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/ -- AbbVie (NYSE: ABBV) and IGI Therapeutics SA, a wholly owned subsidiary of New York -based Ichnos Glenmark Innovation, Inc. (IGI), today announced an exclusive licensing agreement for IGI's lead investigational asset, ISB 2001, developed using IGI's proprietary BEAT® protein platform, for oncology and autoimmune diseases.
艾伯维(纽约证券交易所代码:ABBV)和总部位于纽约的 Ichnos Glenmark Innovation, Inc. (IGI) 的全资子公司 IGI Therapeutics SA 今天宣布达成 IGI 的主要研究资产 ISB 2001 的独家许可协议,该资产使用 IGI 专有的 BEAT® 蛋白平台开发,用于治疗肿瘤学和自身免疫性疾病。
'Multispecifics including trispecific antibodies represent a new frontier in immuno-oncology with the potential to deliver deeper, more durable responses by engaging multiple targets simultaneously,' said
“包括三特异性抗体在内的多特异性抗体代表了免疫肿瘤学的新前沿,通过同时作用于多个靶点,有望带来更深入、更持久的反应,”
Roopal Thakkar , M.D., executive vice president, research and development and chief scientific officer, AbbVie. 'This partnership with IGI reflects our unwavering commitment to advancing novel therapies for patients with multiple myeloma, a disease where significant unmet need remains despite recent progress.'
鲁帕尔·塔卡尔医学博士,艾伯维执行副总裁,研发部门及首席科学官。“与IGI的合作伙伴关系反映了我们对推进多发性骨髓瘤患者新疗法的坚定承诺,尽管最近取得了一些进展,但这种疾病仍然存在显著的未满足需求。”
'ISB 2001 exemplifies the potential of our BEAT® protein platform to generate effective multispecifics that may overcome resistance and improve outcomes in hard-to-treat cancers,' said
“ISB 2001展示了我们BEAT®蛋白平台生成有效多特异性抗体的潜力,这些抗体可能克服耐药性并改善难治性癌症的治疗效果,”
Cyril Konto, M.D., President and CEO of IGI. 'This agreement marks a defining milestone in IGI's scientific journey and reflects our team's deep commitment to delivering meaningful therapies for patients. Our partnership with AbbVie accelerates ISB 2001's path to patients and sharpens our focus on advancing the next generation of BEAT®-enabled assets in oncology.'.
Cyril Konto医学博士,IGI总裁兼首席执行官表示:“该协议标志着IGI科学征程中的一个决定性里程碑,反映了我们团队致力于为患者提供有意义疗法的深厚承诺。我们与AbbVie的合作加速了ISB 2001惠及患者的进程,并进一步集中我们的精力于推进下一代BEAT®技术支持的肿瘤学资产。”
Under the terms of the agreement, AbbVie will receive exclusive rights to develop, manufacture, and commercialize ISB 2001 across North America, Europe, Japan and Greater China. Subject to regulatory clearance, IGI will receive an upfront payment of $700 million and is eligible to receive up to $1.225 billion in development, regulatory, and commercial milestone payments, along with tiered, double-digit royalties on net sales.
根据协议条款,艾伯维将获得在北美、欧洲、日本和大中华区开发、制造和商业化 ISB 2001 的独家权利。根据监管部门的批准,IGI 将获得 7 亿美元的预付款,并有资格获得高达 12.25 亿美元的开发、监管和商业里程碑付款,以及净销售额的分级两位数特许权使用费。
About AbbVie
关于艾伯维
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio.
艾伯维的使命是发现并提供创新药物和解决方案,以解决当今严重的健康问题,并应对未来的医疗挑战。我们力求在免疫学、肿瘤学、神经科学和眼科等多个关键治疗领域,以及我们旗下的艾尔建美学产品和服务中,对人们的生活产生显著影响。
About AbbVie in Oncology
关于艾伯维在肿瘤学领域
AbbVie is committed to elevating standards of care and bringing transformative therapies to patients worldwide living with difficult-to-treat cancers. We are advancing a dynamic pipeline of investigational therapies across a range of cancer types in both blood cancers and solid tumors. We are focusing on creating targeted medicines that either impede the reproduction of cancer cells or enable their elimination.
艾伯维致力于提升护理标准,并为全球患有难治癌症的患者带来变革性的治疗方法。我们正在推进一系列癌症类型的治疗方案,包括血液癌和实体瘤。我们专注于创造靶向药物,这些药物要么阻止癌细胞的繁殖,要么帮助消灭它们。
We achieve this through various, targeted treatment modalities and biology interventions, including small molecule therapeutics, antibody-drug conjugates (ADCs), immuno-oncology-based therapeutics, multispecific antibody and novel CAR-T platforms. Our dedicated and experienced team joins forces with innovative partners to accelerate the delivery of potential breakthrough medicines..
我们通过各种有针对性的治疗方式和生物干预来实现这一目标,包括小分子治疗药物、抗体-药物偶联物(ADC)、基于免疫肿瘤学的治疗方法、多特异性抗体以及新型CAR-T平台。我们专注且经验丰富的团队与创新合作伙伴携手,加速潜在突破性药物的研发和交付。
Today, our expansive oncology portfolio comprises approved and investigational treatments for a wide range of blood cancers and solid tumors. We are evaluating more than 35 investigational medicines in multiple clinical trials across some of the world's most widespread and debilitating cancers. As we work to have a remarkable impact on people's lives, we are committed to exploring solutions to help patients obtain access to our cancer medicines.
