Bexatamig

双抗正值风口，三抗已初露苗头。 2025年1月13日，先声药业旗下抗肿瘤创新药公司先声再明宣布，已与全球制药公司艾伯维（AbbVie）就其处于中国和美国进行临床1期研究阶段的，GPRC5DxBCMAxCD3的TCE三抗管线SIM0500达成许可选择协议，艾伯维将支付给先声再明一定的预付款以及最高10.55亿美元的选择性权益付款和里程碑付款，以及大中华区以外地区的销售分成。 尽管单克隆抗体和双特异性抗体在临床治疗上都发挥了至关重要的作用，但对于恶性肿瘤的治疗疗效仍然有限。随着抗体药物的发展，同时靶向三个特异性抗原结合位点的三特异性抗体，在肿瘤治疗领域展现了非凡的应用前景。 与双特异性抗体相比，三特异性抗体还能够与肿瘤细胞或免疫细胞表面的另一个靶点相结合，或桥接免疫细胞并阻断双信号通路等作用，更有利于将药物或免疫细胞重定向至肿瘤部位，增强结合特异性，提高靶向性，降低脱靶毒性，从而提升抗肿瘤能力。 因此，虽然当下全球暂时没有三抗药物获批，可是已经有不少中国Biotech布局其中。同时，MNC也从2024年开始布局，或许我们将在2025年的BD交易中看到越来越多的三抗管线。 01 MNC悄然入局 2024年三抗的交易数量超过了过去3年的总和且总额近80亿美元。 与双抗的双靶点相比，三抗的抗体组合更加丰富多样，也为抗体药物的研发提供了更多的空间。因此，MNC开始通过并购、许可交易以及股权投资等方式入局三抗/多抗赛道。 近几年三抗交易情况，据公开信息收集整理 可以看到，包括辉瑞、艾伯维、GSK、吉利德以及默沙东这些MNC在2024年都已出手，特别是默沙东一年内就花了近40亿美元并购两家专注于三抗药物开发的公司，可见其对三抗的态度。 其中，以30亿美元卖给默沙东的EyeBio值得一说。EyeBio成立于2021年，迄今为止融资1.3亿美元，而默沙东早在A轮就参与其中。2024年2月，EyeBio公布了其核心管线EYE103的1b/2a期临床积极数据，随后在5月，默沙东便出手并购，到了8月，Clinicaltrials网站便出现了EYE103临床2/3期试验的信息，可谓是惟快不破。 默沙东在2024年1月并购Harpoon的交易则更凸显默沙东对三抗的看好。此次交易除了收获临床中颇具前景的DLL3/CD3抗体管线外（MK6070），还得到了Harpoon多个三特异抗体平台，其中包括在肿瘤微环境中特异性激活的ProTriTAC和TriTAC-XR三特异抗体平台这一前瞻性技术平台。 值得注意的是，据Insight数据库信息，MK6070和罗氏的RO7616789以及泽璟生物的ZG006是全球范围内仅有的三款进入临床阶段的靶向DLL3的三抗管线。到了8月份，第一三共与默沙东签订MK6070的全球共同开发和商业化协议（默沙东保留该药在日本的独家权力），第一三共将付出1.7亿美元的首付款。 有意思的是Harpoon也曾出现在艾伯维的故事里，早在2019年，艾伯维以3000万美元+5000万美元的里程碑付款获得了Harpoon旗下一条三抗管线的全球独家授权。只是后来艾伯维对其重视不够，将权益退回。 此次艾伯维花大价钱收购先声再明的三抗管线，很有可能是受到竞争对手的影响。例如强生旗下就拥有CD38单抗、BCMA-CAR-T、BCMAxCD3双抗、甚至GPRC5DxCD3双抗等多个多发性骨髓瘤（MM）领域产品，而艾伯维自身仅有一款BCMAxCD3双抗似乎显得势单力薄。 先声再明的GPRC5D/BCMA/CD3三抗在前期研究中表现出了针对MM细胞的强大T细胞毒性效应，肿瘤杀伤效果显著，耐受性好，起效剂量低，停药后肿瘤不复发等多重优势。对艾伯维而言，既然错过了GPRC5D/CD3双抗，直接入局BCMA/GPRC5D/CD3三抗也不失为一种选择。 从这些并购事件不难看出，进入临床阶段的三抗管线拥有较高的交易价值。此外，涉及热门靶点的三抗管线，也极具BD潜力。目前，全球的三抗管线已经开始向肿瘤和自免这两大市场推进。 02 超100条管线在研，默沙东靠并购领先 三抗的多样性带来的更多可能性，让药企趋之若鹜。 尽管目前尚未有三抗药物获批，但已有多家生物医药企业布局三特异性抗体，并研发设计出具有迭代优势的靶点组合药物。据不完全统计，目前全球三抗药物管线已超百条，其中约有一半已进入临床阶段，只是大多数尚处于临床早期阶段。 部分在研三抗管线，据公开信息整理 MNC中，赛诺菲布局较多，如靶向Anti-CD3/CD38/CD28的SAR442257，其介导了强烈的肿瘤细胞杀伤作用，与抗CD38单抗相比，SAR442257在体外对CD38高表达和CD38低表达的MM细胞均表现出高3~4个数量级的杀伤效力。SAR443579（NKp46/CD16/CD123）则有可能成为血液瘤患者的新选择。辉瑞开发的Anti-IL-13/IL-4/TSLP(PF-07275315)，属于三功能融合蛋白，针对特应性皮炎已进入临床2期。 从时间上来看，全球的三抗/多抗管线从2021年开始大幅增长，国内同样也是从这一年开始出现增长。到了2024年，已经有多家中国Biotech布局三抗赛道，仅这一年，国内就有超过10条三抗1类新药管线首次在国内获批IND，进展较快的包括天广实、百利天恒、神州细胞、信达生物、嘉和生物、泽璟生物、恩沐生物、博锐生物以及普米斯等。 从适应症分布来看，三抗延续了单抗和双抗类药物类似的思路，最热门的领域依然是肿瘤，整体管线占比超过50%，毕竟抗肿瘤药物市场需求大、医保覆盖范围广，企业有推动创新的动力。 03 国产三抗百花齐放 国内药企正悄然加速三抗赛道的研发。 如基石药业在2024年底宣布旗下用于治疗多种实体瘤的管线CS2009（PD-1/VEGF/CTLA-4三特异性抗体）已在澳大利亚递交临床试验申请。