Covigenix VAX 001
Alternative Names: COVID-19 DNA vaccine - Entos Pharmaceuticals; COVID-2019 DNA vaccine - Entos Pharmaceuticals; Covigenix VAX-001; SARS-COV-2 vaccine - Entos PharmaceuticalsLatest Information Update: 01 Mar 2024
At a glance
- Originator Entos Pharmaceuticals
- Class COVID-19 vaccines; DNA vaccines; Viral 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
- Available For Licensing Yes - COVID 2019 infections
Highest Development Phases
- Phase I/II COVID 2019 infections
Most Recent Events
- 06 Dec 2023 Entos Pharmaceuticals completes a phase-I/II trial in COVID-2019 infections (Prevention) in Burkina Faso, Canada, Senegal and South Africa (IM) (NCT04591184)
- 30 Sep 2022 Entos Pharmaceuticals completes enrollment in its phase-II clinical trial in COVID-2019 infections (Prevention, In adults, In the elderly) in Burkina Faso (IM) (NCT04591184)
- 02 Sep 2021 Entos Pharmaceuticals receives approval from the South African Health Products Regulatory Authority (SAHPRA) to initiate a phase II clinical trial of covigenix VAX 001 in COVID-2019 infections
Development Overview
Introduction
Covigenix VAX 001 is one of the pan-coronavirus fusogenix DNA plasmid vaccine (designated as Covigenix candidate) being developed by Entos Pharmaceuticals, in collaboration with Aegis Life (an Entos Pharmaceuticals spinout), for prevention from the COVID-2019 infections. It encodes multiple antigens from the SARS-CoV-2 proteins delivered by the fusogenix proteo-lipid vehicle. The proprietary fusogenix consists of neutral lipids and Fusion-Associated Small Transmembrane proteins (FAST) that enables efficient delivery of the plasmid DNA payload directly inside the cell. The plasmid DNA will encode selective antigens against which immune response will be induced. Fusogenix provides several advantages over traditional vaccines such as broad distribution due to its favorable tolerability, dose repetition, vaccine stability, production and ability to stimulate both B- and T-cell responses. Clinical development is ongoing in Burkina Faso, Canada, Senegal and South Africa.
The vaccine candidate emerges from a research programme for COVID-19 vaccines [see Adis Insight Drug profile800059290].
Entos Pharmaceuticals is seeking collaborative opportunities for further development of their COVID-19 DNA vaccine [1] .
Key Development Milestones
In September 2021, Entos Pharmaceuticals announced the approval by South African Health Products Regulatory Authority (SAHPRA) to start a phase II clinical trial of covigenix VAX 001 in South Africa. The phase II clinical trial will be conducted at multiple sites in South Africa. The approval is based on positive phase I trial results showing that covigenix VAX 001 met all safety endpoints with no serious adverse events reported [2] .
In December 2023, Entos Pharmaceuticals completed a phase I/II trial designed to evaluate the safety, tolerability, and immunogenicity of a Covigenix VAX 001 in healthy adults 18 years and older (NCT04591184; ENTVAX01-101). The placebo-controlled, randomised, observer-blind trial was initiated in April 2021 and enrolled 268 volunteers in Burkina Faso, Canada, Senegal and South Africa. In April 2021, first volunteer was enrolled in the trial [3] [4] . In September 2021, phase I part of this study was completed in Canada. Results from trial demonstrated that the fusogenix platform is safe and well-tolerated for the intracellular delivery of DNA with the potential to promote positive immunological outcomes at low vaccine doses [2] . In September 2022, the company completed enrollment into the single and two-dose cohorts of the phase II clinical trial in Burkina Faso [5] .
Preclinical studies with covigenix VAX 001 demonstrated potent immunogenicity, conferring protection from infection with SARS-CoV-2 in animal models as reported by Entos Pharmaceuticals in September 2021 [2] .
