Latest news with #GEO-MVA
Associated Press
02-07-2025
- Business
- Associated Press
GeoVax Responds to Growing Mpox Threat With Expedited EU Pathway and Platform Aligned to U.S. Biodefense Objectives
With global cases rising and bipartisan momentum for pandemic preparedness, GeoVax's GEO-MVA vaccine advances on an expedited development track toward commercialization and revenue generation ATLANTA, GA - July 2, 2025 ( NEWMEDIAWIRE ) - GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing multi-antigen vaccines and immunotherapies against infectious diseases and cancer, today emphasized the growing global public health importance of its GEO-MVA Mpox/smallpox vaccine in response to rising public health threats and a rapidly evolving regulatory environment. With favorable regulatory input from the European Medicines Agency (EMA), GEO-MVA is on an expedited path toward market access, accelerating GeoVax's focus toward regulatory approval and commercialization. 'GeoVax is entering a value inflection phase,' said David Dodd, Chairman and CEO. 'The EMA's expedited development path brings us closer to regulatory registration and commercial readiness, providing the opportunity to address urgent public health needs, expanding the critically needed supply option of MVA-vaccine, addressing both expanding outbreak needs and stockpile opportunities.' Modern Platform for Variant-Responsive Stockpiling GeoVax's development-stage continuous avian cell line process is anticipated to provide increased production of MVA-based vaccines, the ability to quickly respond to epidemics and pandemics, local implementation of MVA-based vaccine manufacturing and overall reduced production costs. With confirmed Mpox cases across multiple U.S. states, throughout Europe and new clade Ib outbreaks in West and Central Africa, the urgency for additional MVA-vaccine supply options is increasingly, critically important. 'There is a clear need for diversity in stockpile planning,' Dodd added. 'GEO-MVA is well-positioned to serve as a complementary or alternative solution where current, single-source options fall short. Ending the current monopoly of MVA-vaccine will benefit public health worldwide, providing an expanded supply option of this critically needed vaccine.' EMA Scientific Advice and BARDA RRPV Proposal Expedite Readiness GeoVax recently received favorable Scientific Advice from the EMA, confirming an expedited regulatory development path for GEO-MVA. This milestone enhances the product's standing with international regulatory bodies and opens pathways to revenue-generating opportunities across Europe and beyond. In parallel, GeoVax's advanced MVA-based vaccine manufacturing proposal under BARDA's Rapid Response Partnership Vehicle (RRPV) remains under active review. The program is designed to fund scalable vaccine platforms, eliminating the dependency for stockpiling of MVA-based vaccines relative to high-consequence threats such as smallpox. 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] View the original release on
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
Associated Press
11-06-2025
- Health
- Associated Press
GeoVax Responds to WHO's Fourth Declaration of Mpox as a Global Public Health Emergency
GEO-MVA Provides Potential Opportunity to Expand Mpox Vaccine Supply Amid Growing U.S. and Global Clade 1 Threat ATLANTA, GA - June 11, 2025 ( NEWMEDIAWIRE ) - GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing multi-antigen vaccines and immunotherapies, today issued a statement in response to the World Health Organization's (WHO) fourth declaration of Mpox as a Public Health Emergency of International Concern (PHEIC). The WHO's decision reflects the ongoing global spread of the highly virulent Clade 1 strain of the Mpox virus, which has prompted heightened international concern and a call to action for more robust vaccine strategies. Mpox continues to pose a significant threat to global health, with WHO reporting rising case counts in endemic and non-endemic regions alike. In particular, Clade 1 Mpox - previously confined to Central Africa - is now appearing in Europe, Asia, and North America. In the United States, multiple confirmed Clade 1 cases have been reported across New York, California, Georgia, and New Hampshire. Additionally, Clade 1 viral particles have been detected in wastewater in North Carolina, California, Alabama and Iowa, suggesting silent transmission may be occurring even before symptomatic cases emerge. U.S. and Global Reliance on a Single Supplier Threatens Response Capacity Despite the urgency, the world remains dangerously dependent on a single manufacturer for the preferred Mpox vaccine, based on the Modified Vaccinia Ankara (MVA) platform. This presents significant risks to biosecurity, affordability, and equitable distribution. African nations alone have requested 20 million doses for 2025; global capacity is estimated at only 2–5 million doses annually. GEO-MVA: America's Strategic Vaccine Alternative GeoVax is actively developing GEO-MVA, a U.S.-based MVA vaccine for Mpox and smallpox. GEO-MVA is engineered as an alternative to the existing global supply and has been recognized at global forums as a pivotal component of future pandemic resilience. GeoVax has completed cGMP drug substance manufacturing of GEO-MVA, with fill/finish processes underway. Clinical vials are expected to be available in Q4 '25, enabling clinical trials to begin in 2026. GEO-MVA is also being developed using an advanced continuous avian cell line manufacturing process, intended to: 'WHO's latest declaration underscores that the Mpox crisis is not behind us - it is escalating,' said David Dodd, Chairman & CEO of GeoVax. 'As Clade 1 spreads in the U.S. and globally, we must act now to expand domestic vaccine capacity. Single-source dependency threatens access during geopolitical or logistical disruptions. GEO-MVA offers a scalable, cost-effective, and onshore alternative that supports national security, global equity, and pandemic preparedness.' Strengthening Biosecurity and Public Health Readiness GeoVax is engaged with U.S. federal agencies to align GEO-MVA with government initiatives aimed at onshoring critical pharmaceutical manufacturing and strengthening national pandemic readiness. The company's proposal under BARDA's Rapid Response Partnership Vehicle (RRPV) was selected for award, pending funding, to scale MVA-based vaccine production using advanced U.S. biomanufacturing technologies. GeoVax is calling on global and national policymakers to: 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: 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 Contact: [email protected] 678-384-7220 Investor Relations Contact: [email protected] 212-698-8696
