预约演示
更新于：2025-12-12
Surovatamig
更新于：2025-12-12
概要
基本信息
药物类型 双特异性T细胞结合器 |
别名 AZD0486、TNB-486 |
作用方式 抑制剂、刺激剂 |
作用机制 CD19抑制剂(B淋巴细胞抗原CD19抑制剂)、CD3刺激剂(T细胞表面糖蛋白CD3复合体刺激剂) |
在研适应症 |
非在研适应症- |
原研机构 |
非在研机构- |
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 |
特殊审评孤儿药 (美国)、孤儿药 (欧盟) |
登录后查看时间轴
结构/序列
Sequence Code 524306457L
来源: *****
Sequence Code 631408146H
来源: *****
Sequence Code 931729386H
来源: *****
关联
8
项与 Surovatamig 相关的临床试验NCT07201558
An Open-label, Phase I Study to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Surovatamig Following Single-ascending Dose and Step-up Dose Administration to Adult Participants With Rheumatoid Arthritis or Systemic Lupus Erythematosus
NCT07215585
A Phase III, Multicentre, Open-Label, Randomised Study Evaluating the Efficacy and Safety of R-mini-CHOP x2 Followed by AZD0486 Versus R-mini-CHOP x6 in Elderly or Unfit Participants With Newly Diagnosed Large B-cell Lymphoma (SOUNDTRACK-D2)
CTR20252392
评价AZD0486单药治疗或与其他抗癌药物联合治疗成熟B细胞恶性肿瘤受试者的安全性和有效性的开放标签、多中心、I/II期研究主方案。
子研究1：慢性淋巴细胞白血病和小淋巴细胞淋巴瘤
子研究2：套细胞淋巴瘤
子研究3：大B细胞淋巴瘤
100 项与 Surovatamig 相关的临床结果
登录后查看更多信息
100 项与 Surovatamig 相关的转化医学
登录后查看更多信息
100 项与 Surovatamig 相关的专利（医药）
登录后查看更多信息
2
项与 Surovatamig 相关的文献（医药）2025-04-03EXPERT OPINION ON INVESTIGATIONAL DRUGS
The bispecific antibody AZD0486: an overview of the clinical journey to date with a focus on follicular lymphoma
Review
作者: Hambleton, Harry ; Cheah, Chan Y
INTRODUCTION:
Follicular lymphoma (FL) is the most common indolent lymphoma. Patients with advanced-stage FL typically respond to therapy, then follow a relapsing/remitting course, with shorter progression-free survival with each subsequent line of therapy. Whilst existing CD19-directed therapies such as CAR T-cell therapy have shown promising efficacy in the management of relapsed/refractory FL, immune-mediated adverse events, such as cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity (ICANS), are well described. AZD0486 is a fully human bispecific (CD19×CD3) T-cell engager (TCE) that induces T cell-mediated cytotoxicity but with low-affinity binding of CD3, resulting in a reduction in cytokine release.
AREAS COVERED:
In this review, we describe the key preclinical data for AZD0486 and evaluate in detail the available clinical data from the ongoing phase 1 first-in-human study, including safety, efficacy, pharmacokinetics, and future development plans.
EXPERT OPINION:
Bispecific TCEs are among the most promising novel therapies in use for the management of relapsed/refractory B-cell lymphomas. AZD0486 results in high complete response rates with low incidence of high-grade immune-mediated toxicity compared to alternative TCE therapies. Importantly, it remains active in patients with lymphomas that have lost CD20 expression, an important mechanism of treatment failure following CD20 targeting TCEs.
2021-01-01mAbs2区 · 医学
TNB-486 induces potent tumor cell cytotoxicity coupled with low cytokine release in preclinical models of B-NHL
2区 · 医学
Article
作者: Harris, Katherine E. ; Buelow, Benjamin ; Boudreau, Andrew A. ; Schellenberger, Ute ; Van Schooten, Wim ; Ugamraj, Harshad S. ; Davison, Laura M. ; Iyer, Suhasini ; Malik-Chaudhry, Harbani K. ; Prabhakar, Kirthana ; Pham, Duy ; Ogana, Heather ; Jorgensen, Brett ; Dang, Kevin ; Buelow, Roland ; Trinklein, Nathan D. ; Rangaswamy, Udaya S.
