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REGN 3048

Drug Profile

REGN 3048

Alternative Names: REGN3048

Latest Information Update: 03 May 2018

At a glance

  • Originator Regeneron Pharmaceuticals
  • Developer National Institute of Allergy and Infectious Diseases; Regeneron Pharmaceuticals
  • Class Antivirals; Monoclonal antibodies
  • Mechanism of Action Viral protein inhibitors; 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

Highest Development Phases

  • Phase I Middle East respiratory syndrome coronavirus

Most Recent Events

  • 12 Feb 2018 Phase-I clinical trials in Middle East respiratory syndrome coronavirus (In volunteers) in USA (IV) (NCT03301090) (Regeneron pipeline, May 2018)
  • 02 Oct 2017 Regeneron Pharmaceuticals plans a NIH-sponsored phase I trial for Middle East respiratory syndrome coronavirus by the end of 2017
  • 22 Aug 2016 Regeneron Pharmaceuticals enters into a collaboration agreement with Sanofi to develop human monoclonal antibodies for Middle East respiratory syndrome coronavirus before August 2016

Development Overview

Introduction

REGN 3048 is a fully human spike-protein blocking monoclonal antibody, under development by Regeneron Pharmaceuticals, for the treatment of Middle East respiratory syndrome coronavirus (MERS-CoV). This antibody has an ability to reduce virus titres as well as ameliorate virus induced lung pathology when given post infection. The company is using its VelociGene® and VelocImmune® rapid response technologies. VelocImmune® is used for the rapid generation of fully human monoclonal antibodies, allowing creation of a panel of antibodies that inhibit interaction between the MERS coronavirus spike protein and its receptor, DPP4, thereby preventing virus cell entry. VelociGene® is a large-scale mouse genomic modification platform and was utilised to create a genetically humanised disease model for the MERS infection. Phase I development is underway in the US.

Regeneron Pharmaceuticals is also developing REGN 3051, another spike protein blocking antibody that binds to different epitope of the protein, for the treatment of MERS-CoV [see AdisInsight drug profile 800051915].

Further work on the MERS antibodies is being undertaken by Regeneron in collaboration with the Biomedical Advanced Research and Development Authority. The University of Maryland School of Medicine provided access to an infectious MERS clone and conducted studies with the live virus [1] .

Company Agreements

In August 2016, Regeneron entered into an agreement with the Biomedical Advanced Research and Development Authority (BARDA) of the US Department of Health and Human Services (HHS) to manufacture and study two antibody therapies for the potential prevention and treatment of Middle East Respiratory Syndrome (MERS). Under the terms of the agreement, HHS will provide initial funding of approximately $US8.9 million to support packaging and labelling of the antibodies for human use, the preparation and submission of an IND application with the US FDA and a National Institutes of Health-conducted clinical trial in healthy volunteers. [2]

Regeneron reported that the MERS antibodies have been discovered and developed pursuant to Regeneron's antibody discovery and preclinical development agreement with Sanofi and are subject to Sanofi's opt-in rights for development and commercialisation [2] .

Key Development Milestones

In February 2018, National Institute of Allergy and Infectious Diseases initiated a first-in-human phase I trial to assess the safety, tolerability, pharmacokinetics and immunogenicity of single ascending doses of REGN 3048 co-administered with REGN 3051, in healthy volunteers (15-0109; HHSN272201500005I; NCT03301090). The randomised, double-masking, placebo controlled trial will enrol approximately 48 patients in the US.

Patent Information

In February 2016, Regeneron Pharmaceuticals' patents EP(UK) 1 360 287 and EP(UK) 2 264 163 covering its VelocImmune® propriety technology were revoked by the English High Court upon invalidity claims filed by Kymab. The patents covered genetically modified mice containing human antibody variable region loci and humanised antibodies from such mice [3] .

Drug Properties & Chemical Synopsis

  • Route of administration IV, Parenteral
  • Formulation Infusion
  • Class Antivirals, Monoclonal antibodies
  • Target Viral protein; Virus internalisation
  • Mechanism of Action Viral protein inhibitors; Virus internalisation inhibitors
  • WHO ATC code

    J05A-X (Other antivirals)

  • EPhMRA code

    J5B9 (Antivirals, others)

Development Status

Summary Table

Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
Middle East respiratory syndrome coronavirus - In volunteers Phase I USA IV / Infusion National Institute of Allergy and Infectious Diseases, Regeneron Pharmaceuticals 12 Feb 2018

Commercial Information

Involved Organisations

Organisation Involvement Countries
Regeneron Pharmaceuticals Originator USA
Regeneron Pharmaceuticals Owner USA
Sanofi Collaborator France
National Institute of Allergy and Infectious Diseases Collaborator USA
Biomedical Advanced Research and Development Authority Collaborator USA
University of Maryland School of Medicine Collaborator USA

Future Events

Expected Date Event Type Description Updated
31 Dec 2017 Trial Update Regeneron Pharmaceuticals plans a NIH-sponsored phase I trial for Middle East respiratory syndrome coronavirus by the end of 2017 [4] 03 May 2018

Development History

Event Date Update Type Comment
12 Feb 2018 Phase Change - I Phase-I clinical trials in Middle East respiratory syndrome coronavirus (In volunteers) in USA (IV) (NCT03301090) (Regeneron pipeline, May 2018) Updated 03 May 2018
02 Oct 2017 Trial Update Regeneron Pharmaceuticals plans a NIH-sponsored phase I trial for Middle East respiratory syndrome coronavirus by the end of 2017 [4] Updated 03 May 2018
22 Aug 2016 Licensing Status Regeneron Pharmaceuticals enters into a collaboration agreement with Sanofi to develop human monoclonal antibodies for Middle East respiratory syndrome coronavirus before August 2016 [2] Updated 02 Sep 2016
22 Aug 2016 Company Involvement Regeneron receives grant from Biomedical Advanced Research and Development Authority (BARDA) for antibody drug candidates development in Middle East respiratory syndrome coronavirus [2] Updated 02 Sep 2016
22 Aug 2016 Regulatory Status Regeneron announces intention to submit IND to US FDA [2] Updated 02 Sep 2016
02 Feb 2016 Patent Information Regeneron has patent protection for VelocImmune® technology in Europe [3] Updated 02 Sep 2016
29 Jun 2015 Licensing Status Regeneron Pharmaceuticals enters into a collaboration agreement with Biomedical Advanced Research and Development Authority and University of Maryland School of Medicine to develop human monoclonal antibodies for Middle East respiratory syndrome coronavirus [1] Updated 02 Sep 2016
29 Jun 2015 Phase Change - Preclinical Preclinical trials in Middle East respiratory syndrome coronavirus in USA (Parenteral) Updated 17 Jul 2015

References

  1. Regeneron Rapid Response Platform for Emerging Infectious Diseases Described in Proceedings of the National Academy of Sciences Publication.

    Media Release
  2. Regeneron Announces Agreement with BARDA for the Manufacturing and Testing of New Antibodies Against MERS Virus.

    Media Release
  3. Kymab Succeeds in Revoking Regeneron's UK VelocImmune(R) Patents.

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

    Media Release
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