Latest news with #ModifiedVacciniaAnkara
Associated Press
03-03-2025
- Business
- Associated Press
GeoVax Highlights the Critical Role of MVA-Based Vaccines in U.S. Biodefense Strategy
GeoVax's GEO-MVA: Strengthening U.S. Biodefense ATLANTA, GA - March 3, 2025 ( NEWMEDIAWIRE) - GeoVax Labs, Inc. (Nasdaq: GOVX), a leader in developing vaccines and immunotherapies for infectious diseases and cancer, underscores the strategic importance of its Modified Vaccinia Ankara (MVA) vaccine platform in helping to bolster U.S. biodefense capabilities. Efforts in MVA vaccine design and manufacturing improvements align with key recommendations from the recent " Bolstering U.S. Biodefense: Recommendations For The New Administration' report, published by the Janne E. Nolan Center on Strategic Weapons at the Council on Strategic Risks, a respected think tank specializing in national security and biodefense policy. The report emphasizes the need for robust, diversified medical countermeasures to protect national and global security. Addressing Biodefense Gaps with MVA-Based Solutions The 'Bolstering U.S. Biodefense' report highlights the urgency of strengthening U.S. preparedness against biological threats, including deliberate attacks, emerging infectious diseases, and supply chain vulnerabilities. GeoVax's efforts towards the development of MVA-based vaccines, including GEO-MVA for vaccination against Mpox and smallpox, and efforts to transition to a next-generation manufacturing platform utilizing a continuous avian cell line, directly align with these national security objectives: Vaccine Supply Chain Resilience: Current reliance on a single non-U.S. manufacturer for critical vaccines, such as MVA, poses a national security risk. GeoVax's efforts to transition to a next generation manufacturing platform should allow for the use of existing domestic manufacturing facilities, leading to a reduced dependence on foreign suppliers and enhancing supply chain security. Advanced Biomanufacturing for Scalability: The biodefense report calls for investment in next-generation biomanufacturing. GeoVax is developing a continuous cell line-based MVA manufacturing platform that it expects will result in rapid, high-volume vaccine production, which is currently not feasible utilizing existing MVA directed manufacturing platforms Diverse Medical Countermeasures for Threat Readiness: The Department of Defense's Biodefense Posture Review and National Biodefense Strategy emphasize the need for multiple vaccine approaches. GeoVax's MVA platform complements mRNA and protein-based vaccines, ensuring a broader and more resilient national preparedness framework. Strategic National Stockpile Shortfalls: The 2022 Mpox epidemic revealed significant vaccine shortages in the National Strategic Stockpile, leaving public health officials unable to meet urgent demand. The reliance on a single foreign supplier for any vaccine can further exacerbate these challenges, reinforcing the need for a diversified, U.S.-based vaccine supply. Relevance to the New HHS Administration The transition of leadership at the U.S. Department of Health and Human Services (HHS) presents a pivotal moment for vaccine policy and national preparedness. The Administration has emphasized transparency, safety, and domestic vaccine manufacturing, aligning closely with GeoVax's mission. Alignment with National Health Security Goals: GeoVax's focus on U.S.-based vaccine production supports HHS's priority of reducing dependency on foreign pharmaceutical supply chains, ensuring America's self-sufficiency in pandemic preparedness. Advancing a Diversified Vaccine Portfolio: With a growing consensus that a single vaccine platform is unable to address the breadth of infectious disease concerns, there is a clear recognition of the benefits of having multiple alternative vaccine platforms available. GeoVax's MVA-based approach provides a proven, durable, and safe alternative, reinforcing a well-rounded immunization strategy. Public Trust and Transparency: Given the call for increased scrutiny of vaccine development, GeoVax is committed to transparency, publishing full clinical trial results and working collaboratively with HHS to foster public confidence. Policy Action to Strengthen U.S. Biodefense GeoVax urges policymakers to act swiftly in supporting domestic vaccine production and biodefense innovation. Key recommendations include: Expanding Federal Investment in MVA-Based Vaccines: Increased funding from BARDA, the Department of Defense, and the NIH to accelerate the development, next-generation manufacturing scale up and deployment of GEO-MVA. Accelerating Regulatory Approvals: Streamlined pathways for emergency use authorization and priority review of MVA-based vaccines to strengthen national preparedness. Public-Private Partnerships: Enhanced collaboration between government agencies, biotechnology firms, and global health organizations to integrate MVA-based solutions into pandemic and biodefense planning. A Call for Action 'The 'Bolstering U.S. Biodefense' report clearly articulates the vulnerabilities in our national health security framework. GeoVax is committed to helping address these gaps with our MVA-based vaccines and next-generation manufacturing capabilities,' said David Dodd, Chairman & CEO of GeoVax. 