四季度公布。 过去十年，随着制药行业对新靶点、新机制的追求，OX40/OX40L通路调节而非耗竭的理念在理论上优于传统的免疫抑制策略，赛诺菲也愿意为其支付11亿美元的收购价格。但当临床数据与Dupixent等现行疗法正面相遇时，理论上更好和临床上足够好之间的鸿沟，变得难以逾越。 往 期 推 荐 1 贝壳观察：行业观察 2 贝壳时刻 _ _ _ *声明：本文仅用于分享，不构成任何投资建议，且非治疗方案推荐。 素材来源官方媒体/网络新闻 关于贝壳社 贝壳社（Bioclub）是行业领先的医健创新创业服务平台，构建了"产业空间+ 创业培育+投资孵化+资本赋能"四位一体为核心，叠加"品牌媒体+医学成果转化"，形成"4+2"全链路赋能业务体系，通过深度挖掘全球范围内的高成长项目、精准匹配产业资源及全球生态网络，覆盖企业从孵化培育到加速发展的全周期赋能服务。 目前已在上海、杭州、香港、澳洲墨尔本四大核心城市设立办公室与服务中心，国际化布局完善，积极推进境外业务深耕拓展，搭建成熟全球化服务网络，全方位助力医健企业实现跨境发展与国际化落地。贝壳社以加速科学技术成果转化与产业升级为目标，致力于成为医健领域的孵化器、加速器、连接器。

Brings more than 15 years of corporate, securities, and transactional experience advising public and private life sciences companies SAN DIEGO, July 07, 2026 (GLOBE NEWSWIRE) -- ImageneBio, Inc. (Nasdaq: IMA, “Imagene” or the “Company”), today announced the appointment of Matt Robbins, an experienced life sciences attorney with more than 15 years of corporate, securities, and transactional experience, as General Counsel, effective July 7, 2026. Robbins will oversee Imagene's legal, corporate governance, intellectual property, and compliance functions, providing strategic counsel as the Company advances its lead candidate, IMG-007. “We are thrilled to welcome Matt to the Imagene management team,” said Kristin Yarema, PhD, Chief Executive Officer of Imagene. “Matt’s experience building a legal function inside a clinical-stage biotech company, combined with his years advising life science companies through public offerings and complex transactions, is a great fit for Imagene as we continue to advance and scale up our Phase 2 clinical programs in atopic dermatitis and alopecia areata. As we celebrate our one-year company anniversary later this month, we are entering an exciting new phase of growth with important milestones and data readouts on the horizon. Matt's leadership and expertise will be invaluable as we continue to grow, strengthen our organization, and execute on our strategic priorities.” Robbins is an experienced corporate and securities attorney whose career spans the life sciences industry in both firm and in-house roles. Most recently, he served as General Counsel of Bright Peak Therapeutics, Inc., a venture-backed clinical-stage biotechnology company, where he built the legal function from the ground up. Prior to Bright Peak, he spent nearly nine years at Cooley LLP in San Diego, advising public and private life sciences companies on corporate, securities, and transactional matters. Earlier in his career, he served as a Senior Consultant at Deloitte & Touche LLP. Robbins holds a JD from Northwestern University Pritzker School of Law and a Bachelor of Arts in Economics from the University of California, Los Angeles. He is admitted to the California State Bar. About ImageneBio, Inc. Imagene is a clinical-stage biotechnology company dedicated to developing therapeutics for patients with immunological, autoimmune and inflammatory diseases with differentiated clinical pro The Company’s program, IMG-007, is a receptor targeting, non-T cell-depleting, ADCC-silenced, anti-OX40 monoclonal antibody with an approximately 5-week half-life. Imagene has completed proof-of-concept clinical trials of IMG-007 in both atopic dermatitis and alopecia areata and is currently conducting a Phase 2b clinical trial of IMG-007 in patients with moderate-to-severe atopic dermatitis. Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, without limitation, statements regarding: the expected benefits from appointing Matt Robbins as General Counsel of the Company; the belief that the anti-OX40/OX40L class is on a promising path towards adoption in AD and other inflammatory and autoimmune indications; the potential benefits of OX40/OX40L antagonists generally and IMG-007 specifically in AD and AA; and other statements regarding management’s intentions, plans, beliefs, expectations or forecasts for the future. Words such as “will,” “can,” “expect,” “may,” “plan,” “potential,” “goal,” or other words that convey uncertainty of future events or outcomes are used to identify these forward-looking statements. These statements are subject to a number of risks, uncertainties and assumptions, including, but not limited to: risks associated with the nonclinical and clinical development and regulatory approval of IMG-007, including potential delays in the completion of clinical trials and potential safety and other complications thereof; the timing of the availability of data from the Company’s clinical trials; the clinical utility, potential differentiation and/or benefits and market acceptance of IMG-007; the requirement for additional capital to continue to advance the IMG-007 program, which may not be available on favorable terms or at all; the Company’s ability to attract, hire, and retain skilled executive officers and employees; the Company’s ability to protect its intellectual property and proprietary technologies; the Company’s reliance on third parties, contract manufacturers, and contract research organizations; the possibility that the Company may be adversely affected by other economic, political, business, or competitive factors; and risks associated with changes in applicable laws or regulations or government resources and policies. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties. These and other risks and uncertainties are more fully described in the Company’s filings with the Securities and Exchange Commission (the SEC), including the factors described in the section titled “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on March 10, 2026, and in the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, filed with the SEC on May 7, 2026. You should not place undue reliance on these forward-looking statements, which are made only as of the date hereof. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. Investor Contact: Rebecca Cohen rcohen@imagenebio.com Media Contact: Jason Braco, PhD Valence Communications jason@valencecomms.com