GeoVax Announces Publication of Lassa Fever Vaccine Study Results

100% Single-Dose Protection Observed in Lethal Challenge Model

ATLANTA, GA, Sept. 04, 2019 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE -- GeoVax Labs, Inc. GOVX, a biotechnology company developing human vaccines, today announced publication of its article entitled "A Single Dose of Modified Vaccinia Ankara Expressing Lassa Virus-like Particles Protects Mice from Lethal Intra-cerebral Virus Challenge." The paper appears in the open access journal Pathogens published by MDPI, based in Basel, Switzerland, and can be viewed at https://www.mdpi.com/2076-0817/8/3/133.

GeoVax's Lassa fever vaccine (GEO-LM01) is based on the Company's novel Modified Vaccinia Ankara (MVA) Virus-Like Particle (VLP) platform, which generates noninfectious VLPs in the individual being vaccinated. VLPs mimic a natural infection, triggering the body to produce a robust and durable immune response with both antibodies and T cells. The paper published in Pathogens reports research showing that a single intramuscular (IM) dose of GEO-LM01 provided 100% protection in mice challenged with a lethal dose of ML29 (a Mopeia/Lassa reassortant virus) delivered directly into the brain. This is the first report showing that a single dose of a replication-deficient MVA vector can confer full protection against a lethal challenge.

Lassa fever surpasses Ebola, Marburg, and all other hemorrhagic fevers except Dengue in its public health impact. Caused by LASV, the disease is a scourge on populations in endemic areas of West Africa, where reported incidence is higher. GEO-LM01 is one component of a multivalent hemorrhagic fever virus vaccine being developed by GeoVax. The other vaccine components are for protection against Sudan virus (SUDV), Marburg virus (MARV), and Ebola virus (EBOV). These vaccines are envisioned as either individual monovalent vaccines in epidemic situations or combined as a multivalent vaccine for the protection of the millions of individuals who live in at-risk areas, travelers, military personnel, healthcare workers, and others.

Farshad Guirakhoo, PhD, GeoVax's Chief Scientific Officer, commented, "GEO-LM01 uses GeoVax's proven MVA-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. Using the same platform, we have shown our Zika vaccine (GEO-ZM02) provided single-dose 100% protection in mice against intracranial challenge, and that our Ebola vaccine (GEO-EM01) provided single-dose 100% protection in rhesus macaques. It is remarkable that a replication deficient vector can induce full protection after a single dose as soon as 2 weeks post vaccination. Although we did not attempt to measure protection at earlier timepoints, it is possible that the full protection can be achieved even sooner. We are looking forward to further development of this vaccine so it can be reached to people who need it most."

According to Maria Salvato, a co-author of the paper and a Professor of Medicine at the Institute of Human Virology at the University of Maryland School of Medicine, "We expect MVA-LM01 to be safe for pregnant women and offer a greater breadth of coverage than simple subunit vaccines."

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing human vaccines against infectious diseases and cancer using a novel patented Modified Vaccinia Ankara-Virus Like Particle (MVA-VLP) based vaccine platform. On this platform, MVA, a large virus capable of carrying several vaccine antigens, expresses proteins that assemble into VLP immunogens within (in vivo) the person receiving the vaccine. The production of VLPs in the person being vaccinated mimics virus production in a natural infection, stimulating both the humoral and cellular arms of the immune system to recognize, prevent, and control the target infection. The MVA-VLP derived vaccines elicit durable immune responses in the host similar to a live-attenuated virus, while providing the safety characteristics of a replication-defective vector.

GeoVax's current 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 against chronic Hepatitis B infections and multiple cancers. The Company has designed the leading preventative HIV vaccine candidate to fight against the subtype of HIV prevalent in the larger commercial markets of the Americas, Western Europe, Japan, and Australia; this program is currently undergoing human clinical trials managed by the HIV Vaccine Trials Network (HVTN) with the support of the National Institutes of Health (NIH).  GeoVax's HIV vaccine is also part of collaborative efforts to develop an immunotherapy as a functional cure for HIV.  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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