GeoVax Completes Enrollment of Phase 2 Trial for Next-Generation COVID-19 Vaccine Booster

Multi-antigen Vaccine Designed to Protect Against Evolving SARS-CoV-2 Variants

ATLANTA, GA, September 11, 2023 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced that it has met the enrollment target for its Phase 2 clinical trial evaluating GEO-CM04S1 as a booster for healthy patients who have previously received the Pfizer or Moderna mRNA vaccine (ClinicalTrials.gov Identifier: NCT04639466 ).

The study is designed to evaluate the safety profile and immunogenicity of two GEO-CM04S1 dose levels administered as a COVID-19 vaccine booster among healthy individuals previously vaccinated with one of the FDA approved SARS-CoV-2 mRNA vaccines. The immunological responses measured throughout the study will include both the level of neutralizing antibodies against SARS-CoV-2 variants of concern and specific T cell responses.

GEO-CM04S1 is a next-generation COVID-19 vaccine based on GeoVax’s MVA viral vector platform, which supports the presentation of multiple vaccine antigens to the immune system in a single dose. GEO-CM04S1 encodes for both the spike (S) and nucleocapsid (N) antigens of SARS-CoV-2 and is specifically designed to induce both antibody and T cell responses to those parts of the virus less likely to mutate over time. The more broadly functional engagement of the immune system is designed to protect against severe disease caused by continually emerging variants of COVID-19. Vaccines of this format should not require frequent and repeated modification or updating.

“We would like to thank everyone who partnered with us to complete this important clinical trial enrollment milestone, especially the study volunteers and research staff at our clinical sites in the United States,” said David Dodd, GeoVax Chairman and CEO. “We believe the unique properties of GEO-CM04S1 potentially offer a more robust, durable degree of protection than the current authorized COVID-19 vaccines, not only as a booster vaccine to the currently authorized mRNA vaccines, but as a primary vaccine for highly vulnerable immunocompromised patients.”

Additional Ongoing Trials of GEO-CM04S1

In addition to the booster vaccine trial for which patient enrollment was just completed, GEO-CM04S1 is being evaluated in two other Phase 2 clinical trials:

  • As a primary vaccine in immunocompromised patients (with hematologic cancers receiving cell transplants or CAR-T therapy). ClinicalTrials.gov Identifier: NCT04977024. A recent presentation of unpublished data from the open-label portion of the trial indicates that GEO-CM04S1 is highly immunogenic in these patients, inducing both antibody responses, including neutralizing antibodies, and T cell responses. These data support the progression of the Phase 2 clinical study, which includes a direct comparison to currently approved mRNA vaccines.
  • As a booster vaccine in immunocompromised patients with chronic lymphocytic leukemia (CLL), a recognized high-risk group for whom current mRNA vaccines and monoclonal antibody (MAb) therapies appear inadequate relative to providing protective immunity. ClinicalTrials.gov Identifier: NCT05672355.

Further underscoring the need for next-generation COVID-19 vaccines such as GEO-CM04S1, GeoVax scientists co-authored an article titled, “ MVA-Vectored Universal Beta-Coronavirus Vaccine Design & Development ”, published in the June 2023 issue of the online journal Vaccine Insights. The article, accessible here , provides expert insight into the emergence of SARS-CoV-2 (COVID-19), the risk of new “spillover events” from animal hosts, and how this risk can be addressed proactively. Regarding COVID-19 and its continually evolving variants, the authors describe the limitations of first-generation vaccines and the potential for MVA-vectored vaccines such as GEO-CM04S1 to overcome these limitations.

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin ® , presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. Currently in three Phase 2 clinical trials, GEO-CM04S1 is being evaluated as 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, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL). In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For more information, visit our website: www.geovax.com.

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. 

Contact:

GeoVax Labs, Inc.

