GeoVax Announces First Patients Vaccinated in Phase 2 Clinical Trial of COVID-19 Vaccine Booster in Patients with Chronic Lymphocytic Leukemia

Seeking Improved Immune Response vs mRNA Vaccine Full Patient Enrollment Expected Within Six Months

ATLANTA, GA, August 10, 2023 — GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced that vaccinations have begun in an investigator-initiated clinical trial (ClinicalTrials.gov Identifier: NCT05672355 ) of GEO-CM04S1 in patients with chronic lymphocytic leukemia (CLL), being conducted at City of Hope National Medical Center.

Despite a high vaccination rate, CLL patients may be at high risk for lethal COVID-19 infection due to poor immune response to currently available vaccines. The GEO-CM04S1 vaccine uses a modified vaccinia virus (MVA) backbone to carry SARS-CoV-2 virus antigens that may be more effective at inducing COVID-19 immunity in patients with poor humoral immune responses since MVA strongly induces T cell expansion even in the background of immunosuppression. By targeting both the spike (S) and nucleocapsid (N) protein antigens, GEO-CM04S1 broadens the specificity of the immune responses and protects against the loss of efficacy associated with current vaccines due to the significant sequence variation observed with the spike antigen.

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The study is examining the use of two injections of GEO-CM04S1, three months apart, to assess immune responses in these vulnerable patients, with an mRNA vaccine (currently, the Pfizer-BioNTech Bivalent vaccine) as the control arm. Participants will be randomized 1:1 to receive two boosters with either the GEO-CM04S1 or the control vaccine. The primary immune response outcome will be assessed at 56 days following the first booster injection. Up to 40 participants in each arm will be vaccinated, with immune responses evaluated and compared at the interim and final analyses.

David Dodd, GeoVax President and CEO, stated, “We are very pleased with the rapid start for this third important study for GEO-CM04S1, which we expect will achieve full patient enrollment within six months. We believe the GEO-CM04S1 vaccine, containing the two antigens, S and N, along with the recognized antibody and cellular immune responses resulting from the MVA approach, has the potential to offer greater booster protection than that from the current vaccines in use, as well as provide a greater degree of protection within immunocompromised patients. We expect the CLL trial will add to the data coming from our other ongoing trials, confirming the potential benefit of GEO-CM04S1 in another population of immunocompromised individuals. We look forward to sharing progress reports as we advance.”

About GEO-CM04S1

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 presents both the spike and nucleocapsid antigens of SARS-CoV-2 and is specifically designed to induce both antibody and T cell responses to non-variable parts of the virus. The more broadly specific and functional engagement of the immune system is designed to protect against the new and continually emerging variants of COVID-19. Based on data from animal models and a completed Phase 1 clinical study, vaccine-induced immune responses were shown to recognize both early and later variants of SARS-CoV-2, including the Omicron variant. Vaccines of this format should not require repeated modification and updating.

A recent presentation of unpublished data from the open-label portion of the Phase 2 trial of GEO-CM04S1 ( ClinicalTrials.gov Identifier : NCT04977024 ) in patients undergoing hematological cancer treatment (i.e., patients who have reduced immune system function as a result of treatment ) 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 planned progression of the Phase 2 clinical study, which will include a direct comparison to currently approved mRNA vaccines. GEO-CM04S1 also continues to advance in another Phase 2 clinical trial as a booster for healthy patients who have previously received the Pfizer or Moderna mRNA vaccine (ClinicalTrials.gov Identifier: NCT04639466 ). Data from these studies will form the basis for comparing vaccine potential in unique patient groups as well as the general population.

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.

