Latest news with #Gedeptin
Associated Press
07-05-2025
- Business
- Associated Press
GeoVax Expands Gedeptin(R) Patent Portfolio
Allowed Patent Claims Cover the Synergistic Combination of Gedeptin(R) Therapy with Radiation As a Targeted Approach for Solid Tumors ATLANTA, GA - May 7, 2025 ( NEWMEDIAWIRE ) - GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing immunotherapies and vaccines against solid tumors and infectious diseases, announced today that the U.S. Patent and Trademark Office has issued a Notice of Allowance related to U.S. patent application 17/502,101 entitled 'Enhanced Therapeutic Usage of a Purine Nucleoside Phosphorylase or Nucleoside Hydrolase Prodrug'. The allowed claims further strengthen GeoVax's intellectual property position in the oncology space. The allowed claims describe a method for treating solid tumors - including glioblastoma, breast, prostate, head and neck, glioma, and lung cancers - through the direct intratumoral administration of an adenoviral vector encoding purine nucleoside phosphorylase (Ad/PNP), followed by local administration of the prodrug fludarabine phosphate (F-araAMP), and subsequent radiation therapy. This triple-combination strategy is designed to generate local, targeted cytotoxic activity within the tumor microenvironment while minimizing systemic toxicity. The allowed patent joins the growing Gedeptin intellectual property portfolio, which was exclusively licensed to GeoVax through a prior agreement with PNP Therapeutics, Inc. and the University of Alabama at Birmingham (UAB)/Southern Research. Under the agreement, GeoVax has assumed all licensing rights and IP prosecution responsibilities for the Gedeptin platform. David Dodd, Chairman and CEO of GeoVax, commented, 'This allowed patent underscores the clinical and commercial promise of our Gedeptin platform and demonstrates our commitment to expanding therapeutic options for patients with difficult-to-treat cancers. While the claims do not directly mirror our ongoing clinical programs, they establish a critical foundation for future directions, including potential integration with advanced delivery systems for tumors that are challenging to access.' Dodd continued, 'The USPTO's recognition of this therapeutic method further validates our approach and underscores the growing value of our wholly owned, co-owned, and in-licensed intellectual property estate, now standing at over 135 granted or pending patent applications spread across 23 distinct patent families.' Having successfully completed a Phase 1/2a study, as monotherapy in advanced head and Neck cancer patients, Gedeptin is scheduled to begin a Phase 2 trial in combination with an Immune Check Inhibitor (ICI) for patients with first recurrence of head and neck cancer. The newly allowed claims provide further protection as GeoVax explores expanded applications, including novel device-based delivery approaches in potential partnership with interventional oncology companies. About Gedeptin Gedeptin is a viral-vectored gene therapy that employs a non-replicating adenoviral vector encoding the E. coli enzyme purine nucleoside phosphorylase (PNP). When injected directly into a tumor and followed by systemic administration of the prodrug fludarabine phosphate, PNP enzymatically converts the prodrug into a cytotoxic metabolite (fluoroadenine), resulting in selective killing of tumor cells by disrupting RNA and protein synthesis. This tumor-targeted approach offers several key advantages: Localized cytotoxicity with reduced systemic side effects, Potential synergy with immune checkpoint inhibitors (ICIs), Applicability across multiple solid tumor types, particularly those accessible for intratumoral injection. Gedeptin will soon be evaluated in a Phase 2 clinical trial for patients with first recurrence of head and neck cancer in combination with an approved ICI. It has been granted Orphan Drug Designation by the U.S. FDA for intratumoral treatment of oral and pharyngeal cancers. 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
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
Associated Press
12-03-2025
- Business
- Associated Press
GeoVax Establishing Strategic Presence in Europe With Initial Footprint in the UK
Hub to Advance Global Vaccine and Immuno-Oncology Development ATLANTA, GA - March 12, 2025 ( NEWMEDIAWIRE) - GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company specializing in the development of immunotherapies and vaccines, today announced its initial steps toward establishing a strategic presence in Europe, with the UK as its initial footprint. This move aligns with the Company's commitment to advancing its vaccine and immunotherapy pipeline through global collaborations. Efforts are underway to identify a UK location best suited to align with GeoVax's development and corporate strategy. The Company already has several established connections in the UK and broader European region, including: Scientific Expertise: Professor Teresa Lambe, a principal investigator at the Oxford Vaccine Group, recently joined GeoVax's Scientific Advisory Board. Professor Lambe played a pivotal role in the development of the Oxford/AstraZeneca COVID-19 vaccine and has extensive experience in vaccine design and evaluation. Manufacturing Partnerships: GeoVax maintains an existing contract development and manufacturing organization (CDMO) relationship with Oxford Biomedica PLC (Oxford, UK), as well as additional collaborations with Oxford Biomedica (France), with facilities in Strasbourg and Lyon. Technology Licensing: The Company has a broad licensing agreement with ProBioGen AG (Berlin, Germany) to utilize their AGE1 continuous avian cell line for the manufacture of MVA vaccines. European Collaborations: GeoVax currently collaborates with multiple European-based service providers and UK academic partners, reinforcing the strategic rationale for establishing a presence within the region. To support this initiative, GeoVax is working closely with Professor Teresa Lambe and clinical investigators and scientists in Oxford and other academic centers across the UK to develop preclinical, translational, and clinical projects supporting its pipeline. Additionally, Dr. Deborah Spencer, a highly regarded expert in industry-academic partnerships and public health development, has recently been retained to facilitate and coordinate initiatives in the UK and Europe. Establishing a strategic presence in Europe will support GeoVax's infectious disease vaccine development efforts and play a key role in advancing Gedeptin(R), the Company's lead immuno-oncology candidate. Currently in clinical development for the treatment of advanced head and neck cancers, Gedeptin is anticipated to be further developed for use with immune checkpoint inhibitors as a potential treatment for various other solid tumors. GeoVax holds worldwide rights to Gedeptin for all indications. 'Expanding our presence into Europe represents a critical milestone for GeoVax as we continue to develop innovative solutions for infectious diseases and oncology, especially in building upon our initial UK footprint,' said David Dodd, President and CEO of GeoVax. 'The globally recognized expertise of our key European collaborators and partners will significantly enhance our research and development capabilities. This expansion underscores our commitment to global collaboration and innovation in both vaccine and immuno-oncology development. As we accelerate the development of our infectious disease vaccine candidates and Gedeptin, we look forward to providing continued updates.' 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
