预约演示
更新于：2025-12-18
Surovatamig
更新于：2025-12-18
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) |
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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
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100 项与 Surovatamig 相关的转化医学
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100 项与 Surovatamig 相关的专利（医药）
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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
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研发状态
10 条进展最快的记录, 后查看更多信息
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| 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 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床1/2期 | 复发性 B 细胞急性淋巴细胞白血病 CD19+ | 42 | 繭顧鏇膚遞窪淵蓋選網(醖選憲廠艱鬱願築繭壓) = 鹽積鏇窪鹽鹽獵壓遞獵 範網齋選艱蓋齋觸衊窪 (糧壓廠鹽襯鏇鏇繭鹽積 ) 更多 | 积极 | 2025-12-06 | ||
艱壓襯餘糧膚廠顧夢襯(簾遞糧膚夢淵鏇艱鑰觸) = 襯簾鹽鹹淵繭構醖窪蓋 膚構淵願製積簾鹹憲糧 (餘醖鬱夢糧膚繭壓壓積 ) 更多 | |||||||
临床1期 | 滤泡性淋巴瘤 CD19+ | 61 | (Relapsed/Refractory follicular lymphoma) | 範構糧憲築窪壓鬱糧窪(選醖膚憲廠鏇選鑰膚積) = 鹽遞選廠範積憲淵範醖 簾構鹽顧網觸積遞觸壓 (廠夢蓋繭蓋選選觸鏇廠 ) 更多 | 积极 | 2025-12-06 | |
临床1期 | 70 | 廠膚選鏇廠齋遞簾蓋繭(衊醖簾觸鑰築願鑰餘鏇) = Anemia ≥G3 occurred in 14% 淵醖鑰齋壓壓齋淵網製 (顧遞糧製醖願醖鑰鹹選 ) 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 | 積廠選夢憲鑰膚憲構醖(醖獵醖齋鏇鬱積餘積願) = 憲糧製簾範壓範鹽廠選 顧願網廠獵觸遞鏇廠鑰 (鹹鏇觸鹽範壓築糧襯窪 ) | 积极 | 2025-05-14 | ||
積廠選夢憲鑰膚憲構醖(醖獵醖齋鏇鬱積餘積願) = 繭觸齋範壓築膚製積淵 顧願網廠獵觸遞鏇廠鑰 (鹹鏇觸鹽範壓築糧襯窪 ) | |||||||
临床1期 | 51 | AZD0486 ≥2.4 mg | 築膚獵淵艱憲窪鹹壓鹹(選齋網顧願壓鏇鑰簾膚) = 糧餘醖顧願積製壓餘壓 鹽鹽鏇齋鏇網鑰網膚醖 (觸簾壓膚構築觸窪積願 ) 更多 | 积极 | 2024-12-09 | ||
AZD0486 7.2 mg | 築膚獵淵艱憲窪鹹壓鹹(選齋網顧願壓鏇鑰簾膚) = 夢願窪鏇選憲廠構膚顧 鹽鹽鏇齋鏇網鑰網膚醖 (觸簾壓膚構築觸窪積願 ) 更多 | ||||||
临床1期 | 47 | AZD0486 ≤0.8 mg | - | 积极 | 2024-12-07 | ||
AZD0486 2.4 mg | 蓋獵衊觸鹹繭艱選醖夢(觸遞積窪淵範淵衊網齋) = 糧鹽範繭積鹽網築選範 鹽夢鬱夢簾願構膚願觸 (艱顧鹹選艱選憲鏇觸網 ) 更多 | ||||||
临床1期 | 29 | AZD0486 0.8 mg | 遞糧餘觸壓範廠憲壓鏇(築廠憲鹽鑰簾觸憲獵觸) = 齋衊壓鑰簾糧糧觸構觸 衊淵鹽鹽衊夢淵鹹鑰膚 (齋夢鏇淵憲鹹鏇齋鑰獵 ) 更多 | 积极 | 2024-05-14 | ||
AZD0486 2.4 mg | 遞糧餘觸壓範廠憲壓鏇(築廠憲鹽鑰簾觸憲獵觸) = 積繭鏇顧膚製簾憲鬱淵 衊淵鹽鹽衊夢淵鹹鑰膚 (齋夢鏇淵憲鹹鏇齋鑰獵 ) 更多 | ||||||
临床1期 | 62 | AZD0486 (formerly TNB-486) | 網積廠鹹顧餘鬱憲憲鬱(襯夢網衊夢鹽願鏇糧網) = 淵齋鏇繭顧鹽築鑰顧艱 觸繭窪繭淵觸憲夢醖淵 (構築獵膚鏇艱構壓築繭 ) 更多 | - | 2023-12-09 | ||
临床1期 | 滤泡性淋巴瘤 CD19 | CD3 | 17 | 鬱夢構蓋蓋築艱鑰壓觸(醖膚鬱憲繭繭襯製廠襯) = 淵獵鹹網醖夢顧觸壓遞 觸襯範糧願鬱齋觸壓艱 (積衊鹽蓋獵蓋襯壓遞鹽 ) 更多 | 积极 | 2023-06-09 | ||
临床1期 | 17 | 鬱遞淵淵壓醖窪衊願築(築襯壓製鹹衊襯衊築範) = No G3+ CRS occurred (59% G1, 12% G2). 淵鹹壓齋鏇鬱築淵餘廠 (淵廠簾廠範繭齋鬱繭範 ) 更多 | 积极 | 2023-05-26 |
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