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Research programme: anti-infective antibody therapeutics - Regeneron/BARDA

Drug Profile

Research programme: anti-infective antibody therapeutics - Regeneron/BARDA

Latest Information Update: 06 Feb 2020

At a glance

  • Originator Biomedical Advanced Research and Development Authority; Regeneron Pharmaceuticals
  • Class Anti-infectives; Antibodies; Antivirals
  • Mechanism of Action Immunomodulators
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Research COVID 2019 infections; Infections; Influenza virus infections

Most Recent Events

  • 04 Feb 2020 Regeneron Pharmaceuticals and BARDA expand the agreement to develop antibodies against COVID-2019-infections
  • 04 Feb 2020 Early research in COVID-2019-infections in USA (Parenteral)
  • 02 Oct 2017 Regeneron Pharmaceuticals and BARDA agree to co-develop antibody therapeutics in USA for Influenza virus infections and other infectious diseases

Development Overview

Introduction

Anti-infective antibodies are being developed by Regeneron Pharmaceuticals, in collaboration with the Biomedical Advanced Research and Development Authority (BARDA), i for the treatment of infectious diseases, including influenza virus infections, COVID-2019 infections and multiple other emerging pathogens that pose significant risk to public health. Regeneron is using its proprietary VelociSuite® and VelocImmune technologies to facilitate rapid identification, preclinical validation and development of suitable antibody candidates. Early research is ongoing in the US.

Company Agreements

In February 2020, Regeneron Pharmaceuticals expanded its agreement with the U.S. Department of Health and Human Services (HHS) to develop new treatments combating the COVID-2019 infections. Previously, in October 2017, Regeneron Pharmaceuticals entered into a research and development agreement with the Biomedical Advanced Research and Development Authority (BARDA) of the US Department of Health and Human Services (HHS), for the discovery, research, development and manufacturing of a portfolio of antibodies for the treatment of infectious diseases, including influenza virus and multiple other emerging pathogens. The emerging pathogens treatment portfolio will be developed using an Other Transaction Agreement (OTA) with a term of 10 years, to provide a funding and collaboration vehicle for HHS. Under the terms of the agreement, HHS will fund 80 percent of costs for research, development and manufacturing activities for selected antibodies to Regeneron. BARDA and Regeneron will jointly select up to ten target pathogens. The first selected program will target influenza virus and receive initial funding of more than $US18 million for early-stage antibody discovery, development and manufacturing of the drug. [1] [2]

Drug Properties & Chemical Synopsis

  • Route of administration Parenteral
  • Formulation unspecified
  • Class Anti-infectives, Antibodies, Antivirals
  • Mechanism of Action Immunomodulators
  • WHO ATC code

    J07B-B (Influenza vaccines)

    J07B-X (Other viral vaccines)

  • EPhMRA code

    J7A9 (Other specified single component)

    J7E1 (Influenza vaccines)

Development Status

Summary Table

Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
COVID 2019 infections - - Research USA Parenteral / unspecified Biomedical Advanced Research and Development Authority, Regeneron Pharmaceuticals 04 Feb 2020
Infections - - Research USA Parenteral / unspecified Biomedical Advanced Research and Development Authority, Regeneron Pharmaceuticals 02 Oct 2017
Influenza virus infections - - Research USA Parenteral / unspecified Biomedical Advanced Research and Development Authority, Regeneron Pharmaceuticals 02 Oct 2017

Commercial Information

Involved Organisations

Organisation Involvement Countries
Regeneron Pharmaceuticals Originator USA
Biomedical Advanced Research and Development Authority Originator USA
Regeneron Pharmaceuticals Owner USA
Biomedical Advanced Research and Development Authority Owner USA
US Department of Health and Human Services Funder USA

Development History

Event Date Update Type Comment
04 Feb 2020 Licensing Status Regeneron Pharmaceuticals and BARDA expand the agreement to develop antibodies against COVID-2019-infections [2] Updated 06 Feb 2020
04 Feb 2020 Phase Change Early research in COVID-2019-infections in USA (Parenteral) [2] Updated 06 Feb 2020
02 Oct 2017 Licensing Status Regeneron Pharmaceuticals and BARDA agree to co-develop antibody therapeutics in USA for Influenza virus infections and other infectious diseases [1] Updated 06 Oct 2017
02 Oct 2017 Phase Change Early research in Infections in USA (Parenteral) [1] Updated 06 Oct 2017
02 Oct 2017 Phase Change Early research in Influenza virus infections in USA (Parenteral) [1] Updated 06 Oct 2017

References

  1. Regeneron Announces New Collaborations with HHS to Develop Antibodies Against Ebola, Influenza and Multiple Other Emerging Pathogens.

    Media Release
  2. Regeneron Announces Expanded Collaboration with HHS to Develop Antibody Treatments for New Coronavirus.

    Media Release
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