Delving into the Latest Updates on REGN-5714 with Synapse

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

Anti-Bet v 1 Monoclonal Antibodies, REGN-5714

Target

Bet v 1

Mechanism

Bet v 1 inhibitors(Bet v 1 Protein inhibitors)

Therapeutic Areas

Immune System DiseasesInfectious DiseasesEye Diseases+ [2]

Active Indication-

Inactive Indication

ConjunctivitisRhinitis, Allergic, Seasonal

Originator Organization

Regeneron Pharmaceuticals, Inc.

Active Organization-

Inactive Organization

Regeneron Pharmaceuticals, Inc.

Drug Highest PhasePendingPhase 3

First Approval Date-

Regulation-

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Gene Sequence

Sequence Code 2171CDR1-LCDR2-L

Sequence Code 2278CDR1-LCDR2-L

Sequence Code 10217CDR1-LCDR2-L

Sequence Code 17330CDR1-LCDR3-L

Sequence Code 29028CDR1-L

Sequence Code 38899CDR1-L

Sequence Code 43789VL

Sequence Code 159499CDR1-H

Sequence Code 1146474L

Sequence Code 9822999CDR2-H

Sequence Code 319240641VH

Sequence Code 319240642CDR2-H

Sequence Code 319240643CDR3-H

Sequence Code 319240644VL

Sequence Code 319240645CDR1-LCDR3-L

Sequence Code 319240656VH

Sequence Code 319240657CDR1-H

Sequence Code 319240658CDR3-H

Sequence Code 319240659VL

Sequence Code 319240660CDR1-L

Sequence Code 319240661CDR1-LCDR3-L

Sequence Code 319240705VH

Sequence Code 319240706CDR1-H

Sequence Code 319240707CDR2-H

Sequence Code 319240708CDR3-H

Sequence Code 319240716H

Sequence Code 319240717L

Sequence Code 319240720H

Sequence Code 319240721L

Sequence Code 319240722H

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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7

Literatures (Medical) associated with REGN-5714

02 Oct 2018·Analytical chemistryQ1 · CHEMISTRY

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

Q1 · CHEMISTRY

Article

Author: Yang, Janice ; Olson, William ; Liu, Yashu ; Zhang, Qian ; Badithe, Ashok ; 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.

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

Validation of quantitative, allergen-specific ELISAs.

Article

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

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

Clinical evaluation of recombinant allergens.

Article

Author: Cromwell, Oliver ; Narkus, Annemie

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	US	Regeneron Pharmaceuticals, Inc.	14 Jan 2021
Conjunctivitis	Phase 3	BE	Regeneron Pharmaceuticals, Inc.	14 Jan 2021
Conjunctivitis	Phase 3	CA	Regeneron Pharmaceuticals, Inc.	14 Jan 2021
Conjunctivitis	Phase 3	DK	Regeneron Pharmaceuticals, Inc.	14 Jan 2021
Conjunctivitis	Phase 3	DE	Regeneron Pharmaceuticals, Inc.	14 Jan 2021
Rhinitis, Allergic, Seasonal	Phase 3	US	Regeneron Pharmaceuticals, Inc.	14 Jan 2021
Rhinitis, Allergic, Seasonal	Phase 3	BE	Regeneron Pharmaceuticals, Inc.	14 Jan 2021
Rhinitis, Allergic, Seasonal	Phase 3	CA	Regeneron Pharmaceuticals, Inc.	14 Jan 2021
Rhinitis, Allergic, Seasonal	Phase 3	DK	Regeneron Pharmaceuticals, Inc.	14 Jan 2021
Rhinitis, Allergic, Seasonal	Phase 3	DE	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)	kskgrpmqwb(iydltvqmws) = gkywznzuzi vslggevygv (jtexggwlgk, kuatceskkz - bwoqqihmeh) View more	-	27 Oct 2022
				Placebo (Placebo Only)	kskgrpmqwb(iydltvqmws) = tzywtsyyeh vslggevygv (jtexggwlgk, xhbltemfoi - jftntdwfet) View more
NCT03969849 (Pubmed \| J Allergy Clin Immunol Pract \| J Allergy Clin Immunol) Manual	Phase 1	Hypersensitivity	96	REGN5713-5714-5715	wizwlojxdt(cqxqgpbmcu) = ukrvqjlogf xbrwnqisex (bmdoqubpzf ) View more	Positive	11 Jun 2021
				Placebo	-