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Research programme: Zika virus-like particle vaccine - GeoVax Labs

Drug Profile

Research programme: Zika virus-like particle vaccine - GeoVax Labs

Alternative Names: GEO ZM02; GOVX-ZM01; MVA-ZIKV-NS1; ZIKV Envelope protein vaccine

Latest Information Update: 15 Feb 2021

At a glance

  • Originator GeoVax Labs
  • Developer GeoVax Labs; University of Georgia
  • Class Synthetic vaccines; Virus-like particle vaccines
  • Mechanism of Action Immunostimulants
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity No

Highest Development Phases

  • Preclinical Zika virus infection

Most Recent Events

  • 15 Feb 2021 Preclinical development is ongoing in Zika-virus-infection (Prevention) in USA (IM, Injection)
  • 19 Jun 2017 GeoVax Labs receives SBIR grant from National Institutes of Health for GEO ZM02 and ZIKV Envelope protein development in Zika virus infection
  • 19 Jun 2017 GeoVax Labs plans to initiate preclinical testing and phase I trial for GEO ZM02 and ZIKV Envelope protein vaccine for Zika virus infection

Development Overview

Introduction

GeoVax Labs is developing GOVX ZM01, GEO ZM02 (MVA-ZIKV-NS1) and a ZIKV envelope protein vaccine for the prevention of Zika virus, using its modified vaccinia Ankara vector (MVA-VLP) technology. GEO ZM02 is based on the non-structural-1 (NS1) protein of zika virus, which is not involved in antibody dependent enhancement (ADE) of infection. The platform is used to produce in vivo non-infectious virus-like particles (VLPs) that display Zika virus glycoproteins. The production of VLPs in the person being vaccinated mimics a natural infection, stimulating both antibody and T cells arms of the immune system to recognize, prevent and control the target infection. Preclinical development is underway in the US.

Company Agreements

GeoVax Labs announced in March 2016 that it had collaborations with the Centers for Disease Control and Prevention (CDC) and the University of Texas Medical Branch, for the development of its Zika virus vaccine [1] . Under the agreement with CDC, GeoVax will have an access to Zika virus antibodies available at the CDC, while CDC will conduct preclinical studies of the vaccine candidates [2] .

GeoVax has also entered into a collaborative research agreement with the University of Georgia for the development of the Zika virus vaccine. The University will develop vaccine antigens that elicit immunity against Zika viruses from different lineages and test those vaccines in pre-clinical models [3] .

Key Development Milestones

GeoVax plans to initiate preclinical testing and phase I study to evaluate the immunogenicity and protective efficacy of GEO ZM02 and a second candidate expressing the ZIKV Envelope protein [4] .

In November 2017, Geovax reported that in studies for Zika, a single dose of vaccine protected animals against a lethal challenge [5] .

In September 2017, Geovax released results from a new study performed in Rhesus Macaques, which provided in vivo evidence that prior exposure to Zika virus infection can enhance dengue infections, if the individual is subsequently infected by a dengue carrying mosquito [6] .

GeoVax, in March 2017, reported promising results from the preclinical trials of MVA-ZIKV-NS1 for zika virus infections, wherein the candidate provided 100% protection to mice infected with a lethal dose of Zika virus, which was directly delivered to the brain. All mice administered with a single intramuscular dose of MVA-ZIKV-NS1 survived while the sham-immunised control mice died within a week of infection in the study. Robust humoral and cellular responses were provided by vaccine. The study was funded by a grant from the Centers for Disease Control and Prevention (CDC) [6] [7] . Further, the company reported that GEO ZM02 is based on the NS1 antigen that does not carry the risk of Antibody Dependent Enhancement (ADE) of infection and could potentially block transmission of ZIKV from humans back to its mosquito host [8] .

In November 2016, GeoVax reported that it has commenced preclinical animal studies for zika virus vaccine programme [9] .

In October 2016, GeoVax announced that animal efficacy experiments using two different mouse models developed at the Centers for Disease Control and Prevention (CDC) and the University of Georgia are currently ongoing [10] .

In June 2016, GeoVax reported that it was developing two MVA-VLP Zika virus vaccine candidates using sequences from the Asian strain that spread to the Americas. This strain is linked to microcephaly in newborns and Guillian-Barre syndrome in adults. The first vaccine candidate is designed to express Zika pre-Membrane and Envelope (prME) proteins to produce Zika VLPs intended to elicit neutralizing antibodies that can block the Zika virus at its entry point into the host. The second candidate expresses Zika non-structural protein, that induces protective antibodies and also cellular responses against flavivirus infections in humans, in addition to Zika VLPs. GeoVax also reported that the prME constructs expressed intracellular VLPs in multi-lamellar structures, and that the VLPs were present in the cells in which they were formed and were also secreted into the cell culture supernatant. The company it is planning to evaluate the immunogenicity and protective efficacy of the vaccine candidates in multiple animal models, in collaboration with the Centers for Disease Control (CDC), the University of Georgia, and Emory University [11] [2] .

