(Xisomab 3G3(Oregon Health & Science University)) - 药物靶点：F11_在研适应症：血栓形成_专利_临床

概要

基本信息

药物类型

单克隆抗体

别名

Anti-factor XI Monoclonal Antibody Xisomab 3G3、Anti-FXI Antibody Xisomab 3G3、Gruticibart

+ [8]

靶点

F11

作用机制

F11抑制剂(凝血因子XI抑制剂)

治疗领域

心血管疾病

在研适应症

血栓形成

非在研适应症

导管相关性血栓终末期肾脏病恶性实体肿瘤+ [3]

原研机构

Oregon Health & Science University

在研机构

Oregon Health & Science University

非在研机构

Aronora, Inc.

National Heart, Lung & Blood Institute

最高研发阶段临床2期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

序列信息

Sequence Code 611655732L

来源: *****

Sequence Code 611655733H

来源: *****

关联

3

项与 Xisomab 3G3(Oregon Health & Science University) 相关的临床试验

NCT04465760 / Terminated临床2期

A Phase II Study of Xisomab 3G3, a Monoclonal Antibody Preventing the Activation of FXI by FXIIa, for the Prophylaxis of Catheter-Associated Thrombosis

This phase II trial studies how well xisomab 3G3 works in preventing catheter-associated blood clots (thrombosis) in patients with cancer receiving chemotherapy. Many patients with cancer develop blood clots from their catheters and can have pain, swelling, and other symptoms. They also often require blood thinners, which can increase the risk of bleeding. Xisomab 3G3 is type of drug called a monoclonal antibody that may prevent blood clots caused by a catheter in patients receiving chemotherapy.

开始日期2021-02-25

申办/合作机构

OHSU Knight Cancer Institute

[+2]

NCT03612856 / Completed临床2期

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy/Potency of a Single Dose of Xisomab 3G3, Administered at the Beginning of a Regular Hemodialysis Procedure, in Patients With End-Stage Renal Disease on Chronic Hemodialysis

This study evaluates the safety and efficacy of AB023 (xisomab 3G3) in patients with end stage renal disease on chronic hemodialysis. Two dose levels will be evaluated in two cohorts. Within each cohort the patients will be randomized to receive either AB023 (xisomab 3G3) or placebo (at a ratio of 2:1 active: placebo).

开始日期2018-10-29

申办/合作机构

Aronora, Inc.

NCT03097341 / Completed临床1期

A Phase 1, Single Ascending Dose, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Xisomab 3G3 in Healthy Adult Subjects

The purpose of this study is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of xisomab 3G3 in healthy adult subjects.

开始日期2017-06-05

申办/合作机构

Aronora, Inc.

100 项与 Xisomab 3G3(Oregon Health & Science University) 相关的临床结果

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100 项与 Xisomab 3G3(Oregon Health & Science University) 相关的转化医学

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100 项与 Xisomab 3G3(Oregon Health & Science University) 相关的专利（医药）

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28

项与 Xisomab 3G3(Oregon Health & Science University) 相关的文献（医药）

2023-12-01·ASAIO journal (American Society for Artificial Internal Organs : 1992)

Factor XI Inhibition With Heparin Reduces Clot Formation in Simulated Pediatric Extracorporeal Membrane Oxygenation

Article

作者: Tucker, Erik I ; Cap, Andrew P ; Meyer, Andrew D ; Fraker, Tamara ; Rocha, Jeanette ; Thorpe, Catherine R ; McCarty, Owen J T ; Willis, R Patrick ; Cancio, Tomas ; Gailani, David ; Shatzel, Joseph J

Extracorporeal membrane oxygenation (ECMO) supplies circulatory support and gas exchange to critically ill patients. Despite the use of systemic anticoagulation, blood exposure to ECMO surfaces causes thromboembolism complications. Inhibition of biomaterial surface-mediated activation of coagulation factor XI (FXI) may prevent device-associated thrombosis. Blood was collected from healthy volunteers (n = 13) following the U.S. Army Institute of Surgical Research standard operating procedure for testing in an ex vivo ECMO circuit. A roller-pump circuit circulated either 0.5 U/ml of unfractionated heparin alone or in combination with the anti-FXI immunoglobulin G (IgG) (AB023) for 6 hours or until clot formation caused device failure. Coagulation factor activity, platelet counts, time to thrombin generation, peak thrombin, and endogenous thrombin potential were quantified. AB023 in addition to heparin sustained circuit patency in all tested circuits (5/5) after 6 hours, while 60% of circuits treated with heparin alone occluded (3/8), log-rank p < 0.03. AB023 significantly prolonged the time to clot formation as compared to heparin alone (15.5 vs. 3.3 minutes; p < 0.01) at the 3-hour time point. AB023 plus heparin significantly reduced peak thrombin compared to heparin alone (123 vs. 217 nM; p < 0.01). Inhibition of contact pathway activation of FXI may be an effective adjunct to anticoagulation in extracorporeal life support.

