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GEO-CM02 Being Developed as a Universal Vaccine toAddress Evolving SARS-CoV-2 Variants such as Omicron


GlobeNewswire Inc | Dec 1, 2021 09:00AM EST

December 01, 2021

GEO-CM02 Being Developed as a Universal Vaccine toAddress Evolving SARS-CoV-2 Variants such as Omicron

ATLANTA, GA, Dec. 01, 2021 (GLOBE NEWSWIRE) -- via NewMediaWire -- GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company specializing in developing human vaccines and cancer immunotherapies, announced today that its Chief Scientific Officer, Mark J. Newman, Ph.D., participated in an expert panel discussion on design approaches to produce a universal SARS-CoV-2 vaccine during the World Vaccine & Immunotherapy Congress, being held November 30 December 2 in San Diego, California. Dr. Newman also presented data from ongoing studies of GEO-CM02, GeoVaxs investigational pan coronavirus vaccine.

First-generation SARS-CoV-2 vaccines were rapidly developed and have proven highly efficacious in the human population and were designed to encode the Spike protein (S) with the goal of inducing high levels of neutralizing antibodies. However, potential limitations of narrowly focusing on S are becoming apparent with emerging variants that partially escape neutralization by vaccine induced antibodies, as is currently demonstrated with the emergence of the Omicron variant initially discovered in South Africa but now believed to be spreading globally. Thus, the effectiveness of these vaccines against new SARS-CoV-2 variants and future coronavirus spillover events remains an important question.

Using its novel Modified Virus Ankara - Virus Like Particle (GV-MVA-VLPTM) platform, GeoVax has developed a design strategy for vaccines expected to induce broader immunity through inclusion of multiple, genetically conserved structural and nonstructural proteins from the target pathogen. The GV-MVA-VLPTM platform is known to induce a balanced humoral (antibody) and cellular (T-cells) response against the multiple encoded immunogens, potentially limiting immune escape against emerging variants. Expression of the SARS-CoV-2 spike, membrane and envelope proteins by MVA supports thein vivoformation of virus like particles, or VLPs, which induce both antibody and T-cell responses. Incorporation of sequence-conserved structural and nonstructural proteins can provide targets for T-cell responses to increase the breadth and function of vaccine-induced immune responses. This strategy provides the basis for generating a universal vaccine with augmented potential to alleviate the burden of disease caused by circulating coronaviruses.

In his talk, Dr. Newman discussed GeoVaxs vaccine design strategy for developing a universal SARS-CoV-2 vaccine and presented efficacy and immunogenicity datafor the Companys lead and first-generation vaccine candidate, GEO-CM02, which encodes the Spike (S), Membrane (M) and Envelope (E) proteins. Dr. Newmans presentation is available on GeoVaxs website atwww.geovax.com/investors/events.

Dr. Newman commented, Our studies continue to support the use of MVA as a vector for the design and production of next-generation vaccines encoding multiple coronavirus proteins. The lead candidate encodes the S protein as the antibody target and the M and E proteins as T-cell targets. The combination of S, M and E protein expression supportsin vivoVLP formation and optimal immunogenicity. In our small animal studies, we measured functional immune responses after a single dose that mediated protection from infection and pathogenesis, including protection against the more virulent Beta variant.

About the GV-MVA-VLPTM Platform

GeoVaxs GV-MVA-VLPTM vaccine platform utilizes Modified Vaccinia Ankara (MVA), a large virus capable of carrying several vaccine antigens, that expresses proteins that assemble into virus-like particles (VLP) immunogens in the person receiving the vaccine. The production of VLPs in the person being vaccinated can mimic the virus production that occurs 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 can elicit durable immune responses in the host similar to a live-attenuated virus, while providing the safety characteristics of a replication-defective vector.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing human vaccines and immunotherapies against infectious diseases and cancer using novel proprietary platforms. The Companys portfolio of wholly owned, co-owned, and in-licensed intellectual property, stands at over 70 granted or pending patent applications spread over 20 patent families.

GeoVaxs product pipeline includes ongoing human clinical trials in COVID-19, head and neck cancer, and HIV. Additional research and development programs include preventive vaccines against Zika Virus, hemorrhagic fever viruses (Ebola, Sudan, Marburg, and Lassa) and malaria, as well as immunotherapies for multiple solid tumors.

For additional information about GeoVax, visit our website:www.geovax.com.

Forward-Looking Statements

This release contains forward-looking statements regarding GeoVaxs business plans. The words believe, look forward to, may, estimate, continue, anticipate, intend, should, plan, could, target, potential, is likely, will, expect and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may 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 a variety of factors, including whether: GeoVax is able toobtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVaxs immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVaxs viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVaxs immuno-oncology products and preventative vaccines will be safe for human use, GeoVaxs vaccines will effectively prevent targeted infections in humans, GeoVaxs immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVaxs products, GeoVax will be able to enter into favorable manufacturing and 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-3 and the periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by U.S. federal securities law.

GeoVax Labs, Inc. 6783847220 investor@geovax.com







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