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GeoVax Anticipates Significant 2025 Progress With Catalyst-Rich Milestones Across Key Programs
GeoVax was awarded a BARDA-funded contract to sponsor a 10,000-participant Phase 2b clinical trial
GeoVax’s MVA-based COVID-19 vaccine can serve as an important addition to the global immunization strategy
GeoVax Response to WHO’s Third Declaration of Mpox as a Public Health Emergency of International Concern
READ THE INVESTOR PRESENTATION HERE
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Hello Everyone,
Let’s get a round of applause going for February. In fact, let’s just give it up for 2025 in general. So far it has been an incredible year for our profiles.
Nobody bats 1000% but we have had some tremendous movers so far this year that we have been able to bring you.
Just last week we profiled a company on Wednesday that saw an average trade of 1.56 on the session. It went up the next day and just 2 days after our profile this one was rocking out on incredible interest and hit 2.56 that session. Thats a 64% move off of the average trade. Some did even better and saw higher potential gains.
Let’s take that one and put it on the wall next the other double and triple digit gainers we have seen so far this year.
We have an extremely exciting situation as we head into another busy week.
Pull up GOVX right away and put it at the top of your screen after you write it down.
This is another company that we have yet to profile here on the newsletter.
When you look back at the year chart you are going to see a lot of that volatility that we love here at Insider.
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®, 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® combined with an immune checkpoint inhibitor is planned to initiate during the first half of 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.
GeoVax Response to WHO’s Third Declaration of Mpox as a Public Health Emergency of International Concern
GeoVax Advancing GEO-MVA Vaccine Candidate to Bolster Global Supply Options
ATLANTA, GA – February 27, 2025 (NEWMEDIAWIRE) – GeoVax Labs, Inc. (Nasdaq: GOVX) commented on today’s statement from The World Health Organization (WHO) concerning Mpox. In its statement the WHO reaffirmed the severity of the ongoing Mpox epidemic, issuing its third declaration within six months of Mpox as a Public Health Emergency of International Concern (PHEIC). This follows the initial declaration on August 14, 2024, and the second on November 22, 2024, underscoring the persistent and escalating nature of the outbreak.
The WHO’s declaration comes as Mpox cases, including the more virulent and transmissible Clade 1B strain, continue to erupt globally, with its geographic spread widening. Since 2022, nearly 128,000 confirmed Mpox cases across 130 countries have been reported. The Democratic Republic of the Congo (DRC) has been particularly hard hit having reported more than 60,000 cases and 1,300 deaths in 2024.
Clade 1 Mpox has now spread beyond Africa with cases reported in France, Germany, India, Sweden, Thailand, the U.K., Canada, the U.S., and other nations. In the United States, Clade 1 Mpox cases have now been confirmed in New York, California, Georgia, and New Hampshire, raising significant concerns about its continued spread. These cases underscore the increasing risk of domestic outbreaks and the urgent need for expanded vaccine access and preparedness.
Vaccine Supply Challenges Persist as Outbreaks Grow
Despite the clear global threat, vaccine supply remains critically insufficient:
- Severe shortages – African health agencies have requested 20 million doses in 2025, yet only 2-5 million doses are expected to be available.
- Single-source dependency – The world remains heavily reliant on a single non-U.S.manufacturer for the preferred Mpox vaccine, posing risks of supply chain disruptions.
- High costs and access limitations – In some regions, the preferred Mpox vaccine remains overly expensive, restricting vaccination efforts, particularly in lower-income regions.
GeoVax GEO-MVA: A Critical Potential Solution to the Mpox Vaccine Supply Crisis
GeoVax is actively addressing these challenges with the development of GEO-MVA, its Mpox vaccine candidate. GeoVax has successfully manufactured and released the first clinical drug substance batch of GEO-MVA, with fill/finish and release of clinical product expected for mid-year, supporting the planned initiation of the clinical evaluation of GEO-MVA in the second half of this year.
GEO-MVA, in conjunction with the GeoVax development program of implementing an advanced manufacturing process for MVA vaccines, may offer several key advantages to complement and potentially strengthen the global Mpox response:
- Expanded manufacturing capacity at lower cost – The advanced MVA manufacturing process is directed towards establishing a higher yield, increased production capability with lower production costs.
- U.S.-based production – GEO-MVA can be manufactured domestically, reducing dependence on foreign supply chains and enhancing biosecurity.
GeoVax has strategic partnerships with OXB (France) and ProBioGen (Berlin) to support production scale-up and is working closely with regulatory agencies to expedite approvals and ensure equitable vaccine distribution.
A Call to Action: Strengthening the Global Response
With WHO’s latest emergency declaration confirming the continued and growing global threat of Mpox, immediate action is required:
- Expedited regulatory approval pathways for GEO-MVA and the advanced MVA manufacturing process in order to support an increased global vaccine supply.
