使用IMG-007治疗4周后,患者湿疹面积和严重程度评分(EASI)较基线下降77%,并且54%的患者达到EASI-75的改善标准
观察到在24周内,炎性标志物得到了持久的抑制
IMG-007皮下注射给药(SC)剂型半衰期长达约35天
IMG-007总体耐受性良好,未出现发热或寒颤等不良反应
IMG-007能够阻断OX40-OX40L信号转导,但不引起T细胞耗竭,并且具有较长的半衰期,突显了其差异化的临床特征及其潜在的便捷给药优势
预计将在2025年第一季度启动IMG-007 SC在中重度特应性皮炎(AD)患者中的Phase 2b剂量发现研究
圣地亚哥,加利福尼亚, 2025年1月10日 – 创响生物(Inmagene Biopharmaceuticals, 下简称“创响”),一家处于临床阶段,专注于自身免疫和炎症疾病(I&I)领域创新和差异化治疗的创新药研发公司,今天宣布IMG-007在中重度AD患者中的临床2a期研究取得了更多积极顶线结果,同时IMG-007 SC的1期临床研究也取得了研究结果。
王健博士
创响创始人、董事长兼CEO
“IMG-007是全球唯一处于临床阶段、能在血液和组织中特异性地阻断OX40-OX40L信号传导,同时不清除T细胞的单克隆抗体。IMG-007 的长半衰期与抗OX40/OX40L的研究性单克隆抗体类分子共同表现出的持久疗效相结合,将会让在AD 和其他潜在适应症的维持治疗阶段探索更长的给药间隔(例如每24周一次)成为可能。”
IMG-007 为非耗竭性抗OX40单克隆抗体,通过生物工程改造,消除了抗体依赖的细胞介导的细胞毒性(ADCC)效应,从而降低了潜在的安全性风险。同时,该改造延长了抗体的半衰期,可能有助于减少给药频率。该项2a期开放临床研究(NCT05984784)共纳入来自美国和加拿大的13例患者,评估IMG-007静脉注射(IV)给药在成人中重度AD患者中的安全性、药代动力学(PK)和有效性。与2024年5月发布的中期分析结果相似,在研究的第0、2、4周共三次给药,观察到EASI及其他终点指标均表现出显著且持久的临床疗效。
在给药后第16周,EASI评分较基线平均下降了77%,并且54%的患者达到了EASI-75的改善标准。该疗效表现与其他靶向OX40/OX40L的研究性单克隆抗体在较长治疗周期(至少16周)中的疗效相当。此外,研究中还观察到IMG-007对多种辅助性 T 细胞 (包括 Th1、Th2 和 Th17 细胞) 的血清炎症标志物有持续时间长达 24 周的抑制作用。IMG-007 的总体耐受性良好,未报告严重不良事件 (SAE),无导致停药的不良事件 (AE),且未观察到研究药物相关的 AE。研究中也未有关于发热或寒颤的报告。
此外,创响还开展了一项评估IMG-007皮下注射制剂在16名健康受试者中的安全性和PK特征的1期临床研究(NCT06304740)。研究结果表明,IMG-007 SC的药代动力学特征总体上与静脉注射剂型相似。在预期有效剂量下,18周的随访周期内,血清中药物浓度始终保持在足以阻断OX40/OX40L信号传导所需的水平以上。IMG-007单次皮下注射的平均消除半衰期为34.7天,显著长于其他处于临床开发阶段的OX40/OX40L单克隆抗体。研究还表明,IMG-007 SC具有良好的耐受性和安全性。最常见的不良事件为注射部位反应(ISRs),如注射部位发红、疼痛和瘙痒,且其发生率在安慰剂组(75%)中高于IMG-007组(25%)。所有报告的注射部位反应均为轻度。
创响预计在2025年第一季度,启动在IMG-007皮下注射剂在中重度AD患者中的Phase 2b剂量发现研究。
陆雨芳博士
创响首席医学官
“IMG-007 在 AD 患者中的 2a 期临床研究得到了令人振奋的积极顶线结果。在仅仅 4 周给药后,观察到显著的临床疗效与生物标志物数据以及良好的安全数据,表明消除ADCC活性的 IMG-007不仅保留了预期的阻断 OX40的生物活性,同时提高了耐受性。AD 是一种需要长期治疗的慢性复发性疾病,目前批准的生物制剂通常需要每 2 或 4 周频繁注射。IMG-007 的皮下注射制剂具有较长的半衰期,同时耐受性良好,这可能为 AD 的长期治疗提供一种差异化的给药方案。”
关于创响生物
创响生物是一家全球领先的临床阶段生物技术公司,专注于自身免疫及炎症疾病(I&I)领域的新药研发。公司拥有一条高度差异化的临床管线,其中多个候选药物展现出同类最佳的潜力。其先导化合物IMG-007是一种非耗竭性抗OX40单克隆抗体,目前正处于2期临床研究阶段。另一重要候选药物IMG-004是一种非共价、可逆的BTK抑制剂,具备超长的半衰期及显著的药效学作用,展示出每日一次给药的潜力,已准备进入2期临床研究。更多信息,请访问www.inmagenebio.com.