The therapeutic potential of targeting CD19 in B cell malignancies has garnered attention in the past decade, resulting in the introduction of novel immunotherapy agents. Encouraging clinical data have been reported for T cell-based targeting agents, such as anti-CD19/CD3 bispecific T-cell engager blinatumomab and chimeric antigen receptor (CAR)-T therapies, for acute lymphoblastic leukemia and B cell non-Hodgkin lymphoma (B-NHL). However, clinical use of both blinatumomab and CAR-T therapies has been limited due to unfavorable pharmacokinetics (PK), significant toxicity associated with cytokine release syndrome and neurotoxicity, and manufacturing challenges. We present here a fully human CD19xCD3 bispecific antibody (TNB-486) for the treatment of B-NHL that could address the limitations of the current approved treatments. In the presence of CD19+ target cells and T cells, TNB-486 induces tumor cell lysis with minimal cytokine release, when compared to a positive control. In vivo, TNB-486 clears CD19+ tumor cells in immunocompromised mice in the presence of human peripheral blood mononuclear cells in multiple models. Additionally, the PK of TNB-486 in mice or cynomolgus monkeys is similar to conventional antibodies. This new T cell engaging bispecific antibody targeting CD19 represents a novel therapeutic that induces potent T cell-mediated tumor-cell cytotoxicity uncoupled from high levels of cytokine release, making it an attractive candidate for B-NHL therapy.
100 项与 Surovatamig 相关的药物交易
登录后查看更多信息
研发状态
10 条进展最快的记录, 后查看更多信息
登录
| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 大B细胞淋巴瘤 | 临床3期 | 中国 | 2025-11-11 | |
| 大B细胞淋巴瘤 | 临床3期 | 日本 | 2025-11-11 | |
| 大B细胞淋巴瘤 | 临床3期 | 澳大利亚 | 2025-11-11 | |
| 大B细胞淋巴瘤 | 临床3期 | 比利时 | 2025-11-11 | |
| 大B细胞淋巴瘤 | 临床3期 | 巴西 | 2025-11-11 | |
| 大B细胞淋巴瘤 | 临床3期 | 加拿大 | 2025-11-11 | |
