Immunoglobulin g1, anti-(human platetet glycoprotein vi) fab fragment (humanized monoclonal act017 .gamma.1-chain), disulfide with humanized monoclonal act017 .kappa.-chain、格伦佐西单抗、ACT-017

靶点

GPVI

作用方式

抑制剂

作用机制

GPVI抑制剂(血小板膜糖蛋白VI抑制剂)

治疗领域

在研适应症

非在研适应症

原研机构

在研机构

非在研机构-

权益机构

深圳市康哲药业有限公司

Acticor Biotech SAS

Mediolanum Farmaceutici SpA

最高研发阶段临床3期

首次获批日期-

最高研发阶段(中国)临床3期

特殊审评-

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结构/序列

Sequence Code 616723309H

来源: *****

Sequence Code 616723310L

来源: *****

关联

项与格仑西单抗相关的临床试验

NCT06437431

/ Not yet recruiting临床2/3期IIT

Glenzocimab in Anterior Stroke With Large Ischemic Core Eligible for Endovascular Therapy

Until recently, acute ischemic stroke (AIS) patients with a baseline large infarct core have been generally excluded from clinical trials of endovascular therapy (EVT). A first multicenter randomized trial (Rescue Japan Limit trial) found a significant benefit of EVT in AIS patients with large infarct core (DWI-ASPECTS of 3-5). Another non-randomized multicenter prospective study found a positive association of EVT with 3-month outcome in AIS patients with a baseline CTP ischemic core volume >70mL. More recently, 2 additional randomized trials were published. They both confirmed a strong efficacy of EVT in patients with large infarct core. However, even with EVT, the proportion of good outcome (3-month mRS score of 0-3), remains low in these highly severe AIS patients ranging from 8-30%. Almost 75% of EVT-treated patients are still severely disabled or dead at 3 months. In experimental studies, we and others described the pathophysiological features of the downstream microvascular thrombosis (DMT) in AIS setting highlighting its immediate occurrence and the pivotal role of platelet activation and aggregation. In recent clinical studies, it has been shown that, even with a complete angiographic recanalization after EVT, up to 40% of patients presented no-reflow (NR), a failure of downstream microvascular reperfusion, visible on perfusion imaging performed after EVT. Some clinical studies reported the clinical impact of NR after successful EVT. We found that DMT participated to the development of neurovascular lesions in AIS with both an early ischemic lesion growth risk evolving towards a delayed hemorrhagic transformation (HT) and vasogenic edema risks and therefore worse outcome. Our results suggested that an antiplatelet therapy infused early in AIS patients could reduce both the ischemic lesion but also the risk of delayed vasogenic edema and HT. Platelet glycoprotein VI (GPVI) is a key receptor for collagen and fibrin and plays a major role in platelet activation, platelet recruitment and thrombosis. Furthermore, inhibition of the GPVI does not impair haemostasis and subjects with a genetic or acquired GPVI deficiency are not prone to excessively bleed.
Glenzocimab is a monoclonal antibody directed against the GPVI. It has been developed as an immediate antiplatelet agent with minimal bleeding risk for treating AIS. The ACTIMIS trial, a phase IB/IIA clinical study that assessed for the first time the glenzocimab IV infusion in AIS patients found very promising safety data including a significant reduce of symptomatic HT (1% vs. 7.8%) and mortality rates (7.8% vs. 18.7%), especially in severe AIS patients. Our hypothesis is that IV glenzocimab infusion would improve good functional outcome in large ischemic core AIS patients treated with EVT by reducing the DMT, ischemic lesion growth, and the HT rate.