如今,我们广泛的肿瘤学产品组合包括已获批和正在研究的针对多种血液癌症和实体瘤的治疗方法。我们正在针对一些全球最普遍和最具致残性的癌症进行多项临床试验,评估超过35种研究性药物。在努力对人们的生活产生显著影响的同时,我们致力于探索解决方案,帮助患者获得我们的抗癌药物。
About ISB 2001
关于ISB 2001
ISB 2001 is a first-in-class trispecific T-cell engager that targets BCMA and CD38 on myeloma cells and CD3 on T cells currently in Phase 1 for relapsed/refractory multiple myeloma. Developed using IGI's proprietary BEAT® protein platform, ISB 2001 was engineered with two distinct binders against myeloma-associated antigens to enhance avidity, even at low target expression levels, while aiming to improve safety over first-generation bispecific antibodies. Recently presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting as a Rapid Oral Presentation (.
ISB 2001 是一种首创的三特异性 T 细胞接合器,靶向骨髓瘤细胞上的 BCMA 和 CD38 以及 T 细胞上的 CD3,目前正处于针对复发/难治性多发性骨髓瘤的 I 期临床阶段。ISB 2001 借助 IGI 专有的 BEAT® 蛋白质平台开发,设计了两个不同的骨髓瘤相关抗原结合剂,以在低目标表达水平下增强亲和力,同时旨在提升第一代双特异性抗体的安全性。该研究最近在 2025 年美国临床肿瘤学会 (ASCO) 年会上作为快速口头报告发表。
), data from 35 patients demonstrated a sustained overall response rate (ORR) of 79% and a high complete/stringent complete response (CR/sCR) rate of 30% at active doses ≥ 50 µg/kg in a heavily pretreated population of relapsed/refractory myeloma patients, with a favorable safety profile.
),35 名患者的数据表明,在剂量 ≥ 50 µg/kg 时,经过多线治疗的复发/难治性骨髓瘤患者中,总体缓解率(ORR)持续达到 79%,并且完全/严格完全缓解(CR/sCR)率达到 30%,同时安全性良好。
U.S. Food & Drug Administration granted ISB 2001 Orphan Drug Designation in
美国食品和药物管理局授予ISB 2001孤儿药资格认定
July 2023
2023年7月
and Fast Track Designation for the treatment of relapsed/refractory myeloma patients in May 2025.
2025年5月,获得用于治疗复发/难治性骨髓瘤患者的快速通道资格。
About the BEAT® Multispecific™ Platform
关于BEAT®多特异性™平台
IGI's proprietary BEAT® platform goes beyond traditional bispecific antibody approaches, addressing key engineering bottlenecks that have historically limited large-scale bispecific production. By leveraging a proprietary common light chain library and TCR interface-based heavy chain pairing, BEAT® enables the development of next-generation immune cell engagers with strong therapeutic potential in oncology.
IGI 专有的 BEAT® 平台超越了传统的双特异性抗体方法,解决了长期以来限制大规模双特异性抗体生产的关键工程瓶颈。通过利用专有的通用轻链库和基于 TCR 界面的重链配对,BEAT® 能够开发出具有强大肿瘤治疗潜力的下一代免疫细胞结合剂。
Unlike many engineered formats, BEAT® mirrors the architecture of natural antibodies utilizing both light and heavy chains to enhance stability and function. Key attributes of the BEAT® platform include its multispecific versatility, enabling the design of antibodies that engage diverse immune cell types such as T cells, myeloid cells, and NK cells against multiple antigens.
与许多工程化格式不同,BEAT® 模仿了天然抗体的结构,利用轻链和重链来增强稳定性和功能。BEAT® 平台的关键特性包括其多特异性多功能性,能够设计出针对多种抗原、吸引不同类型免疫细胞(如 T 细胞、髓系细胞和 NK 细胞)的抗体。
The platform also features optimized engineering through high-fidelity heavy chain pairing with a common light chain, allowing for precise Fc modulation and access to a broad structural design space. Additionally, BEAT® supports robust manufacturability, producing correctly assembled multispecific antibodies with favorable stability, extended half-lives, low immunogenicity and high titer yields through standardized process development and manufacturing operations..
该平台还通过高保真的重链与通用轻链配对实现了优化的工程设计,从而允许精确的Fc调节并进入广阔的设计空间。此外,BEAT®支持强大的可制造性,通过标准化的工艺开发和生产操作,生成正确组装的多特异性抗体,具有良好的稳定性、延长的半衰期、较低的免疫原性以及高滴度产量。
About IGI
关于IGI
IGI is a global, fully integrated clinical-stage biotechnology company focused on developing innovative biologics in oncology. Headquartered in
IGI是一家全球性的、完全整合的临床阶段生物技术公司,专注于开发肿瘤学领域的创新生物制品。总部位于
New York, NY
纽约州,纽约市
, IGI is advancing a robust pipeline of novel, first-in-class multispecifics
,IGI 正在推进一系列新颖的、首创新药的多特异性分子的强大研发管线。
aimed at addressing complex diseases and treating patients holistically. Powered by its proprietary BEAT® technology platform, IGI is committed to delivering breakthrough, curative therapies to improve and extend the lives of patients battling hematological malignancies and solid tumors. For more information, visit .
旨在应对复杂疾病并全面治疗患者。IGI凭借其专有的BEAT®技术平台,致力于提供突破性的治愈疗法,以改善和延长患有血液恶性肿瘤和实体瘤的患者生命。欲了解更多信息,请访问 。