Latest news with #DavidDodd
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
03-07-2025
- Health
- Associated Press
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 2025–2026 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: [email protected] 678-384-7220 Investor Relations Contact: [email protected] 212-698-8696 Media Contact: Jessica Starman [email protected]
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
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
21-05-2025
- Business
- Associated Press
GeoVax Applauds EQUIP-A-Pharma Initiative, Reinforces Commitment to Domestic Vaccine Manufacturing and Biodefense Innovation
GeoVax's Advanced MVA Manufacturing Platform Supports ASPR-DARPA Vision for Scalable, AI-Integrated Pharmaceutical Production ATLANTA, GA - May 21, 2025 ( NEWMEDIAWIRE ) - GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company focused on developing vaccines and immunotherapies for infectious diseases and cancer, today welcomed the launch of the EQUIP-A-Pharma initiative - a new joint program between the U.S Department of Health and Human Services (HHS), Administration for Strategic Preparedness and Response (ASPR), the Defense Advanced Research Projects Agency (DARPA), and the private sector. This bold collaboration with private industry seeks to transform pharmaceutical manufacturing by leveraging artificial intelligence and next-generation platforms to expand U.S. production capacity and improve supply chain resilience. David Dodd, Chairman and CEO of GeoVax, commented: 'The EQUIP-A-Pharma initiative is a major step toward strengthening the domestic biomanufacturing backbone our country urgently needs. GeoVax has long championed the same goals this program now advances - self-reliant, scalable, and rapid production of critical medicines. Our advanced MVA manufacturing platform aligns perfectly with this mission, and we stand ready to support the federal government's vision of pharmaceutical independence and pandemic resilience.' GeoVax's Alignment with EQUIP-A-Pharma GeoVax is advancing a next-generation manufacturing platform for its Modified Vaccinia Ankara (MVA) vaccine technology - a platform that eliminates reliance on pathogen-free eggs and instead uses a continuous avian cell line system compatible with existing U.S. GMP infrastructure. This enables: The MVA platform underpins GeoVax's pipeline of multi-antigen vaccines, including its lead candidates GEO-CM04S1 (COVID-19) and GEO-MVA (Mpox and smallpox), and was recently selected under the Biomedical Advanced Research and Development Authority's Rapid Response Partnership Vehicle (RRPV) for further development, pending funding availability. A Strategic Partner for National Health Security GeoVax's domestic manufacturing strategy directly addresses vulnerabilities identified in recent biodefense reviews and the National Strategic Stockpile shortfalls highlighted by the Mpox outbreak. The Company continues to advocate for robust public-private collaboration to accelerate the deployment of resilient, U.S.-sourced medical countermeasures. Dodd concluded: 'GeoVax is committed to delivering scalable solutions that align with the Administration's priorities - from HHS to DARPA to BARDA. EQUIP-A-Pharma represents the future of biomanufacturing in the United States, and we are proud to be among the companies positioned to help build that future.' 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