In June 2017, National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), awarded GeoVax a Small Business Innovative Research (SBIR) grant of $US600 000, in support of its novel Zika vaccine development program. The grant entitled "Advanced Preclinical Testing of a Novel Recombinant Vaccine Against Zika Virus" will support preclinical testing of GeoVax's vaccine candidates in non-human primates in preparation for the initiation of a phase I human clinical study, namely GEO ZM02 and a second expressing the ZIKV Envelope protein. The grant intends to evaluate the immunogenicity and protective efficacy of these two vaccine candidates in non-human primates [4] [12] .

Drug Properties & Chemical Synopsis

  • Route of administration IM
  • Formulation Injection
  • Class Synthetic vaccines, Virus-like particle vaccines
  • Mechanism of Action Immunostimulants
  • WHO ATC code

    J07B-X (Other viral vaccines)

  • EPhMRA code

    J7E9 (All other viral vaccines)

Development Status

Summary Table

Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
Zika virus infection - Prevention Preclinical USA IM / Injection GeoVax Labs, University of Georgia 03 Oct 2016

Commercial Information

Involved Organisations

Organisation Involvement Countries
GeoVax Labs Originator USA
GeoVax Labs Owner USA
National Institute of Allergy and Infectious Diseases Funder USA
Center for Disease Control Funder
University of Georgia Collaborator USA
Emory University Collaborator USA
University of Texas Medical Branch Collaborator USA
Centre for Disease Control Collaborator

Development History

Event Date Update Type Comment
15 Feb 2021 Active Status Review Preclinical development is ongoing in Zika-virus-infection (Prevention) in USA (IM, Injection) Updated 15 Feb 2021
28 Nov 2020 Phase Change - No development reported No recent reports of development identified for preclinical development in Zika-virus-infection(Prevention) in USA (IM, Injection) Updated 28 Nov 2020
19 Jun 2017 Company Involvement GeoVax Labs receives SBIR grant from National Institutes of Health for GEO ZM02 and ZIKV Envelope protein development in Zika virus infection [4] Updated 24 Jun 2017
19 Jun 2017 Trial Update GeoVax Labs plans to initiate preclinical testing and phase I trial for GEO ZM02 and ZIKV Envelope protein vaccine for Zika virus infection [4] Updated 24 Jun 2017
11 Nov 2016 Phase Change - Preclinical Preclinical trials in Zika virus infection (Prevention) in USA [9] Updated 06 Dec 2016
03 Oct 2016 Phase Change - Preclinical Preclinical trials in Zika virus infection (Prevention) in USA (unspecified route) [10] Updated 10 Mar 2017
21 Jun 2016 Trial Update GeoVax plans preclinical studies for Zika virus infection (Prevention) in USA [11] Updated 23 Jun 2016
16 Mar 2016 Licensing Status GeoVax collaborates with the University of Texas Medical Branch and Centre for Disease Control for the development of Zika virus vaccine [1] Updated 28 Mar 2016
04 Feb 2016 Licensing Status GeoVax Labs is collaborating with the University of Georgia to co-develop Zika virus vaccines [3] Updated 05 Feb 2016
04 Feb 2016 Phase Change Early research in Zika virus infection (Prevention) in USA (unspecified route) Updated 05 Feb 2016

References

  1. GeoVax Reports 2015 Year-End Financial Results and Provides Corporate Update.

    Media Release
  2. GeoVax Extends Research Collaborations on Zika Vaccine.

    Media Release
  3. GeoVax to Develop Vaccine Against Zika Virus.

    Media Release
  4. GeoVax Awarded NIH Grant for Zika Vaccine.

    Media Release
  5. GeoVax to Present at the Third International Conference on Vaccines Research and Development.

    Media Release
  6. GeoVax Provides Update on its Zika Vaccine Development.

    Media Release
  7. GeoVax Reports Promising Results for Zika Vaccine.

    Media Release
  8. GeoVax to Present at Upcoming Immuno-Oncology Conference.

    Media Release
  9. GeoVax Reports 2016 Third Quarter Financial Results and Provides Corporate Update.

    Media Release
  10. GeoVax to Present at Upcoming Scientific Conferences on Its Hemorrhagic Fever and Zika Vaccine Programs.

    Media Release
  11. GeoVax Discusses Zika Vaccine Development at American Society for Virology's 35th Annual Meeting.

    Media Release
  12. GeoVax Provides Update on Zika Vaccine Program.

    Media Release
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