REGN-5714(REGN-5714) - 药物靶点：Bet v 1_专利_临床

概要

基本信息

药物类型

单克隆抗体

别名

Anti-Bet v 1 Monoclonal Antibodies

靶点

Bet v 1

作用机制

Bet v 1抑制剂(Bet v 1蛋白抑制剂)

治疗领域

免疫系统疾病感染眼部疾病+ [2]

在研适应症-

非在研适应症

结膜炎季节性过敏性鼻炎

原研机构

Regeneron Pharmaceuticals, Inc.

在研机构-

非在研机构

Regeneron Pharmaceuticals, Inc.

最高研发阶段无进展临床3期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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结构/序列

Sequence Code 319240661CDR1-LCDR3-L

Sequence Code 319240707CDR2-H

Sequence Code 17330CDR1-LCDR3-L

Sequence Code 319240641VH

Sequence Code 319240656VH

Sequence Code 43789VL

Sequence Code 319240660CDR1-L

Sequence Code 2171CDR1-LCDR2-L

Sequence Code 159499CDR1-H

Sequence Code 9822999CDR2-H

Sequence Code 29028CDR1-L

Sequence Code 319240658CDR3-H

Sequence Code 319240716H

Sequence Code 319240642CDR2-H

Sequence Code 319240708CDR3-H

Sequence Code 319240721L

Sequence Code 2278CDR1-LCDR2-L

Sequence Code 319240705VH

Sequence Code 319240720H

Sequence Code 319240643CDR3-H

Sequence Code 1146474L

Sequence Code 319240659VL

Sequence Code 319240722H

Sequence Code 319240706CDR1-H

Sequence Code 319240717L

Sequence Code 10217CDR1-LCDR2-L

Sequence Code 38899CDR1-L

Sequence Code 319240645CDR1-LCDR3-L

Sequence Code 319240644VL

Sequence Code 319240657CDR1-H

关联

3

项与 REGN-5714 相关的临床试验

NCT05430919

/ Completed临床2期

A Two-Part Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy of the Anti-Bet v 1 Monoclonal Antibodies to Reduce Allergic Rhinitis and Conjunctivitis Symptoms and Skin Test Reactivity Upon Exposure to Birch Allergen

Primary objective: To assess the efficacy of a single dose of the anti- Bet v 1 monoclonal antibodies (mAb(s ) in the reduction of allergic nasal symptoms during an out-of-season birch allergen environmental exposure unit (EEU) challenge in participants receiving REGN5713-5714-5715 versus placebo (Part A)

开始日期2022-08-15

申办/合作机构

Regeneron Pharmaceuticals, Inc.

NCT04709575

/ Completed临床3期

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study Assessing the Efficacy of Anti-Bet v 1 Monoclonal Antibodies to Reduce Symptoms of Seasonal Allergic Rhinitis

The primary objective is to assess the reduction of allergic symptoms as measured by combined symptom and medication score (CSMS) during birch pollen season after a single dose of REGN5713-5714-5715 versus placebo.

开始日期2021-01-14

申办/合作机构

Regeneron Pharmaceuticals, Inc.

NCT03969849

/ Completed临床1期

A Two-Part, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Effects of a Single Dose of REGN5713-5714-5715 in Healthy Adult Subjects

The primary objective of the study is to evaluate the safety and tolerability of REGN5713-5714-5715 in healthy adult participants.
The secondary objectives of the study are:
In Part A and Part B:
To characterize the concentration time profile of single doses of REGN5713-5714-5715 in healthy adults
To assess the immunogenicity of single dose of REGN5713-5714-5715.
In Part B:
To assess the inhibition of allergic symptoms as measured by total nasal symptom score (TNSS) provoked by a birch allergen nasal allergen challenge (NAC) in birch-sensitized allergic subjects after a single subcutaneous (SC) dose of REGN5713-5714-5715
To assess the skin test reactivity provoked by a skin prick test (SPT) with serial birch allergen titration after a single SC dose of REGN5713-5714-5715.

开始日期2019-06-03

申办/合作机构

Regeneron Pharmaceuticals, Inc.

100 项与 REGN-5714 相关的临床结果

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100 项与 REGN-5714 相关的转化医学

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100 项与 REGN-5714 相关的专利（医药）

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7

项与 REGN-5714 相关的文献（医药）

2018-10-02·Analytical Chemistry1区 · 化学

Epitope Mapping by HDX-MS Elucidates the Surface Coverage of Antigens Associated with High Blocking Efficiency of Antibodies to Birch Pollen Allergen

1区 · 化学

Article

作者: Yang, Janice ; Olson, William ; Zhang, Qian ; Badithe, Ashok ; Liu, Yashu ; Bautista, Joannie

Epitopes of a native pollen allergen protein, birch Bet v1, against four of the noncompeting anti-Bet v1 antibodies individually or in combination, were identified by solution-phase amide backbone H/D exchange (HDX) coupled with high-resolution Q-TOF or Orbitrap mass spectrometry. The HDX results indicates that the four anti-Bet v1 antibodies protected specific regions of Bet v1, explaining the difference in their blocking efficiency of each antibody against Bet v1 binding to polyclonal IgEs in Bet v1 allergic patients. An in-house HDX-MS system was further developed to explore the surface protection of Bet v1 in the presence of all four antibodies with 100% sequence coverage and high redundancy. The data demonstrated that four anti-Bet v1 antibodies were able to simultaneously bind to Bet v1 in solution to provide the most effective blocking for 9 of 10 tested IgE donors in an in vitro antibody-blocking assay. For the first time, we have applied HDX to elucidate the therapeutic advantage of combination antibodies compared with individual antibodies in treating Bet v1 induced allergy.

