维恩妥尤单抗(Enfortumab Vedotin-ejfv) - 药物靶点：Tubulin x nectin-4_在研适应症：不可切除的尿路上皮癌，局部晚期尿路上皮癌，转移性尿路上皮癌_专利_临床

概要

基本信息

药物类型

ADC

别名

Enfortumab vedotin、Enfortumab Vedotin (Genetical Recombination)、恩诺单抗

+ [15]

靶点

Tubulin x nectin-4

作用方式

抑制剂

作用机制

微管蛋白抑制剂、nectin-4抑制剂(细胞黏附分子nectin-4抑制剂)

治疗领域

肿瘤泌尿生殖系统疾病消化系统疾病+ [2]

在研适应症

不可切除的尿路上皮癌局部晚期尿路上皮癌转移性尿路上皮癌+ [24]

非在研适应症

乳腺癌肺癌

原研机构

Astellas Pharma, Inc.

在研机构

Merck Sharp & Dohme Corp.

Seagen, Inc.

安斯泰来制药（中国）有限公司

+ [10]

非在研机构-

最高研发阶段批准上市

首次获批日期

美国 (2019-12-18),

尿路上皮癌

最高研发阶段(中国)批准上市

特殊审评优先审评 (美国)、突破性疗法 (美国)、加速批准 (美国)、孤儿药 (韩国)

登录后查看时间轴

结构/序列

使用我们的ADC技术数据为新药研发加速。

登录

或

查看完整样例数据

Sequence Code 319372632H

来源: *****

Sequence Code 319372700L

来源: *****

关联

60

项与维恩妥尤单抗相关的临床试验

NCT06356155

/ Not yet recruiting临床2期IIT

A Phase II, Open-label, Single-arm, Multi-center Study of Neoadjuvant Enfortumab Vedotin and Pembrolizumab in Cisplatin-eligible Upper Tract Urothelial Cancer (NEPTUNE)

This trial is a multi-site, single-arm, phase 2 trial of neoadjuvant combination of enfortumab vedotin and pembrolizumab in cisplatin-eligible patients with high-grade localized/locally advanced cT1-4 N0-1 M0 upper tract urothelial cancer who are deemed eligible for curative-intent surgery (radical nephroureterectomy or distal ureterectomy) followed by adjuvant pembrolizumab.

开始日期2025-06-01

申办/合作机构

Rogel Cancer Center: University of Michigan

NCT06041503

/ Not yet recruiting临床2期IIT

A Phase II Multicenter Study of Enfortumab Vedotin With or Without Pembrolizumab in Rare Genitourinary Tumors (E-VIRTUE)

Background:
Many cancers of the testicles and urinary tract are rare diseases; these are diseases that affect less than 200,000 people in the United States. It can be hard to study treatments for these diseases. One combination of drugs-enfortumab vedotin (EV) and pembrolizumab-has already been approved to treat some urinary cancers. Researchers want to see if they can help people with other types of testicle and urinary cancers.
Objective:
To test EV, with or without pembrolizumab, in patients with rarer cancers of the testicles or urinary tract.
Eligibility:
People aged 18 and older with rarer cancers of the testicles or urinary tract.
Design:
Participants will be screened. They will have a physical exam with blood and urine tests. Their ability to perform normal daily activities will be tested. They will have exams of their skin and eyes. They will have imaging scans. A biopsy may be needed: A sample of tissue will be removed from the tumor.
The study drugs are both given through a tube attached to a needle inserted into a vein in the arm. Some participants will receive treatments 3 times during 28-week cycles; others will receive treatments 2 times during 21-day cycles.
All participants may continue to receive treatments for up to 5 years. Imaging scans and other tests will be repeated.
Participants who stop taking the drugs will have follow-up visits every 3 to 4 weeks until the disease gets worse. They will have imaging scans and blood tests.
After that, follow-up visits will continue by phone every 3 months for up to 5 years after study therapy is finished.

开始日期2025-04-16

申办/合作机构

National Cancer Institute

DRKS00034745

/ SuspendedN/AIIT

Prospective validation of membranous NECTIN-4 expression as biomarker to predict enfortumab vedotin + pembrolizumab response in metastatic urothelial cancer

开始日期2025-04-15

申办/合作机构-

100 项与维恩妥尤单抗相关的临床结果

登录后查看更多信息

100 项与维恩妥尤单抗相关的转化医学

登录后查看更多信息

100 项与维恩妥尤单抗相关的专利（医药）

登录后查看更多信息

1,041

项与维恩妥尤单抗相关的文献（医药）

2025-12-01·CANCER CHEMOTHERAPY AND PHARMACOLOGY

Model-informed development of a cost-saving dosing regimen for enfortumab vedotin

Article

作者: Koolen, Stijn Lw ; Boerrigter, Emmy ; Rieborn, Amy ; van Kruchten, Michel ; Willemsen, Annelieke Ecab ; Franken, Mira D ; van der Hulle, Tom ; Op 't Hoog, Catharina Jp ; van der Heijden, Michiel S ; Hendrikx, Jeroen Jma ; Ter Heine, Rob ; Moes, Dirk Jan Ar

Abstract:

Aim:

Enfortumab vedotin is an antibody-drug conjugate (ADC) that has been approved for locally advanced or metastatic urothelial cancer, as monotherapy and in combination with pembrolizumab, and has shown significant benefit in progression-free survival and overall survival for these patients. The economic burden of enfortumab vedotin hampers widespread patient access. The aim of this study was to develop a model-informed alternative dosing regimen that results in equivalent drug exposure while reducing the costs and prevent drug spillage.