'With a new HHS administration, there is a timely opportunity to strengthen domestic vaccine infrastructure and ensure greater national resilience against emerging threats.' GeoVax remains dedicated to advancing innovative, scalable, and accessible vaccine solutions to safeguard public health and national security. References: Council on Strategic Risks. (2025). Bolstering U.S. Biodefense: Strengthening the Nation's Response to Biological Threats. Janne E. Nolan Center on Strategic Weapons. Retrieved from About GeoVax GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines for many of the world's most threatening infectious diseases and therapies for solid tumor cancers. The company's lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine for which GeoVax was recently awarded a BARDA-funded contract to sponsor a 10,000-participant Phase 2b clinical trial to evaluate the efficacy of GEO-CM04S1 versus an approved COVID-19 vaccine. In addition, GEO-CM04S1 is 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. A Phase 2 clinical trial in first recurrent head and neck cancer, evaluating Gedeptin(R) combined with an immune checkpoint inhibitor is planned. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. The Company has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. 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. 678-384-7220 212-698-8696 Media Contact: 202-779-0929
Yahoo
24-02-2025
- Health
- Yahoo
GeoVax Highlights the Role of MVA-Based Vaccines in Advancing Public Health Preparedness
Recent Studies Support Diversified Vaccine Strategies, Aligning with GeoVax's MVA-Based GEO-CM04S1 for Enhanced Protection, Particularly for Immunocompromised Populations ATLANTA, GA - February 24, 2025 (NEWMEDIAWIRE) - GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company specializing in immunotherapies and vaccines, today reaffirms the critical role that mRNA vaccines have played in combating the COVID-19 pandemic and highlights the growing recognition of the need for complementary vaccine platforms, particularly for immunocompromised patients and those requiring broader, more durable immunity. The rapid development and deployment of mRNA vaccines were pivotal in mitigating the initial impact of the pandemic, offering a timely and effective response. However, the scientific literature continues to underscore the importance of a diversified vaccine strategy directed towards enhanced durability and expanded protection against variants for populations that may not mount a sufficiently strong immune response to a single vaccine platform. GeoVax's Modified Vaccinia Ankara (MVA)-based vaccine candidates, such as GEO-CM04S1 (COVID-19), may complement other existing vaccine platforms by addressing specific challenges. Building a More Resilient Vaccine Landscape Recent scholarly analyses, including research from leading experts [1] and a strategic review by the Biomedical Advanced Research and Development Authority (BARDA) [2], stress the importance of broadening vaccine portfolios beyond mRNA. These publications highlight areas where alternative vaccine platforms, such as viral-vector and live-attenuated vaccines, may provide advantages in durability, cellular immunity, and accessibility. GeoVax's MVA-based vaccines may offer an alternative approach, by utilizing a well-established vaccine vector, particularly in high-risk populations. Unlike current mRNA COVID-19 vaccines, GEO-CM04S1 expresses both the Spike (S) and Nucleocapsid (N) antigens, to elicit a broader immune response. This enhanced immunogenicity may be especially valuable for immunocompromised individuals, including transplant recipients and cancer patients, who often exhibit suboptimal responses to mRNA vaccines. GeoVax's MVA-based COVID-19 vaccine can serve as an important addition to the global immunization strategy by offering: Enhanced Immune Response: The inclusion of both Spike and Nucleocapsid antigens in GEO-CM04S1 is intended to elicit a more comprehensive immune response, potentially reducing the need for frequent boosters. Durability and Broader Variant Protection: Studies suggest measures of T-cell responses induced by GEO-CM04S1 