受此消息影响，公司股价一度上涨7%。 市场之所以如此热情，既有康方双抗在2024年的铺垫，也有市场对于后续三抗爆发的期待。 从作用机制来看，PD-1/VEGF/CTLA-4三特异性抗体相对于康方PD-1/VEGF双抗，anti-CTLA-4能促进更多初始T细胞激活、迁移浸润至肿瘤组织。在第39届癌症免疫治疗学会年会上基石药业公布的临床前数据显示，CS2009展示出优于潜在竞品(包括PD-1/CTLA-4双抗、PD-1/VEGFA双抗以及抗PD-1/抗CTLA-4联合疗法)的抗肿瘤活性。 此外，阿斯利康的PD-1/CTLA-4双抗目前也有4项适应症（非小细胞肺癌、胸膜间皮瘤、宫颈癌和头颈鳞癌）处于临床3期阶段，且从前期数据来推断成功概率较高。并且这些靶点都是成熟靶点，组合之下能覆盖包括非小细胞肺癌、卵巢癌、肾细胞癌、宫颈癌、肝细胞癌、胃癌等多个肿瘤适应症。同时对于PD-(L)1疗法响应不佳的PD-L1低表达或PD-L1阴性的群体也能进一步获益。 如果说康方的PD-1/VEGF双抗有希望向K药发起冲击，那么基石药业和宏成药业都有布局的PD-1/CTLA-4/VEGF三抗是否也有进一步的空间呢？ 三特异性抗体按照作用机制的不同主要分为：T细胞接合器、免疫检查点抑制剂、NK 细胞接合器、靶向三个肿瘤相关抗原、延长半衰期的TCE以及三功能融合蛋白等。目前的国产三抗管线类型相对全面。 恩沐生物的CMG1A46药物为靶向CD3/CD19/CD20的三特异性抗体，其适应症为急性淋巴细胞白血病、血液肿瘤、滤泡性淋巴瘤、弥漫性大B细胞淋巴瘤。CMG1A46同时靶向 T细胞表面的CD3以及B细胞上的两个抗原表位CD20和CD19，通过募集CD3+T细胞增强T细胞功能，介导B细胞耗竭并杀死表达CD19/CD20的B细胞。 基石药业的CS2006是靶向4-1BB/PD-L1/HSA的三特异性抗体，它是一款免疫检查点抑制剂，同时靶向肿瘤免疫抑制性PD-1/PD-L1通路和肿瘤免疫刺激性4-1BB通路，发挥PD-L1阻断作用以及4-1BB激活的协同效应，仅局部激活肿瘤定向的特异性免疫应答。 嘉和生物的GB263(Anti-EGFR/cMET/cMET)则走了靶向三个TAA的路径。通过靶向EGFR和两种不同的cMET表位，阻断cMET及EGFR的信号通路，下调cMET和EGFR的蛋白水平。拓创生物的TAVO-412也选择了类似思路。 普米斯生物的PM-8003是靶向PD-L1/TGF-β/VEGF的三功能融合蛋白，通过阻断TGF-β通路可以减少Treg细胞的数量，增加效应T细胞的活性，从而恢复对抗PD-L1治疗的敏感性。 有意思的是，国产三抗才刚加速，四抗就已经起步。 2024年12月20日，百利药业GNC-038四特异性抗体注射液的临床试验申请获得NMPA默示许可。9月20日，百利药业GNC-077多特异性抗体注射液临床试验也获得国家药品监督管理局药品审评中心（CDE）批准。 基于GNC平台，百利天恒开发了多款候选药物。其中，除未披露的GNC-077外，还有3款四特异性抗体已处于临床开发阶段，包括GNC-038（CD3 × 4-1BB × PD-L1 × CD19）、GNC-035（CD3 × 4-1BB × PD-L1 × ROR1）和GNC-039（CD3× 4-1BB × PD-L1 × EGFRvIII）。 可以看到国产多抗在肿瘤领域布局较为全面，考虑到近来MNC频繁收购双抗资产，并着手将肿瘤双抗管线拿去做自免临床，未来三抗在自免市场同样极具想象空间。 04 自免开始卷三抗 TCE的热浪终究开始扑向了自免。 2024年TCE双抗出尽了风头，如CD19/CD3，CD20/CD3等。2024年的交易显示未来三抗TCE将是一个重要的发展方向。2024年10月，GSK宣布以8.5亿美金收购中国恩沐生物的三特异抗体CMG1A46，根据协议，GSK将向恩沐生物支付3亿美金的首付款。 值得注意的是，新闻显示GSK计划开发和商业化CMG1A46，并将重点放在B细胞驱动的自身免疫疾病上，如系统性红斑狼疮（SLE）和狼疮性肾炎（LN），并有可能扩展到相关的自身免疫疾病。 据之前披露的信息，CMG1A46不仅可以杀伤CD19、CD20双阳性的B细胞，还可以清除CD19或者CD20单阳性的细胞，同时在体外的半数效应浓度仅为0.3pM，与传统的1+1型CD20 TCE相比，具有更好的安全性和更强的活性。在体内，CMG1A46可以在24小时内快速的清除B细胞，与传统CD20 TCE双抗相比可以给到更高的剂量，在1mpk的剂量下对B细胞的清除持续了28天。 艾伯维此次收购先声药业的SIM0500三抗，在血液瘤之外，BCMA和GPRC5D靶点在某些自免疾病的B细胞上也有表达，现有靶向BCMA的药物已经在干燥综合症、NMOSD、系统性硬化症、类风湿关节炎等自免疾病中展现出疗效。未来SIM0500在自免领域同样具有开发潜力。 有意思的是，NewCo的风也开始吹到国产多抗上。 2025年1月，药明生物与Candid Therapeutics达成研究服务合作协议，Candid将拥有一款基于药明生物通用型多特异性抗体专利技术平台WuXiBody发现的，处于临床前开发阶段的三特异性抗体的全球权益。就在20多天前，Candid还一口气宣布了三笔关于TCE与中国Biotech的研发合作交易。 2024年11月，维立志博与风险投资公司Aditum Bio就一款三抗药物达成了一项产品的独家选择权及许可协议，双方将基于维立志博CD19/BCMA/CD3三特异性T细胞衔接器（TCE）LBL-051，成立新药研发公司Oblenio。 三特异性抗体管线有望成为2025年靓丽的风口。 *封面图片来源：123rf 如果您认同文章中的观点、信息，或想进一步讨论，请与我们联系；也可加入动脉网行业社群，结交更多志同道合的好友。 近 期 推 荐 声明：动脉网所刊载内容之知识产权为动脉网及相关权利人专属所有或持有。未经许可，禁止进行转载、摘编、复制及建立镜像等任何使用。 动脉网，未来医疗服务平台

