Delving into the Latest Updates on REGN-5714 with Synapse

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

Anti-Bet v 1 Monoclonal Antibodies

Target

Bet v 1

Action

inhibitors

Mechanism

Bet v 1 inhibitors(Bet v 1 Protein inhibitors)

Therapeutic Areas

Immune System DiseasesInfectious DiseasesEye Diseases+ [2]

Active Indication-

Inactive Indication

AnaphylaxisConjunctivitisRhinitis, Allergic, Seasonal

Originator Organization

Regeneron Pharmaceuticals, Inc.

Active Organization-

Inactive Organization

Regeneron Pharmaceuticals, Inc.

License Organization-

Drug Highest PhasePendingPhase 3

First Approval Date-

Regulation-

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Structure/Sequence

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

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)

Start Date15 Aug 2022

Sponsor / Collaborator

Regeneron Pharmaceuticals, Inc.

NCT04709575

/ CompletedPhase 3

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.

Start Date14 Jan 2021

Sponsor / Collaborator

Regeneron Pharmaceuticals, Inc.

NCT03969849

/ CompletedPhase 1

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.

Start Date03 Jun 2019

Sponsor / Collaborator

Regeneron Pharmaceuticals, Inc.

100 Clinical Results associated with REGN-5714

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100 Translational Medicine associated with REGN-5714

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100 Patents (Medical) associated with REGN-5714

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2

Literatures (Medical) associated with REGN-5714

01 Jan 2022·Journal of Allergy and Clinical ImmunologyQ1 · MEDICINE

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

Q1 · MEDICINE

Article

Author: 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.

01 Jan 2022·Journal of Allergy and Clinical ImmunologyQ1 · MEDICINE

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

Q1 · MEDICINE

Article

Author: 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 Deals associated with REGN-5714

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Conjunctivitis	Phase 3	Canada	Regeneron Pharmaceuticals, Inc.	14 Jan 2021
Conjunctivitis	Phase 3	Belgium	Regeneron Pharmaceuticals, Inc.	14 Jan 2021
Conjunctivitis	Phase 3	Denmark	Regeneron Pharmaceuticals, Inc.	14 Jan 2021
Conjunctivitis	Phase 3	Germany	Regeneron Pharmaceuticals, Inc.	14 Jan 2021
Conjunctivitis	Phase 3	United States	Regeneron Pharmaceuticals, Inc.	14 Jan 2021
Rhinitis, Allergic, Seasonal	Phase 3	Germany	Regeneron Pharmaceuticals, Inc.	14 Jan 2021
Rhinitis, Allergic, Seasonal	Phase 3	Canada	Regeneron Pharmaceuticals, Inc.	14 Jan 2021
Rhinitis, Allergic, Seasonal	Phase 3	Belgium	Regeneron Pharmaceuticals, Inc.	14 Jan 2021
Rhinitis, Allergic, Seasonal	Phase 3	Denmark	Regeneron Pharmaceuticals, Inc.	14 Jan 2021
Rhinitis, Allergic, Seasonal	Phase 3	United States	Regeneron Pharmaceuticals, Inc.	14 Jan 2021

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04709575 (CTgov)	Phase 3	Rhinitis, Allergic, Seasonal \| Conjunctivitis	353	REGN5715+REGN5714+REGN5713 (REGN5713-5714-5715)	idhtvddygg(qjxyzmxsgn) = vazoxhgbvz srxosgzawb (sdinjpindu, hdeummpdgl - wrizkhqtpi) View more	-	27 Oct 2022
				Placebo (Placebo Only)	idhtvddygg(qjxyzmxsgn) = ffdlsxqovc srxosgzawb (sdinjpindu, pcwkogfiav - majfdvkqmi) View more
NCT03969849 (Pubmed \| J Allergy Clin Immunol Pract \| J Allergy Clin Immunol) Manual	Phase 1	Hypersensitivity	96	REGN5713-5714-5715	(wylvzbdljt) = kzkjlfzcdc ogtjgsuzpf (fdroktqgrh ) View more	Positive	11 Jun 2021
				Placebo	-
AAAAI2020	Not Applicable	Anaphylaxis	-	REGN5713	yceyjjqfrd(vsishxwdqv) = zvijtswgji twxhdbqdsc (rncmcyzaar )	-	01 Feb 2020
				REGN5714	yceyjjqfrd(vsishxwdqv) = sheeuumcai twxhdbqdsc (rncmcyzaar )

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Biosimilar

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