| 大B细胞淋巴瘤 | 临床3期 | 中国香港 | 2025-11-11 | |
| 大B细胞淋巴瘤 | 临床3期 | 波兰 | 2025-11-11 | |
| 大B细胞淋巴瘤 | 临床3期 | 韩国 | 2025-11-11 | |
| 大B细胞淋巴瘤 | 临床3期 | 土耳其 | 2025-11-11 |
登录后查看更多信息
临床结果
临床结果
适应症
分期
评价
查看全部结果
临床1期 | 70 | 鹽獵鹽觸獵夢構鏇鑰構(網壓網構餘築鹽窪齋簾) = Anemia ≥G3 occurred in 14% 願襯鑰鏇廠築壓製餘獵 (範蓋窪糧遞選顧網憲簾 ) 更多 | 积极 | 2025-05-30 | |||
临床1/2期 | 难治性 B 细胞急性淋巴细胞白血病 CD19+ | CD3 | 24 | 願選獵觸築艱積獵窪顧(醖鹹鏇憲襯鹹蓋襯鏇繭) = 醖淵構製鏇襯夢築壓網 窪築繭襯憲網壓糧齋衊 (醖餘壓夢壓糧壓鏇衊醖 ) | 积极 | 2025-05-14 | ||
願選獵觸築艱積獵窪顧(醖鹹鏇憲襯鹹蓋襯鏇繭) = 觸窪憲鬱簾壓醖獵鬱壓 窪築繭襯憲網壓糧齋衊 (醖餘壓夢壓糧壓鏇衊醖 ) | |||||||
临床1期 | 51 | AZD0486 ≥2.4 mg | 鏇夢鏇築齋觸繭築遞顧(遞膚壓觸繭衊築憲選餘) = 積夢願醖網壓網壓願鬱 憲艱壓窪積糧顧衊構遞 (顧襯獵淵蓋膚繭醖築壓 ) 更多 | 积极 | 2024-12-09 | ||
AZD0486 7.2 mg | 鏇夢鏇築齋觸繭築遞顧(遞膚壓觸繭衊築憲選餘) = 醖遞鹹餘醖築鹽積顧網 憲艱壓窪積糧顧衊構遞 (顧襯獵淵蓋膚繭醖築壓 ) 更多 | ||||||
临床1期 | 47 | AZD0486 ≤0.8 mg | - | 积极 | 2024-12-07 | ||
AZD0486 2.4 mg | 鏇觸壓廠積築膚積鏇觸(餘夢網積築願壓願糧窪) = 膚齋膚構衊繭夢廠壓夢 蓋顧簾簾窪鑰遞積網選 (憲鑰憲窪醖鬱餘窪觸憲 ) 更多 | ||||||
临床1期 | 29 | AZD0486 0.8 mg | 鹹鑰顧選襯壓憲構糧獵(選壓選構窪構鬱鬱齋鹹) = 鹹餘構廠遞醖襯餘獵鑰 製觸繭選構鹹顧蓋鹽憲 (選鏇艱憲壓衊壓製餘繭 ) 更多 | 积极 | 2024-05-14 | ||
AZD0486 2.4 mg | 鹹鑰顧選襯壓憲構糧獵(選壓選構窪構鬱鬱齋鹹) = 範蓋壓積鬱鑰製鹹製繭 製觸繭選構鹹顧蓋鹽憲 (選鏇艱憲壓衊壓製餘繭 ) 更多 | ||||||
临床1期 | 62 | AZD0486 (formerly TNB-486) | 餘繭憲網鏇廠鑰獵遞鹹(糧夢膚憲窪醖築選鹹壓) = 鏇築願鏇簾鏇廠獵積範 鹹簾鬱製醖憲蓋網壓壓 (鬱積願廠艱憲窪築膚網 ) 更多 | - | 2023-12-09 | ||
临床1期 | 滤泡性淋巴瘤 CD19 | CD3 | 17 | 衊齋網襯壓衊製窪壓廠(鑰齋範鹽淵衊鑰齋衊夢) = 艱蓋鑰壓獵觸積壓願簾 糧遞鏇遞窪觸觸醖襯繭 (憲壓窪鬱鹹顧蓋淵構構 ) 更多 | 积极 | 2023-06-09 | ||
临床1期 | 17 | 鏇築鬱鏇鏇廠蓋夢憲鹹(鏇構鏇選繭鹽窪壓餘夢) = No G3+ CRS occurred (59% G1, 12% G2). 遞廠網蓋鑰網膚選築遞 (醖築選範餘憲壓願齋觸 ) 更多 | 积极 | 2023-05-26 |
登录后查看更多信息
转化医学
使用我们的转化医学数据加速您的研究。
登录
或
药物交易
使用我们的药物交易数据加速您的研究。
登录
或
核心专利
使用我们的核心专利数据促进您的研究。
登录
或
临床分析
紧跟全球注册中心的最新临床试验。
登录
或
批准
利用最新的监管批准信息加速您的研究。
登录
或
生物类似药
生物类似药在不同国家/地区的竞争态势。请注意临床1/2期并入临床2期，临床2/3期并入临床3期
登录
或
特殊审评
只需点击几下即可了解关键药物信息。
登录
或
生物医药百科问答
全新生物医药AI Agent 覆盖科研全链路，让突破性发现快人一步
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即开始数据试用!
智慧芽新药库数据也通过智慧芽数据服务平台，以API或者数据包形式对外开放，助您更加充分利用智慧芽新药情报信息。
生物序列数据库
生物药研发创新
免费使用
化学结构数据库
小分子化药研发创新
免费使用