NK cell therapy is gaining momentum as a promising solution to unmet medical needs in cancer treatment, offering safer, targeted options for patients unresponsive to traditional therapies. Increased R&D investment, regulatory support, and successful clinical trials have bolstered confidence in these therapies, while technological advances in cell production are set to meet growing demand. Rising cancer rates and heightened public awareness further amplify market potential, making NK cell therapy a pivotal area of growth in oncology. LAS VEGAS, Nov. 11, 2024 /PRNewswire/ -- DelveInsight's ' NK Cell Therapy Pipeline Insight 2024 ' report provides comprehensive global coverage of pipeline NK cell therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the NK cell therapy pipeline domain. Key Takeaways from the NK Cell Therapy Pipeline Report DelveInsight's NK cell therapy pipeline report depicts a robust space with 140+ active players working to develop 160+ pipeline NK cell therapies. Key NK cell therapy companies such as Amgen, Innate Pharma, Nektar Therapeutics, SMT bio Co., Ltd., Alphageneron Pharmaceuticals, XNK Therapeutics, ImmunityBio, Cellid, Cantargia, Affimed Therapeutics, Takeda, Artiva Biotherapeutics, Sanofi, Dragonfly Therapeutics, INmune Bio, NKGen Biotech, Asclepius Technology Company Group, Glycostem Therapeutics (IPD Therapeutic), Wugen, Celularity, VERAXA, GamidaCell, MiNK Therapeutics, Indapta Therapeutics, ImmunityBio, Inc., Allife Medical Science and Technology, Nkarta, Base Therapeutics, GT Biopharma, Athenex, Ambicion, Biohaven Pharmaceuticals, Acepodia, Bright Path Biotherapeutics, Nkarta Therapeutics, Qihan Biotech, Century Therapeutics, Fate Therapeutics, Chimeric Therapeutics, Senti Biosciences, GICELL, Deverra Therapeutics, Medigen Biotechnology Corporation, GlaxoSmithKline, CytoImmune Therapeutics, Nuwacell Biotechnologies Co., Ltd., and others are evaluating new NK cell therapies to improve the treatment landscape. Promising NK cell therapies in the pipeline such as Bemarituzumab, Monalizumab, NKTR-225, SMT-NK, Enkastim, CellProtect, ALT 803, BVAC-C, PD-L1.t-haNK, Nidanilimab, M ceNK, HER2 t-haNK, AFM-13, TAK-007, IPH4102, AB-101, KDS-1001, AB-201, DF9001, INKmune, IPH65, SNK01, IPH6101 (SAR443579), BCMA