Drug Properties & Chemical Synopsis
- Route of administration IM
- Formulation Injection
- Class COVID-19 vaccines, DNA vaccines, Viral vaccines
- Mechanism of Action Immunostimulants
-
WHO ATC code
J07B-X03 (Covid-19 vaccines)
-
EPhMRA code
J7B (Combinations of Vaccines)
Biomarkers Sourced From Trials
| Indication | Biomarker Function | Biomarker Name | Number of Trials |
|---|---|---|---|
|
cOVID 2019 infections |
Detailed Description |
Twist-related protein 1 (TWIST) T-Cell differentiation antigen CD8 major histocompatibility complex, class II, DO alpha Interferon Gamma (IFNg) HLA-DQB1 HLA-B |
Biomarker
| Drug Name | Biomarker Name | Biomarker Function |
|---|---|---|
| Covigenix VAX 001 | HLA-B | Detailed Description |
| HLA-DQB1 | Detailed Description | |
| Interferon Gamma (IFNg) | Detailed Description, Outcome Measure | |
| major histocompatibility complex, class II, DO alpha | Detailed Description | |
| T-Cell differentiation antigen CD8 | Detailed Description | |
| Twist-related protein 1 (TWIST) | Detailed Description |
Development Status
Summary Table
| Indication | Qualifier | Patient Segment | Phase | Countries | Route / Formulation | Developers | Event Date |
|---|---|---|---|---|---|---|---|
| COVID 2019 infections | - | Prevention | Phase I/II | Burkina Faso, Canada, Senegal, South Africa | IM / Injection | Entos Pharmaceuticals | 16 Apr 2021 |
Commercial Information
Involved Organisations
| Organisation | Involvement | Countries |
|---|---|---|
| Entos Pharmaceuticals | Originator | Canada |
| Entos Pharmaceuticals | Owner | Canada |
| Aegis Life | Collaborator | USA |
Licensing Availability
| Licensing Organisation | Available Indication | Available Phase | Region | Date |
|---|---|---|---|---|
| Entos Pharmaceuticals | COVID 2019 infections | Unspecified | - | 19 Mar 2020 |
Future Events
| Expected Date | Event Type | Description | Updated |
|---|---|---|---|
| 30 Nov 2020 | Trial Update | Entos Pharmaceuticals and Canadian Institutes of Health Research plans a phase I trial for COVID-2019 infections (In adults, In the elderly, Prevention) in November 2020 (NCT04591184) | 21 Apr 2021 |
Development History
| Event Date | Update Type | Comment |
|---|---|---|
| 06 Dec 2023 | Trial Update | Entos Pharmaceuticals completes a phase-I/II trial in COVID-2019 infections (Prevention) in Burkina Faso, Canada, Senegal and South Africa (IM) (NCT04591184) Updated 01 Mar 2024 |
| 30 Sep 2022 | Trial Update | Entos Pharmaceuticals completes enrollment in its phase-II clinical trial in COVID-2019 infections (Prevention, In adults, In the elderly) in Burkina Faso (IM) (NCT04591184) [5] Updated 10 Oct 2022 |
| 14 Sep 2021 | Biomarker Update | Biomarkers information updated Updated 02 Oct 2021 |
| 02 Sep 2021 | Regulatory Status | Entos Pharmaceuticals receives approval from the South African Health Products Regulatory Authority (SAHPRA) to initiate a phase II clinical trial of covigenix VAX 001 in COVID-2019 infections [2] Updated 03 Sep 2021 |
| 02 Sep 2021 | Trial Update | Entos Pharmaceuticals plans a phase II trial for COVID-2019 infections in South Africa (IM) [2] Updated 03 Sep 2021 |
| 02 Sep 2021 | Trial Update | Entos Pharmaceuticals completes a phase-I clinical trial in COVID-2019 infections (Prevention, In adults, In the elderly) in Canada (IM) [3] (NCT04591184) Updated 03 Sep 2021 |
| 16 Apr 2021 | Phase Change - I/II | Phase-I/II clinical trials in COVID-2019 infections (Prevention, In adults, In the elderly) in Canada (IM) [3] (NCT04591184) Updated 21 Apr 2021 |
| 07 Apr 2021 | Phase Change - I/II | Phase-I/II clinical trials in COVID-2019 infections (Prevention) in Senegal, South Africa (IM) (NCT04591184) Updated 01 Mar 2024 |
| 07 Apr 2021 | Phase Change - I/II | Phase-I/II clinical trials in COVID-2019 infections (Prevention, In adults, In the elderly) in Burkina Faso (IM) (NCT04591184) Updated 03 Aug 2022 |
| 19 Oct 2020 | Trial Update | Entos Pharmaceuticals and Canadian Institutes of Health Research plans a phase I trial for COVID-2019 infections (In adults, In the elderly, Prevention) in November 2020 (NCT04591184) Updated 21 Apr 2021 |
| 20 Mar 2020 | Trial Update | Entos Pharmaceuticals plans preclinical trials in COVID-2019 infections (Prevention) [1] Updated 20 Mar 2020 |
| 19 Mar 2020 | Licensing Status | COVID-19 DNA vaccine is available for licensing as of 19 Mar 2020. www.entospharma.com [1] Updated 20 Mar 2020 |
| 19 Mar 2020 | Phase Change | Early research in COVID-2019 infections (Prevention) in Canada (Parenteral) [1] Updated 20 Mar 2020 |
References
-
Entos Pharmaceuticals Is Developing a DNA Vaccine Against COVID-19 Using Its Fusogenix Nanomedicine Platform.
Media Release -
Entos Pharmaceuticals' COVID-19 DNA Vaccine Candidate Approved for Phase 2 Clinical Trial in South Africa.
Media Release -
Aegis Life Announces Start of Phase 1/2 Trial of the Entos COVID-19 DNA Vaccine, Covigenix VAX-001, with First Participants Dosed.
Media Release -
Phase I/II Study to Evaluate Safety, Tolerability, and Immunogenicity of a Prophylactic Plasmid DNA Vaccine Against SARS-CoV-2 [Covigenix VAX-001/VAX-001-1b] in Healthy Adults 18 Years and Older
ctiprofile -
Entos Pharmaceuticals Passes Significant Enrollment Milestone in Phase 2 Clinical Trial of its COVID-19 DNA Vaccine.
Media Release
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