Covid-19 vaccine - GeoVax Labs
Alternative Names: GEO-CM01; GEO-CM02; SARS-COV-2 vaccine - GeoVax Labs; Wuhan coronavirus (2019-nCoV) vaccine - GeoVax LabsLatest Information Update: 25 Sep 2023
At a glance
- Originator GeoVax Labs
- Class COVID-19 vaccines; DNA vaccines; Viral vaccines; Virus-like particle 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
- Preclinical COVID 2019 infections
Most Recent Events
- 20 Sep 2023 Pharmacodynamics data from a preclinical study in COVID-2019 infections (Prevention) released by GeoVax Labs
- 11 Jan 2021 Geovax receives SBIR grant from NIH for COVID-2019 vaccine for the prevention of COVID-2019-infections
- 26 Oct 2020 GeoVax and the National Institute of Allergy and Infectious Diseases enter into a Patent and Biological Materials License Agreement for the development of the COVID-2019 vaccine
Development Overview
Introduction
A DNA-based COVID-19 vaccine is being developed by GeoVax, in collaboration with Bravovax, for the prevention of COVID- 2019 infections either as a primary vaccine or to boost other COVID-19 vaccines. Geovax is using its modified virus ankara-virus-like particles (MVA-VLP/GV-MVA-VLPTM) platform, which generates non-infectious VLPs, mimicking a natural infection through inclusion of multiple structural and nonstructural proteins from the target pathogen, to trigger the body of an individual being vaccinated to produce a robust and durable immune response with both antibodies and T cells. The platform elicits a balanced humoral and cellular response against a range of immunogens, which makes the immune escape against emerging variants less likely. Also, incorporation of sequence-conserved nonstructural proteins provide targets for T-cell responses to increase the breadth and function of vaccine-induced immune responses. The company has designed, constructed, and characterised three vaccine candidates, of which one will be selected in accordance with results from preclinical studies. Preclinical development is underway in the US.
Company Agreements
In December 2020, GeoVax and the National Institute of Allergy and Infectious Diseases entered into a Patent and Biological Materials License Agreement in support of GeoVax’s non-clinical development of vaccines against numerous pathogens. The License Agreement provides GeoVax with access to certain materials and patent rights owned by agencies of the Department of Health and Human Services (HHS) for use in combination with their proprietary technology for the creation of preventive and/or therapeutic vaccines against ebola-zaire, ebola-sudan, lassa virus, marburg virus, zika virus and malaria. The agreement also extends to company's research and development in certain oncology areas. The agreement provides GeoVax with nonexclusive rights for the nonclinical development and manufacturing of its vaccine and immunotherapy candidates using HHS patents and materials. Financial terms were not disclosed. Earlier in October 2020, GeoVax and the National Institute of Allergy and Infectious Diseases, entered into a Patent and Biological Materials License Agreement, for the development of the company's vaccine against the SARS-CoV-2 virus. Under the terms of the agreement, GeoVax gained access to NIAID's patent rights in the stabilized SPIKE protein, and acquired the license to use the materials and patent rights owned by agencies of the United States Department of Health and Human Services (HHS), in combination with the company's proprietary technology, for the development of the vaccine. GeoVax acquired the non-exclusive rights to develop, manufacture and commercialise the vaccine. Financial terms were not disclosed. [1] [2]
In January 2020, GeoVax entered into a research and development agreement with BravoVax for the development vaccine against COVID-2019 infections. Unders the terms of agreement, GeoVax will utilise its MVA-VLP vaccine platform and expertise to design and construct the vaccine using genetic sequences from the ongoing coronavirus. BravoVax will provide further development, including testing and manufacturing support, as well as direct interactions with Chinese public health and regulatory authorities. [3]
Key Development Milestones
In September 2023, preclinical GEO CM02 vaccine efficacy data were released by GeoVax Labs [4] .
As of April 2022, IND enabling studies are underway in USA (GeoVax Labs pipeline, April 2022).
GeoVax Labs plans to initiate human clinical trial before the end of 2020 [5] .
As of August 2021, GeoVax Labs announced that studies till date supported the use of MVA as a vector for the design and production of vaccines encoding multiple coronavirus proteins, using the S protein as the antibody target and the M and E proteins as T-cell targets. The induction of functional antibodies and T-cell responses that mediate protection from infection and pathogenesis were also observed [6] .
As at October 2020, GeoVax had designed four vaccine candidates, with preclinical evaluations for the first candidate underway in collaboration with the University of Texas Medical Branch at Galveston [2] .
In June 2020 GeoVax Labs announced that the preclinical studies are underway for the prevention of COVID-2019 infections [7] .
In March 2020, GeoVax reported that it plans to conduct preclinical studies of three vaccine candidates for prevention of COVID-2019 infections [8] .