CAR-NK 92 cells, DF1001, Allogeneic Natural Killer Cell Therapy (oNKord), WU-NK-101, AFM24, CYNK-001, FLYSYN, GDA-201, AGENT-797, CYNK-101, SAR445514, IDP-023, DF6002, CD19.taNK, Anti-PSMA CAR NK cells, DF2001, NKX101, NK510, GTB-3550, KUR-501, RK-pulsed autologous antigen-presenting cells (APCs), BHV-1100, ACE1702, iPS NKT, Anti-CD19/CD22 CAR NK cell therapy, NKX019, KUR-502, BVAC-P, QN-019a, QN-030a, QN-023a, CNTY-101, FT576, CHM 0201, SENTI-202, AFM28, DF8001, FT522, SNK02, GIC-102, DVX201, Magicell®-NK, GSK4381562, CYTO NK-102, NCR300, and others are under different phases of NK cell therapy clinical trials. In October 2024, Immunitybio announced that the first patients had been dosed in an initial trial studying the potential of the company's CAR-NK cell therapy targeting CD-19 in the treatment of non-Hodgkin's lymphoma (NHL). In July 2024, The U.S. Food and Drug Administration (FDA) gave Nkarta the green light to launch a clinical trial testing its cell therapy candidate NKX019 in people with ANCA-associated vasculitis (AAV) and other autoimmune disorders. In May 2024, KGen Biotech announced that its Safety Review Committee had cleared the Company's cryopreserved autologous, expanded, and enhanced SNK01 to progress into Phase II clinical development. In May 2024, Fate Therapeutics announced that a late-breaking abstract featuring preclinical data from its FT522 program for autoimmune diseases will be featured at the American Society of Gene and Cell Therapy (ASGCT) 27th Annual Meeting. In April 2024, Sanofi moved its natural killer (NK) cell engager candidate SAR443579/IPH6101 to a Phase II trial evaluating the drug's use in treating a range of blood cancers. In April 2024, the FDA granted orphan drug designation to the investigational therapy IGNK001 (Gengleucel) for patients with acute myeloid leukemia (AML). In February 2024, Indapta Therapeutics received FDA Fast Track Designation for its natural killer (NK) cell therapy IDP-023 for patients with multiple myeloma (MM) and non-Hodgkin lymphoma (NHL). Request a sample and discover the recent advances in the NK cell therapy segment @ NK Cell Therapy Pipeline Report The NK cell therapy pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage NK cell therapies, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the NK cell therapy clinical trial landscape. NK Cell Therapy Overview Natural Killer (NK) cell therapy