2006-01-01·Arbeiten aus dem Paul-Ehrlich-Institut (Bundesamt fur Sera und Impfstoffe) zu Frankfurt a.M

Clinical evaluation of recombinant allergens.

Article

作者: Cromwell, Oliver ; Narkus, Annemie

2006-01-01·Arbeiten aus dem Paul-Ehrlich-Institut (Bundesamt fur Sera und Impfstoffe) zu Frankfurt a.M

Validation of quantitative, allergen-specific ELISAs.

Article

作者: Monsalve, Rafael ; Raulf-Heimsoth, Monika ; Fiebig, Helmut ; Fötisch, Kay ; Vieths, Stefan ; Barber, Domingo ; Moingeon, Philippe ; Weber, Bernhard ; di Felice, Gabriella ; Becker, Wolf-Meinhard ; Cromwell, Oliver ; Pini, Carlo ; van Ree, Ronald ; Didierlaurent, Alain

100 项与 REGN-5714 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
结膜炎	临床3期	加拿大	Regeneron Pharmaceuticals, Inc.	2021-01-14
结膜炎	临床3期	德国	Regeneron Pharmaceuticals, Inc.	2021-01-14
结膜炎	临床3期	丹麦	Regeneron Pharmaceuticals, Inc.	2021-01-14
结膜炎	临床3期	美国	Regeneron Pharmaceuticals, Inc.	2021-01-14
季节性过敏性鼻炎	临床3期	丹麦	Regeneron Pharmaceuticals, Inc.	2021-01-14
季节性过敏性鼻炎	临床3期	美国	Regeneron Pharmaceuticals, Inc.	2021-01-14
季节性过敏性鼻炎	临床3期	德国	Regeneron Pharmaceuticals, Inc.	2021-01-14
季节性过敏性鼻炎	临床3期	比利时	Regeneron Pharmaceuticals, Inc.	2021-01-14
季节性过敏性鼻炎	临床3期	加拿大	Regeneron Pharmaceuticals, Inc.	2021-01-14
结膜炎	药物发现	比利时	Regeneron Pharmaceuticals, Inc.	2021-01-14

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04709575 (CTgov)	临床3期	季节性过敏性鼻炎 \| 结膜炎	353	REGN5715+REGN5714+REGN5713 (REGN5713-5714-5715)	顧餘醖壓製鬱壓夢壓蓋(鑰衊壓襯顧遞繭膚壓願) = 繭獵遞鏇鑰齋網願壓鏇範簾觸鏇醖蓋觸憲窪膚 (艱鬱積網鑰膚鹹選淵廠, 憲憲夢顧鑰夢壓窪餘遞 ~ 範獵鹹糧夢糧齋築選壓) 更多	-	2022-10-27
				Placebo (Placebo Only)	顧餘醖壓製鬱壓夢壓蓋(鑰衊壓襯顧遞繭膚壓願) = 艱網廠憲繭製簾窪膚淵範簾觸鏇醖蓋觸憲窪膚 (艱鬱積網鑰膚鹹選淵廠, 齋鬱廠廠壓醖廠願膚廠 ~ 製鑰築繭構艱製鹹觸築) 更多
NCT03969849 (Pubmed \| J Allergy Clin Immunol Pract \| J Allergy Clin Immunol) 人工标引	临床1期	超敏反应	96	REGN5713-5714-5715	(淵網醖衊築廠願壓艱積) = 選鬱願鹽積繭鏇築範築醖範鹹鏇糧憲範鏇襯齋 (製繭淵糧齋鏇夢鏇糧鏇 ) 更多	积极	2021-06-11
				Placebo	-
AAAAI2020	N/A	过敏	-	REGN5713	襯獵醖簾夢壓願選繭製(願壓鹹淵繭築餘製簾鹽) = 艱願築築積壓觸築鏇顧繭鹹廠遞壓獵餘餘壓艱 (夢鹹遞構憲艱簾鑰衊觸 )	-	2020-02-01
				REGN5714	襯獵醖簾夢壓願選繭製(願壓鹹淵繭築餘製簾鹽) = 鏇淵願範築鹽積鹹醖襯繭鹹廠遞壓獵餘餘壓艱 (夢鹹遞構憲艱簾鑰衊觸 )