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Research programme: anti-COVID-2019 monoclonal antibodies - Vanderbilt University Medical Center/National Resilience

Drug Profile

Research programme: anti-COVID-2019 monoclonal antibodies - Vanderbilt University Medical Center/National Resilience

Latest Information Update: 28 Aug 2024

At a glance

  • Originator Vanderbilt University Medical Center
  • 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

  • No development reported COVID 2019 infections

Most Recent Events

  • 28 Aug 2024 No recent reports of development identified for preclinical development in COVID-2019-infections in USA (Parenteral)
  • 28 Aug 2024 No recent reports of development identified for preclinical development in COVID-2019-infections(Prevention) in USA (Parenteral)
  • 27 Mar 2020 Twist Bioscience entered into collaboration agreement with Vanderbilt University Medical Center (VUMC) to supply synthetic genes and antibodies for the development of therapies for COVID-19

Development Overview

Introduction

Human monoclonal antibodies for the treatment and prevention of COVID-2019 infections are being developed by National Resilience (previously Ology Bioservices) in collaboration with Vanderbilt University Medical Center (VUMC) under the Pandemic Prevention Platform (P3) network of the U.S. Defense Advanced Research Projects Agency (DARPA). Preclinical development is underway in the US.

In April 2021, Ology Bioservices was acquired and merged into National Resilience [1] .

As at August 2024, no recent reports of development had been identified for preclinical development in COVID-2019-infections in USA (Parenteral), preclinical development in COVID-2019-infections (Prevention) in USA (Parenteral).

Company Agreements

In March 2020, Twist Bioscience Corporation entered into a collaboration agreement with Vanderbilt University Medical Center (VUMC) to supply synthetic genes and antibodies for the development of therapies for COVID-19. Twist Biopharma will provide custom antibody drug discovery libraries and will screen the libraries for potential antibody therapeutics that would treat patients with COVID-19. [2]

Prior to March 2020, Ology Bioservices (now National Resilience) and Vanderbilt University Medical Center (VUMC) entered into an agreement to develop and manufacture a monoclonal antibody for treatment and prevention of infection with the COVID-19 virus. The aim of the program is to rapidly and efficiently deliver the antibody to the Department of Defense. Under the proposed terms of the pending agreement with VUMC, researchers in the Vanderbilt Vaccine Center (VVC) will be tasked in this program with rapid antibody discovery efforts as a performance site for the Pandemic Prevention Platform (P3) network of the U.S. Defense Advanced Research Projects Agency (DARPA). [3]

Key Development Milestones

Prior to July 2020, the neutralizing monoclonal antibodies were tested in small animals and non-human primates. The monoclonal antibodies demonstrated positive results in preclinical studies [4] .

Financing information

In March 2020, the Department of Defense (DOD) awarded a contract valued at $US14 million with Ology Bioservices to develop and manufacture a monoclonal antibody for treatment and prevention of infection with the COVID-19 virus. The work is supported by the Office of the Assistant Secretary of Defense for Health Affairs with funding from the Defense Health Agency. Under this program, Ology Bioservices will work with Vanderbilt University Medical Center (VUMC) to develop and manufacture the monoclonal antibody. The aim of the program is to rapidly and efficiently deliver the antibody to the Department of Defense [3] .

Drug Properties & Chemical Synopsis

  • Route of administration Parenteral
  • Formulation unspecified
  • Class Antivirals, Monoclonal antibodies
  • 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 - - No development reported (Preclinical) USA Parenteral / unspecified Vanderbilt University Medical Center 28 Aug 2024
COVID 2019 infections - Prevention No development reported (Preclinical) USA Parenteral / unspecified Vanderbilt University Medical Center 28 Aug 2024

Commercial Information

Involved Organisations

Organisation Involvement Countries
Vanderbilt University Medical Center Originator USA
Vanderbilt University Medical Center Owner USA
Department of defence Funder USA
National Resilience Collaborator USA
Twist Bioscience Collaborator USA

Development History

Event Date Update Type Comment
28 Aug 2024 Phase Change - No development reported No recent reports of development identified for preclinical development in COVID-2019-infections in USA (Parenteral) Updated 28 Aug 2024
28 Aug 2024 Phase Change - No development reported No recent reports of development identified for preclinical development in COVID-2019-infections(Prevention) in USA (Parenteral) Updated 28 Aug 2024
12 Apr 2021 Company Involvement Ology Bioservices has been acquired and merged into National Resilience Updated 18 Jun 2021
17 Jul 2020 Phase Change - Preclinical Preclinical trials in COVID-2019 infections in USA (Parenteral) before July 2020 [4] Updated 17 Jul 2020
15 Jul 2020 Phase Change - Preclinical Preclinical trials in COVID-2019 infections (Prevention) in USA (Parenteral) before July 2020 [4] Updated 17 Jul 2020
27 Mar 2020 Licensing Status Twist Bioscience entered into collaboration agreement with Vanderbilt University Medical Center (VUMC) to supply synthetic genes and antibodies for the development of therapies for COVID-19 [2] Updated 01 Apr 2020
23 Mar 2020 Licensing Status Vanderbilt University Medical Center and Ology Bioservices agree to develop and manufacture monoclonal antibody for COVID-2019 infections [3] Updated 01 Apr 2020
23 Mar 2020 Phase Change Early research in COVID-2019 infections (Prevention) in USA (Parenteral) [3] Updated 01 Apr 2020
23 Mar 2020 Phase Change Early research in COVID-2019 infections in USA (Parenteral) [3] Updated 01 Apr 2020

References

  1. Resilience Continues Expansion with Acquisition of Biologics Manufacturing Company Ology Bioservices.

    Media Release
  2. Twist Bioscience Partners with Vanderbilt University Medical Center to Supply Critical Products and Identify Antibody Therapeutics for COVID-19.

    Media Release
  3. Ology Bioservices, Vanderbilt University Medical Center to Develop, Manufacture Monoconal Antibody for Treatment, Prevention of Infection With COVID-19 Virus for Department of Defense.

    Media Release
  4. Twist Bioscience Customer Vanderbilt University Medical Center (VUMC) Announces Publication of Positive Preclinical Results on Neutralizing Antibodies as a Potential Therapy for Preventing and Treating COVID-19.

    Media Release
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