David A. Dodd, chairman, president, and CEO“The innovations in our research, developments, and offerings are grounded in the passion and tireless work of our team, who are devoted to advancing science that can enable people worldwide to live their healthiest lives,” reports David A. Dodd, president and CEO of GeoVax. The leading edge of the high-performance, collaborative, and collegial GeoVax team is Dodd, himself, whose diverse achievements over four decades in the life science industry are widely recognized. Dodd’s previous experience includes executive management for Wyeth, Bristol-Myers Squibb, and other industry-leading companies as well as business and value transformations achieved for Serologicals Corporation and companies needing a new leadership strategy. The GeoVax team, led by Dodd, has propelled the Company into the avant-garde in developing novel vaccines and immunotherapies for unmet patient and public health needs.
GeoVax’s lead product in the vaccine domain is GEO-CMO4S1, currently in two Phase 2 clinical trials. While current authorized COVID-19 vaccines target only the SARS-CoV-2 virus spike protein, GEO-CMO4S1 includes, not only the spike protein, inducing a strong antibody response, but also the nucleocapsid protein, inducing a powerful T-cell response. GEO-CM04S1’s dual induction of strong antibody and T-cell immune responses is especially critical for immunocompromised populations. This brings much-needed therapeutic benefit to people with chronic lymphocytic leukemia and other blood cancers, sickle cell anemia, multiple sclerosis, and other conditions that hinder immune systems from mounting a viable response to antibody-stimulation. “CM04S1” is intended to provide a more efficient, broader, more durable, and safer protection for immunocompromised patients.
Moreover, the vaccine is expected to be delivered without the extreme refrigeration/frozen state that is required of the current authorized vaccines.
In tandem with its groundbreaking vaccine developments in infectious diseases, GeoVax is also focused on improving therapy for patients suffering from solid tumors, initially addressing advanced head and neck cancers. Currently underway is a phase-2 multi-site clinical program for a gene-directed enzyme prodrug therapy (GDEPT) technology (“Gedeptin®”). The FDA granted Gedeptin orphan drug status for the intra-tumoral treatment of anatomically accessible oral and pharyngeal cancers, including cancers of the lip, tongue, gum, floor of the mouth, salivary gland, and other oral cavities. In a phase-1 trial, Gedeptin therapy demonstrated consistent tumor shrinkage by forming oncolytic agents within the tumor, itself, resulting in rapid tumor cell death. GeoVax is currently conducting a multi-site phase 1/2 trial, where the safety and efficacy of repeat cycles of Gedeptin therapy are evaluated on patients with recurrent head and neck squamous cell carcinoma (HNSCC). Recognizing the phase-1 trial results and the critical medical need for therapy among such patients, the FDA has funded the initial portion of the current clinical program.
The basis of GEO-CMO4S1 is Modified Vaccinia Ankara (“MVA”), a well-recognized vaccine platform originally developed as a safer smallpox vaccine for immunocompromised individuals. MVA is well known for its safety and versatility, having been repurposed as a platform for approved vaccines currently in use worldwide. The MVA vaccine platform allows multiple antigens of a target pathogen (“virus”) to be encoded, increasing the breadth of immune response and the ability to induce both strong antibody and strong T-cell responses in the vaccinated patients, such as immunocompromised people.
GeoVax also has demonstrated and validated its abilities in MVA vaccine development against hemorrhagic fever viruses like Ebola Zaire, Ebola Sudan, Marburg, Lassa, and other infectious threats such as Zika, and HIV viruses.
GeoVax recently announced plans to develop a high-yield, high-capacity, continuous cell line system for manufacturing MVA-based vaccines and immunotherapies. This will result in a proprietary cell line manufacturing system at lower-cost, higher-yield and, scalable versatility for MVA vaccine and immunotherapy applications, overcoming the limitations of the current manufacturing process of MVA-based vaccines, rendering that process antiquated. In addition, GeoVax recently acquired the right to produce a single vaccine using MVA to treat monkeypox and smallpox. The Company intends to become the first and primary US-based supplier of MVA for such pox-related viruses.
The innovations in our research, developments, and offerings are grounded in the passion and tireless work of our team, who are devoted to advancing science that can enable people worldwide to live their healthiest lives
The diversity, ingenuity, and relevance of the GeoVax’s programs are clear evidence of another kind of efficacy – that of a well led, highly capable, and fully integrated team. It is no surprise that GeoVax has become a leader in developing next-generation therapies and vaccines to solve some of the most pressing medical concerns affecting the world today.
GeoVax’s Next-Generation COVID-19 Vaccine Shows High Immunogenicity in Immunocompromised Patients
Monday, June 05, 2023
New and Unpublished Data from Phase 2 Open-Label Safety Study of GEO-CM04S1 Presented at Two Recent Scientific Meetings
ATLANTA -GeoVax Labs Inc., announced today the presentation of updates on the development of its next-generation SARS-CoV-2 vaccine, GEO-CM04S1, including preliminary data from an ongoing Phase 2 clinical trial, during the Vaccines Summit Boston 2023 and the Congress for the International Society for the Advancement of Cytometry (CYTO) 2023 meetings.