is an innovative approach in immunotherapy that harnesses the power of NK cells, a vital component of the innate immune system. Unlike T cells, which require prior sensitization to target cancer cells, NK cells can recognize and kill abnormal cells without prior exposure. This unique ability makes NK cell therapy a promising option for treating various cancers, including hematologic malignancies like leukemia and lymphoma, as well as solid tumors. By isolating and activating NK cells from a patient's blood or using engineered NK cells from healthy donors, researchers aim to enhance the immune response against tumors, leading to improved patient outcomes. Recent advancements in genetic engineering, such as the introduction of chimeric antigen receptors (CAR) into NK cells, are further enhancing their specificity and efficacy against cancer cells. The clinical applications of NK cell therapy are expanding rapidly, supported by a growing body of research and early-phase clinical trials. These studies have shown promising results, demonstrating the ability of NK cell therapy to induce durable remissions in patients with refractory cancers. Furthermore, the off-the-shelf nature of certain NK cell therapies allows for quicker treatment deployment compared to traditional CAR-T cell therapies, which require a personalized approach. Challenges remain, including optimizing NK cell expansion, persistence, and overcoming the immunosuppressive tumor microenvironment. However, ongoing research into combination therapies, such as pairing NK cell therapy with checkpoint inhibitors or monoclonal antibodies, is expected to enhance the therapeutic potential of NK cells and provide new hope for cancer patients. Find out more about NK cell therapy @ Novel NK Cell Therapies A snapshot of the Pipeline NK Cell Therapies mentioned in the report: Learn more about the emerging NK cell therapies @ NK Cell Therapy Clinical Trials NK Cell Therapy Therapeutics Assessment The NK cell therapy pipeline report proffers an integral view of the emerging NK cell therapies segmented by stage, product type, molecule type, and route of administration. Scope of the NK Cell Therapy Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Oral, Intravenous, Subcutaneous, Parenteral, Topical Therapeutics Assessment By Molecule Type: Vaccines, Monoclonal antibody, Peptides, Polymer, Small molecule Key NK Cell Therapy