Research programme: anti-infective monoclonal antibody therapeutics - Regeneron/BARDA
Latest Information Update: 28 Mar 2024
At a glance
- Originator Regeneron Pharmaceuticals
- Class Anti-infectives; Antivirals; Monoclonal antibodies
- Mechanism of Action Immunomodulators
-
Orphan Drug Status
No
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity Yes
Highest Development Phases
- No development reported COVID 2019 infections; Infections; Influenza virus infections
Most Recent Events
- 28 Mar 2024 No recent reports of development identified for research development in COVID-2019-infections in USA (Parenteral)
- 22 Aug 2023 Regeneron Pharmaceuticals and Biomedical Advanced Research and Development Authority agreed to co-develop COVID-19 monoclonal antibody therapy for SARS-CoV-2 infection
- 22 Aug 2023 Regeneron pharmaceuticals plans a clinical trial for SARS-CoV-2 infections in 2023
Development Overview
Introduction
Anti-infective monoclonal antibodies are being developed by Regeneron Pharmaceuticals, in collaboration with the Biomedical Advanced Research and Development Authority (BARDA), 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.
As at November 2021, no recent reports of development had been identified for research development in Infections in USA (Parenteral), research development in Influenza-virus-infections in USA (Parenteral).
As at March 2024, no recent reports of development had been identified for research development in COVID-2019-infections in USA (Parenteral).
Company Agreements
In August 2023, Regeneron Pharmaceuticals announced that the Biomedical Advanced Research and Development Authority (BARDA) has entered into an agreement with Regeneron to support clinical development, clinical manufacturing and the regulatory licensure process of a next-generation COVID-19 monoclonal antibody therapy for the prevention of SARS-CoV-2 infection. The agreement is part of ‘Project NextGen,’ an initiative by the U.S. Department of Health and Human Services (HHS) to advance a pipeline of new, innovative vaccines and therapeutics for COVID-19. The new contract has an estimated value of up to approximately $US326 million of government funding. Earlier, in February 2020, Regeneron Pharmaceuticals expanded its agreement with the US 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 BARDA of the US 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] [3]
Drug Properties & Chemical Synopsis
- Route of administration Parenteral
- Formulation unspecified
- Class Anti-infectives, Antivirals, Monoclonal antibodies
- 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 | - | - | No development reported (Research) | USA | Parenteral / unspecified | Regeneron Pharmaceuticals | 28 Mar 2024 |
| Infections | - | - | No development reported (Research) | USA | Parenteral / unspecified | Regeneron Pharmaceuticals | 28 Nov 2021 |
| Influenza virus infections | - | - | No development reported (Research) | USA | Parenteral / unspecified | Regeneron Pharmaceuticals | 28 Nov 2021 |
Commercial Information
Involved Organisations
| Organisation | Involvement | Countries |
|---|---|---|
| Regeneron Pharmaceuticals | Originator | USA |
| Regeneron Pharmaceuticals | Owner | USA |
| Biomedical Advanced Research and Development Authority | Funder | USA |
Future Events
| Expected Date | Event Type | Description | Updated |
|---|---|---|---|
| 31 Dec 2023 | Trial Update | Regeneron pharmaceuticals plans a clinical trial for SARS-CoV-2 infections in 2023 (9396871) | 24 Aug 2023 |
Development History
| Event Date | Update Type | Comment |
|---|---|---|
| 28 Mar 2024 | Phase Change - No development reported | No recent reports of development identified for research development in COVID-2019-infections in USA (Parenteral) Updated 28 Mar 2024 |
| 22 Aug 2023 | Licensing Status | Regeneron Pharmaceuticals and Biomedical Advanced Research and Development Authority agreed to co-develop COVID-19 monoclonal antibody therapy for SARS-CoV-2 infection [3] Updated 24 Aug 2023 |
| 22 Aug 2023 | Trial Update | Regeneron pharmaceuticals plans a clinical trial for SARS-CoV-2 infections in 2023 [3] Updated 24 Aug 2023 |
| 28 Nov 2021 | Phase Change - No development reported | No recent reports of development identified for research development in Infections in USA (Parenteral) Updated 28 Nov 2021 |
| 28 Nov 2021 | Phase Change - No development reported | No recent reports of development identified for research development in Influenza-virus-infections in USA (Parenteral) Updated 28 Nov 2021 |
| 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
-
Regeneron Announces New Collaborations with HHS to Develop Antibodies Against Ebola, Influenza and Multiple Other Emerging Pathogens.
Media Release -
Regeneron Announces Expanded Collaboration with HHS to Develop Antibody Treatments for New Coronavirus.
Media Release -
Regeneron Announces Agreement with BARDA Supporting Development of Next-Generation Antibody Therapy for COVID-19 Prevention.
Media Release
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