Financing information
In January 2021, National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) has awarded Small Business Innovative Research (SBIR) grant entitled, “Preclinical Development of GV-MVA-VLP Vaccines Against COVID-19” to Geovax company for the ongoing development, construction, preclinical testing and in preparation for human clinical trials of COVID-2019 vaccine [9] .
In June 2020, GeoVax announced closing of $USD1 million private placement offering. The funds will be utilised to continue the work for COVID-19 vaccine [10]
Drug Properties & Chemical Synopsis
- Formulation unspecified
- Class COVID-19 vaccines, DNA vaccines, Viral vaccines, Virus-like particle vaccines
- Mechanism of Action Immunostimulants
-
WHO ATC code
J07B-X (Other viral vaccines)
-
EPhMRA code
J7A9 (Other specified single component)
Biomarker
| Drug Name | Biomarker Name | Biomarker Function |
|---|---|---|
| Covid-19 vaccine - GeoVax Labs | ACE2 | Outcome Measure |
| AMH | Detailed Description, Outcome Measure | |
| Apolipoprotein H antibodies | Eligibility Criteria | |
| B-cell lymphoma 2 (Bcl-2) | Arm Group Description | |
| B-lymphocyte antigen CD19 | Arm Group Label | |
| B-lymphocyte antigen CD20 | Arm Group Description, Brief Title, Official Title | |
| Bilirubin | Eligibility Criteria, Outcome Measure | |
| C-reactive protein (CRP) | Brief Summary, Detailed Description, Eligibility Criteria, Outcome Measure | |
| C1QL1 | Outcome Measure | |
| Calprotectin | Detailed Description | |
| Cardiac Troponin I | Eligibility Criteria, Outcome Measure | |
| CGA | Eligibility Criteria | |
| chorionic gonadotropin beta subunit 5 | Eligibility Criteria | |
| colony stimulating factor 2 receptor, alpha, low-affinity (granulocyte-macrophage) | Outcome Measure | |
| corticotropin releasing hormone | Outcome Measure | |
| Creatine | Outcome Measure | |
| Creatinine | Outcome Measure | |
| Cytokeratin 20 | Arm Group Description | |
| D-dimer | Eligibility Criteria | |
| D-Urobilinogen | Eligibility Criteria | |
| Estradiol-17beta 3-sulfate | Outcome Measure | |
| Ferritin | Eligibility Criteria, Outcome Measure | |
| Ferrocytochrome | Eligibility Criteria | |
| Fibrinogen | Eligibility Criteria | |
| FSH | Eligibility Criteria | |
| fuzzy planar cell polarity protein | Outcome Measure | |
| GNPTAB | Eligibility Criteria | |
| Gut Microbiome | Brief Title, Official Title | |
| heat shock 27kDa protein 3 | Outcome Measure | |
| hypertrichosis 2 (generalized, congenital) | Eligibility Criteria | |
| immunoglobulin heavy constant epsilon | Outcome Measure | |
| Insulin | Brief Summary, Outcome Measure | |
| Interferon alpha (IFN-alpha) | Outcome Measure | |
| Interferon Gamma (IFNg) | Brief Summary, Detailed Description, Outcome Measure | |
| Interleukin-2 (IL-2) | Outcome Measure | |
| Interleukin-4 (IL-4) | Outcome Measure | |
| Interleukin-5 (IL-5) | Outcome Measure | |
| Interleukin-6 (IL-6) | Eligibility Criteria, Outcome Measure | |
| KRT88P | Eligibility Criteria | |
| L-Lactic acid | Eligibility Criteria | |
| mutated in colorectal cancers | Brief Summary | |
| PCNA | Arm Group Label | |
| PD-1/CD279 | Eligibility Criteria, Outcome Measure | |
| PD-L1/CD274 | Brief Title, Eligibility Criteria, Official Title, Outcome Measure | |
| Phosphonoacetate | Outcome Measure | |
| prion protein (testis specific) | Outcome Measure | |
| Progesterone | Brief Summary, Detailed Description, Outcome Measure | |
| Protein S | Outcome Measure | |
| protein tyrosine phosphatase, non-receptor type 6 | Eligibility Criteria | |
| Protoporphyrin IX | Eligibility Criteria | |
| pyrroline-5-carboxylate reductase 1 | Outcome Measure | |
| RBP4 | Outcome Measure | |
| serine peptidase inhibitor, Kunitz type 1 | Outcome Measure | |
| serine racemase | Outcome Measure | |
| seryl-tRNA synthetase | Brief Summary, Detailed Description, Eligibility Criteria, Outcome Measure | |
| Soluble transferrin receptor | Outcome Measure | |
| suppression of tumorigenicity 14 (colon carcinoma) | Outcome Measure | |
| T-box 1 | Eligibility Criteria | |
| T-Cell differentiation antigen CD8 | Detailed Description, Outcome Measure | |
| T-cell surface antigen CD4 | Detailed Description, Eligibility Criteria, Outcome Measure | |
| TF | Outcome Measure | |
| Thromboxane | Outcome Measure | |
