Delving into the Latest Updates on REGN-5713 with Synapse

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

Target

Bet v 1

Action

inhibitors

Mechanism

Bet v 1 inhibitors(Bet v 1 Protein inhibitors)

Therapeutic Areas

Immune System DiseasesEye Diseases

Active Indication

AnaphylaxisConjunctivitis, Allergic

Inactive Indication

Rhinitis, Allergic, Seasonal

Originator Organization

Regeneron Pharmaceuticals, Inc.

Active Organization

Regeneron Pharmaceuticals, Inc.

Inactive Organization-

License Organization-

Drug Highest PhasePhase 3

First Approval Date-

Regulation-

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This study is researching 2 experimental drugs, REGN5713 and REGN5715, which are called REGN5713-5715 when mixed together (called "study drug") to reduce eye allergy signs and symptoms due to birch tree pollen allergy.
The aim of the study is to see how safe and effective the study drug is at lowering allergic eye signs and symptoms compared with placebo. A placebo looks like a treatment but does not contain any real medicine.
The study is looking at several other research questions, including:
* What side effects may happen from taking the study drug
* How much study drug is in the blood at different times
* Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects).

Start Date19 Nov 2024

Sponsor / Collaborator

Regeneron Pharmaceuticals, Inc.

NCT05430919

/ CompletedPhase 2

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)

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.

100 Clinical Results associated with REGN-5713

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100 Translational Medicine associated with REGN-5713

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100 Patents (Medical) associated with REGN-5713

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1

Literatures (Medical) associated with REGN-5713

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.

100 Deals associated with REGN-5713

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Conjunctivitis, Allergic	Phase 3	United States	Regeneron Pharmaceuticals, Inc.	19 Nov 2024
Conjunctivitis, Allergic	Phase 3	Canada	Regeneron Pharmaceuticals, Inc.	19 Nov 2024
Conjunctivitis	Preclinical	Belgium	Regeneron Pharmaceuticals, Inc.	14 Jan 2021
Conjunctivitis	Preclinical	Denmark	Regeneron Pharmaceuticals, Inc.	14 Jan 2021
Conjunctivitis	Preclinical	Germany	Regeneron Pharmaceuticals, Inc.	14 Jan 2021
Rhinitis, Allergic, Seasonal	Preclinical	Canada	Regeneron Pharmaceuticals, Inc.	14 Jan 2021
Rhinitis, Allergic, Seasonal	Preclinical	United States	Regeneron Pharmaceuticals, Inc.	14 Jan 2021
Rhinitis, Allergic, Seasonal	Preclinical	Belgium	Regeneron Pharmaceuticals, Inc.	14 Jan 2021
Rhinitis, Allergic, Seasonal	Preclinical	Germany	Regeneron Pharmaceuticals, Inc.	14 Jan 2021
Rhinitis, Allergic, Seasonal	Preclinical	Denmark	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)	dpobsjscal(lcisebjofp) = dcaynmpndw ajmfvuklkt (zehxmluyqx, icwjnlwegi - khvdukoowk) View more	-	27 Oct 2022
				Placebo (Placebo Only)	dpobsjscal(lcisebjofp) = gdnnxqrdyd ajmfvuklkt (zehxmluyqx, xltoruswwf - ateeutsxka) View more

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Biosimilar

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