Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

Research programme: anti-coronavirus antibodies - Vir Biotechnology

Drug Profile

Research programme: anti-coronavirus antibodies - Vir Biotechnology

Alternative Names: 2019-nCoV - Vir Biotechnology; SARS-CoV - Vir Biotechnology; SARS-CoV-2 - Vir Biotechnology

Latest Information Update: 22 Apr 2020

At a glance

  • Originator Vir Biotechnology
  • Class Antivirals; Monoclonal antibodies
  • 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

Most Recent Events

  • 06 Apr 2020 Vir Biotechnolgy and GlaxoSmithKline collaborate to discover and develop monoclonal antibodies COVID-2019 infections
  • 30 Mar 2020 Generation Bio and Vir Biotechnology agree co-develop monoclonal antibodies for COVID-2019 infections
  • 25 Mar 2020 Vir Biotechnology in-licenses Xtend™ Fc technology from Xencor

Development Overview

Introduction

Fully human monoclonal antibodies are being developed by Vir Biotechnology utilising its antibody screening platform for the prevention and treatment of COVID-2019 infections. The antibodies are designed to bind and neutralise Wuhan coronavirus (2019-nCoV). The company also identified antibodies targeting SARS-CoV-2 spike protein in the region that the virus uses to enter cells through the cellular receptor ACE2. The coronavirus spike protein plays a key role in the early steps of viral infection. Infection with SARS-CoV-2 causes the newly named disease, Covid-19. Early research is underway in the US.

The antibody screening platform identifies the antibodies produced from survivors of an infection and further engineer them to enhance their therapeutic potential. The company is also utilising its whole genome CRISPR-based screening capabilities (innate immunity platform) to identify and target the host receptor that allows Wuhan coronavirus infection.

The company is also investigating other approaches to identify additional potential therapies for SARS-CoV-2. In addition to testing these two antibodies, the company is also exploring the isolation of new antibodies specific for this virus using its antibody technology platform [1] .

VIR 7831 and VIR 7832 has been advanced in development for the treatment of COVID-2019 infections [see Adis Insight drug profile 800058114 and 800058115].

Company Agreements

In April 2020, Vir Biotechnology and GlaxoSmithKline enter into binding agreement to research, develop and commercialise products for the prevention, treatment and prophylaxis of COVID-2019 infections. Under the collaboration, both the parties will develop and commercialise monoclonal antibodies targeting SARS-CoV-2, and other coronaviruses; vaccines targeting SARS-CoV-2, and other coronaviruses and therapeutics based on genome-wide CRISPR screening of host targets expressed in connection with exposure to SARS-CoV-2 under the Functional Genomics Program. For a period of four years following the closing of the Stock Purchase Agreement (as mentioned below), the parties will conduct certain research and development activities for each of the three programs. Vir Biotechnology will be responsible for the development and clinical manufacturing activities for the antibody program, and for conducting the initial development activities directed to a vaccine for the vaccine program. GSK will be responsible for the commercialisation activities for the antibody program (except in People’s Republic of China, Hong Kong, Macau and Taiwan) and the later-stage development, manufacturing and commercialisation activities for the vaccine program and the development, manufacturing and commercialisation activities for the functional genomics program. Subject to an opt-out mechanism, the parties will share all development costs in accordance with the budget for each of the collaboration programs, with Vir Biotechnology bearing 72.5% of the development costs for the antibody program, 27.5% of the development costs for the vaccine program, and the both companies sharing equally the development costs for the functional genomics program. Under the Antibody Program, both the company will initialy advance the development of VIR 7831 and VIR 7832, for the treatment and prevention of COVID-2019 infections. In exchange of technology access of Vir Biotechnology, GlaxoSmithKline will make an equity investment of $US250 million in Vir Biotechnology. [2]

In March 2020, Vir Biotechnology and Generation Bio, entered into a research and development agreement to explore the potential of latter’s non-viral gene therapy platform to extend the impact and reach of Vir’s current or future human monoclonal antibodies (mAb) against SARS-CoV-2. Under the collaboration the companies aim to develop long-lasting therapies for both population-wide prevention and treatment. Generation Bio’s platform is designed to deliver genetic information directly to cells without the use of adeno-associated viruses (AAV), thereby instructing the patient’s body to produce the antibody itself. This approach may enable maintenance of stable levels of antibody expression for years, providing continuous protection against the target virus. The non-viral gene therapy platform coupled with Vir’s potent neutralizing antibodies, has the potential to provide effective, long-lasting protection against SARS-CoV-2. Other financial details of the agreement were not disclosed. [3]