elicit protection against emerging variants, minimizing the need for frequent reformulation. Better Suitability for Immunocompromised Populations: Clinical trials demonstrate that GEO-CM04S1 elicits robust T-cell responses in patients unable to generate adequate antibody responses to conventional (spike-only) COVID-19 vaccines. This is critical for individuals with immune systems compromised by disease (e.g. cancers, genetic defects) or immunosuppressive therapies. Scalability and Global Accessibility: GeoVax is further addressing vaccine availability with plans to transition manufacturing to a Next-Generation MVA manufacturing platform, with the potential for improved production efficiency and reduced costs, facilitating global distribution. A Proven Technology with a Strong Safety Record MVA was originally developed as a safer smallpox vaccine. MVA-based vaccines have been safely administered for decades. MVA's extensive track record aligns with the U.S. Department of Health and Human Services' (HHS) emphasis on vaccine safety, durability, and transparency. The well-documented safety and efficacy of MVA-based vaccines positions them as an important complement to existing mRNA-based approaches. Government and Industry Support for Diversified Vaccine Strategies Under BARDA's $5 billion Project NextGen initiative, GeoVax was awarded a contract to conduct a 10,000-participant Phase 2b clinical trial evaluating an Omicron-updated version of GEO-CM04S1 in a comparison format against an approved mRNA COVID-19 vaccine. This study aims to validate the value of multi-antigen MVA-based COVID-19 vaccines in long-term pandemic preparedness and protection against future health threats. Positioning for the Future of Vaccine Innovation "The success of mRNA vaccines in responding to COVID-19 has been remarkable, but the evolving nature of infectious diseases calls for a diversified, complementary approach to immunization," said David Dodd, Chairman & CEO of GeoVax. "Our MVA-based vaccines offer enhanced protection for those who need it most, including immunocompromised patients and populations requiring longer-lasting immunity. We are committed to advancing vaccine innovation in collaboration with public and private stakeholders." As the industry moves towards a more integrated and diversified vaccine ecosystem, GeoVax's MVA-based vaccines should provide a scalable, durable, and globally accessible solution that enhances the existing landscape, ensuring broader protection for all populations. References: Plotkin, S. A., Robinson, J. M., Fitchett, J. R. A., & Gershburg, E. (2024). Vaccine development should be polytheistic, not monotheistic. Clinical Infectious Diseases, 79(6), 15181520. Parish, L. A., Rele, S., Hofmeyer, K. A., Luck, B. B., & Wolfe, D. N. (2025). Strategic and technical considerations in manufacturing viral vector vaccines for the Biomedical Advanced Research and Development Authority threats. Vaccines, 13(73). About GeoVax GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines for many of the world's most threatening infectious diseases and therapies for solid tumor cancers. The company's lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine for which GeoVax was recently awarded a BARDA-funded contract to sponsor a 10,000-participant Phase 2b clinical trial to evaluate the efficacy of GEO-CM04S1 versus an approved COVID-19 vaccine. In addition, GEO-CM04S1 is 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. A Phase 2 clinical trial in first recurrent head and neck cancer, evaluating Gedeptin(R) combined with an immune checkpoint inhibitor is planned. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. The Company has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. 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: Media Contact:sr@ View the original release on
Associated Press
18-02-2025
- Business
- Associated Press
GeoVax Pledges Continued Support for Vaccine Innovation, Transparency, and Public Health
GeoVax's Vaccine Development Programs Align with Anticipated HHS Focus on Vaccine Safety, Diversification and Domestic Biosecurity ATLANTA, GA - February 18, 2025 ( NEWMEDIAWIRE) - GeoVax Labs, Inc. (Nasdaq: GOVX), a leader in vaccine and immunotherapy development, congratulates Robert F. Kennedy, Jr. on his confirmation as Secretary of the U.S. Department of Health and Human Services (HHS). RFK Jr.'s appointment provides a significant opportunity for healthcare innovation, transparency, and public trust, reinforcing national priorities such as vaccine safety, diversified vaccine platforms, and strengthened domestic manufacturing. GeoVax stands ready to support these initiatives by delivering next-generation vaccines and advanced vaccine