Companies: Amgen, Innate Pharma, Nektar Therapeutics, SMT bio Co., Ltd., Alphageneron Pharmaceuticals, XNK Therapeutics, ImmunityBio, Cellid, Cantargia, Affimed Therapeutics, Takeda, Artiva Biotherapeutics, Sanofi, Dragonfly Therapeutics, INmune Bio, NKGen Biotech, Asclepius Technology Company Group, Glycostem Therapeutics (IPD Therapeutic), Wugen, Celularity, VERAXA, GamidaCell, MiNK Therapeutics, Indapta Therapeutics, ImmunityBio, Inc., Allife Medical Science and Technology, Nkarta, Base Therapeutics, GT Biopharma, Athenex, Ambicion, Biohaven Pharmaceuticals, Acepodia, Bright Path Biotherapeutics, Nkarta Therapeutics, Qihan Biotech, Century Therapeutics, Fate Therapeutics, Chimeric Therapeutics, Senti Biosciences, GICELL, Deverra Therapeutics, Medigen Biotechnology Corporation, GlaxoSmithKline, CytoImmune Therapeutics, Nuwacell Biotechnologies Co., Ltd., and others. Key Pipeline NK Cell Therapies: Bemarituzumab, Monalizumab, NKTR-225, SMT-NK, Enkastim, CellProtect, ALT 803, BVAC-C, PD-L1.t-haNK, Nidanilimab, M ceNK, HER2 t-haNK, AFM-13, TAK-007, IPH4102, AB-101, KDS-1001, AB-201, DF9001, INKmune, IPH65, SNK01, IPH6101 (SAR443579), BCMA CAR-NK 92 cells, DF1001, Allogeneic Natural Killer Cell Therapy (oNKord), WU-NK-101, AFM24, CYNK-001, FLYSYN, GDA-201, AGENT-797, CYNK-101, SAR445514, IDP-023, DF6002, CD19.taNK, Anti-PSMA CAR NK cells, DF2001, NKX101, NK510, GTB-3550, KUR-501, RK-pulsed autologous antigen-presenting cells (APCs), BHV-1100, ACE1702, iPS NKT, Anti-CD19/CD22 CAR NK cell therapy, NKX019, KUR-502, BVAC-P, QN-019a, QN-030a, QN-023a, CNTY-101, FT576, CHM 0201, SENTI-202, AFM28, DF8001, FT522, SNK02, GIC-102, DVX201, Magicell®-NK, GSK4381562, CYTO NK-102, NCR300, and others. Dive deep into rich insights for new NK cell therapies, visit @ NK Cell Therapy Drugs Table of Contents For further information on the NK cell therapy pipeline therapeutics, reach out @ NK Cell Therapy Treatment Drugs Related Reports NK Cell Therapy Market NK Cell Therapy Market Insights, Epidemiology, and Market Forecast – 2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key NK cell therapy companies including Sanofi, Dragonfly Therapeutics, INmune Bio, NKGen Biotech, Asclepius Technology Company Group, Glycostem Therapeutics (IPD Therapeutic), Wugen, Celularity, VERAXA, GamidaCell, MiNK Therapeutics, Indapta Therapeutics, among others. 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