Methods:

Population pharmacokinetic modelling was used to simulate a dosing regimen leading to equivalent exposure by using the published population pharmacokinetic model in the registration reports. The alternative dosing regimen was based on weight-bands derived from the established non-linear relationship between body weight and systemic exposure, and the usage of whole vials based on fixed doses to prevent spillage. Equivalent exposure compared to the approved body weight-based dosing regimen was defined as conservative equivalent boundaries of 90–111% for the calculated geometric mean ratios (GMRs) of area under the concentration-time curve and trough concentration.

Results:

A weight-band based dosing regimen for each dose level of enfortumab vedotin was developed. The GMRs for all pharmacokinetic outcomes were within the predefined equivalence boundaries. In addition, a more even exposure distribution was observed across the body weight quartiles. The average costs savings across all dose levels and per weight-band were approximately 15%.

Conclusion:

The proposed alternative dosing regimen shows that drug costs and spillage of enfortumab vedotin can be reduced while maintaining an equivalent and more evenly distributed exposure in treated patients.

2025-05-01·CURRENT OPINION IN ONCOLOGY

Antibody–drug conjugates in rare genitourinary tumors: review and perspectives

Review

作者: Yousefi-Rad, Abbas ; Simon, Nicholas ; Atiq, Saad ; Gurram, Sandeep ; Apolo, Andrea B. ; Sarwar, Md. Shahid ; Banday, A. Rouf ; Chelluri, Raju ; Boudjadi, Salah ; Kydd, Andre R. ; Chandran, Elias ; Stukes, Ian ; Weng, Sally

Purpose of review:

Rare cancers of the genitourinary (GU) tract are often clinically aggressive yet have few or no standard-of-care treatments. Multiple antibody–drug conjugates (ADCs) have been approved in solid malignancies. This review explores the use of ADCs in rare GU tumors in the context of biological pathways and ongoing research in solid tumors.

Recent findings:

Few clinical trials of ADCs focus on recruiting participants with rare tumors of the GU tract, including trials testing enfortumab vedotin as monotherapy or combined with pembrolizumab, and sacituzumab govitecan as monotherapy or combined with atezolizumab. We highlight many ongoing trials of novel ADCs for advanced/metastatic solid tumors and emphasize the potential eligibility of patients with rare GU tumors for tumor-agnostic trials.

Summary:

ADCs are being tested in multiple solid tumors, including rare GU tumors. Ongoing preclinical research supports the use of some ADCs in several rare GU tumors and improves our understanding of their pathophysiology.

2025-05-01·CURRENT OPINION IN UROLOGY

Antibody–drug conjugates in urothelial carcinoma: current status and future

Review

作者: Tagawa, Scott T. ; Martinez, Juana ; Palmer, Jessica ; Ruder, Samuel ; Arham, Abdul Baseet

Purpose of review:

Antibody–drug conjugates (ADCs) are quickly becoming frontline standard of care in many tumor types, including urothelial carcinoma. This review summarizes recent clinical investigations into the use of ADCs targeting nectin-4, trophoblast cell surface antigen-2 (Trop-2), human epidermal growth factor receptor 2 (HER-2), and other antigens in urothelial carcinoma.

Recent findings:

This review covers efficacy and toxicity data of ADCs alone and in combination with immunotherapy; mechanisms of resistance; and preclinical studies that provide biological basis for clinical approaches.

Summary:

Enfortumab vedotin and sacituzumab govitecan can be used in an unselected group of patients with urothelial carcinoma whereas HER-2 ADCs have only been administered in those with high expression or amplification. Most are being studied in combination with immune checkpoint inhibitors. Data supports use of enfortumab vedotin in combination with pembrolizumab as first-line therapy in metastatic/unresectable locally advanced urothelial carcinoma. Sacituzumab govitecan may be used as later-line option in these patients. HER-2 therapy is still under investigation but has many recent promising results.