- Expand policy and funding support for alternative vaccine manufacturing sources.
- Enhance collaboration with global health agencies to ensure vaccine equity, especially in underserved regions.
“Today’s WHO announcement highlights the urgency of expanding Mpox vaccine supply and ensuring rapid response capabilities,” said David Dodd, Chairman & CEO of GeoVax. “GeoVax remains committed to bolstering global preparedness through GEO-MVA and our efforts to establish an advanced MVA manufacturing process, offering a scalable, accessible, and domestically produced solution to combat this ongoing public health crisis.”
GeoVax Anticipates Significant 2025 Progress With Catalyst-Rich Milestones Across Key Programs
Strategic Progress Across COVID-19, Mpox, Oncology Therapies and AI Integration Positions GeoVax for Strong Momentum
ATLANTA, GA – February 5, 2025 (NEWMEDIAWIRE) – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today outlined its 2025 strategic milestones and business outlook. Building on a history of delivering on key commitments, GeoVax enters 2025 with a robust pipeline, a catalyst-rich milestone schedule, and an unwavering commitment to addressing unmet medical needs on a global scale.
An Important Year Ahead for GEO-CM04S1, a Next-Generation COVID-19 Vaccine
GEO-CM04S1 continues to demonstrate potential for both immunocompromised patients and as a booster vaccine for those previously inoculated with mRNA vaccines. In 2025, the Company anticipates completion of the evaluation trial among Chronic Lymphocytic Leukemia (CLL) patients, a patient population recognized to currently have minimal COVID-19 vaccine options. Interim data reported in Q4 2024 suggest GEO-CM04S1 may offer superior immune responses to CLL patients compared to an mRNA vaccine.
GeoVax also expects to report final results from its healthy adults booster trial, offering valuable data on the vaccine’s safety and immunogenicity profile. Another pivotal milestone for GEO-CM04S1 in 2025 is the anticipated initiation of patient enrollment in the BARDA-funded Project NextGen Phase 2b trial, which will evaluate GEO-CM04S1 compared to an authorized mRNA vaccine within a 10,000-patient study. As both a booster and a primary vaccine for immune-compromised patient populations, GEO-CM04S1 remains central to GeoVax’s mission to address the ongoing and evolving challenges of COVID-19.
As part of its strategy, GeoVax will continue to explore and establish strategic partnerships and collaborations to accelerate the development, commercialization, and global accessibility of GEO-CM04S1.
GEO-MVA: Addressing Biosecurity and Global Health Gaps
GEO-MVA, a vaccine designed to combat Mpox and Smallpox, has emerged as a critical solution amid rising global biosecurity concerns. In 2025, the Company plans to initiate clinical evaluations for GEO-MVA while continuing discussions with various stakeholders regarding the opportunity to utilize GEO-MVA among underserved populations in regions including Africa. With ongoing geopolitical and logistical challenges limiting vaccine availability, GEO-MVA’s ability to offer multi-disease protection, minimal refrigeration needs, and scalability through implementation of an advanced MVA manufacturing process, GEO-MVA represents a potential transformative resource for both national biosecurity strategies and global health initiatives.
GeoVax recognizes that addressing these critical global challenges requires collaborative efforts. In 2025, the Company will actively pursue strategic partnerships with governments, NGOs, and private-sector stakeholders to maximize the impact and reach of its GEO-MVA platform.
Gedeptin: Unlocking Potential in Solid Tumor Cancer Therapy
GeoVax’s oncology program, centered around Gedeptin®, continues to progress in addressing unmet medical needs in solid tumor therapies. Following encouraging results from Phase 1 and Phase 1/2 trials, Gedeptin is advancing into a Phase 2 clinical trial in 2025, where it will be evaluated in combination with an immune checkpoint inhibitor, targeting first recurrent head and neck cancer. This trial aims to validate the potential synergy between Gedeptin’s targeted gene-directed enzyme prodrug therapy and the powerful immune responses activated by checkpoint inhibitors.
As an FDA-designated Orphan Drug for anatomically accessible oral and pharyngeal cancers, Gedeptin is strategically positioned to address not only head and neck cancers but also other solid tumor indications, such as triple-negative breast cancer, soft tissue sarcoma and melanoma. GeoVax’s clinical roadmap for Gedeptin represents a significant market opportunity, with the potential to reshape how these cancers are treated worldwide.
GeoVax remains open to collaborations with oncology leaders, academic research institutions, and industry partners to further enhance the clinical impact and commercial success of Gedeptin.
Next-Generation Manufacturing: Pioneering Scalable Vaccine Production
To amplify the value of its clinical programs, GeoVax is also focused on advancing MVA vaccine manufacturing through validation of continuous cell line manufacturing processes, ensuring consistent, high-quality vaccine production capabilities. These advancements address long-standing challenges in vaccine scalability and cost-effectiveness, positioning GeoVax as a leader in MVA-based vaccine manufacturing solutions, potentially implementing a proprietary MVA manufacturing process supporting more flexible, localized MVA manufacturing at lower production cost, specifically enabling vaccine self-sufficiency manufacturing in low-middle income regions such as Africa.
