GeoVax Labs Inc (GOVX)

[Apophis]

2017 Highlights To Date:
Progress in Zika Vaccine Development. In June, at the American Society for Microbiology (ASM) conference (ASM MICROBE 2017), GeoVax ( GOVX
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) presented research showing that a single dose of its Zika vaccine (GEO-ZM02) gave 100% protection in mice challenged with a lethal dose of Zika virus (ZIKV) delivered directly into the brain. This is the first report of i) a Zika vaccine based on the ZIKV non-structural (NS1) protein, and ii) single-dose protection against ZIKV using an immunocompetent lethal mouse challenge model. The vaccine was tested at the Centers for Disease Control and Prevention (CDC) in Ft. Collins, CO with funding by a grant from the CDC. Importantly, GeoVax's ( GOVX ) approach to a Zika vaccine is unique as it is based on the NS1 protein of ZIKV and thus will avoid the Antibody Dependent Enhancement (ADE) of infection safety issue, which is a concern for other Zika vaccines under development.
Also in June, the National Institutes of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), awarded GeoVax ( GOVX
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) a Small Business Innovative Research (SBIR) grant of $600,000 to support advanced preclinical testing, including non-human primates studies, for its Zika vaccine development program in preparation for a Phase 1 human clinical study.
Promising Results for Lassa Fever Vaccine. In July, GeoVax ( GOVX
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) reported a significant step forward in the development of a vaccine candidate for protection against Lassa hemorrhagic fever virus (LASV). Efficacy testing in a murine challenge model (using a chimeric LASV reassortant) showed a single dose of GEO-LM01, provided 100% protection to mice infected with a lethal dose of the challenge virus. The study was conducted, and successfully repeated, at the Institute of Human Virology at the University of Maryland School of Medicine. GeoVax ( GOVX ) recently expanded its LASV vaccine development efforts through a collaboration with The Scripps Research Institute. With no vaccine available, LASV continues to kill more than 5000 people each year in West African countries where the virus is endemic.
Earlier, a single dose of GeoVax's ( GOVX
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) Ebola (EBOV) vaccine (GEO-EM01) was shown to protect 100% of rhesus monkeys against death. GeoVax ( GOVX
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) is also developing vaccines against Sudan virus (SUDV) and Marburg virus (MARV), two other lethal hemorrhagic fever viruses for which no effective vaccine currently exists. In addition to developing the four individual hemorrhagic fever vaccines (EBOV, LASV, SUDV, MARV), the Company's goal is to combine the vaccines into a single tetravalent vaccine to provide broad protection for individuals at-risk for these viruses.
HIV Preventive Vaccine Development - New Clinical Trial Begun with NIH Support. In January, GeoVax ( GOVX

) initiated a human clinical trial of its preventive HIV vaccine, GOVX-B11, being developed to address the clade B HIV subtype prevalent in the U.S. and other areas of the developed world. The Phase 1 trial (designated HVTN 114) is being conducted by the HIV Vaccine Trials Network (HVTN) with funding from NIAID. HVTN 114 will enroll up to 30 individuals who participated in an earlier Phase 2a trial of GOVX-B11 and will test the ability of additional vaccinations to increase the antibody responses elicited by the GeoVax (.
) vaccine.
During 2017, GeoVax ( GOVX
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) continued its work under a NIAID contract of up to $7.8 million for production of the DNA component of GOVX-B11 intended for later-stage clinical trials. The Company also continued work under two SBIR grants from NIAID for both its clade B HIV vaccine, and for its vaccine for the clade C HIV subtype prevalent in Africa.