开始日期2026-09-01

申办/合作机构

Fondation Ophtalmologique Adolphe de Rothschild

CTIS2023-509615-92-00

/ Completed临床2期IIT

Glenzocimab in Anterior stroke with Large Ischemic Core eligible for Endovascular therapy

开始日期2024-05-01

申办/合作机构-

ISRCTN15443962

/ Suspended临床2期

A phase II, randomised, double-bLInd, placeBo-controllEd tRiAl To invEstigate the efficacy and safety of glenzocimab and the mechanism of inhibiting platelet GPVI as a treatment for ST-elevation myocardial infarction (LIBERATE)

开始日期2024-01-15

申办/合作机构

University of Birmingham

100 项与格仑西单抗相关的临床结果

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100 项与格仑西单抗相关的转化医学

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100 项与格仑西单抗相关的专利（医药）

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项与格仑西单抗相关的文献（医药）

2026-05-01·CURRENT OPINION IN HEMATOLOGY

The interface of hemostasis and inflammation: endothelial–platelet dynamics in thrombosis

Review

作者: Branfield, Siobhan

Purpose of review:

This review summarizes current understanding of platelet–endothelial contributions to thrombosis, emphasizing molecular crosstalk [von Willebrand factor (VWF)/ADAMTS13 balance, P-selectin, platelet glycoprotein VI (GPVI), integrins, extracellular vesicles, neutrophil extracellular traps (NETs)], high-risk clinical settings, and translational advances. Highlighting GPVI-directed therapeutics, the VWF/ADAMTS13 axis in COVID-19, and opportunities and challenges for targeting the platelet–endothelial interface.

Recent findings:

Clinical and translational studies support the safety and potential efficacy of targeting platelet–endothelial interfaces. GPVI inhibitors (Glenzocimab, Revacept) have advanced through phase I/II studies with reassuring bleeding profiles and suggest benefit in ischemic stroke and lesion-directed settings. Direct interruption of platelet–VWF interactions (Caplacizumab) is established in immune thrombotic thrombocytopenic purpura (TTP), while studies show a persistent VWF/ADAMTS13 imbalance in severe COVID-19 and inflammatory states linked to microthrombosis and worse outcomes. Antiadhesion strategies (P-selectin blockade) and modulators of immunothrombosis (NET inhibitors, targeting extracellular vesicle) are also in evaluation.

Summary:

Targeting platelet–endothelial crosstalk has potential to reduce pathologic thrombosis while preserving hemostasis. Clinical proof of principle exists for focused approaches (anti-VWF in TTP; P-selectin blockade in vaso-occlusion; emerging GPVI inhibitors). Priorities are: defining disease contexts and timing where interface targeting is effective; validating biomarkers (VWF/ADAMTS13 ratio, soluble P-selectin, platelet activation signatures) for patient selection; and conducting adequately powered trials with rigorous bleeding endpoints.

2025-12-01·EUROPEAN HEART JOURNAL

Reticulated platelets in coronary artery disease: a multidimensional approach unveils prothrombotic signalling and novel therapeutic targets

Article

作者: Bernlochner, Isabell ; Laugwitz, Karl-Ludwig ; Nicolai, Leo ; Wu, Tianjiao ; Santovito, Donato ; Peano, Clelia ; Raka, Leonora ; Manz, Quirin ; Han, Jiaying ; Baumbach, Jan ; Raake, Philip W J ; Kühne, Stephanie ; von Scheidt, Moritz ; List, Markus ; Louadi, Zakaria ; Ruland, Jürgen ; Condorelli, Gianluigi ; Tsoy, Olga ; Müller, Michaela ; Chiarito, Mauro ; Schwartz, Leon ; Modica, Jessica ; Babyak, Olena ; Arend, Lis ; Kirmes, Kilian ; Viggiani, Giacomo ; Bernett, Judith ; Bloxham, Conor J ; Hoffmann, Markus ; Klug, Melissa ; Newaz, Khalique ; Bongiovanni, Dario ; Conca Dioguardi, Carola ; Ciora, Octavia-Andreea ; Rosenbaum, Marc

Abstract:

Background and Aims:

Reticulated platelets (RPs), hyperreactive and RNA-rich, are associated with increased risk of cardiovascular events and suboptimal response to antiplatelet therapy in coronary artery disease (CAD). However, the underlying mechanisms remain poorly defined. This study aimed to characterize the molecular and functional phenotype of RPs in CAD and assess their potential as therapeutic targets.