944

项与维恩妥尤单抗相关的新闻（医药）

2025-04-14

·药智网

ADC新锐加码AI制药

今日，迈威生物宣布与深势科技达成战略合作。双方将充分发挥各自在生物药研发和人工智能（AI）大模型领域的优势，共同打造生物药研发大模型平台。而就在不久前，迈威生物宣布与英矽智能达成战略合作，基于双方各自在ADC研发和人工智能（AI）领域的技术优势，以AI赋能ADC创新药研发。1ADC收获在即迈威生物成立于2017年，在ADC技术平台构建、单/双抗分子发现等领域具备突出优势，并已打通ADC药物从研发到生产的全产业链。自主研发的IDDC™平台与Mtoxin™毒素技术已在多项目中得到验证。现有16个品种处于不同阶段，包括12个创新品种和4个生物类似药。在研管线中ADC疗法最为亮眼，其中9MW2821被寄予厚望。该药是一款采用化学修饰偶联技术且具有自主知识产权的创新型定点抗体偶联药物，作用靶点为Nectin-4。药智数据显示，目前全球已有超过10种用于治疗实体瘤的靶向Nectin-4 ADC管线正在临床开发中。其中Padcev是美国及中国批准的唯一一种靶向Nectin-4 ADC药物，用于治疗尿路上皮癌及或膀胱癌，2024年该药销售额超过20亿美元。而迈威生物的9MW2821已有多个适应症进入3期阶段，处于全球前列。表1 全球处于临床阶段的Nectin-4 ADC管线数据来源：药智数据根据迈威生物新闻稿，9MW2821注射入人体后，可与肿瘤细胞表面的Nectin-4结合并进入细胞，通过酶解的作用，定向释放细胞毒素，从而实现对肿瘤的精准杀伤。此外，9MW2821还具有组分均一，纯度较高以及便于产业化等特点.目前，该药在多适应症展现BIC潜力：针对尿路上皮癌，单药、联合PD-1单抗治疗均挺进Ⅲ期进度位居全球第二；针对宫颈癌，全球首个且唯一一个挺进Ⅲ期的Nectin-4 ADC。2押注AI，加速研发创新目前迈威生物已在ADC领域积累一定优势，而其近期在AI领域的频繁动作，有望进一步巩固其在新药研发领域的综合竞争力。据悉，深势科技凭借其自主研发的Uni-Smart科学文献多模态大模型、Uni-Mol分子构象大模型和Uni-Fold蛋白折叠大模型等一系列生命科学大模型，构建了完整的微观世界认知与计算体系。此次合作将融合迈威生物ADC技术优势与深势科技RiDYMO®平台优势，共同探索突破创新靶点机制研究，加速药物分子从0到1的发现，推动生物药研发从“实验驱动”迈向“计算驱动”，进一步提升研发效率。而英矽智能是生成式人工智能驱动药物研发领域的先锋，已构建覆盖生物、化学、临床医学和科学研究的一体化药物研发平台Pharma.AI。其中生物板块下属PandaOmics、Generative Biologics等引擎，通过赋能药物靶点识别和从头生成分子片段提升研发效率。根据合作协议，双方将结合各自的平台优势，开发具有全新生物机制、创新结构和药学活性的新一代毒素载荷，提升ADC创新效率，并助力AI平台升级迭代。AI与ADC的协同效应，有望助力迈威生物构建更高的技术壁垒，在ADC赛道从跟随者向引领者跃迁的同时，开辟AI医药创新生态的新战场。参考来源：1.迈威生物：迈威生物与深势科技达成战略合作，共筑AI for Science大模型驱动的创新药研发新范式2.迈威生物：AI赋能ADC创新药研发，迈威生物宣布与英矽智能达成战略合作3.药智数据权威榜单定义行业标杆，赋能企业品牌价值！识别二维码，解锁年度惊喜！声明：本内容仅用作医药行业信息传播，不代表药智网立场。对本文有异议或投诉，请联系maxuelian@yaozh.com。责任编辑 | 小月石合作、投稿 | 马老师 18323856316（同微信）阅读原文，是受欢迎的文章哦

