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Research programme: antibody therapy - Regeneron Pharmaceuticals

Drug Profile

Research programme: antibody therapy - Regeneron Pharmaceuticals

Latest Information Update: 09 May 2020

At a glance

  • Originator Regeneron Pharmaceuticals
  • Class Antibodies; Antivirals
  • Mechanism of Action Virus internalisation inhibitors
  • 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
  • Available For Licensing Yes

Highest Development Phases

  • Preclinical COVID 2019 infections

Most Recent Events

  • 05 May 2020 Preclinical trials in COVID-2019 infections (Prevention) in USA (Parenteral) before May 2020
  • 05 May 2020 Preclinical trials in COVID-2019 infections in USA (Parenteral) before May 2020
  • 16 Apr 2020 Regeneron plans a clinial trial for COVID-2019 infections in USA, in June 2020

Development Overview

Introduction

Multi-antibody cocktail therapy is being developed by Regeneron Pharmaceuticals for the prevention and the treatment of COVID-19 infections by using its VelociMab® technology. Coronavirus display a glycoprotein called spike protein on their surface, which after binding to host cells spreads the infection. Regeneron intends to develop antibodies that are engineered to bind to these proteins leading to reduced interaction with host cells thereby neutralising the virus. The company will make a use its genetically modified VelocImmune® mice for the generation of fully human antibodies. Company has also isolated antibodies from the patients who have recovered from COVID-19 infections to have large pool of potent antibodies. Using multi-antibody approach, Regeneron plans to select top two antibodies for cocktail therapy that will bind to different parts of the virus protecting against different viral mutants. Preclinical development is underway in US.

VelociMab® technology utilises high throughput method to screen and identify antibodies specific to the target and allow rapid generation of cell line for recombinant human antibodies. By exploiting VelociMab® technology company is making manufacturing ready cell lines once lead antibodies are selected.

The lead candidate, REGN COV2 is in preclinical development for the treatment and prevention of COVID-19 infections [see Adis Insight drug profile 800058539].

Regeneron Pharmaceuticals seeks partnership for the development of antibody cocktail therapy programme (Regeneron Pharmaceuticals website, March 2020).

Key Development Milestones

As of May 2020, antibody therapy programme is in preclinical development for the prevention and the treatment of COVID-19 infections [1] .

Patent Information

As at March 2020, company has a patents for genetically engineered mice capable of producing chimeric antibodies that are part human and part mouse in US and Europe [2]

Drug Properties & Chemical Synopsis

  • Route of administration Parenteral
  • Formulation unspecified
  • Class Antibodies, Antivirals
  • Target Coronavirus spike glycoprotein; Virus internalisation
  • Mechanism of Action Virus internalisation inhibitors
  • WHO ATC code

    J05A-X (Other antivirals)

  • EPhMRA code

    J5B (Antivirals, excluding anti-HIV products)

Development Status

Summary Table

Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
COVID 2019 infections - - Preclinical USA Parenteral / unspecified Regeneron Pharmaceuticals 05 May 2020
COVID 2019 infections - Prevention Preclinical USA Parenteral / unspecified Regeneron Pharmaceuticals 05 May 2020

Commercial Information

Involved Organisations

Organisation Involvement Countries
Regeneron Pharmaceuticals Originator USA
Regeneron Pharmaceuticals Owner USA

Licensing Availability

Licensing Organisation Available Indication Available Phase Region Date
Regeneron Pharmaceuticals - Unspecified - 19 Mar 2020

Future Events

Expected Date Event Type Description Updated
30 Jun 2020 Trial Update Regeneron plans a clinial trial for COVID-2019 infections in USA, in June 2020 [3] 20 Apr 2020

Development History

Event Date Update Type Comment
05 May 2020 Phase Change - Preclinical Preclinical trials in COVID-2019 infections (Prevention) in USA (Parenteral) before May 2020 [1] Updated 09 May 2020
05 May 2020 Phase Change - Preclinical Preclinical trials in COVID-2019 infections in USA (Parenteral) before May 2020 [1] Updated 09 May 2020
16 Apr 2020 Trial Update Regeneron plans a clinial trial for COVID-2019 infections in USA, in June 2020 [3] Updated 20 Apr 2020
19 Mar 2020 Licensing Status Research programme: antibody cocktail therapeutics - Regeneron is available for licensing as of 19 Mar 2020. https://www.regeneron.com/collaborations Updated 26 Mar 2020
19 Mar 2020 Patent Information Regeneron Pharmaceuticals has patent protection for genetically engineered mice capable of producing chimeric antibodies in US and Europe [2] Updated 26 Mar 2020
17 Mar 2020 Phase Change Early research in Coronavirus infections in USA (Parenteral) Updated 26 Mar 2020
17 Mar 2020 Phase Change Early research in COVID-2019 infections (Prevention) in USA (Parenteral) Updated 26 Mar 2020

References

  1. Regeneron Reports First Quarter 2020 Financial and Operating Results.

    Media Release
  2. REGENERON PHARMACEUTICALS. Internet-Doc 2020;.

    Available from: URL: https://investor.regeneron.com/static-files/a79ec34b-62ca-4b7b-9564-279c096689aa
  3. FDA Accepts for Priority Review Biologics License Application for REGN-EB3 to Treat Ebola.

    Media Release
  4. Regeneron and Sanofi Begin Global Kevzara(R) (sarilumab) Clinical Trial Program in Patients with Severe COVID-19.

    Media Release
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