Company’s COVID-19 Vaccine Candidate GEO-CM04S1 Continues to Advance in COVID-19 Phase 2 Clinical Trials While the Experimental Universal Vaccine Candidate GEO-CM02 Demonstrated Single-Dose, 100% Protection in Lethal Animal Challenge Model

 

ATLANTA, GA, April 12, 2022 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company specializing in developing human vaccines and cancer immunotherapies, announces today that on April 21, 2022, its Chief Scientific Officer, Mark J. Newman, Ph.D., will participate in an expert panel discussion on the topic of Pan-Corona and Universal Vaccines during the World Vaccine Congress in Washington, DC on April 18-21, 2022.

COVID-19 Vaccine Platform

• GEO-CM04S1: The Company’s lead COVID-19 vaccine candidate GEO-CM04S1 is being tested in both healthy and immunocompromised patients in separate Phase 2 clinical trials.

• GEO-CM02: GeoVax continues to assess the experimental vaccine candidate GEO-CM02 as the basis for a potential universal coronavirus vaccine.

The Need

First-generation SARS-CoV-2 vaccines were rapidly developed and have proven highly efficacious in the human population. Most of these first-generation vaccines were designed to encode the S protein of the SARS-CoV-2 virus with the goal of inducing high levels of neutralizing antibodies. However, potential limitations of narrowly focusing on the S protein are becoming apparent with emerging variants capable of partially escaping neutralization by vaccine induced antibodies, as has been seen with the Omicron variant. Thus, the effectiveness of these vaccines against new SARS-CoV-2 variants and future coronavirus spillover events remains of immense concern.

About the Modified Virus Ankara - Virus Like Particle (GV-MVA-VLP^TM) Platform

Using its novel Modified Virus Ankara - Virus Like Particle (GV-MVA-VLP^TM) 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-VLP^TM platform is known to induce a broadly specific and balanced antibody and cellular (T-cells) response against the multiple encoded immunogens, potentially limiting immune escape by emerging variants. For the GEO-CM02 vaccine candidate expression of the SARS-CoV-2 spike (S), membrane (M) and envelope (E) proteins by MVA supports the in vivo formation of virus like particles (VLPs), which induce both antibody and T-cell responses. Incorporation of other sequence-conserved structural and nonstructural proteins will provide targets for T-cell responses to increase the breadth and function of vaccine-induced immune responses.

Unique compared to other vaccines approved or under development, the GeoVax vaccine candidates are therefore specifically designed to provide a broader and more long-lived level of protective immunity against SARS-CoV-2 which should protect against emerging variants while avoiding the potential side effects that can limit vaccine utility and acceptance. This program was supported by a Small Business Innovation Research (SBIR) grant from the NIH during 2021. In small animal studies, the Company measured functional immune responses after a single dose that mediated protection from infection and pathogenesis, including protection against the more virulent Beta variant. Additional studies are planned for 2022 to prepare for IND filing and subsequent human clinical trials.

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. GeoVax’s product pipeline includes two ongoing Phase 2 clinical trials of GEO-CM04S1 (formerly COH04S1) for COVID-19 as a universal booster vaccine to mRNA vaccines authorized by the U.S. Food and Drug Administration (FDA) and as a primary vaccine for use in immunocompromised patients. In addition to GEO-CM04S1 for COVID-19, GeoVax is developing GEO-CM02 as a pan-coronavirus vaccine. The Company is also conducting a Phase 1/2 clinical trial of Gedeptin^® for treatment of head and neck cancer. Gedeptin^® has been granted orphan drug status by the FDA. 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. The Company’s 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.

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

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GeoVax Labs, Inc.

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