2023-10-01·Access microbiology

Identification of secondary metabolites containing a diketopiperazine core in extracts from myxobacterial strains with growth inhibition activity against a range of prey species

Article

作者: Radford, Emily J. ; Whitworth, David E. ; Allison, Gordon

Myxobacteria produce a variety of bioactive secondary metabolites, and with a wealth of under-researched species they hold vast potential for undiscovered compounds. With the ever-increasing need for new antibiotics, the development of novel therapeutics is vitally important. Therefore, this study aimed to extract and elucidate antimicrobial metabolites from the following myxobacteria: Myxococcus xanthus CA010 and AB022; Corallococcus exiguus DSM 14696T; Myxococcus stipitatus DSM 14675T; and Corallococcus aberystwythensis AB050AT. Metabolite mixtures were extracted in acetone from XAD-16 resin incubated in liquid cultures and analysed using GC-MS. Bioactivity was identified using a growth inhibition assay against a panel of clinically relevant prey species including Gram-positive and Gram-negative bacteria and a fungus. Growth of Klebsiella pneumoniae and Enterococcus faecalis was most affected by the metabolite mixtures and the mixtures from AB022 and AB050AT were effective against the most prey. GC-MS analysis revealed metabolites with roles in the synthesis and degradation of amino acids and fatty acids, but also identified compounds A and B with a diketopiperazine (DKP) core. With previously confirmed bioactivity of compound A, it is suggested that these DKP compounds are contributing to the antimicrobial activity observed. Furthermore, many compounds could not be identified and so these unknowns present further potential for novel bioactive compounds.

2023-08-01·Veterinary microbiology

Identification of new conserved linear B-cell epitopes in the 3AB and 3C protein of Senecavirus A

Article

作者: Liu, Xing ; Sun, Haifeng ; Jiang, Ping ; Li, Jian ; Gao, Yanni ; Yan, Junfang ; Bai, Juan

Senecavirus A (SVA) is a member of the Picornaviridae family, Senecavirus genus. The outbreak of swine vesicular disease caused by SVA has presented a significant threat to pig husbandry and public health, resulting in substantial economic losses. In this study, recombinant SVA 3AB and 3C proteins were expressed in the prokaryotic system, purified, and utilized to generate eight monoclonal antibodies (mAbs) specific to SVA 3AB or 3C proteins. Three B-cell epitopes recognized by these mAbs were subsequently identified by Western blotting. The mAbs 3G3, 3D6, and 3B7 against 3AB recognize the epitope ⁹⁰NAYDGPKKNS¹⁰⁰; the mAbs 2C10, 2C8, and 2D12 against 3C recognize the epitope ⁷⁵FTHHGLPTDL⁸⁵, and the mAbs 3C4 and 4A11 against 3C recognize the epitope ⁹⁵DQMPARNSRV¹⁰⁵. Moreover, all three epitopes are highly conserved in different SVA strains and are exposed on the surface of 3AB or 3C proteins, potentially representing important B-cell epitopes. This study constitutes the first report of SVA nonstructural protein epitopes, which may be beneficial for developing innovative detection methods and vaccines and for investigating the roles of 3AB and 3C in viral replication.

