更新于：2024-05-28
Obexelimab
奥贝利单抗
更新于：2024-05-28
概要
基本信息
药物类型 双特异性抗体 |
别名 Obexelimab (USAN)、AMG 729、AMG-729 + [5] |
靶点 |
作用机制 CD19抑制剂(B淋巴细胞抗原CD19抑制剂) |
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- |
序列信息
Sequence Code 1697872L
来源: *****
Sequence Code 14476743H
来源: *****
关联
8
项与 奥贝利单抗 相关的临床试验一项在IGG4相关性疾病患者中评价OBEXELIMAB疗效和安全性的III期、多中心、随机、双盲、安慰剂对照研究（INDIGO)
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With An Open Label Safety and Dose Confirmation Run-In Period, To Evaluate the Efficacy and Safety of Obexelimab in Patients With Warm Autoimmune Hemolytic Anemia (SApHiAre)
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Obexelimab in Patients With IgG4-Related Disease (INDIGO)
100 项与 奥贝利单抗 相关的临床结果
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100 项与 奥贝利单抗 相关的转化医学
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100 项与 奥贝利单抗 相关的专利（医药）
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13
项与 奥贝利单抗 相关的文献（医药）2023-12-02Expert opinion on biological therapy
Antibody based therapeutics for autoimmune hemolytic anemia
Review
作者: Fattizzo, Bruno ; Cavallaro, Francesca ; Barcellini, Wilma
INTRODUCTION:
Autoimmune hemolytic anemia (AIHA) treatment has been revolutionized by the introduction of target therapies, mainly monoclonal antibodies (MoAbs).
AREAS COVERED:
The anti-CD20 rituximab, which targets Ab production by B-cells, induces 80% of response in warm-type AIHA (wAIHA) and 50-60% in cold agglutinin disease (CAD). Other B-cell targeting MoAbs including ianalumab, povetacicept, and obexelimab are under active study. The anti-CD38 MoAb daratumumab has been used in several reports to target long-lived plasma-cells responsible for AIHA relapse, being effective even in multi-refractory cases. Anti-complement MoAbs will soon change the treatment paradigm in CAD; the anti-C1s sutimlimab rapidly increased Hb in more than 80% of the cases. Finally, MoAbs inhibiting the neonatal Fc receptor (FcRn), such as nipocalimab, can reduce the half-life of the pathogenic autoAbs, representing a promising treatment for wAIHA.
EXPERT OPINION:
MoAbs offer the potential to improve efficacy by reducing toxicity. However, there is a huge need for clinical trials exploring response duration rather than short-term efficacy. Complement inhibitors and anti-FcRns do not abrogate autoAb production and are being developed as long-term therapies. Thus, the combination of B-cell/plasma cell targeting drugs deserves to be explored. On the other hand, their rapid efficacy should be exploited for the acute AIHA phase.
2023-12-01Arthritis & rheumatology (Hoboken, N.J.)
Obexelimab in Systemic Lupus Erythematosus With Exploration of Response Based on Gene Pathway Co‐Expression Patterns: A Double‐Blind , Randomized, Placebo‐Controlled , Phase 2 Trial
Article
作者: Khosroshahi, Arezou ; James, Judith A ; Rathi, Gaurav ; Koumpouras, Fotios ; Askanase, Anca ; Arora, Sujata ; Guthridge, Joel ; Matijevic, Mark ; June, Joshua ; Merrill, Joan T ; Burington, Bart ; Zack, Debra J ; Wax, Stephen ; Foster, Paul ; Smith, Miles ; Machua, Wambui ; Wang, Xiaodong ; Gao, Minggeng ; Sheikh, Saira Z
Objective:
Obexelimab is an investigational, bifunctional, noncytolytic monoclonal antibody that binds CD19 and FcyRIIb to inhibit B cells, plasmablasts, and plasma cells. This trial evaluated the efficacy and safety of obexelimab in the treatment of patients with systemic lupus erythematosus (SLE).
Methods:
During screening, patients with active, non–organ‐threatening SLE received corticosteroid injections to ameliorate symptoms while immunosuppressants were withdrawn (≤10 mg/day prednisone equivalent and ≤400 mg/day hydroxychloroquine allowed). Patients with improved disease activity were randomized 1:1 to obexelimab 5 mg/kg intravenously or placebo once every 2 weeks until week 32 or loss of improvement (LOI).
