Latest news with #GEO-CM04S1
Yahoo
09-07-2025
- Health
- Yahoo
GeoVax Highlights Critical Role of Multi-Antigen COVID-19 Vaccines as Nimbus Variant Underscores Persistent and Evolving Public Health Threat
With COVID-19 continuing to mutate and over 40 million immunocompromised Americans still at risk, GeoVax's GEO-CM04S1 vaccine offers potential broader, more durable protection through a unique multi-antigen approach ATLANTA, GA - July 3, 2025 (NEWMEDIAWIRE) - GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing multi-antigen vaccines and immunotherapies, today emphasized the urgent need for innovation in COVID-19 vaccination as the NB.1.8.1 variant - commonly known as "Nimbus" - spreads rapidly across the globe. Nimbus, a highly transmissible Omicron subvariant classified by the World Health Organization as a "Variant Under Monitoring," is now dominant in multiple U.S. states and surging across Europe and Asia. Though not more severe, its rapid spread and potential for immune escape reflect an increasingly clear reality: COVID-19 is not going away, and it will continue to evolve. "The emergence of the Nimbus variant is a stark reminder that we need smarter' vaccines, not just newer ones," said David Dodd, Chairman and CEO of GeoVax. "Our GEO-CM04S1 vaccine was designed for this purpose and is built to potentially provide broader and longer-lasting protection, especially for the immunocompromised patients most at risk." GEO-CM04S1: Multi-Antigen Protection for the Immunocompromised Unlike mRNA vaccines that rely solely on the Spike protein, GEO-CM04S1 delivers both Spike (S) and Nucleocapsid (N) antigens, stimulating an immune response that includes not only an antibody response, but also robust T-cell activity. This is believed to be critical for cross-variant protection and extended durability, particularly in individuals with weakened immune systems. GEO-CM04S1 is currently being evaluated in two Phase 2 clinical trials, focused on populations at greatest risk from COVID-19 complications, including blood cancer patients scheduled to receive stem cell transplant therapy. In one of the ongoing Phase 2 trials, the mRNA control arm was discontinued due to poor immunogenicity with the remainder of the trial only including GEO-CM04S1 which surpassed the immunogenicity target, reinforcing the limitations of monovalent vaccines and the important value of a multi-antigen vaccine approach in such high-risk patient populations. "There are more than 40 million immunocompromised individuals in the U.S. alone," said Dodd. "They are underserved by the current, FDA-approved vaccine options that deliver only an antibody response and require a better solution with both breadth and longevity of protection." Public Vaccine Policy and Regulatory Changes Support Platform Diversification Recent guidance from the U.S. Food and Drug Administration (FDA) calls for diversified vaccine platforms and risk-based regulatory pathways. Additionally, the CDC's narrowed 20252026 booster recommendations - now focused on adults 65+ and immunocompromised individuals - closely mirror GeoVax's clinical strategy and target population. GEO-CM04S1 has been proposed under BARDA's Rapid Response Partnership Vehicle (RRPV) for surge manufacturing support and integration into long-term public health preparedness efforts. The proposal, "Innovation in Clinical Manufacturing of MVA-Vectored COVID-19 Vaccines", was selected by the RRPV, pending funding availability. "As public health moves toward more targeted, durable, and inclusive vaccination strategies, GEO-CM04S1 is positioned to deliver where first generation COVID-19 vaccines fall short," Dodd added. In addition to targeting today's variants, GEO-CM04S1 is structurally designed to adapt to future mutations and serve as a platform for multi-pathogen preparedness. As part of GeoVax's broader MVA-based portfolio, the platform underpins vaccine candidates for Mpox, smallpox, and hemorrhagic fever viruses, offering scale and flexibility across infectious disease threats. About GeoVax GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumor cancers. The Company's lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin(R), having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax is also developing a vaccine targeting Mpox and smallpox and, based on recent regulatory guidance, anticipates progressing directly to a Phase 3 clinical evaluation, omitting Phase 1 and Phase 2 trials. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. For more information about the current status of our clinical trials and other updates, visit our website: Forward-Looking Statements This release contains forward-looking statements regarding GeoVax's 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 to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax's immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax's 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, GeoVax's immuno-oncology products and preventative vaccines will be safe for human use, GeoVax's vaccines will effectively prevent targeted infections in humans, GeoVax's 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 GeoVax's 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 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 law. Company Contact:info@ Investor Relations Contact:geovax@ Media Contact:Jessica Starmanmedia@ Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Associated Press
17-06-2025
- Health
- Associated Press
GeoVax Highlights Positive Immune Response Results From GEO-CM04S1 in CLL Patients at the European Hematology Association 2025 Meeting