抗体药物偶联物临床3期临床结果生物类似药引进/卖出

2025-04-12

·生物制品圈

抗体偶联药物相关周围神经病变的研究进展

摘要抗体偶联药物（ADC）是一类新型的靶向抗肿瘤药物，同时具备抗体的高靶向性和小分子药物的高活性，是肿瘤靶向治疗的一种新兴疗法。近年来，随着ADC被积极开发和广泛应用，越来越多的临床研究结果显示ADC的周围神经毒性，严重的周围神经病变会对患者的生活造成严重影响，即使是轻微的周围神经病变，也会在一定程度上对患者的生活质量产生负面影响，因此临床治疗过程中应予积极关注，并根据周围神经病变程度采取相应管理措施。本文对ADC相关周围神经病的临床表现、发生率、发生机制以及管理策略等进行综述，以期为临床更加安全应用ADC提供一定参考。_正文_随着肿瘤治疗研究的不断发展，抗体偶联药物（antibody-drug conjugate，ADC）也取得长足进步，相比传统化疗药物，ADC能兼具小分子细胞毒素药物的肿瘤杀伤效果以及抗体药物的高度选择性，进一步提高肿瘤患者生存获益。但ADC仍存在不容忽视的不良反应，多项临床研究已报道ADC相关的肝毒性[1]、血液毒性[2]、眼毒性[3]、皮肤毒性[4]及胃肠道毒性[5]等。越来越多的临床研究结果显示ADC对神经系统也具有潜在毒性[6]，主要表现为周围神经病变（peripheral neuropathy），包括无力、麻木和疼痛等症状[7]。周围神经病变可能导致患者输注时间延长或剂量降低，从而对患者生活质量产生负面影响，严重甚至可能危及患者生命[8]。因此，本文旨在对ADC相关的周围神经病变的临床表现、发生率、发生机制以及管理策略进行综述，以期为临床安全应用ADC提供参考。ADC概述ADC的基本结构包括三个主要部分：大分子单克隆抗体、连接子以及小分子细胞毒素。ADC通过静脉给药进入人体循环，抗体部分与肿瘤细胞表面抗原结合，经过细胞内吞作用进入肿瘤细胞中与溶酶体融合，裂解连接子，释放小分子细胞毒素，释放的细胞毒素通过损伤DNA或微管蛋白，抑制肿瘤细胞DNA复制或阻滞细胞周期诱导细胞凋亡，并可通过旁观者效应对周围的肿瘤细胞产生杀伤作用[9]。ADC是目前肿瘤药物治疗的热点，截止2023年12月全球已上市15种ADC，包括靶向6种不同抗原（CD19、CD22、CD30、CD33、CD79b、BCMA）的7种抗血液系统恶性肿瘤ADC，以及靶向6种不同抗原（HER2、EGFR、Nectin-4、TROP2、TF、FRα）的8种抗实体肿瘤ADC，包括乳腺癌、肺癌以及胃癌等。此外，临床试验中的ADC数量也正在迅速增加，ADC抗体靶点范围不断扩大、连接子技术持续优化以及更多创新的小分子细胞毒素有望为肿瘤患者带来新的希望[10]。表1归纳了15种ADC的靶点、小分子细胞毒素、适应证等信息。ADC相关周围神经病变的临床表现和分级周围神经病变是一种以感觉、运动和自主神经功能障碍为特征的复杂疾病[11]。大量临床试验显示ADC相关周围神经病变的临床表现包括：外周感觉神经病变、外周运动神经病变、神经痛、感觉异常、感觉障碍、肌无力、步态障碍、多神经病变等。根据2017美国国家癌症研究所的《常见不良事件评价标准（CTCAE）5.0版》，ADC相关周围神经病变可分为5级，具体见表2。ADC相关周围神经病变的严重程度，从轻微的感觉不适或疼痛到严重的生命威胁事件均可能发生，多数ADC相关周围神经病变在1~2级，通过减少剂量或停止治疗能得到改善，但也有部分患者在使用ADC期间产生较严重的周围神经病变且无改善导致停药。如接受enfortumab vedotin单药治疗的753例患者中[12, 13]，有53%发生了周围神经病变，包括周围感觉神经病（40%）、周围运动神经病（7%）和肌无力（7%），其中48%是1~2级反应，5%是3~4级反应；在对有改善的周围神经病变患者（n=319）的最后一次评估时，14%完全改善，46%部分改善，但还有40%未得到改善，且有7%因周围神经病变停止治疗。ADC相关周围神经病变的发生概况相关临床试验结果显示，在目前全球上市的15种ADC中，有9种相关周围神经病变的发生率大于10%。最常导致周围神经病变的是以甲基澳瑞他汀E（monomethyl auristatin E, MMAE）为细胞毒素的5种ADC，此前也有荟萃分析表明，含有MMAE细胞毒性分子的ADC引起周围神经病变的风险较高[14]。如brentuximab vedotin，周围神经病变是其临床应用中最显著的相关毒性，也是其降低剂量和停止治疗的主要原因，并且症状具有剂量依赖性和累积性[15]。ECHELON-1研究[16]显示，在接受brentuximab vedotin治疗的662例霍奇金淋巴瘤患者中，有76%产生周围神经病变，12%产生3级及以上周围神经病变。一项开放标签、多中心、Ⅱ期临床研究[17]显示，在disitamab vedotin治疗的43例泌尿上皮癌患者中，有74.5%产生周围神经病变，25.6%产生3级周围神经病变。