| Toll-Like Receptor 4 (TLR4) | Outcome Measure | |
| Tumor necrosis factor alpha (TNF-alpha) | Outcome Measure | |
| Vitamin A | Outcome Measure | |
| vitronectin | Arm Group Description, Arm Group Label, Detailed Description, Official Title, Outcome Measure | |
| Y Chromosome | Eligibility Criteria | |
| zinc finger protein 415 | Arm Group Description |
Development Status
Summary Table
| Indication | Qualifier | Patient Segment | Phase | Countries | Route / Formulation | Developers | Event Date |
|---|---|---|---|---|---|---|---|
| COVID 2019 infections | - | Prevention | Preclinical | USA | unspecified / unspecified | GeoVax Labs | 10 Jun 2020 |
Commercial Information
Involved Organisations
| Organisation | Involvement | Countries |
|---|---|---|
| GeoVax Labs | Originator | USA |
| GeoVax Labs | Owner | USA |
| National Institute of Allergy and Infectious Diseases | Technology Provider | USA |
| University of Texas Medical Branch | Collaborator | USA |
| BravoVax | Collaborator | China |
Scientific Summary
Pharmacodynamics
In preclinical studies, the GEO CM02 vaccine induced immune responses that were efficacious against the original Wuhan strain and BA.1 Omicron variant with a single dose. The animals were protected prior to the detection of neutralising antibodies, likely indicating a critical T-cell contribution. GEO CM02 significantly reduced or eliminated inflammation and immunopathology in the lungs of vaccinated animals [4] .
Future Events
| Expected Date | Event Type | Description | Updated |
|---|---|---|---|
| 31 Dec 2020 | Trial Update | GeoVax plans a clinical trial for COVID-19 infections before the end of 2020 [5] | 30 Mar 2020 |
Development History
| Event Date | Update Type | Comment |
|---|---|---|
| 20 Sep 2023 | Scientific Update | Pharmacodynamics data from a preclinical study in COVID-2019 infections (Prevention) released by GeoVax Labs [4] Updated 25 Sep 2023 |
| 17 Jan 2022 | Biomarker Update | Biomarkers information updated Updated 20 Jan 2022 |
| 11 Jan 2021 | Company Involvement | Geovax receives SBIR grant from NIH for COVID-2019 vaccine for the prevention of COVID-2019-infections [9] Updated 14 Jan 2021 |
| 26 Oct 2020 | Licensing Status | GeoVax and the National Institute of Allergy and Infectious Diseases enter into a Patent and Biological Materials License Agreement for the development of the COVID-2019 vaccine [2] Updated 29 Oct 2020 |
| 10 Jun 2020 | Phase Change - Preclinical | Preclinical trials in COVID-2019 infections (Prevention) in USA (unspecified route) before June 2020 [7] Updated 15 Jun 2020 |
| 30 Mar 2020 | Trial Update | GeoVax Labs plans preclinical development in COVID-2019 infections (Prevention) [8] Updated 02 Apr 2020 |
| 18 Mar 2020 | Trial Update | GeoVax plans a clinical trial for COVID-19 infections before the end of 2020 [5] Updated 30 Mar 2020 |
| 27 Jan 2020 | Licensing Status | GeoVax entered into a research and development agreement with BravoVax for the development of Coronavirus vaccine [3] Updated 04 Feb 2020 |
| 27 Jan 2020 | Phase Change | Early research in COVID-2019-infections (Prevention) in USA (unspecified route) [3] Updated 04 Feb 2020 |
References
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GeoVax Announces License Agreement with NIH to Support Continued Advancements in Vaccine Development.
Media Release -
GeoVax Announces License Agreement with NIH to Support COVID-19 Vaccine Development.
Media Release -
GeoVax and BravoVax (Wuhan, China) to Collaborate on Development of Coronavirus Vaccine.
Media Release -
GeoVax Next-Generation COVID-19 Vaccine Data Presented at Keystone Symposia Conference.
Media Release -
GeoVax Progresses in Coronavirus (COVID-19) Vaccine Development Program.
Media Release -
GeoVax Presents COVID-19 Vaccine Data at the European Society of Medicine (ESMED) General Assembly.
Media Release -
GeoVax to Present COVID-19 Vaccine Program at National Foundation for Infectious Diseases Annual Conference on Vaccinology Research.
Media Release -
GeoVax Applauds and Comments on Passage of $2 Trillion CARES Act.
Media Release -
GeoVax Awarded NIH Grant to Advance COVID-19 Vaccine Development.
Media Release -
GeoVax Announces Closing of $1 Million Private Placement.
Media Release
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