IMG-007(IMG-007) - 药物靶点：OX40_在研适应症：特应性皮炎，湿疹，斑秃_专利_临床

A Phase 2b, Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel-group, Dose-finding Study to Evaluate the Efficacy and Safety of IMG-007 in Adult Participants With Moderate-to-Severe Atopic Dermatitis

The purpose of this study is to evaluate the efficacy and safety of different dose regimens of IMG-007, compared to placebo.

开始日期2025-06-17

申办/合作机构

Inmagene Biopharmaceuticals Ltd.

NCT06304740

/ Terminated临床1期

A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of a Single Subcutaneous Dose of IMG-007 in Healthy Participants

This is a double-blind, randomized, placebo-controlled study to assess the safety and PK profile of a single subcutaneous dose of IMG-007 in healthy participants. The study will comprise of a 5-week screening period, a 3-day In-patient Period in a clinical research unit (CRU) and an Out-patient Follow-up Period up to 127 days. The study will include 3 dose cohorts which will be enrolled sequentially. Participants will receive a single subcutaneous dose of IMG-007 or placebo at Baseline according to their assigned dose.

开始日期2024-03-06

申办/合作机构

Inmagene Biopharmaceuticals Ltd.

NCT06060977

/ Completed临床1/2期

A Phase 1b/2a Study to Evaluate the Safety, Pharmacokinetics and Efficacy of IMG-007 in Adult Alopecia Areata Participants With 50% or Greater Scalp Hair Loss

The primary objective of the study is to evaluate the safety of IMG-007 in adults with Alopecia Areata.

开始日期2023-09-25

申办/合作机构

Inmagene Biopharmaceuticals Ltd.

100 项与 IMG-007 相关的临床结果

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100 项与 IMG-007 相关的转化医学

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100 项与 IMG-007 相关的专利（医药）

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2

项与 IMG-007 相关的文献（医药）

2024-09-01·Dermatology and Therapy

Extended Half-life Antibodies: A Narrative Review of a New Approach in the Management of Atopic Dermatitis

Review

作者: Yilmaz, Orhan ; Torres, Tiago

Atopic dermatitis (AD) is a chronic, inflammatory skin disease characterized by intense pruritus and eczematous lesions, significantly impacting physical health and quality of life. The pathogenesis of AD involves genetic predisposition, immune dysregulation, and environmental factors, with a defective skin barrier playing a crucial role. Treatment options for AD include both topical and systemic therapies, with advanced treatments like Janus kinase inhibitors and biologics offering significant improvements but facing limitations in safety and dosing frequency. Extended half-life antibodies represent a promising advancement for the management of immune-mediated inflammatory diseases, including AD. These antibodies, engineered for prolonged circulation and reduced dosing frequency, target key cytokines and immune pathways known to be involved in the pathogenesis of AD, offering potential for less frequent administration while maintaining efficacy. Currently, two such agents are in phase 2 trials. APG777, targeting interleukin-13 (IL-13), and IMG-007, targeting OX40 receptor, have shown promising preclinical and early clinical results. They demonstrated prolonged half-lives and the potential for less frequent dosage regimen, along with significant improvements in AD symptoms. These therapies could enhance patient adherence and reduce healthcare burdens by decreasing injection frequencies and clinic visits. As research continues, extended half-life antibodies could significantly improve AD management and patient quality of life. Further studies will determine the long-term safety and efficacy of extended half-life antibodies, with ongoing innovations in antibody engineering likely to broaden their applications and benefits.

BIODRUGS

The Role of OX40 Pathway Inhibition as a New Therapeutic Strategy for Atopic Dermatitis

Review

作者: Alvarenga, José Miguel ; Torres, Tiago ; Mohamed, Adam ; Oliveira Dos Santos, David ; Mohamed, Amir

Atopic dermatitis is a chronic inflammatory skin disease affecting approximately 15-20% of children and 2-10% of adults worldwide. Epidermal barrier dysfunction and immune dysregulation are central to its pathogenesis, creating a self-perpetuating cycle in which barrier disruption exacerbates inflammation, which in turn further impairs skin barrier integrity. The OX40/OX40L axis, involving the co-stimulatory receptor OX40 expressed on T cells and its ligand OX40L on antigen-presenting cells, plays a critical role in sustaining T cell-driven inflammatory responses in AD. Despite recent therapeutic advances, many patients remain inadequately controlled, and key unmet needs persist. Inhibitors of the OX40/OX40L pathway represent a novel therapeutic approach by modulating multiple effector and memory T-cell subsets implicated in disease pathogenesis. Amlitelimab, an anti-OX40L monoclonal antibody, has demonstrated sustained efficacy and a favorable safety profile in phase IIa and IIb trials. Rocatinlimab, targeting OX40, has also shown promising results in a phase IIb study and has progressed into multiple phase III trials, with supportive top-line data. In contrast, telazorlimab has shown more modest efficacy and has not advanced to later-stage development. Next-generation agents, including IMG-007, STAR-0310, APG990, and APG279, have been engineered with extended half-lives and attenuated antibody-dependent cellular cytotoxicity to support longer dosing intervals and improve tolerability. While these findings are encouraging, direct comparative studies among agents and versus established therapies are lacking, and long-term efficacy and safety data are still needed. This narrative review explores the role of the OX40/OX40L axis in atopic dermatitis pathogenesis and critically evaluates emerging therapies targeting this pathway, aiming to inform their future integration into clinical practice.