Associated Press
23-04-2025
- Business
- Associated Press
GeoVax to Report First Quarter 2025 Financial Results and Provide Corporate Update on May 1, 2025
GeoVax to Host Conference Call at 4:30 PM ET ATLANTA, GA - April 23, 2025 ( NEWMEDIAWIRE ) - GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing immunotherapies and vaccines against cancer and infectious diseases, today announced that it will report first quarter 2025 financial results on Thursday, May 1, 2025, after the close of U.S. markets. Following the release, management will host a live conference call and webcast, including Q&A, at 4:30 p.m. ET to provide a corporate update and discuss financial results. Conference Call Details To access the live conference call, participants may register here. The live audio webcast of the call will be available under 'Events and Presentations' in the Investor Relations section of the GeoVax website at To participate via telephone, please register in advance here. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. While not required, it is recommended that participants join the call ten minutes prior to the scheduled start. An archive of the audio webcast will be available on GeoVax's website approximately two hours after the conference call and will remain available for at least 90 days following the event. 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 View the original release on
Associated Press
16-04-2025
- Business
- Associated Press
GeoVax Provides Update on BARDA Project NextGen and Outlines 2025 Business Momentum
Company Reaffirms Commitment to Innovation in COVID-19, Oncology, and Biosecurity Amid Strategic Program Developments ATLANTA, GA - April 16, 2025 ( NEWMEDIAWIRE ) - GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies for infectious diseases and cancer, today addressed the termination of its Project NextGen (PNG) award by the Biomedical Advanced Research and Development Authority (BARDA), effective April 11, 2025. The Company also provided a comprehensive business update across its core programs, including the next-generation COVID-19 vaccine (GEO-CM04S1), cancer immunotherapy (Gedeptin(R)), Mpox/smallpox vaccine (GEO-MVA), and advanced MVA manufacturing process. GeoVax expressed disappointment in the HHS/BARDA action but remains committed to the critical medical need addressed by GEO-CM04S1, particularly among the more than 40 million immunocompromised Americans - and over 400 million people globally - who remain inadequately protected by the current authorized COVID-19 vaccines. Thus far, clinical data in support of GEO-CM04S1 demonstrate encouraging support of the potential of GEO-CM04S1 for providing (a) more robust immune response, (b) increased durability and (c) protective immunity for those patients with depleted immune systems inadequately responding to the current authorized COVID-19 vaccines. The Company also noted recent public statements by HHS leadership acknowledging the potential enhanced value of multi-antigen vaccines addressing respiratory viruses. Of special note is that GEO-CM04S1 was the only multi-antigen/polyvalent COVID-19 vaccine candidate selected under the PNG initiative. 'While the recent HHS/BARDA Stop Work Order action was disappointing and surprising, our commitment to protecting vulnerable populations remains unchanged, and our clinical momentum is strong in support of our ongoing Phase 2 GEO-CM04S1 programs,' said David Dodd, Chairman and CEO of GeoVax. Continued Progress Across a Catalyst-Rich Pipeline GEO-CM04S1: Advancing to Meet Unmet COVID-19 Needs GEO-CM04S1 continues to demonstrate potential as both a primary and booster vaccine, especially in immunocompromised patients. Key milestones anticipated during 2025 include: GEO-CM04S1 is a multi-antigen COVID-19 vaccine, utilizing a synthetic-MVA platform, expressing both S and N antigens, offering the potential for broader, more durable protection than current mRNA vaccines. Gedeptin(R): Advancing into Phase 2 in Solid Tumors GeoVax's oncology program, utilizing the Gedeptin(R) technology, is planned to progress to a Phase 2 trial in combination with an immune checkpoint inhibitor for first recurrent head and neck cancer. Gedeptin has received Orphan Drug designation for use among advanced head & neck cancer patients. The Gedeptin technology provides potential for expansion into other solid tumors including triple-negative breast cancer, melanoma, and soft tissue sarcoma. GEO-MVA: Addressing Biosecurity and Global Vaccine Equity GeoVax anticipates initiating clinical trials in 2025 for GEO-MVA, its Mpox/smallpox vaccine candidate. The Company has successfully produced cGMP clinical product and is focused on completing the vaccine vialing in support of initiating clinical evaluation during H2 2025. GEO-MVA positions GeoVax to offer a U.S.-developed alternative to foreign-sourced vaccines amid rising global biosecurity threats and constrained supply. Advanced Manufacturing: Scaling MVA for Global Reach GeoVax is advancing continuous cell line manufacturing for MVA-based vaccines, offering a path to scalable, cost-effective production - including localized manufacturing for low- and middle-income countries. This innovation addresses critical gaps in vaccine self-sufficiency and supply resilience. Outlook for 2025 Despite the PNG award termination, GeoVax anticipates a milestone-rich 2025 across its portfolio. The Company will continue to engage with government and industry partners, pursue clinical trial completions, and drive innovation through expanded AI integration to optimize development, trial operations, and manufacturing efficiency. 'Our scientific foundation is strong and our strategy is clear,' added Dodd. 'GeoVax remains committed to delivering transformative solutions for unmet medical needs in infectious disease and cancer. We're advancing with purpose and fully prepared to deliver on the promise of our development program.' For further details on GeoVax's programs and progress, visit 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: 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 View the original release on