Results:
In this study, 104 patients were randomized. Analysis of the primary endpoint, proportion of patients reaching week 32 without LOI, used an efficacy‐evaluable (EE) population defined as patients who completed the study or withdrew for flare or treatment‐related toxicity. This endpoint did not reach statistical significance: 21 of 50 obexelimab‐treated patients (42.0%) versus 12 of 42 patients (28.6%) treated with a placebo (P = 0.183). Time to LOI was increased in obexelimab‐treated patients versus patients treated with a placebo in the EE (hazard ratio [HR] 0.53, P = 0.025) and intention‐to‐treat (HR 0.59, P = 0.062) populations. In obexelimab‐treated patients, B cells decreased approximately 50%, and trough concentration and inclusion in baseline gene expression clusters with high B cell pathway modules were associated with increased time to LOI. Obexelimab was associated with infusion reactions but was generally safe and well‐tolerated.
Conclusion:
Although the primary endpoint was not reached, secondary analysis showed time to LOI was significantly increased in obexelimab‐treated patients, and analysis of patient subsets defined by gene expression patterns at baseline suggests a responding subpopulation.image
2023-11-01Revue des maladies respiratoires
Review
作者: Schleinitz, N ; Gaubert, J-Y ; Muller, R ; Habert, P ; Ebbo, M ; Groh, M ; Gaigne, L
INTRODUCTION:
While IgG4-related disease (IgG4-RD) was initially described in the early 2000s, its polymorphic clinical manifestations were previously reported under different names ; they have in common the presence of IgG4+ oligoclonal plasma cells and fibrosis.
STATE OF THE ART:
Ruling out certain differential diagnoses, the diagnosis of IgG4-RD is based on a bundle of clinical, biological and histological features. Chest involvement is variable and can affect the mediastinum, bronchi, parenchyma, pleura and/or, more rarely, bones and (pericardium, aorta, coronary…) vascular structures. The most frequent radiological manifestations are peribronchovascular thickening, mediastinal lymphadenopathy, and nodular or interstitial patterns. Pleural involvement and posterior mediastinal fibrosis are less frequent, while thoracic paravertebral tissue thickening is highly specific. Systemic corticosteroids are the cornerstone of treatment. In case of relapse or as frontline therapy in case of risk factors for relapse and/or poor tolerance of corticosteroids), a steroid-sparing agent (most often rituximab) is added, and biannual maintenance infusions are associated with a lower risk of relapse.
PERSPECTIVES:
An international consensus has recently led to the development of classification criteria that should standardize the diagnostic approach and homogenize the enrolment of patients in epidemiological as well as therapeutic studies. Other treatments are also under evaluation, including biologics targeting T2 inflammation, CD-19 (inebilizumab, obexelimab), SLAMF7 (elotuzumab) surface proteins, Bruton's tyrosine kinase, and the JAK/STAT pathway.
CONCLUSIONS:
Substantial progress has been made over recent years in understanding IgG4-RD pathophysiology, and personalized patient care seems to be an achievable medium-term goal.