121

项与 IMG-007 相关的新闻（医药）

2026-03-29

·未来药研所

半年一次，疗效不减！重度特应性皮炎患者迎来新希望

目前正在临床研究阶段、旨在实现每24周（约半年）仅需注射一次的OX40靶向疗法。这代表了特应性皮炎治疗从“频繁用药”向“超长效维持”的革命性迈进。核心突破：瞄准“半年一针”的OX40靶向药目前，实现“半年一次”给药最有希望的候选药物是IMG-007（由创响生物研发）。它是一种人源化抗OX40单克隆抗体，通过阻断OX40/OX40L信号通路，调控导致特应性皮炎的关键T细胞免疫反应。超长半衰期：其设计使其具有长达34.7天的半衰期，这是实现超长给药间隔的药理学基础。关键临床进展：其他迈向“长效治疗”的潜力新药除了IMG-007，还有多款旨在延长给药间隔的新药正在研发中，共同构成了特应性皮炎的“长效疗法”矩阵：药物名称 (研发公司) 靶点/机制核心特点与最新进展 CM512 (康诺亚) 全球首款长效TSLP x IL-13双阻断剂（双特异性抗体）半衰期长达70天，I期临床显示可实现2-3个月给药一次，正在快速推进II期临床。 APG777 (未明确) 长效抗IL-13单克隆抗体具有延长半衰期设计，2期（APEX）试验显示，第16周时患者EASI评分平均改善71%，起效迅速（第2周显效），旨在降低注射频率。 IBI3002 (信达生物) 抗IL-4Rα/TSLP双特异性抗体同时阻断两个关键炎症通路，通过Fc区改造延长半衰期，为长效治疗提供可能，目前处于I/II期临床。 ZL-1503 (再鼎医药) IL-13/IL-31R双特异性抗体同时靶向炎症（IL-13）和致痒（IL-31）通路，具有延长半衰期，全球I/Ib期研究已完成首例给药。为何“超长效”是重大突破？对于重度特应性皮炎患者而言，长期频繁用药（如每2周或每4周注射一次）是巨大的身心和经济负担，严重影响治疗依从性和生活质量。“半年一次”乃至“数月一次”的疗法若能实现，将意味着：治疗依从性革命性提升：极大减轻患者往返医院和频繁自我注射的负担。长期疾病管理更稳定：稳定的血药浓度有助于实现更持续、平稳的病情控制，减少波动。降低总体治疗成本：虽然单次费用可能较高，但考虑到给药频率大幅降低、交通和时间成本减少，长期看可能更具经济性。当前已上市的主流生物制剂（作为参照）目前国内已上市的主流生物制剂（如度普利尤单抗、司普奇拜单抗）仍需每2-4周注射一次。新型JAK抑制剂（如艾玛昔替尼）则为每日口服。这些药物为患者提供了有效选择，但“超长效”仍是未被满足的临床需求。总结：以IMG-007为代表的、旨在实现“半年一针”的OX40靶向疗法，正处于临床验证的关键阶段。同时，CM512、APG777等多款长效生物制剂也在快速研发中。这些突破共同指向一个未来：重度特应性皮炎患者有望从频繁的用药中解放出来，通过极低的给药频率实现长期、稳定的病情控制，这无疑是颠覆性的新希望。我们始终关注全球医学前沿，致力于将最权威、最实用的科研成果转化为大众听得懂的健康知识。免责声明：本文仅作信息交流之目的，文中观点不代表本人本号立场，亦不代表支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。免责声明：本文仅作信息交流之目的，本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在【未来药研所】微信公众号留言联系。如有其他合作需求，请联系mglin68@icloud.com 官方咨询：分享，点赞，在看，传递全球医药最新前沿