678-384-7220

By Maria Thacker Goethe August 1, 2025
As Washington heads into August recess, Georgia Life Sciences is counting down the days to the 2025 Georgia Life Sciences Summit , taking place August 26–27 in Sandy Springs . With just one month to go, this pivotal gathering will bring together innovators, investors, policymakers, and ecosystem leaders at a time when the national policy landscape is shifting rapidly—and not always in our favor. In just the past week, we’ve seen: A short-lived but deeply disruptive pause in NIH funding : The White House Office of Management and Budget (OMB) temporarily halted the issuance of NIH research grants, contracts, and training awards—impacting institutions nationwide, including here in Georgia. After significant backlash from Congress, research leaders, and advocacy groups, the administration quickly reversed course and released the funds. However, this episode underscores the growing unpredictability of federal research funding—one of the lifelines for our academic and startup ecosystem. The return of pharmaceutical tariffs : The administration announced a 15% tariff on European pharmaceutical imports , though it will not take effect until a national security review is completed. While far lower than the previously floated 200% rate, this move still poses a concern for supply chains and U.S. companies relying on EU-based manufacturing. Escalating pressure on drug pricing : President Trump has now issued direct letters to CEOs of 17 major pharmaceutical companies demanding implementation of Most Favored Nation (MFN) pricing within 60 days. The directive includes MFN pricing for all existing Medicaid drugs, future Medicare and commercial launches, and even repatriation of foreign revenues. While regulatory specifics remain vague, the message is clear: the administration is increasing its pressure on pricing reform—and that could have broad implications for biotech innovation, particularly among smaller companies. At the same time, a new BIO report shows that early-stage biotech funding continues to contract. Series A investment remains flat, IPOs are sluggish, and Q2 startup funding dropped to just $900 million—down from $2.6 billion in Q1. Layoffs across the sector have surged. This paints a sobering picture for many companies in Georgia and beyond. In this environment, Georgia Life Sciences remains committed to elevating our state’s voice, regionally and nationally . We continue to advocate for stable federal funding, smart policies, and the resources innovators need to survive and thrive. The Georgia Life Sciences Summit will be a platform to do just that, demonstrating the resilience of our ecosystem, celebrating homegrown successes, and shaping the future of health innovation in Georgia. I hope to see you there.
By Maria Thacker Goethe July 28, 2025
By: Clary Estes “Small companies are the lifeblood of the industry and a lot of what they do, and what they’re experiencing, greatly affects the industry as a whole,” said Chad Wessel, Director of Industry Analysis at the Biotechnology Innovation Organization (BIO). He spoke with Bio.News in an interview about BIO’s 2025 report, “ The State of Emerging Biotech Companies: Investment, Deal, and Pipeline Trends ,” focused on the biotech industry from the early-stage perspective. As researchers found, the current landscape is challenging, but there are still opportunities. “In the last couple years, we’ve had a little bit of a contraction of the industry. During COVID, we kind of had this sugar rush for the industry,” said Wessel. “A lot of companies were being created. A lot of money was being thrown out there. A lot more companies were being funded. And in the last couple of years, there has been a little bit more of a correction, and we’re seeing funding levels going down to what we’ve seen prior to COVID.” “But when you add on other challenges, like the political landscape and everything, it is leaning towards a very challenging environment for a lot of companies,” he continued. Bearish venture capital “In venture capital, yes, you have a lot of money, but it’s going to fewer companies at higher average amounts,” explained Wessel. “It’s creating this competitive haves and have-nots type marketplace or environment. So it just makes it a lot more competitive and more challenging to raise funds.” Instead of finding new opportunities, venture capitalists are investing more in companies they are already working with. As the BIO report found, the amount of new series A-1 investment rounds into biopharma remained flat between 2023 and 2024, while the number of U.S. companies receiving their first series A-1 tranche went from 102 to 100. This is in comparison to 181 in 