其次是以美登素类为细胞毒性分子的2种ADC，mirvetuximab soravtansine和trastuzumab emtansine，以及拓扑异构酶Ⅰ抑制剂为细胞毒性分子的2种ADC，sacituzumab govitecan、trastuzumab deruxtecan，表3总结了9种ADC的最新说明书和临床试验中报告的周围神经病变的发生率（临床研究中提及的外周感觉神经病变、外周运动神经病变、神经痛、感觉异常、感觉障碍、肌无力、步态障碍、多神经病变等周围神经症状的发生率之和）。一项回顾性研究[32]显示，21%（n=16）接受brentu-ximab vedotin治疗的患者发生周围神经病变，12%（n=9）患者因为周围神经病变停用该药。另一项关于disitamab vedotin治疗胃癌的多中心真实世界研究显示[33]，55%（n=11）患者发生周围神经病变，主要表现为感觉减退，10%患者（n=2）发生3级以上周围神经病变，1例患者因周围神经病变中断治疗。目前尚缺乏大型研究的数据，但根据已有的数据来看，ADC相关周围神经病变的发生率相对较高，在临床应用过程中应重点关注。ADC相关周围神经病变的发生机制药物性周围神经病是一种常见的神经系统毒性，发生机制尚未完全明确。但现有临床研究表明ADC相关周围神经病变多由细胞毒素及其代谢物介导[34]，ADC细胞毒素影响周围神经细胞的机制包括[11, 35]：（1）周围神经细胞抗原与ADC的抗体结合，特异性胞吞ADC产生毒性；（2）周围神经细胞通过非特异性胞吞ADC产生毒性；（3）旁观者效应毒性，ADC在进入细胞后被溶酶体分解释放细胞毒素，释放的细胞毒素通过被动扩散、转运体介导等方式进入周围神经细胞产生毒性；（4）连接子与药物连接的不稳定，导致非特异性细胞毒素提前释放到血液中，产生ADC的脱靶毒性。此前也有研究表明无论靶向的抗原种类，也无论抗原在健康组织中的表达程度，具有相同类型细胞毒素的ADC通常具有高度相似的毒性特征[36]。目前周围神经病变发病率≥10%的ADC的细胞毒素主要是微管抑制剂（包括MMAE和美登素类）以及拓扑异构酶抑制剂（包括喜树碱衍生物和伊立替康活性代谢产物SN-38）。微管抑制剂对微管的破坏是其主要的抗肿瘤活性，但也中断了神经元内蛋白质和其他成分的主动转运，导致了周围神经病变的发生发展[37, 38]。DNA拓扑异构酶能催化DNA链的断裂和结合，拓扑异构酶抑制剂通过抑制其活性可阻止肿瘤细胞的增殖[39]，但该类药物引起周围神经病变的机制有待进一步研究。非临床研究也提供了关于ADC引起的周围神经毒性的证据。一项研究探讨了ADC在大鼠或猴子中的周围神经毒性，发现这些药物会导致感觉神经和运动神经的损伤，神经传导速度显著降低。组织学分析显示，这些ADC导致神经纤维变性和髓鞘丢失[40, 41]。一项在乳腺癌模型中评估ADC（Y078-DM1）的安全性研究发现其能导致显著的神经毒性，表现为神经传导速度减慢和神经纤维变性[42]。ADC相关周围神经病变的管理目前已有文拉法辛、度洛西汀和加巴喷丁等药物用于降低化疗药物导致的周围神经病变的发生率或严重程度的研究和推荐[43-45]，但尚无针对ADC相关周围神经病变的预防或治疗药物临床试验，《抗体偶联药物安全性跨学科管理中国专家共识》[46]仅推荐对于ADC相关的感觉异常周围神经病变使用B族维生素（维生素B1、B6、B12和复合维生素B）、叶酸和烟酰胺。根据《化疗诱导的周围神经病变诊治中国专家共识（2022版）》[47]、《中国肿瘤整合诊治技术指南神经保护》[48]和美国临床肿瘤学会临床实践指南[49]，ADC相关周围神经病变的处理主要为调整剂量或停药：首先根据CTCAE标准分级判断周围神经病变严重程度，通常情况下，在使用ADC治疗期间发生1级周围神经病变的患者一般无需调整剂量；对于2级或3级周围神经病变，可以通过临床判断来确定是否应暂停治疗，直至周围神经病变恢复至1级或更低，并在后续治疗中降低剂量；剂量降低后仍发生4级周围神经病变的患者需停止治疗。结语ADC作为最新的抗肿瘤药物之一，给广大肿瘤患者带来了希望，但其在临床使用中的神经毒性特别是周围神经病变发生率较高，对疗效和患者生活质量的影响不可忽视，而且ADC相关周围神经病变机制并未完全明确，导致周围神经病变的防治及应对策略缺乏体系。另外，不同ADC导致周围神经损害的发生率和转归情况可能不同，这取决于特定药物的组成和患者的个体反应。因此，对于新药研发者，应继续探索ADC抗体靶点范围、优化连接子技术以及发现新的小分子细胞毒素，最大程度上降低ADC相关周围神经毒性。对于医院药师，应及时了解ADC相关周围神经病变背景知识，进一步研究ADC相关周围神经毒性临床特征和机制，在临床应用时加强监测和科学管理，进一步提高患者的临床获益和生活质量。参考文献详见《中国新药与临床杂志》, 2025年2月，第44卷第2期识别微信二维码，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。

