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

作用方式

抑制剂

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

过敏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.

权益机构-

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 319240641VH

Sequence Code 17330CDR1-LCDR3-L

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 319240721L

Sequence Code 319240708CDR3-H

Sequence Code 2278CDR1-LCDR2-L

Sequence Code 319240705VH

Sequence Code 1146474L

Sequence Code 319240720H

Sequence Code 319240643CDR3-H

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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2

项与 REGN-5714 相关的文献（医药）

2022-01-01·Journal of Allergy and Clinical Immunology1区 · 医学

Targeting immunodominant Bet v 1 epitopes with monoclonal antibodies prevents the birch allergic response

1区 · 医学

Article

作者: Badithe, Ashok ; Franklin, Matthew C ; Sleeman, Matthew A ; Orengo, Jamie M ; Atanasio, Amanda ; Ben, Li-Hong ; Kamat, Vishal ; Jones, Jennifer ; Hernandez, Annabel Romero ; Yancopoulos, George D ; Murphy, Andrew J ; Bautista, Joannie ; Olson, William

BACKGROUNDBlocking the major cat allergen, Fel d 1, with mAbs was effective in preventing an acute cat allergic response.OBJECTIVESThis study sought to extend the allergen-specific antibody approach and demonstrate that a combination of mAbs targeting Bet v 1, the immunodominant and most abundant allergenic protein in birch pollen, can prevent the birch allergic response.METHODSBet v 1-specific mAbs, REGN5713, REGN5714, and REGN5715, were isolated using the VelocImmune platform. Surface plasmon resonance, x-ray crystallography, and cryo-electron microscopy determined binding kinetics and structural data. Inhibition of IgE-binding, basophil activation, and mast cell degranulation were assessed via blocking ELISA, flow cytometry, and the passive cutaneous anaphylaxis mouse model.RESULTSREGN5713, REGN5714, and REGN5715 bind with high affinity and noncompetitively to Bet v 1. A cocktail of all 3 antibodies, REGN5713/14/15, blocks IgE binding to Bet v 1 and inhibits Bet v 1- and birch pollen extract-induced basophil activation ex vivo and mast cell degranulation in vivo. Crystal structures of the complex of Bet v 1 with immunoglobulin antigen-binding fragments of REGN5713 or REGN5715 show distinct interaction sites on Bet v 1. Cryo-electron microscopy reveals a planar and roughly symmetrical complex formed by REGN5713/14/15 bound to Bet v 1.CONCLUSIONSThese data confirm the immunodominance of Bet v 1 in birch allergy and demonstrate blockade of the birch allergic response with REGN5713/14/15. Structural analyses show simultaneous binding of REGN5713, REGN5714, and REGN5715 with substantial areas of Bet v 1 exposed, suggesting that targeting specific epitopes is sufficient to block the allergic response.

2022-01-01·Journal of Allergy and Clinical Immunology1区 · 医学

Novel antibody cocktail targeting Bet v 1 rapidly and sustainably treats birch allergy symptoms in a phase 1 study

1区 · 医学

Article

作者: Lorah Perlee ; Michelle DeVeaux ; Bram Volckaert ; George D. Yancopoulos ; Meagan P. O’Brien ; David M. Weinreich ; Amanda Atanasio ; Divya Ramesh ; Kristof Lesneuck ; Gary Herman ; Peter W. Hellings ; Robert Dingman ; Philippe Gevaert ; Natalie De Ruyck ; Hisham Abdallah ; Claire Q. Wang ; Jarno De Craemer ; Jamie M. Orengo ; Vishal Kamat ; Sylvie Rottey ; Mohamed A. Kamal ; Jan de Hoon

BACKGROUNDThe efficacy of an allergen-specific IgG cocktail to treat cat allergy suggests that allergen-specific IgG may be a major protective mechanism elicited by allergen immunotherapy.OBJECTIVESExtending these findings, we tested a Bet v 1-specific antibody cocktail in birch-allergic subjects.METHODSThis was a phase 1, randomized, double-blind, study with 2 parts. Part A administered ascending doses of the Bet v 1-specific antibody cocktail REGN5713/14/15 (150-900 mg) in 32 healthy adults. Part B administered a single subcutaneous 900-mg dose or placebo in 64 birch-allergic subjects. Total nasal symptom score response to titrated birch extract nasal allergen challenge and skin prick test (SPT) with birch and alder allergen were assessed at screening and days 8, 29, 57, and 113 (SPT only); basophil activation tests (n = 26) were conducted.RESULTSSingle-dose REGN5713/14/15 significantly reduced total nasal symptom score following birch nasal allergen challenge relative to baseline. Differences in total nasal symptom score areas under the curve (0-1 hour) for subjects treated with REGN5713/14/15 versus those given placebo (day 8: -1.17, P = .001; day 29: -1.18, P = .001; day 57: -0.85, P = .024) and titration SPT with birch difference in area under the curve of mean wheal diameters for subjects treated with REGN5713/14/15 versus placebo (all P < .001) were sustained for ≥2 months; similar results were observed with alder SPT. REGN5713/14/15 was well tolerated. Basophil responsiveness to birch-related allergens was significantly decreased in subjects treated with REGN5713/14/15 versus those given placebo on days 8, 57, and 113 (all P < .01).CONCLUSIONSSingle-dose REGN5713/14/15 was well tolerated and provided a rapid (1 week) and durable (2 months) reduction in allergic symptoms after birch allergen nasal allergen challenge, potentially offering a new paradigm for the treatment of birch allergy symptoms.

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	比利时	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	德国	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	德国	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
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	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

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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)	襯獵構遞積網顧壓鏇遞(齋淵艱構觸積選窪鹽夢) = 膚鹹鹽窪繭觸鹽簾製餘淵艱願積鬱艱鑰範鹹廠 (顧壓壓齋憲膚鏇鏇簾壓, 廠窪鹽鏇廠壓製憲獵範 ~ 鬱範願簾築衊壓鏇衊積) 更多	-	2022-10-27
				Placebo (Placebo Only)	襯獵構遞積網顧壓鏇遞(齋淵艱構觸積選窪鹽夢) = 膚窪憲淵糧廠鬱夢觸築淵艱願積鬱艱鑰範鹹廠 (顧壓壓齋憲膚鏇鏇簾壓, 築膚鏇遞艱餘壓蓋製膚 ~ 獵廠醖積鏇蓋餘鹽鹽觸) 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	(壓窪鑰選獵築繭鏇繭夢) = 廠觸築艱構繭選膚壓遞鑰選遞憲糧觸簾鏇醖觸 (醖餘鹽糧襯餘鑰襯願夢 ) 更多	积极	2021-06-11
				Placebo	-
AAAAI2020	N/A	过敏	-	REGN5713	構窪壓餘觸艱廠繭簾淵(膚顧鹹遞夢餘鏇衊遞積) = 窪餘壓艱獵遞範齋選鑰壓遞夢遞遞繭醖積鏇廠 (構蓋網壓餘膚繭壓壓觸 )	-	2020-02-01
				REGN5714	構窪壓餘觸艱廠繭簾淵(膚顧鹹遞夢餘鏇衊遞積) = 艱鬱願淵選鏇襯窪夢鑰壓遞夢遞遞繭醖積鏇廠 (構蓋網壓餘膚繭壓壓觸 )