In March 2020, Vir Biotechnology entered into a license agreement with Xencor to obtain non-exclusive access to Xencor's Xtend™ Fc technology to extend the half life of antibodies that are being developed by Vir Biotechnology for the potential treatment of COVID-19 infections. According to the terms of the agreement, the sole responsilibility of research, development, regulatory and commercial activities along with its costs, lies with Vir Biotechnology. Earlier, in August 2019, Vir Biotechnology had entered into a separate patent license agreement with Xencor, Inc. Under the terms of the agreement, Vir Biotechnology obtained a non-exclusive, sublicensable license to incorporate Xencor’s half-life extension Fc region-related technologies into, and to evaluate, antibodies that target influenza A and HBV, and a worldwide, non-exclusive, sublicensable license to develop and commercialize products containing antibodies incorporating such technologies for all uses, including the treatment, palliation, diagnosis and prevention of human or animal diseases, disorders or conditions. The Vir Biotechnology is obligated to use commercially reasonable efforts to develop and commercialize an antibody product that incorporates Xencor’s half-life extension Fc-related technologies, for each of the influenza A and HBV research programs. These technologies are used in the Vir Biotechnology VIR 2482 and VIR 3434 product candidates. In consideration for the grant of the license, the Vir Biotechnology paid Xencor an upfront fee. For each of the influenza A and HBV research programs, the company will be required to pay Xencor development and regulatory milestone payments of up to $US17.8 million in the aggregate, and commercial sales milestone payments of up to $US60.0 million in the aggregate, for a total of up to $US77.8 million in aggregate milestones for each program and $US155.5 million in aggregate milestones for both programs. On a product-by-product basis, the company will also be obligated to pay tiered royalties based on net sales of licensed products in the low single-digits. The royalties are payable, on a product-by-product and country-by-country basis, until the expiration of the last to expire valid claim in the licensed patents covering such product in such country [4] [5]

In March 2020, Vir Biotechnology signed a letter of intent with Biogen for the development and clinical manufacturing of human monoclonal antibodies for the treatment of COVID-19 infections. Subject to the completion of a definitive agreement, Biogen would continue cell line development, process development, and clinical manufacturing activities in order to advance the development of Vir’s proprietary antibodies. [6]

In March 2020, Vir Biotechnology entered into a research collaboration agreement with the National Institutes of Health (NIH) and the National Institute of Allergy and Infectious Diseases (NIAID) and Vaccine Research Center (VRC) to advance characterisation and development of human monoclonal antibodies against coronaviruses including SARS-CoV-2. Under the terms of the agreement Vir and NIAID will work together to identify and optimise combinations of antibodies against coronaviruses including SARS-CoV-2, SARS and MERS as well as antibodies that may be effective across additional types of coronaviruses. [7]

In February 2020, Vir Biotechnology entered into a development and manufacturing collaboration to advancer and produce human monoclonal antibodies for treatment of COVID-2019 infections. Under the terms of the agreement, the companies will work together on the clinical development, manufacturing, and commercialisation of proprietary antibodies of Vir Biotechnology. Cell-line development, process and formulation development as well as initial manufacturing for clinical development will be conducted by WuXi Biologics. Once regulatory approval are recieved, WuXi Biologics has the rights to commercialise therapies in Greater China, and Vir has the rights to commercialise therapies in all other markets worldwide. Financial details were not disclosed. [8]

Key Development Milestones

As of February 2020, Vir Biotechnology identified antibodies from an existing library of 20 fully human antibodies that bind and neutralize related coronaviruses such as SARS-CoV and Coronaviruses that infect animals [1] .

In January 2020, Vir Biotechnology reported that it is evaluating monoclonal antibodies from its library of fully-human mAbs that are able to neutralise zoonotic coronaviruses, to identify mAbs that may have the potential to treat and prevent COVID-2019 infections [9] .