抗体药物偶联物临床研究临床结果

2025-04-10

·GlobeNewswire-Health Care

Ottimo Pharma Strengthens Board with Appointment of Roger Dansey, M.D. to its Board of Directors

Dansey, a former senior executive at Pfizer and Seagen, Inc., brings extensive experience in immuno-oncology and drug developmentBoard appointment reinforces Company’s commitment to advancing Jankistomig, a one-of-a-kind PD-1/VEGFR2 dual paratopic antibody, into clinical developmentIND-clearance for Jankistomig on track for late 2025 LONDON and BOSTON, April 10, 2025 (GLOBE NEWSWIRE) -- Ottimo Pharma (“Ottimo”), an innovative biotech company developing one-of-a-kind PD-1/VEGFR2 dual paratopic antibodies to extend the lives of patients living with cancer, today announces the appointment of Robert Dansey, M.D., a prominent leader in oncology research and drug development, to its board of directors. Dr. Dansey is an accomplished biopharmaceutical leader, who has contributed significantly to the clinical development and subsequent approvals of breakthrough cancer medicines such as Keytruda (pembolizumab), Xgeva/Prolia (denosumab), Zydelig (idelalisib), Adcetris (brentuximab vedotin), Padcev (enoftumab vedotin), Tivdak (tisotumab vedotin) and Tukysa (tucatinib). Currently, he serves as an independent director on the boards of both Inovio Inc. and Kronos Bio Inc. He is also an advisor to the Research and Development organization at Pfizer Inc. and previously, served as the Chief Development Officer and Chief Oncology Officer at Pfizer Oncology. Prior to Pfizer, Dr. Dansey was Chief Medical Officer and President of Research and Development at Seagen Inc. Earlier in his career, he held senior leadership positions at Merck Inc, Gilead Sciences and Amgen. “As one of the leading experts in oncology research, Roger has made significant contributions to the treatment of cancers. His deep oncology and extensive leadership experience will be invaluable as we progress Jankistomig, our PD-1/VEGFR2 dual pathway antibody, towards first-in-human studies,” said David Epstein, Chair and Chief Executive Officer at Ottimo Pharma. “We are honored to welcome Roger to the Ottimo Board of Directors.” “Jankistomig represents a remarkable opportunity to elevate the impact of next generation immunotherapies across cancers,” said Dr. Dansey. “I am thrilled to join David, the Ottimo board of directors, and the entire Ottimo team at this pivotal time as we seek to further advance immunotherapy and improve patient outcomes.” About Ottimo PharmaOttimo Pharma is a private biotechnology company, co-founded by Medicxi and Jonny Finlay, that emerged from stealth in October 2024 to rapidly advance the clinical development of exquisitely designed dual pathway antibodies to extend the lives of patients living with cancer. The Company’s lead asset, Jankistomig, is differentiated from bi-specific antibody fusions, as a first-in-class, one-of-a-kind, dual paratopic, single-agent IgG1 investigatory antibody that is designed to enable cooperative binding of immune checkpoint inhibition and angiogenesis in the tumor microenvironment (TME). This innovative approach aims to offer a wider therapeutic window for patients, with the potential to improve outcomes across multiple solid tumor indications. Ottimo is currently advancing IND-enabling studies for Jankistomig, with planned IND clearance in late 2025. Ottimo is backed by a global syndicate of life science investors including Medicxi, OrbiMed, Avoro Capital, Samsara BioCapital, RTW Investments, Decheng Capital, Janus Henderson Investors, J.P. Morgan Life Sciences Private Capital, and Invus. The Ottimo board includes Francesco De Rubertis, Co-Founder and Partner of Medicxi, Peter Thompson, General Partner at OrbiMed, Mark Chin, Partner at Avoro Capital, and Srinivas Akkaraju, founder, and Managing General Partner at Samsara BioCapital. For more information, please visit: www.ottimopharma.com. For Media Inquiries:Dana Kahn Cooper+1-732-239-6664dana@coopercommunications.com For Further Information:Ottimo PharmaE-mail: info@ottimopharma.com A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/292f4a82-a32a-4a02-af04-355edb6b83fd

高管变更免疫疗法临床申请

100 项与维恩妥尤单抗相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
-	维恩妥尤单抗	L01XC	DB13007

