NI 007
Alternative Names: Anti-SARS-CoV-2 neutralising antibody; NI007Latest Information Update: 08 Sep 2020
At a glance
- Originator ethris; Neurimmune Therapeutics
- Developer Ethris; Neurimmune Therapeutics
- Class Antivirals; Monoclonal antibodies; RNA
- Mechanism of Action Immunomodulators
-
Orphan Drug Status
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
- 08 Sep 2020 Preclinical trials in COVID-2019 infections in Switzerland (Inhalation) before September 2020 (Neurimmune Therapeutics pipeline, September 2020)
- 01 Apr 2020 Neurimmune and Ethris agree to co-develop NI 007 for COVID-2019 infections
- 01 Apr 2020 Early research in COVID-2019 infections in Switzerland (Inhalation)
Development Overview
Introduction
NI 007 is an mRNA-encoded, neutralising anti-SARS-CoV-2 monoclonal antibody, being jointly developed by Neurimmune and Ethris, by using Neurimmune's Reverse Translational Medicine (RTMTM) technology platform, for the treatment of COVID-19 infections. Neutralising antibodies will be translated into therapeutic SNIM®RNA products for inhalation. Preclinical development of an inhalation formulation, is underway in Switzerland.
Neurimmune's RTMTM technology focusses on the cloning of authentic human antibodies from healthy participants, or from patients who recovered from disease, by translating the immune memory of functionally active antibodies into transformative immunotherapeutics. With Ethris' proprietary pulmonary SNIM®RNA technology, the technology can express human SARS-CoV-2 neutralising antibodies directly in the lung to rapidly achieve effective pulmonary antibody concentrations.
Company Agreements
In April 2020, Neurimmune entered into a research and development agreement with Ethris, to develop mRNA-encoded, neutralising anti-SARS-CoV-2 antibodies, administered by inhalation, for the treatment of COVID-19 infections. Under the terms of the agreement, Neurimmune and Ethris will jointly conduct research and development activities while sharing costs and revenues resulting from the collaboration. The companies intend to initiate manufacturing of the drug for planned clinical trials. [1]
Key Development Milestones
As of September 2020, preclinical development of NI 007 for the treatment of COVID-19 infections was underway in Switzerland (Neurimmune Therapeutics pipeline, September 2020)
Patent Information
Drug Properties & Chemical Synopsis
- Route of administration Inhalation
- Formulation unspecified
- Class Antivirals, Monoclonal antibodies, RNA
- Mechanism of Action Immunomodulators
-
WHO ATC code
J05A-X (Other antivirals)
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EPhMRA code
J5B9 (Antivirals, others)
Table of Contents
Development Status
Summary Table
Indication | Qualifier | Patient Segment | Phase | Countries | Route / Formulation | Developers | Event Date |
---|---|---|---|---|---|---|---|
COVID 2019 infections | - | - | Preclinical | Switzerland | Inhalation / unspecified | Ethris, Neurimmune Therapeutics | 08 Sep 2020 |
Commercial Information
Involved Organisations
Organisation | Involvement | Countries |
---|---|---|
Neurimmune Therapeutics | Originator | Switzerland |
ethris | Originator | Germany |
Neurimmune Therapeutics | Owner | Switzerland |
ethris | Owner | Germany |
Future Events
Expected Date | Event Type | Description | Updated |
---|---|---|---|
31 Dec 2020 | Trial Update | Neurimmune and Ethris plans a clinical trial for COVID-2019 infections (Inhalation), in the fourth quarter of 2020 (700320499) [1] | 13 Apr 2020 |
Development History
Event Date | Update Type | Comment |
---|---|---|
08 Sep 2020 | Phase Change - Preclinical | Preclinical trials in COVID-2019 infections in Switzerland (Inhalation) before September 2020 (Neurimmune Therapeutics pipeline, September 2020) Updated 08 Sep 2020 |
01 Apr 2020 | Licensing Status | Neurimmune and Ethris agree to co-develop NI 007 for COVID-2019 infections [1] Updated 06 Apr 2020 |
01 Apr 2020 | Phase Change | Early research in COVID-2019 infections in Switzerland (Inhalation) [1] Updated 06 Apr 2020 |
01 Apr 2020 | Regulatory Status | Neurimmune announces intention to submit regulatory applications for clinical trials of NI 007 for COVID-2019 infections [1] Updated 06 Apr 2020 |
31 Mar 2020 | Trial Update | Neurimmune and Ethris plans a clinical trial for COVID-2019 infections (Inhalation), in the fourth quarter of 2020 [1] Updated 13 Apr 2020 |
References
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Neurimmune and Ethris Sign Collaboration Agreement to Rapidly Develop Inhaled mRNA-based Antibody Therapy for the Treatment of COVID-19.
Media Release
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