Coronavirus vaccine - Stemirna Therapeutics/Tongji University
Latest Information Update: 05 Jan 2023
At a glance
- Originator Stemirna Therapeutics; Tongji University
- Developer Stemirna Therapeutics
- Class COVID-19 vaccines; RNA vaccines
- Mechanism of Action Immunostimulants
-
Orphan Drug Status
No
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity No
Highest Development Phases
- Phase I/II COVID 2019 infections
Most Recent Events
- 11 Nov 2022 Stemirna Therapeutics completes a phase-I/II clinical trials in COVID-2019 infections (Prevention) in Laos (IM) (NCT05144139)
- 03 Dec 2021 Phase-I/II clinical trials in COVID-2019 infections (Prevention) in Laos (IM) (NCT05144139)
- 03 Dec 2021 Stemirna Therapeutics plans a phase I/II trial for COVID-19 infection (In adult, In the elderly, Prevention) in Laos (NCT05144139)
Development Overview
Introduction
A ribonucleic acid (mRNA) based vaccine to prevent COVID-19 infections is being co-developed by Stemirna Therapeutics, Chinese Center for Disease Control and Prevention (CDC) and Tongji University. The vaccine uses mRNA technology and encodes surface proteins of the corona virus, which can activate an immune response. Clinical development is underway in Laos.
Stemirna Therapeutics has mRNA synthesis platform, which is used for development of mRNA-based medicines for various indications. mRNA synthesis platform uses DNA templates to synthesize mRNA in vitro. Further template optimisation, codon optimisation in coding sequence and modified nucleotide used to improve translational efficiency of mRNA.
Key Development Milestones
In November 2022, Stemirna Therapeutics completed a phase I/II trial that evaluated the safety, immunogenicity and immune persistence of COVID-19 mRNA vaccine for the prevetion of healthy volunteers from COVID-19 infection (NCT05144139; SWC002). The randomised and open-labeled trial was initiated in December 2021 enrolled 480 healthy volunteers in Laos [1]
Drug Properties & Chemical Synopsis
- Route of administration IM
- Formulation unspecified
- Class COVID-19 vaccines, RNA vaccines
- Mechanism of Action Immunostimulants
-
WHO ATC code
J07B (Viral Vaccines)
-
EPhMRA code
J7E (Viral Vaccines)
Development Status
Summary Table
| Indication | Qualifier | Patient Segment | Phase | Countries | Route / Formulation | Developers | Event Date |
|---|---|---|---|---|---|---|---|
| COVID 2019 infections | - | Prevention | Phase I/II | Laos | IM / unspecified | Stemirna Therapeutics | 03 Dec 2021 |
Commercial Information
Involved Organisations
| Organisation | Involvement | Countries |
|---|---|---|
| Tongji University | Originator | China |
| Stemirna Therapeutics | Originator | China |
| Stemirna Therapeutics | Owner | China |
| Tongji University | Owner | China |
| National Institutes for food and drug Control | Collaborator | China |
| China Center for Disease Control and Prevention | Collaborator | China |
Development History
| Event Date | Update Type | Comment |
|---|---|---|
| 11 Nov 2022 | Trial Update | Stemirna Therapeutics completes a phase-I/II clinical trials in COVID-2019 infections (Prevention) in Laos (IM) (NCT05144139) Updated 05 Jan 2023 |
| 03 Dec 2021 | Phase Change - I/II | Phase-I/II clinical trials in COVID-2019 infections (Prevention) in Laos (IM) (NCT05144139) Updated 01 Apr 2022 |
| 03 Dec 2021 | Trial Update | Stemirna Therapeutics plans a phase I/II trial for COVID-19 infection (In adult, In the elderly, Prevention) in Laos (NCT05144139) Updated 07 Dec 2021 |
| 29 Jun 2021 | Trial Update | Stemirna Therapeutics and Chinese Academy of Medical Sciences plans a investigator-sponsored clinical trial in COVID-2019 infections (Prevention) (NCT04944381) Updated 07 Jul 2021 |
| 23 Mar 2020 | Phase Change - Preclinical | Preclinical trials in COVID-2019 infections (Prevention) in China (parenteral) before March 2020 Updated 26 Mar 2020 |
References
-
A Phase I/II Clinical Trial to Evaluate the Safety, Immunogenicity and Immune Persistence of COVID-19 mRNA Vaccine in Healthy People Aged 18 Years and Above.
ctiprofile
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