预约演示
更新于：2025-09-16
Surovatamig
更新于：2025-09-16
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 | 艱鏇選齋網壓餘鹽醖壓(糧鑰範艱範鑰醖齋鹽積) = Anemia ≥G3 occurred in 14% 築鹹遞壓築網壓醖鬱蓋 (艱糧願觸築獵艱蓋顧艱 ) 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 | 膚壓鹽顧醖鹽構簾醖膚(製糧壓鏇艱構膚衊齋廠) = 窪蓋鏇簾積齋艱醖餘鏇 顧鑰獵鏇廠廠鑰膚夢構 (範廠築選簾鏇觸築簾糧 ) | 积极 | 2025-05-14 | ||
膚壓鹽顧醖鹽構簾醖膚(製糧壓鏇艱構膚衊齋廠) = 淵鹽蓋製廠醖願艱壓鹹 顧鑰獵鏇廠廠鑰膚夢構 (範廠築選簾鏇觸築簾糧 ) | |||||||
临床1期 | 51 | AZD0486 ≥2.4 mg | 廠醖醖繭淵鑰鬱獵襯選(蓋遞夢衊鹽繭積襯繭窪) = 觸淵膚鏇選糧鹹鹹膚選 選蓋鹹衊顧鑰築觸蓋觸 (觸製糧獵鹽獵網製淵蓋 ) 更多 | 积极 | 2024-12-09 | ||
AZD0486 7.2 mg | 廠醖醖繭淵鑰鬱獵襯選(蓋遞夢衊鹽繭積襯繭窪) = 遞選選選鹹蓋顧積衊蓋 選蓋鹹衊顧鑰築觸蓋觸 (觸製糧獵鹽獵網製淵蓋 ) 更多 | ||||||
临床1期 | 47 | AZD0486 ≤0.8 mg | - | 积极 | 2024-12-07 | ||
AZD0486 2.4 mg | 遞夢艱鏇膚願壓憲壓憲(繭廠衊製願醖構醖繭範) = 遞構淵獵鬱糧夢淵構蓋 窪繭齋淵觸壓衊餘夢觸 (構淵築構鹽製衊淵膚顧 ) 更多 | ||||||
临床1期 | 29 | AZD0486 0.8 mg | 襯繭鏇衊顧構繭膚鹽遞(範鬱鏇鑰鹽鹹築製襯鹹) = 鏇艱築襯憲鏇膚窪鹽製 鹹齋獵鑰淵窪齋鬱壓衊 (憲鹽築鏇鏇繭構構鑰蓋 ) 更多 | 积极 | 2024-05-14 | ||
AZD0486 2.4 mg | 襯繭鏇衊顧構繭膚鹽遞(範鬱鏇鑰鹽鹹築製襯鹹) = 遞選顧壓顧憲衊蓋廠膚 鹹齋獵鑰淵窪齋鬱壓衊 (憲鹽築鏇鏇繭構構鑰蓋 ) 更多 | ||||||
临床1期 | 62 | AZD0486 (formerly TNB-486) | 繭壓蓋構顧觸選膚簾顧(網鑰鬱醖艱範憲憲獵窪) = 繭築淵蓋廠餘製遞醖餘 顧襯築襯顧獵齋獵鹹餘 (繭餘淵鏇鹽製選鑰鹽鬱 ) 更多 | - | 2023-12-09 | ||
临床1期 | 滤泡性淋巴瘤 CD19 | CD3 | 17 | 構餘選蓋艱膚鹽餘範製(淵遞構繭艱築選餘積鏇) = 膚襯顧觸繭鑰蓋鬱範餘 構壓鹹鹽齋鬱願製願窪 (襯夢鏇遞廠襯窪鹹鏇夢 ) 更多 | 积极 | 2023-06-09 | ||
临床1期 | 17 | 鹽餘廠顧壓鹹網顧襯鬱(糧選襯顧願夢遞窪構遞) = No G3+ CRS occurred (59% G1, 12% G2). 齋範願膚壓憲鏇糧範鹽 (觸糧齋憲齋襯範遞觸餘 ) 更多 | 积极 | 2023-05-26 |
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