Each of the presentations included unpublished data from the open-label portion of the Phase 2 trial of CM04S1 (ClinicalTrials.gov Identifier: NCT04977024) in patients undergoing hematological cancer treatment (i.e., patients who have reduced immune system function as a result of treatment). The preliminary analysis indicated CM04S1 is highly immunogenic in these patients, inducing both antibody responses, including neutralizing antibodies as well as T cell responses. These data support the planned progression of the Phase 2 clinical study, which includes a direct comparison to currently approved mRNA vaccines.
Kelly McKee, M.D., GeoVax’s Chief Medical Officer, commented, “These data extend to severely immunocompromised patients our earlier findings in healthy adults that GEO-CM04S1 stimulated a robust, durable, and broad-based humoral and cellular immune response against multiple SARS-CoV-2 variants. Validation of these findings in additional patients with hematologic malignancies, who have received CAR-T and stem cell transplants, is underway as we seek to provide a vaccine solution to those individuals unable to mount adequate protective responses with currently available COVID-19 vaccines.”
CM04S1 continues to advance in a second Phase 2 clinical trial as a booster for healthy patients who have previously received the Pfizer or Moderna mRNA vaccine (ClinicalTrials.gov Identifier: NCT04639466). Data from these studies will form the basis for comparing vaccine potential in unique patient groups as well as the general population.
GeoVax Receives BARDA Project NextGen Award to Conduct Phase 2b Clinical Study Evaluating the Companys Next-Generation COVID-19 Vaccine Candidate, GEO-CM04S1
Tuesday, June 25, 2024
10,000-participant randomized Phase 2b study will evaluate and compare GeoVax’s multi-antigen, vaccine candidate (GEO-CM04S1) to an approved vaccine against COVID-19 under BARDA’s Clinical Studies Network
Project NextGen is a $5 billion initiative by the U.S. Department of Health and Human Services to develop innovative vaccines and therapeutics providing broader and more durable protection against current and future COVID-19 viral strains
ATLANTA, GA - GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced that it received an award through the Rapid Response Partnership Vehicle (RRPV) to advance development of GEO-CM04S1, GeoVax’s dual-antigen next-generation COVID-19 vaccine, in a Phase 2b clinical trial. The RRPV is a Consortium funded by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS).
Under the agreement, GeoVax will sponsor a 10,000-participant, randomized, Phase 2b double-blinded study to compare the efficacy, safety, and immunogenicity of GEO-CM04S1 with a U.S. Food and Drug Administration (FDA)-approved mRNA COVID-19 vaccine. Preparations for the study are underway, and execution of the study will be fully funded by BARDA under its Clinical Studies Network.
The direct award to GeoVax of approximately $24.3 million, which may increase to as much as $45 million, will fund the manufacturing of clinical materials and support for the Phase 2b clinical trial, including regulatory activities. BARDA has made separate awards through its Clinical Studies Network to support execution of the study. That funding will represent approximately $343M from the Project NextGen program for a CRO to execute the clinical trial using GeoVax’s vaccine.
“We are honored and proud to receive this award from BARDA to advance our next-generation vaccine against COVID-19. This contract not only provides the vital resources for advancing the development of GEO-CM04S1, but it also advances our MVA platform in infectious diseases,” said David Dodd, Chairman & CEO of GeoVax.
Mr. Dodd continued, “First-generation COVID-19 vaccines were beneficial during the peak of the pandemic but are limited in breadth and durability of clinical protection, requiring frequent updates. Now that COVID-19 is in an endemic stage, many people continue to have their everyday lives impacted in meaningful ways. Furthermore, there are an estimated 23 million adults in the U.S. with immunocompromised conditions who are less likely to have an adequate response to current vaccines and are more likely to potentially experience severe COVID-19 symptoms, hospitalization and the risk of death, even after vaccination. GEO-CM04S1 was designed to address these limitations by inducing durable neutralizing antibody and T-cell-based immunity against current and future SARS-CoV-2 variants. Our vaccine has continued to demonstrate induction of potent immune responses with potential to drive broad and durable clinical protection, and we eagerly anticipate commencing the Phase 2b study to further demonstrate the value and advantages of our technology.”
Funding for this award is provided under Project NextGen, a $5 billion initiative by HHS to advance a pipeline of new, innovative vaccines and therapeutics providing broader and more durable protection for COVID-19 than the first generation COVID vaccines and medicines. BARDA is supporting the development of new vaccines and therapeutics to better address the waning immunity and resistance to current and future SARS-CoV2 viral strains. GeoVax’s vaccine candidate provides many of the features identified by BARDA including broader protection among variants of concern (VOC) and a longer duration of protection.
This project is being funded with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), under Other Transaction (OT) number: 75A50123D00005.