Methods:

RPs and mature platelets (MPs) were isolated from CAD patients based on RNA content and CD41 expression. Paired RP vs MP comparisons were conducted within each donor. Transcriptomic profiling (RNA-seq) was integrated with high-dimensional proteomics (mass cytometry) and validated in independent cohorts. Functional studies, including flow cytometry-based platelet–platelet binding, in vitro thrombosis, platelet spreading, and intracellular phospho-protein profiling, assessed the impact of PI3K and GPVI pathways. Results were curated in Platlas, an open-access interactive web resource.

Results:

Among 95 CAD patients, RPs exhibited elevated activation marker expression and enrichment of prothrombotic pathways compared with MPs. RNA-seq revealed upregulation of GP6, TBXA2R, and VWF transcripts, novel GPVI splicing, and RP-specific non-coding RNAs including novel circRNAs. Proteomic and functional assays confirmed heightened PI3K and GPVI signalling, with increased phosphorylation of AKT, PI3K, and SYK, and elevated reactive oxygen species production. RPs showed increased aggregation, spreading and greater recruitment in thrombus formation, which were significantly reduced by PI3K (LY294002) and GPVI (glenzocimab) inhibition.

Conclusions:

This study provides the first mechanistic explanation for RP hyperreactivity, revealing a distinct molecular profile and identifying GPVI and PI3K inhibition as promising targets for tailored antiplatelet therapy in CAD patients with elevated RPs.

2025-07-21·EUROPEAN HEART JOURNAL

EMA601 and glenzocimab: two glycoprotein VI inhibitory Fabs with different potency