GeoVax recognizes that strong manufacturing partnerships are vital to bringing these innovations to market efficiently and cost-effectively. The Company plans to collaborate with manufacturing partners worldwide to scale up production capabilities and meet the growing global demand for MVA-based vaccines.
AI Integration: Optimizing Processes and Driving Innovation
In alignment with its 2025 objectives, GeoVax has expanded the integration of Artificial Intelligence (AI) across its vaccine development and cancer immunotherapy activities. Leveraging AI is anticipated to accelerate vaccine development, optimize cancer therapies, streamline clinical trials, and enhance manufacturing processes, potentially in the following manners:
- Vaccine and Therapy Innovation: Predicting pathogen mutations and optimizing GEO-CM04S1 and Gedeptin® design, ensuring effectiveness in variant-proof vaccines and cancer therapies.
- Clinical Trial Optimization: Refining patient selection, accelerating recruitment, and enhancing diversity for trials targeting high-risk and underserved populations.
- Streamlined Manufacturing: Enhancing scalability and logistics, enabling efficient production and distribution, particularly in underserved regions.
Addressing a $55+ Billion Pipeline Market Opportunity
GeoVax’s pipeline addresses significant unmet and underserved medical needs worldwide in both infectious disease vaccines and oncology, representing a collective potential global market opportunity in excess of $55 billion. Each program – GEO-CM04S1, GEO-MVA, and Gedeptin – addresses significant gaps in existing treatment and prevention strategies, backed by emerging clinical data and a focus towards achieving the necessary regulatory milestones in support of product registration.
David Dodd, Chairman & CEO of GeoVax, commented: “2024 was a transformative year for GeoVax, and our focus and commitment in 2025 is unwavering, focused on critically needed unmet medical needs. Our pipeline, enriched with value-driven milestones, positions us well for successful growth and development. Collaborations and partnerships remain core to our strategy, ensuring our innovations reach those who need them most. With GEO-CM04S1, GEO-MVA, Gedeptin, our MVA manufacturing advancements, and leveraging AI to optimize our processes and drive innovation, we are prepared to make meaningful contributions to global health, delivering value to our fellow shareholders, various stakeholders and, providing compelling career development opportunities to our staff colleagues.”
MVA TECHNOLOGY OVERVIEW
GeoVax’s vaccines are constructed to induce broader immunity through inclusion of multiple antigens into a single virus/vaccine platform. This is possible through the use of the company’s MVA vaccine platform, a large virus capable of incorporating multiple antigens into a vaccine platform.
Utilizing MVA, as a vaccine vector, allows for the targeting of multiple sites on a pathogen or cancer cell. Doing this is intended to result in a more robust and durable protective immune response. In addition, using MVA as a vaccine platform allows for the construction of vaccines which are capable of generating virus-like particles (VLPs) in the person receiving the vaccine.
The production of VLPs in the person being vaccinated is intended to mimic viral production that occurs in a natural infection, stimulating both the humoral (antibody) and cellular (T-cell) arms of the immune system to recognize, prevent, and control future infections.
MVA vectored vaccines can elicit durable (long-acting) immune responses while also possessing an excellent safety profile. MVA-VLP vaccines are designed to mimic authentic viruses in form but are not infectious or capable of replicating. As a result, VLPs can cause the body’s immune system to recognize and kill targeted infectious agents to prevent an infection or can be designed to target cancerous cells resulting in inhibited growth or destruction of tumors. VLPs can also train the immune system to recognize and kill virus-infected cells to control infection and reduce the length and severity of disease.
GEDEPTIN TECHNOLOGY OVERVIEW
A Phase 1/2 trial (NCT03754933), evaluating the safety and efficacy of repeat cycles of Gedeptin therapy in patients with recurrent head and neck squamous cell carcinoma (HNSCC), with tumor(s) accessible for injection and no curable treatment options recently completed enrollment at the Stanford University Cancer Institute, the Emory University Winship Cancer Institute, and the Thomas Jefferson University Sidney Kimmel Cancer Center.
The trial design involved repeat administration using Gedeptin followed by systemic fludarabine (prodrug). Expansion towards a larger, Phase 2 patient trial is anticipated. The FDA has granted Gedeptin orphan drug status for the intra-tumoral treatment of anatomically accessible oral and pharyngeal cancers, including cancers of the lip, tongue, gum, floor of mouth, salivary gland and other oral cavities. Also, the initial Phase 1/2 clinical study was funded by the FDA pursuant to its Orphan Products Clinical Trials Grants Program.
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), 1518-1520. https://doi.org/10.1093/cid/ciae460
- 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). https://doi.org/10.3390/vaccines13010073
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