关于IMG-007
IMG-007为人源化抗OX40单克隆抗体,消除了ADCC效应,同时具有较长的半衰期。OX40与OX40L信号通路在多种自身免疫和炎症性疾病的发病机制中起着关键作用。非临床研究表明,IMG-007能够有效阻断OX40-OX40L信号通路。其皮下注射制剂的半衰期为34.7天,表明它具有支持开发更具竞争力的给药方案的潜力。目前,IMG-007正在进行二期临床研究。该药物最初由HUTCHMED公司发现。
前瞻性声明
本新闻稿包含前瞻性陈述。虽然创响认为这些预测是基于合理的假设,但这些前瞻性陈述可能会受到多种风险和不确定因素的影响,实际结果可能与此类前瞻性陈述中的预期存在重大差异。
Forward-Looking Statements
This press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including, without limitation, statements regarding: the potential benefits of IMG-007, including its potential to provide a differentiated clinical profile and convenient dosing regimens, its ADCC function potentially improving IMG-007’s tolerability profile and retaining desired biological activity of OX40 blockage and its prolonged half-life enabling potentially less frequent dosing regimen; the planned Phase 2b dose-finding study with IMG-007’s SC formulation in patients with moderate to severe AD and the timing thereof; the Company’s plans to explore the potential for long dosing intervals for IMG-007 for maintenance therapy in AD and other potential indications; the Company’s highly differentiated clinical-stage pipeline having multiple candidates with best-in-class potential; and IMG-004 being ready for Phase 2 development. These statements are subject to a number of risks, uncertainties and assumptions, including, but not limited to: preliminary results may not be indicative of results that may be observed in the future; the timing and success of clinical trials and potential safety and other complications thereof; there have been no head-to-head trials conducted comparing IMG-007 to other investigational OX40/OX40L-targeting mAbs with longer duration of treatments; the uncertainties associated with the Company’s platform technologies, as well as risks associated with the clinical development and regulatory approval of product candidates, including potential delays in the commencement, enrollment and completion of clinical trials; uncertainties in obtaining successful clinical results for product candidates and unexpected costs that may result therefrom; risks related to the failure to realize any value from product candidates and preclinical programs being developed and anticipated to be developed; risks related to the inability of the Company to obtain sufficient additional capital to continue to advance its product candidates and its preclinical programs, including additional capital from the proposed merger with Ikena Oncology, Inc. (Ikena) and the concurrent private placement; the risk that the conditions to closing of the proposed merger and concurrent private placement are not satisfied and other risks related to the timing, approvals, consummation and anticipated benefits of the proposed merger. 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. You should not place undue reliance on these forward-looking statements, which are made only as of the date hereof or as of the dates indicated in the forward-looking statements. Inmagene expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.
更多信息,请联系:
创响生物
Anna Vardanyan, MD, PhD
Senior Vice President, Business and Corporate Development
public.relations@inmagenebio.com
投资者关系:
Bruce Mackle
LifeSci Advisors, LLC
bmackle@lifesciadvisors.com