manufacturing technology that enhance biosecurity, public health resilience, and vaccine confidence. GeoVax's Commitment to a Robust, Transparent and Secure Vaccine Future GeoVax's mission aligns closely with the new administration's policy priorities, particularly in reducing reliance on foreign pharmaceutical supply chains, increasing vaccine safety and durability, and ensuring access for underserved populations. The Company's proprietary Modified Vaccinia Ankara (MVA) platform offers a promising alternative to other vaccine technologies such as mRNA, providing broad-spectrum, durable immunity across multiple infectious diseases via a recognized safe vaccine platform. Key initiatives supporting the goals for vaccine safety and transparency include: Diversified Vaccine Development – GeoVax's GEO-CM04S1, a next-generation COVID-19 vaccine, and GEO-MVA, a dual-purpose Mpox and smallpox vaccine, align with the advocacy for alternative vaccine platforms beyond mRNA. These vaccines are designed to offer long-term immunity with a well-documented safety profile. Transparency as a Pillar of Public Trust – As David Dodd, Chairman and CEO of GeoVax, has emphasized, restoring trust in vaccines requires clear communication, open regulatory processes, and full transparency regarding safety, efficacy, and potential risks. GeoVax supports the call for greater industry accountability and public engagement, ensuring that vaccine development aligns with the highest standards of ethical science. Strengthening U.S. Biosecurity – GeoVax's anticipated domestic vaccine manufacturing capabilities reinforce the bipartisan legislative commitment to reducing dependence on foreign pharmaceutical supply chains, thereby enhancing national pandemic preparedness. Ethical Vaccine Development & Public Confidence – GeoVax embraces open regulatory processes, rigorous safety standards, and public access to data, ensuring confidence in its vaccines. These principles align with the call for increased scrutiny and transparency in vaccine development and approval. Equitable Access & Global Preparedness – With cost-effective, scalable technology that does not require ultra-cold storage, GeoVax's vaccines are well-suited for domestic and global distribution, ensuring broad access to critical immunizations, particularly for immunocompromised and underserved communities. David Dodd: 'Transparency is the Key to Restoring Vaccine Trust' Reflecting on the challenges of vaccine hesitancy, David Dodd has been a vocal advocate for transparency in vaccine development and regulatory processes. In a recent op-ed, he emphasized: 'Trust in vaccines has become a critical battleground for public health. Addressing public concerns openly and honestly is the only way to bridge the growing divide between science and skepticism. Transparency is a necessity, not an option. GeoVax remains committed to clear communication, scientific integrity, and ensuring that public confidence in vaccines is based on facts, not fear.' ( This perspective directly supports the stated goals of strengthening public trust, reducing regulatory opacity, and ensuring vaccine safety through independent oversight. GeoVax's proactive approach to transparent vaccine development is a model for responsible biotech leadership. A New Era for U.S. Healthcare and Pandemic Preparedness RFK Jr.'s confirmation as HHS Secretary provides a renewed opportunity in support of vaccine diversification, transparency, and strategic biomanufacturing initiatives. GeoVax's innovative vaccine pipeline supports these goals, positioning the Company as a vital partner in safeguarding national and global public health. GeoVax's vaccine development strategy builds upon successful national initiatives, such as Operation Warp Speed and Project NextGen, by prioritizing pandemic preparedness and biosecurity resilience. Through continued engagement with federal agencies and global health organizations, the Company seeks to accelerate vaccine development, expand domestic manufacturing, and enhance pandemic response efforts. David Dodd, Chairman and CEO of GeoVax, stated: 'Secretary Kennedy's confirmation presents an opportunity to redefine public health with greater emphasis on safety, accessibility, and innovation. GeoVax proudly supports the commitment to reducing dependence on foreign pharmaceutical supply chains, diversifying vaccine technology, and restoring trust in public health solutions. We stand ready to collaborate with HHS and other healthcare stakeholders to advance a safer, more resilient healthcare future.' About GeoVax GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines for many of the world's most threatening infectious diseases and therapies for solid tumor cancers. The company's lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine for which GeoVax was recently awarded a BARDA-funded contract to sponsor a 10,000-participant Phase 2b clinical trial to evaluate the efficacy of GEO-CM04S1 versus an approved COVID-19 vaccine. In addition, GEO-CM04S1 is 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. A Phase 2 clinical trial in first recurrent head and neck cancer, evaluating Gedeptin(R) combined with an immune checkpoint inhibitor is planned. