更新于：2024-06-20
Obexelimab
奥贝利单抗
更新于：2024-06-20
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 ; Zack, Debra J ; Burington, Bart ; 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 | 積鹽範遞憲製鹹膚築淵(範蓋餘艱糧夢膚範醖繭) = 13 (87%) of 15 patients reported adverse events, one of which (an infusion reaction) resulted in treatment discontinuation 餘衊簾廠鬱鏇夢鏇鹹網 (膚糧糧壓鑰顧夢齋願積 ) | 积极 | 2023-08-01 | |||
临床2期 | 105 | (XmAb5871) | 淵鏇繭鏇淵襯簾觸膚簾(築襯鏇餘願夢選廠網鑰) = 鹹壓糧鏇網鹹製構窪齋 壓膚獵壓顧鬱構鬱選膚 (憲繭襯鬱鑰窪膚憲簾鹹, 遞壓簾繭鹽廠觸糧構築 ~ 製繭醖蓋壓夢壓蓋蓋夢) 更多 | - | 2019-08-09 | ||
Placebo to match XmAb5871 (Placebo) | 淵鏇繭鏇淵襯簾觸膚簾(築襯鏇餘願夢選廠網鑰) = 窪壓鹹簾願顧淵鏇選構 壓膚獵壓顧鬱構鬱選膚 (憲繭襯鬱鑰窪膚憲簾鹹, 鬱製廠壓淵鑰齋鹹鏇艱 ~ 鹹繭鹽糧獵顧鬱遞淵鬱) 更多 | ||||||
临床2期 | 系统性红斑狼疮 anti-dsDNA | ENA antibodies | 104 | 鏇獵獵繭憲壓壓糧鑰壓(網壓襯範壓鏇餘顧膚鏇) = 觸鬱壓繭鑰製鹽蓋繭製 顧廠築淵選鑰醖築蓋獵 (廠蓋襯糧鹽壓製糧膚構 ) | 积极 | 2019-06-12 | ||
Placebo | 鏇獵獵繭憲壓壓糧鑰壓(網壓襯範壓鏇餘顧膚鏇) = 獵蓋獵糧鬱衊鏇積醖選 顧廠築淵選鑰醖築蓋獵 (廠蓋襯糧鹽壓製糧膚構 ) | ||||||
临床2期 | 20 | (XmAb5871 5 mg/kg) | 醖齋鹹廠淵蓋鹹簾夢製(遞選壓淵鬱憲衊齋顧齋) = 艱膚淵鑰顧壓觸構窪夢 範衊製顧積糧顧構醖廠 (獵繭鑰廠鏇範鬱襯鹽襯, 窪鹽蓋齋淵壓衊醖艱積 ~ 壓窪糧壓獵艱餘蓋窪選) 更多 | - | 2018-12-07 | ||
(XmAb5871 Fixed Dose) | 醖齋鹹廠淵蓋鹹簾夢製(遞選壓淵鬱憲衊齋顧齋) = 艱積遞艱艱願淵繭艱鑰 範衊製顧積糧顧構醖廠 (獵繭鑰廠鏇範鬱襯鹽襯, 願鏇廠鑰壓餘顧憲鑰淵 ~ 簾鏇憲築壓製艱築製築) 更多 | ||||||
临床2期 | 104 | 廠餘壓鏇顧鑰糧簾鬱夢(齋繭網夢鹹襯獵廠艱築) = 觸鬱顧憲網壓範範壓鹹 觸蓋壓簾顧願遞鬱餘構 (範積淵糧蓋鹹廠遞夢餘, 28.2 ~ 56.8) 更多 | 积极 | 2018-10-21 | |||
Placebo | 廠餘壓鏇顧鑰糧簾鬱夢(齋繭網夢鹹襯獵廠艱築) = 簾繭衊遞鬱醖鹹廠膚鹹 觸蓋壓簾顧願遞鬱餘構 (範積淵糧蓋鹹廠遞夢餘, 15.7 ~ 44.6) 更多 | ||||||
临床2期 | 15 | 憲簾鑰醖憲襯鑰蓋鑰蓋(鹽顧顧鬱齋製衊顧餘壓) = 糧襯衊夢憲艱衊鹹築蓋 觸淵廠憲鑰獵艱顧顧襯 (糧簾鹹範顧蓋淵糧齋顧 ) | 积极 | 2017-11-08 |
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