GeoVax receives notification of authorization for Ebola vaccine

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A single dose of GEO-EM01 provided 100% protection in the assessment of the lethal challenge

Atlanta, Georgia, October 14, 2021 (GLOBE NEWSWIRE) – via NewMediaWireGeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing human immunotherapies and vaccines against infectious diseases and cancer, today announced that the United States Patent and Trademark Office has issued a notice of clearance for the application. of patent no.15 / 543,139 entitled “Replication Deficient Modified Vaccinia Ankara (MVA) expressing Ebola virus glycoprotein (GP) and matrix protein (VP40). “

GeoVax demonstrated that a single intramuscular (IM) dose of its vaccine candidate, GEO-EM01, provided 100% protection in rhesus macaques subjected to a lethal dose of Ebola virus (EBOV). This is the first report indicating that a replication-deficient MVA vector can confer complete protection against lethal challenge by EBOV after single dose vaccination in macaques. GEO-EM01 is based on the company’s new modified Vaccinia Ankara (MVA) -like particle (VLP) platform, which generates non-infectious VLPs in the vaccinated individual. VLPs mimic a natural infection, prompting the body to produce a robust and long-lasting immune response with both antibodies and T cells.

In addition to its vaccine against EBOV, GeoVax is also developing preventive vaccines against other hemorrhagic fever viruses that are highly fatal to humans. In July 2021, the Company announced the results of preclinical efficacy studies of its candidate vaccine against Sudan Ebola virus (SUDV), in which a single dose of the vaccine protected 100% of animals subjected to a lethal dose of SUDV. . This is the first report indicating that a replication-deficient MVA vector can confer complete protection against SUDV after a single dose. This work was carried out in collaboration with researchers from the University of Texas Medical Branch (UTMB). In addition, GeoVax is leading a multi-stakeholder collaboration for the development of its vaccine candidates against SUDV and Marburg virus (MARV). The collaboration between GeoVax, UTMB and Battelle Memorial Institute researchers uses the NIAID preclinical suite of services. As part of this collaboration, the SUDV and MARV vaccine candidates from GeoVax are tested for their immunogenicity and efficacy in the reference model of non-human primates. In addition, GeoVax’s Lassa fever virus (LASV) vaccine is advancing in preclinical studies with financial support from the US Department of Defense.

David Dodd, President and CEO of GeoVax, said, “While our corporate focus and development priorities continue to be our COVID-19 vaccine and cancer immunotherapy programs, the development of Vaccines against the deadly hemorrhagic fever viruses is also of interest and under study as part of our term focus. This patent allocation is in addition to our growing portfolio of proprietary, co-owned and licensed intellectual property, which now stands at more than 70 granted or pending patent applications, spread across 20 patent families.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing human vaccines against infectious diseases and cancer using new, patented platforms. Our vaccine platform based on the modified Ankara-Virus Like Particle (MVA-VLP) vaccine uses MVA, a large virus capable of carrying multiple vaccine antigens, which expresses proteins that assemble into VLP immunogens in the person receiving the vaccine. vaccine. The production of VLP in the vaccinated person can mimic the production of virus in a natural infection, stimulating both the humoral and cellular arms of the immune system to recognize, prevent and control the target infection. Vaccines derived from MVA-VLP can elicit long-lasting immune responses in the host similar to those of a live attenuated virus, while providing the safety characteristics of a replication-defective vector.

In September 2021, GeoVax expanded its immuno-oncology pipeline and added a new technology platform through the acquisition of the exclusive rights to Gedeptin®, a new patented product for the treatment of solid tumors through a strategy of gene therapy known as GDEPT (Gene-Directed Enzyme Prodrug Therapy). In GDEPT, a vector is used to selectively transduce tumor cells with a non-human gene, which expresses an enzyme capable of converting a non-toxic prodrug into a highly toxic anti-tumor compound. A phase 1/2 trial is currently being enrolled to assess the safety and efficacy of repeated cycles of treatment with Gedeptin in patients with recurrent squamous cell carcinoma of the head and neck (HNSCC), with tumors accessible for injection and no curable treatment options. The initial phase of the study is funded by the FDA as part of its Orphan Product Clinical Trials Grants Program. A course of Gedeptin therapy consists of three intra-tumor injections over a period of two days, followed by an infusion of a prodrug, fludarabine phosphate, once a day for three days. The FDA has granted orphan drug status to Gedeptin for the treatment of HNSCC. GeoVax’s license to Gedeptin includes the rights to extend its use to all human diseases and / or conditions, including, but not limited to, other cancers.

GeoVax’s MVA-VLP development programs focus on preventive vaccines against COVID-19, HIV, Zika virus and hemorrhagic fever viruses (Ebola, Sudan, Marburg and Lassa), as well as therapeutic vaccines against several cancers. The Company has designed a preventive HIV vaccine candidate to combat the HIV subtype prevalent in commercial markets in the Americas, Western Europe, Japan and Australia; Human clinical trials for this program are managed by the HIV Vaccine Trials Network (HVTN) with support from the National Institutes of Health (NIH). GeoVax’s HIV vaccine is also part of a collaborative effort towards a working cure for HIV.

Forward-looking statements

This press release and the related conference call contain forward-looking statements regarding GeoVax’s business plans and financial results. The words “believe”, “can”, “estimate”, “continue”, “anticipate”, “intend”, “should”, “plan”, “could”, “target”, “target” “will be “,” Expect “and similar expressions, as far as we are concerned, are intended to identify forward-looking statements. We have based these forward-looking statements in large part on our current expectations and projections regarding future events and financial trends that we believe could affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to various factors, including whether: GeoVax is able to derive potential benefits from the patent protection it has received, GeoVax vaccines may elicit immune responses desired, and these vaccines can be used effectively as a primary or booster to other vaccines, GeoVax viral vector technology adequately enhances immune responses to cancer antigens, GeoVax can develop and manufacture its vaccines with desired characteristics by timely, GeoVax vaccines will be safe for humans, GeoVax vaccines will effectively prevent targeted infections in humans, GeoVax vaccines will receive the necessary regulatory approvals to be licensed and marketed, GeoVax is raising the required capital to complete the development of the vaccine, there is the development of competitive products q If they may be more efficient or easier to use than GeoVax products, GeoVax will be able to enter into favorable manufacturing, distribution agreements and other factors over which GeoVax has no control.

Further information on our risk factors is contained in our registration statement on Form S-1 and the periodic reports on Forms 10-Q and 10-K that we have filed and will file with the SEC. Any forward-looking statements we make here speak only as of the date on which they are made. Factors or events that could cause our actual results to vary may occur from time to time, and we cannot predict all of them. We assume no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as required by law.

GeoVax Labs, Inc.
6783847220
[email protected]

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