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

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

No development reported Zika virus infection

Most Recent Events

28 Feb 2023 No recent reports of development identified for preclinical development in Zika-virus-infection(Prevention) in USA (IM, Injection)
21 Apr 2022 GeoVax Labs has patent pending for preventive vaccines against Zika virus and uses thereof in USA
15 Feb 2021 Preclinical development is ongoing in Zika-virus-infection (Prevention) in USA (IM, Injection)

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.

As at February 2023, no recent reports of development had been identified for preclinical development in Zika-virus-infection (Prevention) in USA (IM, Injection).

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

As of April 2022, zika virus-like particle vaccine is under priority review voucher program for Zika virus infections (GeoVax Labs pipeline, April 2022).

As of April 2022, IND enabling studies are underway in USA (GeoVax Labs pipeline, April 2022).

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].

Patent Information

As at April 2022, GeoVax Labs owns one US patent application directed to preventive vaccines against Zika virus and uses thereof. This application, if issued, will expire in 2037, exclusive of any patent term adjustments or extensions^[13].

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)

Event Date	Update Type	Comment
28 Feb 2023	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 Feb 2023
21 Apr 2022	Patent Information	GeoVax Labs has patent pending for preventive vaccines against Zika virus and uses thereof in USA ^[13] Updated 22 Apr 2022
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

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