2021, reflecting the COVID influx to emerging biotechs. Comparatively, as the BIO report found, the average amount for A-1 transactions in the U.S. saw a remarkable increase of 700% in the last 15 years, with the average amount raised sitting at $60 million in 2024. The rest of the world stayed relatively steady in comparison to the U.S.’s persistent growth. And with the more bearish tendencies of investors, Wessel and team observed an interesting trend. “2024 was the first year that clinical programs actually raised more venture dollars than pre-clinical, which hasn’t happened in a while,” said Wessel. “I think the last time that happened was in 2018. This ties into some of the information that we’ve heard anecdotally, which is that a lot of VC firms are focusing on the companies that they currently have in their portfolio, rather than adding new companies.” Licensing and deals dip It is not too surprising, then, that as investors shore up what they already have in the pipelines, the R&D pipeline and licensing have slowed somewhat. As the BIO report observed, long-term growth in the R&D pipeline continues with an overall growth of 145% since 2010. Yet, the 2024 expansion rate (4.6%) subsided slightly, trailing the 5-year average of 6.7%. “The growth has slowed on new programs, and more of those programs are being licensed with larger companies,” explained Wessel. “There are fewer options for big companies to backfill their pipeline with products because a lot of them are already out.” The data also shows a notable slowing of the R&D typically done by large biopharma companies. “The areas that are not licensed out as much are the ones with some of the higher patient populations and subsequently the ones that are not being run by small companies,” said Wessel. “These are areas like endocrine and cardiovascular diseases, which are areas where there are a lot of things like type 2 diabetes, psoriasis , high blood pressure, etc. Those all have a lot of burden on the healthcare sector or the patient population, and those aren’t really being worked on that much by smaller companies.” Comparatively – and also not surprisingly – oncology has stayed at the top of the clinical pipeline, along with neurology and infectious disease. “Same thing with licensing,” said Wessel. “While there are deals that are still happening, the upfront amount is lower currently than it has been in years past, and most of the value is tied up into milestone payments, which may or may not happen.” This is also being felt when it comes to new companies going public, which has been an oft-discussed challenge in the biotech industry for the last few years. “The IPO market has still been challenging,” Wessel says. “We went from having 40 companies a year going public, down to 15 in 2023, and now we’re back up in 2025, but it’s still down from the pre-COVID era timeframe.” Biopharma layoffs Another notable characteristic of this year’s biopharma landscape has been uptick in layoffs. “Sometimes it’s just the nature of the economy. But the amount that we’ve seen in the last few years is quite a bit higher,” said Wessel. “To counter that, we don’t really have a way of measuring job creation, but we do know it’s happening. We just are unable to put a value on that.” The BIO report found that layoff announcements ticked up to 65 during Q1 of 2025. While two points lower than Q1 of the previous year, this still marks a jump from 2024’s Q2, Q3, and Q4, which saw the number of layoff announcements at 41, 54, and 46, respectively. All in all, Wessel noted, the biotech industry is still in a bit of a holding period when it comes to trying to navigate the coming months. “It’s too early to be able to say much about the coming years for the industry based on these numbers,” he said. “It takes a little time for reality to kind of catch up for multiple reasons. But what I can say is that we do know that companies are reducing their pipelines. We do know that companies are laying off individuals. We do know that companies are having a challenge of raising funds and continue doing their best to try to maintain operations as long as they can until they can get funds.” “We know the challenge is out there, but we’re going to have to kind of wait and see a little bit on the data side of things to understand how everything is going to catch up going forward.” Source: https://bio.news/bioeconomy/bio-2025-state-of-emerging-biotechs-report-market-trends/?mkt_tok=NDkwLUVIWi05OTkAAAGb7m5php-rTOf0a_GTaj5pj7Zl-HlpVM25WtyVvCYudM82a9GKjoazUg9sqU66hlAbhqbEuYvcX3C4EqfBG7Q
By Maria Thacker Goethe July 26, 2025
Pioneer Institute has released updated #340B state fact sheets for 2025
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