Article

作者: Stegner, David ; Nieswandt, Bernhard ; Navarro, Stefano

项与格仑西单抗相关的新闻（医药）

2025-10-19

·聚创马特

Med风向标｜2025年10月19日

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引进/卖出申请上市

2025-07-09

·生物制品圈

放射性药物升温：Actithera 融资 7550 万美元入局

摘要：德国生物技术公司 Actithera 近日完成 7550 万美元 B 轮融资，押注放射性药物赛道。这笔资金将用于推进其靶向 Claudin 18.2 的放射免疫疗法 ACT017 进入临床，并搭建放射性药物研发平台。在诺华、拜耳等巨头纷纷加码的背景下，Actithera 的入局凸显放射性药物领域的投资热度，也折射出该领域从 “小众治疗” 向 “广谱应用” 的转型趋势。一、融资背后：放射性药物成资本新宠Actithera 的 B 轮融资由 Forbion 和通和毓承联合领投，现有投资者拜耳旗下 Leaps by Bayer 跟投。公司成立于 2021 年，专注于开发基于单克隆抗体的放射性药物（放射免疫疗法），此次融资距离其 2022 年 2200 万美元 A 轮仅过去两年，估值已实现数倍增长。“放射性药物正在经历‘第二次革命’。”Forbion 合伙人 Jan van de Winkel 指出，第一次革命以诺华的 Lutathera（治疗胃肠胰神经内分泌肿瘤）为标志，证明了放射性药物的临床价值；而当前的热潮则聚焦于抗体靶向技术，可将放射性同位素精准递送至实体瘤，突破传统放疗的局限性。数据显示，2024 年全球放射性药物融资总额突破 120 亿美元，较 2020 年增长 3 倍，Actithera 的融资正是这一趋势的缩影。二、核心资产：Claudin 18.2 靶向药的差异化布局Actithera 的核心管线 ACT017 是一款靶向 Claudin 18.2 的放射免疫疗法，采用锕 - 225（Ac-225）作为放射性同位素。Claudin 18.2 在胃癌、胰腺癌等实体瘤中高表达，是当前肿瘤靶向治疗的热门靶点，但传统抗体药物偶联物（ADC）在实体瘤中的穿透性有限。“ACT017 的优势在于‘交叉火力效应’。”Actithera 首席科学官 Ulrich Lauer 解释，放射性同位素释放的 α 粒子可穿透多个细胞直径，即使抗体未精准结合所有肿瘤细胞，仍能通过辐射杀伤周边病灶，尤其适合治疗微转移或残留病灶。临床前数据显示，ACT017 在胃癌模型中可使肿瘤体积缩小 80% 以上，且对正常组织损伤较小。公司计划 2025 年启动 ACT017 的 I/II 期临床试验，首推适应症为 Claudin 18.2 阳性胃癌，后续将扩展至胰腺癌等其他实体瘤。三、平台野心：从 “单一药物” 到 “技术生态”除 ACT017 外，Actithera 正搭建放射性药物研发平台，涵盖三个核心模块：抗体筛选系统：通过 AI 预测抗体与肿瘤抗原的结合效率，优先选择高内化、低脱靶的候选分子；同位素偶联技术：开发稳定的化学 linker，确保放射性同位素在体内不脱落，降低全身毒性；生产工艺优化：与拜耳合作建立锕 - 225 的规模化生产流程 —— 这种同位素依赖核反应生成，全球年产量不足 100 毫克，是放射免疫疗法商业化的主要瓶颈。“我们不只是开发一款药物，而是要解决放射性药物从研发到生产的全链条痛点。”Actithera CEO Holger Zimmermann 表示，公司已与多家核医学机构达成合作，探索放射性同位素的供应链优化方案。四、巨头环伺：放射性药物赛道的 “红海化” 隐忧Actithera 的入局正值放射性药物领域竞争白热化。诺华凭借 Lutathera 和 Pluvicto（治疗前列腺癌）占据先发优势，2024 年相关营收超 30 亿美元；拜耳通过收购 Noria Therapeutics 加码 α 粒子疗法；默克、罗氏也在加速布局放射免疫疗法管线。更激烈的竞争来自 ADC 与放射性药物的 “靶点重叠”。Claudin 18.2 靶向 ADC 已有多家企业进入临床，如阿斯利康的 Zolbetuximab 已获 FDA 批准用于胃癌，其与 ACT017 的直接对决或将不可避免。“放射性药物的优势在于治疗晚期或转移性肿瘤，但需要证明与 ADC 相比的生存获益。”van de Winkel 指出，Actithera 的差异化在于选择 α 粒子（杀伤范围小、毒性集中）而非 β 粒子（如钇 - 90），这可能降低对骨髓等正常组织的损伤，但临床优势仍需验证。五、未来挑战：从临床到商业化的多重关卡尽管融资顺利，Actithera 仍面临三重考验：同位素供应：锕 - 225 的稀缺性可能限制 ACT017 的商业化规模，公司需与核反应堆运营商建立长期合作；临床设计：放射免疫疗法的剂量爬坡、安全性评估标准与传统药物不同，需与监管机构密切沟通；支付体系：放射性药物单次治疗费用常达数十万美元，如何说服医保覆盖将是商业化关键。但行业对放射性药物的前景仍持乐观态度。随着精准靶向技术的进步，放射性药物正从罕见病向常见病拓展，预计 2030 年全球市场规模将突破 200 亿美元。Actithera 的 7550 万美元融资，既是对这一赛道的押注，也是小型 biotech 在巨头环伺下寻求突围的缩影 —— 在放射性药物的 “第二次革命” 中，能否凭借技术差异化占据一席之地，仍需时间检验。参考来源：https://www.biospace.com/business/actithera-raises-75-5m-to-play-in-sizzling-radiopharma-space识别微信二维码，添加生物制品圈小编，符合条件者即可加入生物制品微信群！请注明：姓名+研究方向！版权声明本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观不本站。