2026-03-18

·医学联络官

特应性皮炎药物国产替代将至

× 获取更多行业报告🧾、白皮书📖、投资报告📊、市场洞察📃、趋势报告📈、蓝皮书📘，请添加小编微信号🆔MedicalLiasion  特应性皮炎人数多，市场空间大，目前仍存在巨大未满足的临床需求，生物制剂是特应性皮炎治疗的下一个重要方向  我国特应性皮炎患者人数于2022年达7070万例，其中儿童/青少年达3470万例。预计到2030年达8170万人，其中儿童/青少年达3650万例。2022年我国中重度特应性皮炎市场规模达5.2亿美元，轻度特应性皮炎市场规模达4.1亿美元，中重度特应性皮炎市场规模占比55.9%。未来，随着生物制剂渗透率的逐步提升，预计到2030年我国特应性皮炎市场规模达42.6亿美元。  目前，指南建议中重度特应性皮炎在使用外用药物的同时，可联合系统免疫抑制剂、短期糖皮质激素、紫外线疗法或生物制剂等。但糖皮质激素、抗组胺药等存在疗效有限、起效较慢、不良反应等不足，对于激素应答不佳的难治性中重度特应性皮炎患者，指南推荐使用生物制剂或JAK抑制剂等。我们认为，鉴于生物制剂的优异疗效，我们认为生物制剂是特应性皮炎治疗的下一个重要方向。  IL-4R单抗已崭露头角，度普利尤单抗2023年销售额预计突破100亿美元，JAK1抑制剂发展方兴未艾，OX40单抗有望成为特应性皮炎明日之星  IL-4R是特应性皮炎的重磅靶点，赛诺菲的度普利尤单抗全球是唯一一款获批用于特应性皮炎适应症的IL-4R药物，2022年全球销售额达86.8亿美元（+46.1%），2023年全球销售额有望突破百亿美元。JAK1抑制剂是中重度特应性皮炎领域的新星，全球共两款JAK1抑制剂获批AD适应症，分别是艾伯维的乌帕替尼和辉瑞的阿布昔替尼，其中乌帕替尼2022年全球销售额达25.2亿美元（+52.7%）。OX40抑制剂在AD的发展方兴未艾，安进的Rocatinlimab和赛诺菲的Amlitelimab有望实现4周给药一次，大大提升患者的用药便利性。  重点标的：特应性皮炎药物国产替代将至，康诺亚的CM310和恒瑞医药的艾玛昔替尼均于2023年底递交上市申请，泽璟制药、和黄医药、诺诚健华、冠昊生物等企业的特应性皮炎药物正处于临床阶段  康诺亚：CM310是一款高效的IL-4Rα拮抗性抗体，于2023年12月向国家药监局递交上市申请。具有FIC和BIC的潜力。  恒瑞医药：艾玛昔替尼于2023年12月向NMPA递交上市申请。16周时，艾玛昔替尼8mg、4mg组获得IGA应答的受试者比分别为42.0%和36.3%，EASI-75应答分别为66.1%和54.0%。  泽璟制药：杰克替尼是泽璟制药旗下一款JAK抑制剂，中重度特应性皮炎适应症目前处于临床Ⅲ期。  和黄医药：IMG-007是InnoMed与和黄医药联合开发的一款OX40抑制剂，2023年5月，IMG-007获FDA批准IND。  风险提示：创新药研发的不确定性、研发进展不及预期、商业化进展不及预期、药品降价风险，医药行业政策风险等。点击“阅读原文”可下载完整版PPT！！具体内容如下点击“阅读原文”可下载完整版PPT！！ 👇点击“阅读原文”加入医学联络官俱乐部！！

2026-03-18

·BioSpace

ImageneBio Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) - March 17, 2026

SAN DIEGO, March 17, 2026 (GLOBE NEWSWIRE) -- ImageneBio, Inc. (Nasdaq: IMA) (“Imagene” or the “Company”) today announced that on March 16, 2026 the Company’s Compensation Committee of the Board of Directors (the “Compensation Committee”) granted equity awards to two newly hired employees in the form of restricted stock units (“RSUs”) and non-qualified stock options (“NSOs”) for an aggregate of 38,442 RSUs and 43,000 NSOs as an inducement material to their acceptance of employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4). The employment inducement awards were granted under the Company’s 2025 Inducement Plan. Each NSO has an exercise price equal to $6.20 per share, the closing price on March 16, 2026. The NSOs will vest over four years, with 25% of the shares vesting on the one-year anniversary of the vesting commencement date and the remaining 75% of the shares vesting in equal monthly installments over the following 36 months subject to the grantee’s continued service through each vesting date. The RSUs will vest over four years, with equal installments vesting annually beginning on the one-year anniversary of the vesting commencement date subject to the grantee’s continued services through each vesting date. The equity awards are subject to the terms and conditions of the Company’s 2025 Inducement Plan and the terms and conditions of the applicable equity award agreement covering such grant. 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, nondepleting anti-OX40 monoclonal antibody with multiple differentiating features. Imagene has completed Phase 1b/2a 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. For more information, please visit . Investor and Media Contact: ir@imagenebio.com

