Research programme: anti-COVID-2019 monoclonal antibodies - Vanderbilt University Medical Center/National Resilience
Latest Information Update: 18 Jun 2021
At a glance
- Originator Vanderbilt University Medical Center
- Class 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
- Preclinical COVID 2019 infections
Most Recent Events
- 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
- 23 Mar 2020 Vanderbilt University Medical Center and Ology Bioservices agree to develop and manufacture monoclonal antibody for COVID-2019 infections
- 23 Mar 2020 Early research in COVID-2019 infections (Prevention) in USA (Parenteral)
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] .
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 | - | Prevention | Preclinical | USA | Parenteral / unspecified | Vanderbilt University Medical Center | 17 Jul 2020 |
| COVID 2019 infections | - | - | Preclinical | USA | Parenteral / unspecified | Vanderbilt University Medical Center | 17 Jul 2020 |
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 |
|---|---|---|
| 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
-
Resilience Continues Expansion with Acquisition of Biologics Manufacturing Company Ology Bioservices.
Media Release -
Twist Bioscience Partners with Vanderbilt University Medical Center to Supply Critical Products and Identify Antibody Therapeutics for COVID-19.
Media Release -
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 -
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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