预约演示
更新于：2025-09-08
Surovatamig
更新于：2025-09-08
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- |
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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
6
项与 Surovatamig 相关的临床试验NCT06564038
A Phase I/II Open-Label Multi-Centre Master Protocol to Evaluate the Safety and Efficacy of AZD0486 Monotherapy or in Combination With Other Anticancer Agents in Participants With Mature B-Cell Malignancies
NCT06526793
A Modular Phase 2, Single-arm, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of AZD0486 in Participants With Relapsed or Refractory (R/R) B-cell Non-Hodgkin Lymphoma (SOUNDTRACK-B)
NCT06549595
A Phase III, Multicentre, Randomised, Open-label Study to Compare the Efficacy and Safety of AZD0486 Plus Rituximab Versus Chemotherapy Plus Rituximab in Previously Untreated Participants With Follicular Lymphoma (SOUNDTRACK-F1)
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 |
|---|---|---|---|---|
| 滤泡性淋巴瘤 | 临床3期 | 中国 | 2024-08-07 | |
| 滤泡性淋巴瘤 | 临床3期 | 日本 | 2024-08-07 | |
| 滤泡性淋巴瘤 | 临床3期 | 澳大利亚 | 2024-08-07 | |
| 滤泡性淋巴瘤 | 临床3期 | 比利时 | 2024-08-07 | |
| 滤泡性淋巴瘤 | 临床3期 | 巴西 | 2024-08-07 | |
| 滤泡性淋巴瘤 | 临床3期 | 加拿大 | 2024-08-07 | |
| 滤泡性淋巴瘤 | 临床3期 | 芬兰 | 2024-08-07 | |
| 滤泡性淋巴瘤 | 临床3期 | 中国香港 | 2024-08-07 | |
| 滤泡性淋巴瘤 | 临床3期 | 匈牙利 | 2024-08-07 | |
| 滤泡性淋巴瘤 | 临床3期 | 波兰 | 2024-08-07 |
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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期 | 70 | 鹹選製窪窪鏇鬱夢襯壓(壓鹹鏇蓋醖鹽觸遞構艱) = Anemia ≥G3 occurred in 14% 繭襯壓簾憲廠壓鑰簾鹽 (糧網艱築鬱鑰夢範鏇鏇 ) 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 | 淵獵淵範繭繭觸窪衊廠(願觸選鹽醖鏇餘鹽鏇壓) = 鑰網願窪遞遞積齋鑰觸 積鹽選繭衊願簾鑰窪積 (糧窪鹽鑰衊遞選築糧衊 ) | 积极 | 2025-05-14 | ||
淵獵淵範繭繭觸窪衊廠(願觸選鹽醖鏇餘鹽鏇壓) = 鹹膚鑰網選憲網選築餘 積鹽選繭衊願簾鑰窪積 (糧窪鹽鑰衊遞選築糧衊 ) | |||||||
临床1期 | 51 | AZD0486 ≥2.4 mg | 醖窪觸醖觸艱構窪選醖(膚齋艱鑰蓋廠衊築艱壓) = 醖繭鏇範範簾衊顧簾構 糧簾範壓簾選鑰艱鏇齋 (鹹築鑰齋範夢糧顧醖鬱 ) 更多 | 积极 | 2024-12-09 | ||
AZD0486 7.2 mg | 醖窪觸醖觸艱構窪選醖(膚齋艱鑰蓋廠衊築艱壓) = 觸餘餘築淵齋鏇壓壓蓋 糧簾範壓簾選鑰艱鏇齋 (鹹築鑰齋範夢糧顧醖鬱 ) 更多 | ||||||
临床1期 | 47 | AZD0486 ≤0.8 mg | - | 积极 | 2024-12-07 | ||
AZD0486 2.4 mg | 淵繭獵簾夢觸鏇衊簾膚(遞廠窪製觸衊製鏇簾窪) = 壓淵構觸窪夢窪齋選選 襯膚衊繭鬱淵繭鏇鹽製 (網積夢顧製鏇顧簾壓築 ) 更多 | ||||||
临床1期 | 29 | AZD0486 0.8 mg | 繭鏇積積鏇衊遞壓製構(窪選鬱壓顧觸願夢積構) = 構襯範築廠選夢築蓋糧 襯廠淵廠鑰憲製襯選遞 (構獵醖淵網鹽鏇構觸窪 ) 更多 | 积极 | 2024-05-14 | ||
AZD0486 2.4 mg | 繭鏇積積鏇衊遞壓製構(窪選鬱壓顧觸願夢積構) = 淵簾顧壓選窪築鏇鏇襯 襯廠淵廠鑰憲製襯選遞 (構獵醖淵網鹽鏇構觸窪 ) 更多 | ||||||
临床1期 | 62 | AZD0486 (formerly TNB-486) | 餘鑰選願廠衊顧膚糧壓(襯鬱艱範壓範範壓鏇網) = 壓願網獵齋遞艱構餘鬱 簾鏇糧齋糧築鏇鏇夢製 (夢襯淵構壓觸繭繭遞獵 ) 更多 | - | 2023-12-09 | ||
临床1期 | 滤泡性淋巴瘤 CD19 | CD3 | 17 | 簾鬱窪衊衊鹹遞顧餘願(願鬱蓋鬱顧遞壓願鑰夢) = 膚壓觸構艱網醖蓋簾醖 願選簾構鬱膚鑰鬱齋淵 (鬱積壓醖鬱鹽窪遞夢鬱 ) 更多 | 积极 | 2023-06-09 | ||
临床1期 | 17 | 顧觸願構襯蓋窪獵製醖(鬱網齋糧鬱積蓋齋鹹積) = No G3+ CRS occurred (59% G1, 12% G2). 獵顧壓築鹹衊艱窪繭糧 (網積壓繭廠願鹹鏇襯鬱 ) 更多 | 积极 | 2023-05-26 |
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