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. The Company has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. 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. 678-384-7220 212-698-8696 Media Contact: 202-779-0929
Yahoo
27-01-2025
- Business
- Yahoo
GeoVax Advanced MVA Manufacturing Process: Aimed to Enhance Vaccine Supply Worldwide
Process Expected to Increase Production Yield, Flexibility at Lower Cost ATLANTA, GA - January 27, 2025 (NEWMEDIAWIRE) - GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company specializing in vaccines and immunotherapies, has shared updates about its development-stage advanced Modified Vaccinia Ankara (MVA) vaccine manufacturing process. This anticipated process provides the potential to not only address today's pressing health challenges but also paves the way for more efficient, flexible and lower-cost MVA-vaccine manufacturing. The Power and Versatility of the MVA Platform The MVA platform is uniquely designed to incorporate multiple antigens into a single vaccine. This versatility allows GeoVax to develop vaccines targeting multiple aspects of a single pathogen or several pathogens simultaneously. Originally developed as a safer smallpox vaccine, the MVA platform offers distinct advantages, including: Protection against diseases such as Mpox and smallpox. Multi-antigen vaccines like GEO-CM04S1, which targets both the Spike (S) and Nucleocapsid (N) antigens of SARS-CoV-2. Stability under minimal refrigeration and the potential for freeze-drying (lyophilization), simplifying distribution in resource-limited settings. Advancing MVA Manufacturing Current vaccine manufacturing methods rely on Chicken Embryo Fibroblast (CEF) cells, requiring pathogen-free eggs. This process is costly, time-consuming, and dependent on limited egg supplies, providing barriers to rapid, real-time MVA manufacturing, as well as hindering the flexibility necessary to establish local MVA manufacturing of critically important vaccines. GeoVax is addressing these barriers through an advanced MVA Manufacturing process utilizing an avian cell line licensed from ProBioGen AG (Berlin). Key features include: A continuous avian suspension cell line process that eliminates the need for pathogen-free eggs. Compatibility with standard manufacturing equipment, reducing setup time, simplifying the MVA manufacturing process, increasing scalability and lowering manufacturing costs. This advanced MVA manufacturing process is expected to significantly simplify vaccine production, particularly in middle- and low-income regions where supply chain issues often hinder access to critical vaccines. Addressing Global Health Needs "Our advanced MVA manufacturing process represents not only a transformative manufacturing advance but also addresses a public health imperative," said David Dodd, Chairman and CEO of GeoVax. "By tackling disease protection, logistical hurdles, and manufacturing challenges, we aim to empower regions like Africa with the tools needed to combat current and future health crises." GeoVax's MVA vaccines have demonstrated robust performance in clinical trials, with ongoing Phase 2 studies for GEO-CM04S1, its COVID-19 vaccine candidate, showing broad and durable immune responses. Supported by its BARDA Project NextGen Award and partnerships with leading manufacturing and development organizations, GeoVax is positioned to enhance vaccine access and delivery on a global scale. Recent Conference Presentations GeoVax CEO David Dodd recently presented the company's strategic initiatives and the potential of GEO-MVA at: Biotech Showcase: January 14, 2025 Emerging Growth Conference: January 16, 2025 About GeoVax GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines for many of the world's most threatening infectious diseases and therapies for solid tumor cancers. The company's lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine for which GeoVax was recently awarded a BARDA-funded contract to sponsor a 10,000-participant Phase 2b clinical trial to evaluate the efficacy of GEO-CM04S1 versus an approved COVID-19 vaccine. In addition, GEO-CM04S1 is 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. A Phase 2 clinical trial in first recurrent head and neck cancer, evaluating Gedeptin(R) combined with an immune checkpoint inhibitor is planned to initiate in mid-2025. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. The Company has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. 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: Investor Relations Contact: Media Contact: info@ sr@ 678-384-7220 212-698-8696 202-779-0929 Sign in to access your portfolio