研发状态

批准上市

10 条最早获批的记录,

登录

后查看更多信息

适应症	国家/地区	公司	日期
不可切除的尿路上皮癌	欧盟	Astellas Pharma Europe Ltd.	2024-09-24
不可切除的尿路上皮癌	冰岛	Astellas Pharma Europe Ltd.	2024-09-24
不可切除的尿路上皮癌	列支敦士登	Astellas Pharma Europe Ltd.	2024-09-24
不可切除的尿路上皮癌	挪威	Astellas Pharma Europe Ltd.	2024-09-24
局部晚期尿路上皮癌	欧盟	Astellas Pharma Europe Ltd.	2022-04-13
局部晚期尿路上皮癌	冰岛	Astellas Pharma Europe Ltd.	2022-04-13
局部晚期尿路上皮癌	列支敦士登	Astellas Pharma Europe Ltd.	2022-04-13
局部晚期尿路上皮癌	挪威	Astellas Pharma Europe Ltd.	2022-04-13
转移性尿路上皮癌	欧盟	Astellas Pharma Europe Ltd.	2022-04-13
转移性尿路上皮癌	冰岛	Astellas Pharma Europe Ltd.	2022-04-13
转移性尿路上皮癌	列支敦士登	Astellas Pharma Europe Ltd.	2022-04-13
转移性尿路上皮癌	挪威	Astellas Pharma Europe Ltd.	2022-04-13
尿路上皮癌	美国	Astellas Pharma US, Inc.	2019-12-18

未上市

10 条进展最快的记录,

登录

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
肌层浸润性膀胱癌	临床3期	美国	Merck Sharp & Dohme Corp.	2019-07-24
肌层浸润性膀胱癌	临床3期	日本	Merck Sharp & Dohme Corp.	2019-07-24
肌层浸润性膀胱癌	临床3期	阿根廷	Merck Sharp & Dohme Corp.	2019-07-24
肌层浸润性膀胱癌	临床3期	澳大利亚	Merck Sharp & Dohme Corp.	2019-07-24
肌层浸润性膀胱癌	临床3期	比利时	Merck Sharp & Dohme Corp.	2019-07-24
肌层浸润性膀胱癌	临床3期	加拿大	Merck Sharp & Dohme Corp.	2019-07-24
肌层浸润性膀胱癌	临床3期	哥伦比亚	Merck Sharp & Dohme Corp.	2019-07-24
肌层浸润性膀胱癌	临床3期	丹麦	Merck Sharp & Dohme Corp.	2019-07-24
肌层浸润性膀胱癌	临床3期	法国	Merck Sharp & Dohme Corp.	2019-07-24
肌层浸润性膀胱癌	临床3期	德国	Merck Sharp & Dohme Corp.	2019-07-24