May 22, 2026
ALPHARETTA, Ga., May 21, 2026 (GLOBE NEWSWIRE) -- Micron Biomedical today announced the grand opening of its world-class manufacturing facility spanning more than 26,000 square feet in Alpharetta, Georgia. The opening marks the most advanced commercial-scale manufacturing site for Micron’s dissolvable vaccine and therapeutic technology in the world and positions the company for pivotal clinical trials that will accelerate the availability of needle-free vaccines and therapeutics that can be self-administered at home. “A significant body of evidence has shown that our dissolvable microarray technology is as effective as — or more effective than — conventionally injected medicines. Parents, patients, government officials, drug developers, public health leaders, and payers also prefer needle-free vaccines and therapeutics that are simpler and more cost-effective to transport and store,” said Steven Damon, CEO of Micron Biomedical . “Our novel technology requires equally innovative manufacturing equipment capable of scaling production, and this facility brings us one step closer to making that vision a reality.” Micron’s technology uses a dissolvable microarray “button” that is applied directly to the skin and, when pressed, painlessly delivers medications that dissolve in the uppermost layers of skin. The facility houses all of the equipment and manufacturing capabilities to design and produce Micron’s technology at scale including R&D facilities, wet labs, dry labs, storage and professional office spaces. Micron Biomedical’s grand opening ceremony was attended by business leaders, elected officials, investors, members of academia and other stakeholders. Representatives from the CDC were also in attendance as recently the CDC launched its first-ever clinical trial of a needle-free vaccine, evaluating a novel rotavirus vaccine, CC24, delivered via Micron Biomedical’s dissolvable microarray technology. The trial, at Emory University, builds on research, published in The Lancet, about self-administered seasonal influenza vaccine via Micron Biomedical’s dissolvable microarray technology, as well as studies across other disease indications, including measles and rubella . “Georgia is emerging as one of the country’s most important biotech manufacturing hubs, attracting talented scientists, engineers, business leaders and creating exciting economic and professional opportunities for our residents,” said Todd Jones, Georgia House Representative . “With its award winning first-in-the industry technology, Micron Biomedical is among the state’s leaders in simultaneously transforming the health of people around the world with never-before-possible access to medicine and vaccines - and in investing in the workforce of tomorrow with high paying jobs and growth opportunities." This year, published research reinforced consumer preference for microarray technology and Micron Biomedical was recognized as the number two most innovative company in its class by Fast Company for addressing global demand for simplified administration and distribution of vaccines and drugs. The scientific community support includes recent commentary in The Lancet which called Micron’s technology “game-changing in humanitarian settings.” Micron’s technology class has also been identified as the highest global priority innovation for overcoming immunization barriers in low- and middle-income countries by the Vaccine Innovation Prioritisation Strategy (VIPS) Alliance. “This milestone reflects the type of coordinated ecosystem growth outlined in Georgia Life Sciences’ recently released Roadmap for Georgia’s Life Sciences Sector — bringing together industry, startups, manufacturers, educators, investors, and policymakers to strengthen the state’s innovation and manufacturing capabilities,” said Maria Thacker Goethe, President and CEO of Georgia Life Sciences , who attended the ribbon cutting ceremony. “With this cutting-edge facility, Micron is helping advance Georgia’s position as a national leader in biotechnology, medical technology, and life sciences innovation while reinforcing the state’s role as a scale-up manufacturing hub for the Southeast.” “Ribbon cuttings are always special and momentous events, but this one is especially satisfying because it points to an infrastructure for pivotal clinical trials of technologies being studied at Emory that have the potential to save lives and reduce disease burden by expanding coverage and access to critical medications,” said Christina Rostad MD, pediatric infectious disease associate professor at Emory University and lead investigator of the CD244 trial who provided commentary remotely. “Our team at Emory University is excited to be a part of the celebration and look forward to continuing to explore the potential of Micron Biomedical’s dissolvable microarray vaccine technology.“ About Micron Biomedical Micron Biomedical is the leader in dissolvable microarray-based, drug and vaccine administration technology with a growing pipeline of needle-free versions of previously injectable-only medicines. Micron Biomedical is a clinical-stage life science company on a rapid path to commercializing its proprietary dissolvable, microarray technology. Micron’s technology is designed to improve access and achieve better health outcomes globally through injection-free, painless, and simple and/or self-administration of drugs and vaccines, and by eliminating or reducing the need for cold chain transport and storage, enhancing safety and efficacy, and improving patient compliance. Micron partners with and/or receives funding from private and public entities including pharmaceutical and biotech companies, the Gates Foundation, the Centers for Disease Control and Prevention (CDC), PATH and the Georgia Research Alliance. For more information visit www.micronbiomedical.com . Press Contact Shira Derasmo M: +1-917-280-2497 E: pr@micronbiomedical.com A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/31153de2-caed-4aa2-b291-ebeed2652b70 A video accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/d855a883-fb26-47ce-9831-8ef1e0b93f43 
May 13, 2026
Georgia Life Sciences thanks Dr. Marty Makary for his service as Commissioner of the U.S. Food and Drug Administration during a period of significant change across the nation’s health and regulatory agencies.
May 12, 2026
Georgia Life Sciences is pleased to announce Tim Opler as a featured keynote speaker at the 2026 Georgia Life Sciences Summit, taking place August 25-26 at the Sandy Springs Performing Arts Center in Atlanta. A leading voice in biotech investment banking, Tim Opler serves as Managing Director in Stifel’s Global Healthcare Group, where he advises innovative life sciences companies on financing, growth strategy, and market positioning across the healthcare landscape. Tim brings deep insight into the evolving biotech investment environment, emerging industry trends, and the factors shaping the future of life sciences innovation and commercialization. Join us for this timely discussion with one of the industry’s most respected financial leaders as we explore the opportunities and challenges defining the next era of life sciences growth . 
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