GEO-CM04S1 Demonstrates Superior T Cell Responses Compared to mRNA Vaccine in Phase 2 Trial Among Immunocompromised Patients ATLANTA, GA - June 17, 2025 ( NEWMEDIAWIRE ) - GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing multi-antigen vaccines and immunotherapies for infectious diseases and cancer, today highlighted new clinical data presented at the 2025 European Hematology Association (EHA) Hybrid Congress, which took place June 12-15 in Milan, Italy. The data were featured in a poster presentation by Alexey V. Danilov, M.D., Ph.D., Associate Director of the Toni Stephenson Lymphoma Center and Professor in the Department of Hematology and Hematopoietic Cell Transplantation at City of Hope Comprehensive Cancer Center in Duarte, California. The poster titled 'MVA-Based GEO-CM04S1 Vaccine Results in Improved Cellular Immune Response in Patients with Chronic Lymphocytic Leukemia (CLL) Compared with mRNA-Based Vaccine: Initial Results of a Phase II Randomized Study', detailed findings from an ongoing randomized Phase 2 clinical trial (NCT05672355), and highlighted interim results showing superior cellular immune responses induced by GEO-CM04S1 compared to those induced by an authorized mRNA-based COVID-19 vaccine in CLL patients, a population known to exhibit suboptimal protective responses to COVID-19 and other vaccines due to immune dysfunction. Key Findings from the Study 'These findings reinforce the clinical and immunologic advantages of our multi-antigen approach,' said Kelly T. McKee, Jr., M.D., Chief Medical Officer of GeoVax. 'GEO-CM04S1's robust cellular response in immunocompromised individuals, especially patients with hematologic malignancies like CLL, provides further validation of our MVA platform's potential to address critical gaps in COVID-19 protection.' About GEO-CM04S1 GEO-CM04S1 is a next-generation COVID-19 vaccine based on a synthetic Modified Vaccinia Ankara (MVA) vector. Unlike single-antigen vaccines, it expresses both the Spike (S) and Nucleocapsid (N) proteins of SARS-CoV-2, aiming to provide broader, cross-reactive, and more durable immunity. The vaccine is currently being evaluated in three Phase 2 clinical trials across various patient populations, including immunocompromised individuals and healthy adults. About GeoVax GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumor cancers. The Company's lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin(R), having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax is also developing a vaccine targeting Mpox and smallpox and, based on recent regulatory guidance, anticipates progressing directly to a Phase 3 clinical evaluation, omitting Phase 1 and Phase 2 trials. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. For more information about the current status of our clinical trials and other updates, visit our website: Forward-Looking Statements This release contains forward-looking statements regarding GeoVax's 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 to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax's immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax's 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, GeoVax's immuno-oncology products and preventative vaccines will be safe for human use, GeoVax's vaccines will effectively prevent targeted infections in humans, GeoVax's 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 GeoVax's 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 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 law. Company Contact: [email protected] 678-384-7220 Investor Relations Contact: [email protected] 212-698-8696 Media Contact: Jessica Starman [email protected]
Yahoo
12-06-2025
- Business
- Yahoo
GeoVax to Participate in BIO International Convention 2025
ATLANTA, GA - June 12, 2025 (NEWMEDIAWIRE) - GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing multi-antigen vaccines and immunotherapies, today announced that company representatives will attend the 2025 BIO International Convention being held June 16-19, 2025 at the Boston Convention and Exhibition Center in Boston, Massachusetts. The BIO International Convention is the world's largest gathering of the biotechnology industry, attracting thousands of biotechnology and pharmaceutical executives from around the globe. The event provides an ideal venue for companies to engage with potential partners, investors, and policymakers. During the convention, GeoVax will participate in business development and partnering meetings to discuss its expanding pipeline of infectious disease and cancer immunotherapies, including GEO-MVA, a Modified Vaccinia Ankara (MVA)-based vaccine targeting Mpox and smallpox; GEO-CM04S1, a multi-antigen COVID-19 vaccine candidate; and Gedeptin(R), a gene-directed enzyme prodrug therapy for the treatment of solid tumors. GeoVax's participation at BIO 2025 supports its broader business development strategy, including ongoing efforts to establish strategic partnerships, expand manufacturing capabilities, and align with public and private sector priorities in pandemic preparedness, oncology, and biodefense. About GeoVax GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumor cancers. The Company's lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin(R), having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. The Company is also developing GEO-MVA, a vaccine targeting Mpox and smallpox. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. For more information about the current status of our clinical trials and other updates, visit our website: Company Contact:info@ Investor Relationsgeovax@ Contact: Media Contact:Jessica Starmanmedia@ View the original release on Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