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


ASCO_GU2025 人工标引	N/A	转移性尿路上皮癌一线	215	Enfortumab vedotin plus Pembrolizumab (EVP)	壓構遞遞蓋衊窪醖願糧(觸餘顧築餘壓遞淵鹹網) = 窪憲觸憲觸夢鹽簾襯鏇願淵鹽壓廠築憲襯築艱 (膚窪餘網壓壓衊繭鑰範 ) 更多	积极	2025-02-13
NCT04963153 (ETCTN 10483, ASCO_GU2025) 人工标引	临床1期	转移性尿路上皮癌 FGFR3 Mutation \| FGFR2 Mutation	9	Erdafitinib + Enfortumab Vedotin	膚獵窪願蓋餘鹹積餘餘(淵壓範觸夢蓋構餘憲壓) = hyperphosphatemia (88%), mucositis (88%), high AST (88%), hypercalcemia (75%), palmar plantar erythrodysesthesia (75%), peripheral neuropathy (75%), alopecia (63%), diarrhea (63%), hypoalbuminemia (63%) and hypomagnesemia (63%). 鏇鬱廠襯憲齋壓築窪糧 (網淵網鬱鹹鏇鏇膚壓簾 ) 更多	积极	2025-02-13
UNITE (ASCO_GU2025) 人工标引	N/A	尿路上皮癌	33	Enfortumab vedotin and pembrolizumab	顧餘鹹廠鏇獵壓壓構鹹(淵願壓艱顧糧簾襯淵醖) = 獵餘餘醖遞積顧鹹廠鹹齋鹽齋糧顧範膚簾鹹鑰 (願鹹製餘淵製廠淵憲壓, 31 ~ 66) 更多	积极	2025-02-13
NCT04223856 (EV-302 \| KEYNOTE-A39, ASCO_GU2025) 人工标引	临床3期	尿路上皮癌一线	886	enfortumab vedotin in combination with pembrolizumab	餘憲鑰願糧夢窪壓艱窪(蓋夢鏇衊鏇鏇蓋製餘醖) = 衊壓獵顧蓋夢選鹹糧齋構範範鹹壓鹽糧醖鹽選 (襯鏇醖獵願艱顧選積鏇, 10.4 ~ 16.6) 更多	积极	2025-02-13
NCT04223856 (EV-302 \| KEYNOTE-A39, ASCO_GU2025) 人工标引	临床3期	尿路上皮癌一线	886	chemotherapy	餘憲鑰願糧夢窪壓艱窪(蓋夢鏇衊鏇鏇蓋製餘醖) = 廠築蓋獵鹹餘製齋顧艱構範範鹹壓鹽糧醖鹽選 (襯鏇醖獵願艱顧選積鏇, 6.2 ~ 6.5) 更多	积极	2025-02-13
ESMO_ASIA2024	N/A	晚期尿路上皮癌末线	117	Enfortumab vedotin	窪積鹹襯壓獵齋蓋廠艱(繭廠夢範淵選憲繭築鑰) = 廠鏇夢窪齋壓窪夢蓋餘夢積艱壓鑰衊選壓獵遞 (壓鹽廠構餘膚鏇遞鬱襯 ) 更多	积极	2024-12-07
ESMO_ASIA2024	N/A	转移性尿路上皮癌	18	Enfortumab vedotin + Pembrolizumab	觸衊鹹遞鏇簾齋艱廠餘(製壓艱鑰餘鏇窪襯構鑰) = 窪衊選膚獵齋築範構願糧淵顧蓋構鏇膚觸齋夢 (鬱製鹽選鏇選衊憲繭鬱 ) 更多	积极	2024-12-07
ESMO_ASIA2024	N/A	转移性尿路上皮癌	18	Enfortumab vedotin	選壓壓顧範廠齋積網膚(襯選淵壓衊憲鬱顧觸齋) = 築齋鹹繭願顧簾淵壓遞構膚醖願遞選網築遞簾 (構繭鏇齋構壓醖選鹽齋 )	积极	2024-12-07
NCT04995419 (EV-203, Pubmed \| Cancer Med)	临床2期	尿路上皮癌 platinum‐based chemotherapy	40	Enfortumab vedotin 1.25 mg/kg	蓋獵顧鏇淵艱壓積積獵(襯簾簾壓網艱遞憲蓋繭) = 蓋鹹憲鬱構鹽廠鹽齋襯夢鹽網襯繭蓋淵構觸衊 (願壓鹹顧廠艱淵糧餘獵, 22.7% ~ 54.2%) 更多	积极	2024-11-01
NCT04225117 (EV-202, Pubmed \| J Clin Oncol)	临床2期	头颈部肿瘤 nectin-4	46	Enfortumab Vedotin 1.25 mg/kg	夢鏇廠遞糧膚艱艱獵鏇(餘顧鏇製製鹹觸鏇壓構) = 鏇襯醖艱窪淵鑰顧鬱積淵糧選醖壓艱鑰憲餘衊 (顧遞獵齋鹽顧憲鏇繭顧 ) 更多	积极	2024-10-31
NCT04223856 (EV-302 \| EV-302/KEYNOTE-A39 \| KEYNOTE-A39, CTgov)	临床3期	局部晚期尿路上皮癌 \| 尿路上皮癌	886	Enfortumab Vedotin+Pembrolizumab (Enfortumab Vedotin + Pembrolizumab)	鬱鬱積餘衊廠鹹夢繭鹽(範網齋製簾網憲繭夢選) = 蓋艱鹽齋網膚簾選糧憲壓獵鹽鏇繭壓繭範願顧 (選壓糧築夢觸窪蓋鏇顧, 醖醖簾壓鏇淵艱築獵鹽 ~ 壓觸顧鏇觸鑰膚鏇觸艱) 更多	-	2024-09-27
	临床3期	局部晚期尿路上皮癌 \| 尿路上皮癌	886	carboplatin+gemcitabine+cisplatin (Standard of Care)	鬱鬱積餘衊廠鹹夢繭鹽(範網齋製簾網憲繭夢選) = 廠網衊遞鏇遞選鬱鬱廠壓獵鹽鏇繭壓繭範願顧 (選壓糧築夢觸窪蓋鏇顧, 製壓築鏇蓋夢衊膚簾鬱 ~ 選鏇築鏇憲衊蓋糧餘夢) 更多	-	2024-09-27
NCT04223856 (ESMO2024) 人工标引	临床3期	局部晚期尿路上皮癌 \| 转移性尿路上皮癌	800	Enfortumab vedotin (EV) + Pembrolizumab (P) (Nectin-4 H-score <150)	蓋衊獵觸鹹鏇齋膚範鹽(鹹遞憲範觸鏇鹹廠餘蓋) = 遞糧淵築衊窪憲憲積鏇窪憲淵觸顧獵夢窪網獵 (夢淵鑰鹽憲遞窪遞淵夢 ) 更多	积极	2024-09-15
NCT04223856 (ESMO2024) 人工标引	临床3期	局部晚期尿路上皮癌 \| 转移性尿路上皮癌	800	Platinum-based chemotherapy (chemo) (Nectin-4 H-score <150)	蓋衊獵觸鹹鏇齋膚範鹽(鹹遞憲範觸鏇鹹廠餘蓋) = 製繭構積選鏇遞網膚顧窪憲淵觸顧獵夢窪網獵 (夢淵鑰鹽憲遞窪遞淵夢 ) 更多	积极	2024-09-15