Drug Properties & Chemical Synopsis

  • Route of administration Parenteral
  • Formulation unspecified
  • Class Antivirals, Monoclonal antibodies
  • Target Coronavirus spike glycoprotein
  • Mechanism of Action Immunomodulators
  • WHO ATC code

    J05 (Antivirals for Systemic Use)

  • EPhMRA code

    J5 (Antivirals for Systemic Use)

Development Status

Summary Table

Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
COVID 2019 infections - - Research USA Parenteral / unspecified Vir Biotechnology 22 Jan 2020
COVID 2019 infections - Prevention Research USA Parenteral / unspecified Vir Biotechnology 22 Jan 2020

Commercial Information

Involved Organisations

Organisation Involvement Countries
Vir Biotechnology Originator USA
Vir Biotechnology Owner USA
Generation Bio Technology Provider USA
Xencor Technology Provider USA
GlaxoSmithKline Collaborator United-Kingdom
Biogen Collaborator USA
National Institutes of Health (USA) Collaborator USA
National Institute of Allergy and Infectious Diseases Collaborator USA
WuXi Biologics Collaborator China
Vaccine Research Center Collaborator USA

Future Events

Expected Date Event Type Description Updated
31 Aug 2020 Trial Update Vir Biotechnology plans phase I/II trial for COVID-2019 infections in August 2020 [10] 31 Mar 2020

Development History

Event Date Update Type Comment
06 Apr 2020 Licensing Status Vir Biotechnolgy and GlaxoSmithKline collaborate to discover and develop monoclonal antibodies COVID-2019 infections [2] Updated 22 Apr 2020
30 Mar 2020 Licensing Status Generation Bio and Vir Biotechnology agree co-develop monoclonal antibodies for COVID-2019 infections [3] Updated 03 Apr 2020
25 Mar 2020 Licensing Status Vir Biotechnology in-licenses Xtend™ Fc technology from Xencor [5] Updated 01 Apr 2020
25 Mar 2020 Trial Update Vir Biotechnology plans phase I/II trial for COVID-2019 infections in August 2020 [10] Updated 31 Mar 2020
12 Mar 2020 Licensing Status Vir Biotechnology signs a letter of intent with Biogen for the development and manufacture of monoclonal antibodies for COVID-19 infections [6] Updated 18 Mar 2020
11 Mar 2020 Licensing Status Vir Biotechnology, National Institutes of Health, National Institute of Allergy and Infectious Diseases and Vaccine Research Center enters into a research collaboration for monoclonal antibodies for COVID-2019 infections in US [7] Updated 17 Mar 2020
25 Feb 2020 Licensing Status Vir Biotechnology and WuXi Biologics enters development and manufacturing agreement for monoclonal antibodies for COVID-2019-infections [8] Updated 28 Feb 2020
22 Jan 2020 Phase Change Early research in COVID-2019-infections (Prevention) in USA (Parenteral) [9] Updated 30 Jan 2020
22 Jan 2020 Phase Change Early research in COVID-2019-infections in USA (Parenteral) [9] Updated 30 Jan 2020

References

  1. Vir Biotechnology Identifies Two Antibodies That Bind to the Spike Protein of 2019-nCoV, Newly Named as SARS-CoV-2.

    Media Release
  2. GSK and Vir Biotechnology enter collaboration to find coronavirus solutions .

    Media Release
  3. Generation Bio and Vir Biotechnology to Collaborate on Research to Leverage Scalable Non-Viral Gene Therapy Platform for Durable Production of Monoclonal Antibodies Against Coronavirus That Causes COVID-19.

    Media Release
  4. SEC - VIR Botechnology. Internet-Doc 2019;.

    Available from: URL: https://sec.report/Document/0001193125-19-236592/
  5. Xencor and Vir Biotechnology Enter License Agreement for Use of Xtend(T) XmAb(R) Antibody Technology in Investigational Antibodies to Treat COVID-19.

    Media Release
  6. Vir Biotechnology Announces Intent to Collaborate with Biogen on Manufacturing of Antibodies to Potentially Treat COVID-19.

    Media Release
  7. Vir Biotechnology Announces Research Collaboration with the National Institutes of Health Vaccine Research Center on Antibodies Against Coronaviruses .

    Media Release
  8. Vir Biotechnology and WuXi Biologics Announce Collaboration for Global Development of Antibodies to Treat COVID-19.

    Media Release
  9. Vir Biotechnology applying multiple platforms to address public health risk from Wuhan coronavirus.

    Media Release
  10. Vir Biotechnology Proceeding with Two Clinical Development Candidates for COVID-19.

    Media Release
Back to top