10-06-2025
- Health
- Yahoo
GeoVax Announces Upcoming Presentation at the European Hematology Association 2025 Congress Highlighting Positive Immune Response Data for GEO-CM04S1 in CLL Patients
ATLANTA, GA - June 10, 2025 (NEWMEDIAWIRE) - GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing multi-antigen vaccines and immunotherapies against infectious diseases and solid tumors, today announced that clinical data for its next-generation COVID-19 multi-antigen vaccine candidate, GEO-CM04S1, will be presented at the European Hematology Association (EHA) 2025 Hybrid Congress, taking place June 1215, 2025, in Milan, Italy and online. Alexey V. Danilov, M.D., Ph.D., Associate Director of the Toni Stephenson Lymphoma Center and Professor in the Department of Hematology and Hematopoietic Cell Transplantation at the City of Hope Comprehensive Cancer Center in Duarte, California, will present a poster titled: "MVA-Based GEO-CM04S1 Vaccine Results in Improved Cellular Immune Response in Patients with Chronic Lymphocytic Leukemia (CLL) Compared with mRNA-Based Vaccine: Initial Results of a Phase II Randomized Study". The poster will be featured on Saturday, June 14, 2025, from 18:30 to 18:30 CEST in the Poster Hall, as part of the session on Infections in Hematology (including supportive care/therapy). The presentation will highlight initial results from a Phase II randomized clinical trial highlighting the superior cellular immune response of GEO-CM04S1 compared to an authorized mRNA-based COVID-19 vaccine in CLL patients - a population known to exhibit suboptimal protective responses to COVID-19 and other vaccines due to immune dysfunction. The findings will underscore the differentiated mechanism and clinical potential of the GeoVax MVA multi-antigen platform, particularly in immunocompromised individuals. "GEO-CM04S1 continues to show promise as a vaccine option for populations with suboptimal protection from existing COVID-19 vaccines," said Kelly T. McKee, Jr., M.D., Chief Medical Officer of GeoVax. "We are proud to have these important data showcased at EHA2025, reflecting the real-world needs of patients with hematologic malignancies." About GEO-CM04S1 GEO-CM04S1 is a multi-antigen COVID-19 vaccine designed using a synthetic Modified Vaccinia Ankara (MVA) vector platform. The vaccine expresses both spike (S) and nucleocapsid (N) antigens of SARS-CoV-2, aiming to provide broader and more durable immune protection. It is currently being evaluated in Phase 2 clinical trials in both immunocompromised and healthy adults. About GeoVax GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumor cancers. The Company's lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin(R), having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. The Company is also developing GEO-MVA, a vaccine targeting Mpox and smallpox. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. For more information about the current status of our clinical trials and other updates, visit our website: Company Contact:info@ Investor Relations Contact:geovax@ Sign in to access your portfolio
Associated Press
04-06-2025
- Business
- Associated Press
GeoVax to Showcase Innovative COVID 19 Vaccine Data at the Keystone Symposia on Vaccinology
Data from Two Key Studies Highlight Cross‑Reactivity and Broad‑Spectrum Immunity of GEO-CM04S1 and GeoVax Multi-Antigen Vaccine Technology ATLANTA, GA - June 4, 2025 ( NEWMEDIAWIRE ) - GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing multi-antigen vaccines and immunotherapies, today announced that members of its scientific team and academic collaborators will present two pivotal poster presentations at the upcoming Keystone Symposia on Vaccinology: Horizons Across Disease, Demography and Technology, June 4-7, 2025, in Washington DC. These presentations, sharing data advancing GeoVax's portfolio in the battle against COVID‑19 and emerging variants, will be featured in the following sessions: 'These presentations underscore our commitment to advancing innovative MVA-vaccine vector-based strategies to optimally target the continually evolving SARS-CoV2 virus,' said Mark Newman, PhD, Chief Scientific Officer at GeoVax. 'The data we are sharing at the Keystone conference showcase the importance of inducing broadly specific immune responses, specifically T-cell responses to both the Spike and Nucleocapsid viral proteins. We envision use of this type of vaccine in populations where first-generation products have failed to induce optimally efficacious responses, including multiple types of immunocompromised patients.' GeoVax's participation at Keystone further demonstrates its leadership in leveraging next‑generation technologies to combat infectious diseases and reinforce preparedness against emerging variants. The event will bring together experts and innovators from across the globe to discuss the latest advancements in the field. For more information on the Keystone Conference, please visit the Keystone Symposia website: About GeoVax GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumor cancers. The Company's lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin(R), having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. The Company is also developing GEO-MVA, a vaccine targeting Mpox and smallpox. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. For more information about the current status of our clinical trials and other updates, visit our website: Company Contact: [email protected] 678-384-7220 Investor Relations Contact: [email protected] 212-698-8696