临床2期

100 项与 IMG-007 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
特应性皮炎	临床2期	美国	Inmagene Biopharmaceuticals Ltd.	2025-06-17
特应性皮炎	临床2期	加拿大	Inmagene Biopharmaceuticals Ltd.	2025-06-17
湿疹	临床2期	美国	Inmagene Biopharmaceuticals Ltd.	2025-06-17
湿疹	临床2期	加拿大	Inmagene Biopharmaceuticals Ltd.	2025-06-17
斑秃	临床2期	美国	Inmagene Biopharmaceuticals Ltd.	2023-09-25
斑秃	临床2期	加拿大	Inmagene Biopharmaceuticals Ltd.	2023-09-25
中度特应性皮炎	临床2期	美国	Inmagene Biopharmaceuticals Ltd.	2023-08-09
中度特应性皮炎	临床2期	加拿大	Inmagene Biopharmaceuticals Ltd.	2023-08-09
重度特应性皮炎	临床2期	美国	Inmagene Biopharmaceuticals Ltd.	2023-08-09
重度特应性皮炎	临床2期	加拿大	Inmagene Biopharmaceuticals Ltd.	2023-08-09

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT06060977 (CTgov)	临床1/2期	斑秃	29	IMG-007 (IMG-007 300 mg)	遞夢製願製簾顧糧窪顧 = 鏇鹹鏇鑰顧襯壓鏇襯夢襯鹹鬱鑰遞築廠餘糧艱 (鑰構鹹選艱壓製鬱鏇窪, 築鏇夢網憲積糧淵夢築 ~ 積鹽製艱襯淵醖夢淵築) 更多	-	2026-02-09
				IMG-007 (IMG-007 600 mg)	遞夢製願製簾顧糧窪顧 = 願簾觸餘獵廠齋餘積築襯鹹鬱鑰遞築廠餘糧艱 (鑰構鹹選艱壓製鬱鏇窪, 繭鏇醖蓋淵窪襯糧淵簾 ~ 衊衊鏇製糧膚淵網製窪) 更多
NCT05984784 (CTgov)	临床1/2期	中度特应性皮炎 \| 重度特应性皮炎	13	IMG-007	窪壓繭憲築鏇醖顧繭廠 = 夢襯積壓簾餘製壓膚製醖網膚構遞遞壓範憲構 (鑰憲餘顧範憲壓選鬱齋, 繭築齋糧餘製淵觸鏇窪 ~ 壓襯鹽遞壓願蓋鏇齋製) 更多	-	2025-11-06
NCT06060977 (NEWS) 人工标引	临床2期	斑秃	29	IMG-007 300mg	鬱積願選糧醖憲餘顧鏇(夢製襯夢膚壓鑰鑰選繭) = 簾鹹築範製鏇膚襯構襯遞鏇鹽窪醖艱夢壓遞襯 (簾淵夢製獵顧鏇鑰獵遞 )	积极	2025-04-25
				IMG-007 600mg	鬱積願選糧醖憲餘顧鏇(夢製襯夢膚壓鑰鑰選繭) = 壓糧選築鹹築夢糧製窪遞鏇鹽窪醖艱夢壓遞襯 (簾淵夢製獵顧鏇鑰獵遞 ) 更多
NCT06304740 (NEWS) 人工标引	临床1期	特应性皮炎	16	IMG-007 SC	夢網顧遞襯壓製鹽願鹽(願遞齋窪鏇構選構衊鹽) = 壓鹹築淵齋觸廠獵願製壓鑰淵蓋窪繭夢範艱簾 (夢製繭顧製獵製製獵獵 ) 更多	积极	2025-01-10
				Placebo	積鹽憲築積築願獵願憲(鑰鬱簾顧憲壓築製鹽顧) = 簾壓蓋鹽襯艱簾顧夢選繭簾顧蓋夢壓廠醖鏇艱 (遞顧夢遞簾網鑰襯積壓 )
NCT05984784 (Company_Website \| NEWS) 人工标引	临床2期	特应性皮炎	13	IMG-007 300 mg	衊餘廠蓋繭醖觸願衊壓(顧膚網鹽構鏇觸遞範鏇) = 簾襯蓋鏇鹹鏇築構糧構齋顧獵製製選遞憲衊淵 (淵簾廠艱鬱襯簾鑰築廠 ) 更多	积极	2024-05-06
NCT05353972 (NEWS) 人工标引	临床1期	特应性皮炎	44	IMG007	築窪餘積餘築遞夢衊餘(鬱鏇觸遞窪襯艱製簾膚) = IMG-007组未见比安慰剂组更高比例的特别不良事件（除了无剂量相关性的一些孤立 COVID-19病例），没有受试者报告任何与治疗相关的不良事件。重要的是，未报告发热或寒战事件。遞齋廠範廠餘鏇齋衊蓋 (觸艱選簾夢襯窪艱窪鏇 )	积极	2023-08-21
				placebo