1

项与 Xisomab 3G3(Oregon Health & Science University) 相关的新闻（医药）

2023-11-23

·医药地理

突破性XIa抑制剂能否搅动百亿抗凝市场？

日前，诺华与资产管理公司黑石集团成立的生物制药公司Anthos Therapeutics宣布，在1287名具有中至高卒中风险房颤（AF）患者中开展的AZALEA-TIMI71临床2期研究达到主要终点。AZALEA-TIMI71研究共纳入1287例有中度至高度卒中风险的房颤患者，旨在评估Abelacimab（150mg或90mg，每月1次）对比利伐沙班（20mg，每日1次）治疗房颤的有效性和安全性。研究的主要终点为主要出血事件或临床相关非主要出血事件的复合发生率。结果显示，相比于利伐沙班，Abelacimab表现出了降低患者的出血事件发生率的压倒性优势。值得注意的是，Abelacimab是第一款可以有效减少大出血事件发生的凝血因子XIa抑制剂。表1：Abelacimab药物基本信息来源：CPM新药研发监测数据库，中国医药工业信息中心抗凝新星：XIa因子抑制剂家族Abelacimab是一种新型、高选择性、全人源单克隆抗体，可靶向凝血因子XI并将之锁定在无活性状态，因此对凝血因子XI及其活化形式凝血因子XIa产生双重抑制。凝血因子XI（FXI）是Rosenthal等人在1953年发现的凝血级联中的一种凝血蛋白,主要由肝细胞合成，以酶原形式循环，通过活化的FXII和凝血酶转化为活化形式FXIa。FXIa是一种促凝血剂，在内源性凝血接触系统中起重要作用。流行病学和临床前研究发现，FXI水平升高较平均水平个体发生静脉血栓形成和卒中的风险更高，因此，FXI缺乏与心血管和静脉血栓栓塞（VTE）事件风险降低有关，阻断FXI和/或FXIa的抗体和反义寡核苷酸可以在动物模型中减少血栓形成。与其它凝血因子不同，FXI缺乏的人很少发生自发性出血，许多人即使接受手术也不会明显出血。由此看来，FXI对止血作用很小，这与其抑制对止血栓的形成几乎没有干扰；相反，FXI在阻塞性血栓的形成中起重要作用。据中国医药工业信息中心CPM新药研发监测数据库信息，目前全球在研的6种XIa因子抑制剂中，根据药物作用靶点和机制不同，可分为三种类型，即反义寡核苷酸（ASO）、单抗和小分子药物。Osocimab、Abelacimab和Xisomab 3G3是静脉注射的单克隆抗体，作用快速有效，且持续时间相对较长；IONIS-FXIRX是一种反义寡核苷酸，可减少FXI合成，但需要数周才能完成；Milvexian和Asundexian是口服的活性小分子抑制剂，半衰期短，需要每天给药。表2: Osocimab药物基本信息来源：CPM新药研发监测数据库，中国医药工业信息中心表3: Xisomab 3G3药物基本信息来源：CPM新药研发监测数据库，中国医药工业信息中心表4: IONIS-FXIRX药物基本信息来源：CPM新药研发监测数据库，中国医药工业信息中心表5: Milvexian药物基本信息来源：CPM新药研发监测数据库，中国医药工业信息中心表6：Asundexian药物基本信息来源：CPM新药研发监测数据库，中国医药工业信息中心表7: 不同类型XIa因子抑制剂盘点整理自中国医药工业信息中心谁能撬开百亿抗凝市场据统计，血栓形成、血块阻塞血管会导致心脏病发作或中风，两者合计导致的死亡人数约占全球死亡人数的1/4。在中国医药工业信息中心Pharma ONE智能药物大数据分析平台中搜索“血栓”这一疾病类型，可以看到2022年全球该疾病相关药物销售额超7百亿美金。图1: 2022年血栓用药全球销售额来源：Pharma ONE智能药物大数据分析平台中国医药工业信息中心抗凝药物是预防和治疗血栓的基石，目前临床常用的药物主要有直接口服抗凝剂（DOAC）、维生素K拮抗剂（VKA）和肝素等。其中，沙班类药物占据主流地位，利伐沙班、阿哌沙班、艾多沙班均属于这一类别。通过分析Pharma ONE数据库中利伐沙班、阿哌沙班、艾多沙班的全球销售数据，可以看出，该类药物的全球销售额逐年稳步上升，其中，阿哌沙班于2018年销售额首次超越利伐沙班，并呈现出快速放量状态。图2: 全球利伐沙班、阿哌沙班、艾多沙班销售额趋势来源：Pharma ONE智能药物大数据平台中国医药工业信息中心由于传统抗凝药物存在许多局限性，且易受外界影响导致抗凝不足，沙班类药物虽已被证实具有更高安全性，但该类药物同样存在传统抗凝、抗栓药物的共同弊病：出血。当前研究已经证实，新型XIa因子抑制剂相较利伐沙班能有效降低患者的出血概率。未来，这类药物能否凭借其独特的抗凝机制成为血栓疾病市场的有力竞争者，我们将拭目以待。年度发布2023年《全球药研新动态》《中国医院市场用药格局》（2023版）2023年《数图药讯》权威发布2021年度中国医药工业百强榜单解读中国仿制药发展报告（2022版）《2023年专利到期药品概述》医药行业专项报告中国医药中间体和原料药行业调研报告中国非甾体抗炎类原料药市场调研报告中国祛痰类原料药市场调研报告中国钙拮抗剂类原料药市场调研报告中国血管紧张素Ⅱ受体拮抗剂类原料药市场调研报告中国口服血糖调节类原料药市场调研报告中国中枢兴奋类原料药市场调研报告中国抗痛风类原料药市场调研报告中国脑血管病类原料药市场调研报告END如需获取更多数据洞察信息或公众号内容合作，请联系医药地理小助手微信号：pharmadl001

