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GeoVax Awarded NIH Fast Track Phase I/II Grant to Advance Lassa Fever Vaccine

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Deadly epidemic continues in Nigeria; Lassa virus remains endemic in West Africa

GeoVax Labs, Inc. (OTCQB: GOVX), a biotechnology company developing innovative human vaccines, announced today that the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), has awarded the Company a Fast Track Phase I/II Small Business Innovative Research (SBIR) grant in support of its novel Lassa virus vaccine development program. The $300,000 grant is for Phase I of the project; the Company anticipates a total project budget of up to $1.9 million following the anticipated Phase II award.

The grant, entitled “Construction and efficacy testing of novel recombinant vaccine designs for eliciting both broadly neutralizing antibodies and T cells against Lassa virus”, will support preclinical testing of GeoVax’s vaccine candidates in preparation for human clinical trials. The work will be performed in collaboration with the Institute of Human Virology at the University of Maryland, The Scripps Research Institute (Scripps), and the University of Texas Medical Branch.

GeoVax previously announced that its vaccine candidate, GEO-LM01, provided 100% protection after a single intramuscular immunization, to mice infected with a lethal dose of a Lassa virus (LASV) composed of multiple strains delivered directly into the brain. Through the work supported by this grant, the Company now seeks to build on its success to implement a novel immunogen design for eliciting broadly cross-reactive neutralizing antibodies. Capitalizing on recent breakthroughs in the structural characterization of LASV glycoprotein by Scripps, GeoVax plans to develop and test novel immunogen designs in the context of its proprietary vaccine platform.

Farshad Guirakhoo, PhD, Chief Scientific Officer at GeoVax, commented, “The studies funded by this grant will build upon previous work that demonstrates the full protective efficacy of GeoVax’s MVA recombinant vaccines after a single inoculation. We are particularly excited about this collaboration which could enable us to generate a universal vaccine for Lassa fever by inducing broadly neutralizing antibodies to the LASV glycoprotein designed by Scripps.”

Dr. Guirakhoo continued, “The urgent need for a vaccine is exemplified by the record-high outbreak of Lassa fever in Nigeria with more than 1495 suspected cases and 119 deaths in the last few months according to the WHO report on March 23, 2018. The infection of 17 healthcare workers highlights the need for infection prevention and control measurements to stop the spread of disease in healthcare workers and prevent cross-border spread into neighboring countries. More people have been diagnosed with Lassa fever in the first two months of this year than in all of 2017.”

GEO-LM01 uses GeoVax’s proven Modified Vaccinia Ankara (MVA) Virus-Like Particle (VLP) vaccine platform that has been shown to be safe and to induce durable antibody and T cell responses in multiple human clinical trials for GeoVax’s prophylactic HIV vaccine. In contrast to other Lassa vaccines in development that rely on a single glycoprotein antigen, GEO-LM01 includes an additional matrix protein that form VLPs with the LASV glycoproteins. Upon infection of human cells, the MVA-driven expression of non-infectious VLPs that bear natively-folded glycoproteins on their surface, trigger an effective and durable immune response.

Using the same MVA-VLP platform, a single dose of GeoVax’s Ebola (EBOV) vaccine has been shown to protect 100% of rhesus monkeys against death. Moreover, a single dose of GeoVax’s Zika vaccine showed full protection in preclinical animal models. GeoVax is also developing vaccines against Sudan virus (SUDV) and Marburg virus (MARV), two other lethal filoviruses for which no effective vaccine currently exists. In addition to developing the four individual vaccines (EBOV, LASV, SUDV, MARV), the Company’s ultimate goal is to combine them into a single tetravalent vaccine to provide broad protection for individuals at risk for these viruses.

More About Lassa Fever
Lassa fever is caused by an infection with LASV, a member of the Arenaviridae virus family. The virus can cause severe and often fatal hemorrhagic illnesses in an overlapping region with EBOV. The virus is spread by rats that live in large numbers in agricultural areas near human habitations. In contrast to the unpredictable epidemics of filoviruses such as EBOV, LASV is endemic in West Africa with an annual incidence of over 300,000 and leading to 5,000 to 10,000 deaths. Recent study data suggests that the number of annual LASV cases may in fact be significantly higher, with three million infections and 67,000 deaths (placing upwards of 200 million individuals at risk). Today, no treatment or vaccine is available to stem LASV epidemics, even though LASV kills more people in one year than the EBOV did in the last 41 years after its first epidemic in 1976 in West Africa.

About GeoVax
GeoVax Labs, Inc., is a clinical-stage biotechnology company developing human vaccines against infectious diseases using its MVA-VLP vaccine platform. The Company’s development programs are focused on preventive vaccines against HIV, Zika virus, hemorrhagic fever viruses (EBOV, SUDV, MARV and LASV), and malaria, as well as therapeutic vaccines for chronic Hepatitis B infections and cancers. GeoVax’s vaccine platform mimics 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.

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. 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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