100 项与 奥贝利单抗 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 |
|---|---|---|---|---|
| 自身免疫性溶血性贫血 | 临床3期 | 美国 | 2023-09-25 | |
| 自身免疫性溶血性贫血 | 临床3期 | 日本 | 2023-09-25 | |
| 自身免疫性溶血性贫血 | 临床3期 | 意大利 | 2023-09-25 | |
| 自身免疫性溶血性贫血 | 临床3期 | 波兰 | 2023-09-25 | |
| 自身免疫性溶血性贫血 | 临床3期 | 西班牙 | 2023-09-25 | |
| 自身免疫性溶血性贫血 | 临床3期 | 中国台湾 | 2023-09-25 | |
| 自身免疫性溶血性贫血 | 临床3期 | 土耳其 | 2023-09-25 | |
| 自身免疫性溶血性贫血 | 临床3期 | 英国 | 2023-09-25 | |
| 免疫球蛋白G4相关疾病 | 临床3期 | 美国 | 2022-12-15 | |
| 免疫球蛋白G4相关疾病 | 临床3期 | 日本 | 2022-12-15 |
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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2期 | 15 | 製網鏇齋網築願網壓壓(繭築襯製淵夢構鹹鹽憲) = 13 (87%) of 15 patients reported adverse events, one of which (an infusion reaction) resulted in treatment discontinuation 鏇遞衊襯積鬱蓋築構醖 (選醖網簾鬱襯醖窪餘廠 ) | 积极 | 2023-08-01 | |||
临床2期 | 105 | (XmAb5871) | 獵繭衊鑰顧構鑰窪簾繭(餘壓簾憲構夢糧艱鹹艱) = 膚鹹淵廠淵範窪鹹壓齋 網範顧願製獵觸網蓋壓 (餘獵遞構窪觸獵廠憲襯, 糧積製醖鑰鑰繭鏇糧膚 ~ 鏇膚構壓餘蓋憲簾繭鑰) 更多 | - | 2019-08-09 | ||
Placebo to match XmAb5871 (Placebo) | 獵繭衊鑰顧構鑰窪簾繭(餘壓簾憲構夢糧艱鹹艱) = 鬱艱窪簾構蓋範繭範夢 網範顧願製獵觸網蓋壓 (餘獵遞構窪觸獵廠憲襯, 觸淵顧糧膚獵餘築積艱 ~ 壓構窪衊淵顧壓夢製鹹) 更多 | ||||||
临床2期 | 系统性红斑狼疮 anti-dsDNA | ENA antibodies | 104 | 餘齋餘襯鏇淵鑰糧網夢(獵膚窪觸構鑰鏇願鹽壓) = 製簾顧選繭廠獵鹽選遞 鹽醖簾夢艱築夢窪廠鬱 (淵蓋膚觸願簾築鬱窪築 ) | 积极 | 2019-06-12 | ||
Placebo | 餘齋餘襯鏇淵鑰糧網夢(獵膚窪觸構鑰鏇願鹽壓) = 夢艱選範衊遞醖顧製鑰 鹽醖簾夢艱築夢窪廠鬱 (淵蓋膚觸願簾築鬱窪築 ) | ||||||
临床2期 | 20 | (XmAb5871 5 mg/kg) | 鹹構鹹壓膚鏇範繭積鹽(網艱廠鹽壓淵膚醖窪獵) = 鏇壓餘鏇艱蓋鬱顧遞鑰 繭鹹膚夢餘願糧簾壓淵 (襯鹹蓋淵鹹憲構鏇鏇築, 壓顧憲觸蓋醖網夢醖製 ~ 衊網餘選願壓構願範鏇) 更多 | - | 2018-12-07 | ||
(XmAb5871 Fixed Dose) | 鹹構鹹壓膚鏇範繭積鹽(網艱廠鹽壓淵膚醖窪獵) = 網壓獵衊鹹醖艱積窪蓋 繭鹹膚夢餘願糧簾壓淵 (襯鹹蓋淵鹹憲構鏇鏇築, 糧窪鹽觸廠鹹淵鬱蓋醖 ~ 網艱憲願蓋選繭艱鹹願) 更多 | ||||||
临床2期 | 104 | 鏇網製築簾壓窪繭餘鏇(廠鏇遞遞艱願艱憲遞淵) = 糧衊築夢網淵積鬱鑰艱 窪構網餘觸艱遞顧夢構 (窪餘鹹鬱獵簾觸鬱選獵, 28.2 ~ 56.8) 更多 | 积极 | 2018-10-21 | |||
Placebo | 鏇網製築簾壓窪繭餘鏇(廠鏇遞遞艱願艱憲遞淵) = 鹹鹹醖鹽簾簾窪窪製餘 窪構網餘觸艱遞顧夢構 (窪餘鹹鬱獵簾觸鬱選獵, 15.7 ~ 44.6) 更多 | ||||||
临床2期 | 15 | 醖製鏇簾淵餘鹽膚範膚(憲簾蓋鑰觸願鬱鬱餘積) = 窪願鬱範壓廠蓋遞獵膚 遞膚網遞構選壓鹽壓艱 (糧壓壓憲壓遞鏇鹽鏇願 ) | 积极 | 2017-11-08 |
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