Associated Press
27-01-2025
- Business
- Associated Press
GeoVax Advanced MVA Manufacturing Process: Aimed to Enhance Vaccine Supply Worldwide
Process Expected to Increase Production Yield, Flexibility at Lower Cost ATLANTA, GA - January 27, 2025 ( NEWMEDIAWIRE) - GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company specializing in vaccines and immunotherapies, has shared updates about its development-stage advanced Modified Vaccinia Ankara (MVA) vaccine manufacturing process. This anticipated process provides the potential to not only address today's pressing health challenges but also paves the way for more efficient, flexible and lower-cost MVA-vaccine manufacturing. The Power and Versatility of the MVA Platform The MVA platform is uniquely designed to incorporate multiple antigens into a single vaccine. This versatility allows GeoVax to develop vaccines targeting multiple aspects of a single pathogen or several pathogens simultaneously. Originally developed as a safer smallpox vaccine, the MVA platform offers distinct advantages, including: Protection against diseases such as Mpox and smallpox. Multi-antigen vaccines like GEO-CM04S1, which targets both the Spike (S) and Nucleocapsid (N) antigens of SARS-CoV-2. Stability under minimal refrigeration and the potential for freeze-drying (lyophilization), simplifying distribution in resource-limited settings. Advancing MVA Manufacturing Current vaccine manufacturing methods rely on Chicken Embryo Fibroblast (CEF) cells, requiring pathogen-free eggs. This process is costly, time-consuming, and dependent on limited egg supplies, providing barriers to rapid, real-time MVA manufacturing, as well as hindering the flexibility necessary to establish local MVA manufacturing of critically important vaccines. GeoVax is addressing these barriers through an advanced MVA Manufacturing process utilizing an avian cell line licensed from ProBioGen AG (Berlin). Key features include: A continuous avian suspension cell line process that eliminates the need for pathogen-free eggs. Compatibility with standard manufacturing equipment, reducing setup time, simplifying the MVA manufacturing process, increasing scalability and lowering manufacturing costs. This advanced MVA manufacturing process is expected to significantly simplify vaccine production, particularly in middle- and low-income regions where supply chain issues often hinder access to critical vaccines. Addressing Global Health Needs 'Our advanced MVA manufacturing process represents not only a transformative manufacturing advance but also addresses a public health imperative,' said David Dodd, Chairman and CEO of GeoVax. 'By tackling disease protection, logistical hurdles, and manufacturing challenges, we aim to empower regions like Africa with the tools needed to combat current and future health crises.' GeoVax's MVA vaccines have demonstrated robust performance in clinical trials, with ongoing Phase 2 studies for GEO-CM04S1, its COVID-19 vaccine candidate, showing broad and durable immune responses. Supported by its BARDA Project NextGen Award and partnerships with leading manufacturing and development organizations, GeoVax is positioned to enhance vaccine access and delivery on a global scale. Recent Conference Presentations GeoVax CEO David Dodd recently presented the company's strategic initiatives and the potential of GEO-MVA at: Biotech Showcase: January 14, 2025 Emerging Growth Conference: January 16, 2025 About GeoVax GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines for many of the world's most threatening infectious diseases and therapies for solid tumor cancers. The company's lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine for which GeoVax was recently awarded a BARDA-funded contract to sponsor a 10,000-participant Phase 2b clinical trial to evaluate the efficacy of GEO-CM04S1 versus an approved COVID-19 vaccine. In addition, GEO-CM04S1 is 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. A Phase 2 clinical trial in first recurrent head and neck cancer, evaluating Gedeptin(R) combined with an immune checkpoint inhibitor is planned to initiate in mid-2025. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. The Company has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. 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.
