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GeoVax Awarded $658,000 NIH Grant for its HIV Vaccine Program

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GeoVax Labs, Inc. (OTCQB: GOVX), a biotechnology company developing human vaccines, announced today it has received a Notice of Award from the National Institute of Allergy and Infectious Disease (NIAID), part of the U.S. National Institutes of Health (NIH), for a Phase II Small Business Innovative Research (SBIR) grant in support of its HIV vaccine development program. The grant award of $658,159 will fund the second year of a two-year project period with a total budget of $1,398,615.

The grant, entitled “Enhancing Protective Antibody Responses for a DNA/MVA HIV Vaccine”, supports preclinical studies in non-human primates (NHP) evaluating the immunogenicity and protective efficacy of the GeoVax Clade B HIV preventive vaccine (GOVX-B11) with or without a bivalent (two component) protein boost. Clade B is the subtype of HIV most prevalent in the developed world – primarily the Americas, Western Europe, Australia and Japan.

GOVX-B11 is a DNA/MVA vaccine that expresses non-infectious virus-like particles (VLPs). Clinical trials for GOVX-B11 are being conducted by the HIV Vaccine Trials Network (HVTN) with funding from NIAID. The HVTN has tested various doses and combinations of the DNA and MVA (MVA62B) vaccines in 500 people, and is currently testing a late protein boost in individuals who participated in the HVTN 205 Phase 2a trial of GOVX-B11. In this trial (HVTN 114), these “late boosts” consist of the GeoVax MVA62B vaccine with or without a gp120 protein vaccine. The gp120 protein is the same protein used to boost immune responses in the partially protective RV144 trial in Thailand, and is being used to assess the effect of late boosts of GOVX-B11.

While HVTN 114 is ongoing, newer proteins are being manufactured to be used as the bivalent boost in future clinical trials of GOVX-B11. The preclinical studies funded by this SBIR grant are testing these newer proteins in nonhuman primates (NHP) for the potential to increase the protective potential of GOVX-B11.

Harriet L. Robinson, PhD, Director of GeoVax’s HIV vaccine program, commented, “In the first year of our SBIR program, the bivalent boost has shown excellent ability to enhance antibody responses to the V1V2 region of the HIV envelope protein (Env). We are pleased with this result because antibody to V1V2 correlated with protection in the partially successful RV144 trial in Thailand. The second year of the SBIR will allow us to test the ability of the enhanced V1V2 antibody to increase the protective level of our vaccine in NHP. Meanwhile, the cGMP products for evaluating the bivalent protein boost in humans are falling into place.”

About GeoVax

GeoVax Labs, Inc., is a clinical-stage biotechnology company developing human vaccines against infectious diseases using its Modified Vaccinia Ankara-Virus Like Particle (MVA-VLP) vaccine platform. The Company’s development programs are focused on preventive vaccines against HIV, Zika Virus, hemorrhagic fever viruses (Ebola, Sudan, Marburg, and Lassa), and malaria, as well as therapeutic vaccines for chronic Hepatitis B infections and cancers. GeoVax’s vaccine platform supports in vivo production of non-infectious VLPs from the cells of the very person receiving the vaccine, mimicking a natural infection, stimulating both the humoral and cellular arms of the immune system to recognize, prevent, and control the target infection. For more information, visit www.geovax.com.

Forward-Looking Statements

Certain statements in this document are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act. These statements are based on management's current expectations and are subject to uncertainty and changes in circumstances. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax can develop and manufacture its vaccines with the desired characteristics in a timely manner, GeoVax's vaccines will be safe for human use, GeoVax's vaccines will effectively prevent targeted infections in humans, GeoVax’s vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete vaccine development, there is development of competitive products that may be more effective or easier to use than GeoVax's products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control. GeoVax assumes no obligation to update these forward-looking statements, and does not intend to do so. More information about these factors is contained in GeoVax's filings with the Securities and Exchange Commission including those set forth at "Risk Factors" in GeoVax's Form 10-K.

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