临床2期寡核苷酸突破性疗法

100 项与 Xisomab 3G3(Oregon Health & Science University) 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
导管相关性血栓	临床2期	美国	National Heart, Lung & Blood Institute	2021-02-25
恶性实体肿瘤	临床2期	美国	National Heart, Lung & Blood Institute	2021-02-25
多发性骨髓瘤	临床2期	美国	National Heart, Lung & Blood Institute	2021-02-25
终末期肾脏病	临床2期	美国	Aronora, Inc.	2018-10-29
血栓形成	临床2期	美国	Aronora, Inc.	2018-10-29
神经系统疾病	临床前	美国	Aronora, Inc.	2018-11-17
脓毒症	临床前	美国	Aronora, Inc.	-

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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


NCT04465760 (CTgov)	临床2期	导管相关性血栓 \| 恶性实体肿瘤 \| 多发性骨髓瘤	9	Xisomab 3G3	選醖鹹膚遞膚鹹簾壓憲(範築壓衊齋窪蓋壓壓願) = 範鏇築製襯餘獵壓憲淵鑰衊遞範網膚壓遞窪築 (夢顧範壓齋憲鏇鹹膚齋, 鹹願夢壓繭範艱蓋廠壓 ~ 選獵醖夢繭衊鹹糧襯淵) 更多	-	2024-01-02
NCT03612856 (ASH2020) 人工标引	临床2期	终末期肾脏病	24	AB023 0.25 mg/kg	醖壓構艱艱夢蓋繭糧憲(夢築構膚餘範網鏇顧餘) = 憲範淵廠廠艱網淵鬱廠醖糧壓鹽壓顧壓顧鏇醖 (遞遞構網築鬱齋遞網醖 ) 更多	积极	2020-11-05
				AB023 0.5 mg/kg	醖壓構艱艱夢蓋繭糧憲(夢築構膚餘範網鏇顧餘) = 繭範鏇顧鹽選遞顧願憲醖糧壓鹽壓顧壓顧鏇醖 (遞遞構網築鬱齋遞網醖 ) 更多
NCT03612856 (CTgov)	临床2期	血栓形成 \| 终末期肾脏病	27	AB023- Dose 1 (AB023 (Xisomab 3G3)- Dose 1)	願範網夢窪選糧築淵範(糧獵積淵壓繭襯範鏇選) = 齋積築壓選襯獵簾憲壓廠鑰壓鹽製壓鏇選淵遞 (壓淵網鹹遞構壓積觸製, 淵襯壓範製憲齋鑰顧遞 ~ 構糧窪鬱鏇獵鹽蓋範糧) 更多	-	2020-07-22
				AB023-Dose 2 (AB023 (Xisomab 3G3)- Dose 2)	願範網夢窪選糧築淵範(糧獵積淵壓繭襯範鏇選) = 簾築範蓋鬱鹽觸觸遞襯廠鑰壓鹽製壓鏇選淵遞 (壓淵網鹹遞構壓積觸製, 夢範顧衊遞糧遞網網艱 ~ 膚遞構蓋觸憲簾範蓋獵) 更多
NCT03097341 (CTgov)	临床1期	血栓形成	21	xisomab 3G3- Dose 1 (Xisomab 3G3- Dose 1)	醖窪壓製製餘繭構獵襯(積鹽衊襯觸積鹹醖獵蓋) = 積憲醖構醖膚築醖鏇壓積獵構鬱壓網壓醖範鑰 (糧鑰製淵襯餘築餘餘廠, 製餘築憲壓蓋鹹獵蓋遞 ~ 構壓齋鹽鏇願醖遞繭蓋) 更多	-	2019-05-20
				xisomab 3G3-Dose 2 (Xisomab 3G3- Dose 2)	醖窪壓製製餘繭構獵襯(積鹽衊襯觸積鹹醖獵蓋) = 衊衊餘鑰壓窪範窪顧網積獵構鬱壓網壓醖範鑰 (糧鑰製淵襯餘築餘餘廠, 遞簾繭鹹餘鹽積醖範齋 ~ 夢鏇積餘鹽鏇艱觸簾製) 更多
NCT03097341 (Pubmed) 人工标引	临床1期	血栓形成	21	AB023	淵醖繭製鬱鏇鑰獵廠鹽(餘膚選製壓獵襯衊積積) = 壓壓襯網繭範艱夢膚鹹齋繭築壓築壓遞觸積鏇 (顧衊鏇襯觸願齋積鬱壓 )	积极	2019-04-01
				Placebo	淵醖繭製鬱鏇鑰獵廠鹽(餘膚選製壓獵襯衊積積) = 積選夢夢積艱範願顧繭齋繭築壓築壓遞觸積鏇 (顧衊鏇襯觸願齋積鬱壓 )