放射疗法抗体药物偶联物免疫疗法

2024-07-26

·FierceBiotech

Acticor halts phase 2/3 stroke trial for blood thinner over futility

Results from a phase 2b trial in myocardial infarction are expected at the end of next year. Acticor Biotech is discontinuing a phase 2/3 study of a blood thinner given alongside heart surgery based on the results of a futility analysis.The French company had been testing the drug, glenzocimab, as an adjunct to mechanical thrombectomy in patients who have suffered an acute ischemic stroke. More than 100 patients have been enrolled in the study to date, with the futility analysis conducted on data from the first 78 participants.“In the light of the information provided to the members of the Independent Monitoring Committee (IMC), and in accordance with the futility criteria defined in the protocol, the IMC recommends that the GREEN study be discontinued,” Acticor said in a Friday release.Glenzocimab, which is Acticor’s sole asset, is an antibody fragment that’s directed against platelet glycoprotein VI (GPVI). The protein is critical for blood clot formation but doesn’t affect the regulation of bleeding, making it an ideal target for safely inhibiting platelet clumps.Glenzocimab is undergoing or in line for a number of clinical trials in relation to strokes or heart attacks, but this isn’t the first time the drug has come up short. In April, glenzocimab failed to hit the primary endpoint of reducing the risk of severe disability or death in the wake of a stroke across a separate phase 2/3 study. Early hopes for glenzocimab were that it could cut the risk of uncontrolled bleeding that can be a side effect of widely prescribed blood thinners such as COX-1 inhibitor aspirin and P2Y12 antagonist Plavix. This theory was back up by a small first-in-human study of the drug in healthy volunteers that read out in 2019.Those hopes continued into January 2024, when a phase 1b/2a study showed a reduction in mortality and brain bleeding among stroke patients who received the drug.Results from a phase 2b trial in myocardial infarction, a term for a heart attack, are expected at the end of next year.

临床2期临床3期

100 项与格仑西单抗相关的药物交易

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KEGG	Wiki	ATC	Drug Bank
-	-	-	DB16175

研发状态

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适应症	最高研发状态	国家/地区	公司	日期
急性缺血性卒中	临床3期	美国	Acticor Biotech SAS	2021-09-23
急性缺血性卒中	临床3期	德国	Acticor Biotech SAS	2021-09-23
新型冠状病毒感染	临床2期	法国	Acticor Biotech SAS	2020-12-16
急性呼吸窘迫综合征	临床2期	法国	Acticor Biotech SAS	2020-12-16
肺栓塞	临床2期	法国	Acticor Biotech SAS	-

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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


NCT04659109 (GARDEN, Pubmed 1 \| Pubmed 2) 人工标引	临床2期	新型冠状病毒感染	61	Glenzocimab	廠壓蓋網繭選觸鹹積製(糧艱顧壓簾糧積鏇廠夢) = 選鹹選製鬱艱鹹鹽積膚廠積積顧願窪觸築艱艱 (簾膚衊獵淵網餘鏇選構 ) 更多	-	2024-06-17
				Placebo	廠壓蓋網繭選觸鹹積製(糧艱顧壓簾糧積鏇廠夢) = 鏇鬱獵願餘範繭積鑰積廠積積顧願窪觸築艱艱 (簾膚衊獵淵網餘鏇選構 ) 更多
NCT03803007 (ACTIMIS, Pubmed) 人工标引	临床1/2期	急性缺血性卒中	166	Glenzocimab 1000 mg	鏇遞遞鹽顧襯醖艱壓範(夢衊衊鏇襯顧艱觸鬱構) = 簾構廠廠構鹹艱廠製淵網糧膚觸製積顧衊選範 (鏇鏇網鏇壓窪製鏇壓鏇 )	积极	2024-02-01
				Placebo	-
NCT03803007 (ACTIMIS, ESOC2022) 人工标引	临床1/2期	颅内出血	166	Glenzocimab	餘艱構壓遞繭膚糧艱願(窪製廠壓壓淵糧顧窪範) = 鹹築鏇壓遞獵鬱壓遞遞衊艱淵鬱淵窪鹹範簾鑰 (觸餘簾蓋鏇簾鬱蓋窪構 ) 更多	积极	2022-05-09
				Placebo	餘艱構壓遞繭膚糧艱願(窪製廠壓壓淵糧顧窪範) = 獵憲衊醖願製願構鑰窪衊艱淵鬱淵窪鹹範簾鑰 (觸餘簾蓋鏇簾鬱蓋窪構 ) 更多