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

Seeking Improved Immune Response vs mRNA Vaccine

ATLANTA, GA, July 20, 2023 — GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced the start of an investigator-initiated clinical trial (ClinicalTrials.gov Identifier: NCT05672355 ), titled “ Randomized observer-blinded phase 2 trial of COVID-19 booster with GEO-CM04S1 or Pfizer-BioNTech Bivalent vaccine in patients with chronic lymphocytic leukemia ,” at City of Hope National Medical Center, led by Alexey Danilov, M.D., PhD as principal investigator. GEO-CM04S1, a multi-antigenic SARS-CoV-2 vaccine that targets the spike (S) and nucleocapsid (N) proteins of SARS-CoV-2, is actively under clinical study by GeoVax in severely immunocompromised individuals, as well as in healthy adults for use as a universal heterologous booster.

Despite a high vaccination rate, chronic lymphocytic leukemia (CLL) patients may be at high risk for lethal COVID-19 infection due to poor immune response to COVID-19 infections or vaccination. The GEO-CM04S1 vaccine uses a modified vaccinia virus (MVA) backbone 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. Targeting both the spike and nucleocapsid protein antigens broaden the specificity of the immune responses and protects against the loss of efficacy associated with the significant sequence variation observed with the spike antigen.

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The study will examine the use of two injections of GEO-CM04S1 three months apart to assess immune responses in these vulnerable patients, with 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 56 days following the first booster injection. Up to 40 participants will be treated in each arm, with immune responses evaluated at the interim and final analyses in each arm.

Brian Koffman, M.D.C.M., FCFP DABFP (retired) MS Ed, Executive Vice President and Chief Medical Officer of the CLL Society, a nonprofit dedicated to the unmet needs of those diagnosed with CLL/small lymphocytic lymphoma (SLL), commented, “Despite the current authorized COVID-19 vaccines providing protective immunity among the majority of patient populations, individuals with CLL/SLL, regardless of their treatment status, have had less predictable and often insufficient immune responses to the currently authorized vaccines. Within the CLL/SLL patient population, more robust and durable protective immunity is needed, especially next-generation vaccines that could induce stronger T cell and antibody responses. This trial leverages past success with a similar type of vaccine used for protection against a different viral infection in the immunocompromised to develop a vaccine intended to provide enhanced and more durable protection against COVID-19 infections in the high-risk CLL/SLL population. The CLL Society and the CLL/SLL community welcome this study and look forward to the results.”

Kelly McKee, M.D., GeoVax Chief Medical Officer, commented, “Unpublished clinical data recently presented at several medical conferences confirmed our earlier findings in healthy adults that GEO-CM04S1 stimulated a robust, durable, and broad-based humoral and cellular immune response against multiple SARS-CoV-2 variants, and by extension, to immunocompromised patients. Validation of these findings in additional patients with hematologic malignancies, who have received CAR-T and stem cell transplants, is underway as we seek to provide a vaccine solution to those individuals unable to mount adequate protective responses with currently available COVID-19 vaccines. We expect the CLL trial will further confirm the potential benefit of CM04S1 in another population of immunocompromised individuals.”

David Dodd, GeoVax President, and CEO, added, “ We are excited to begin this third important study for CM04S1 and look forward to sharing progress reports as we advance. We believe the 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.”

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. 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 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 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. 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 two Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a COVID-19 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. In addition, GEO-CM04S1 is in 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.

Source: GeoVax

BIO Statement on the Section 232 Pharmaceutical Proclamation

April 4, 2026
April 2, 2026- WASHINGTON, D.C. – John F. Crowley, President and CEO of the Biotechnology Innovation Organization (BIO) , released the following statement on Section 232 Pharmaceutical Proclamation. “A thriving American biotechnology ecosystem is essential to growing the U.S. economy, strengthening national security, and improving the health and well‑being of everyday Americans. While we appreciate the Administration’s recognition of the need for tariff exemptions for certain critical biotech products, the reality is that any tariffs on America’s medicines will raise costs, impede domestic manufacturing, and delay the development of new treatments - all while doing nothing to enhance our national security. “U.S. biotech companies have been eager to expand investments here at home, but tariffs, along with an uncertain policy environment and efforts to force “most‑favored nation” schemes, work directly against that goal. The risks are especially acute for small and mid‑size biotech companies, which develop more than half of all FDA‑approved medicines yet often lack the capital to build dedicated manufacturing facilities as they weather an industry defined by high costs, long development timelines, and significant risk. “The fact is: tariffs divert scarce resources away from research and development, weaken American biotech against China’s rising industry, and ultimately, harm health and economic wellbeing of Americans. “We stand ready to work with the Administration on a long‑term strategy that encourages biotechnology investment, reduces the time, cost, and uncertainty of developing new medicines, expands U.S. biomanufacturing capacity, and ensures American innovation is fairly valued overseas. Tariffs and MFN are not the answer." Source - https://www.bio.org/press-release/bio-statement-section-232-pharmaceutical-proclamation

Georgia Life Sciences Announces 2026 Georgia BioGENEius Challenge Winner

April 1, 2026
Atlanta, GA (April 1, 2026) – Georgia Life Sciences (GLS) is proud to announce that Saisurya Lakkimsetti, a junior at Lakeside High School in Columbia County, has been named the winner of the 2026 Georgia BioGENEius Challenge. The Georgia BioGENEius Challenge took place, as part of the statewide Georgia Science and Engineering Fair (GSEF) at the Classic Center in Athens, Georgia. Forty-seven students from across Georgia competed for this year’s title and cash prize. Jaehyeon Lee, an 11th-grade student from Walton High School, was named runner-up in this year’s competition. The Georgia BioGENEius Challenge recognizes outstanding high school students who are conducting innovative biotechnology research with real-world applications. This year’s top projects, presented in the Global Healthcare Challenge track, demonstrated exceptional scientific rigor and forward-thinking potential in addressing critical healthcare challenges. Saisurya’s research focuses on identifying potential inhibitors for Endocan, a protein known to play a role in glioblastoma tumor growth. Using advanced computational modeling techniques—including AlphaFold and molecular docking tools—she screened thousands of small molecules to identify compounds that may block tumor-promoting signaling pathways. Her work identified several promising candidates that could serve as a foundation for future drug development targeting glioblastoma. Jaehyeon’s project investigates how varying glucose concentrations affect regeneration in planaria, modeling impaired wound healing in diabetic conditions. By testing graded glucose environments and measuring regeneration indicators such as growth and differentiation, Jaehyeon demonstrated that lower glucose levels enhance regeneration while higher levels inhibit healing. The study establishes a model to better understand hyperglycemia’s impact on diabetic wound healing. “The work by these students is a powerful example of the innovation and determination we see in Georgia’s next generation of life sciences leaders,” said Maria Thacker Goethe, President and CEO of Georgia Life Sciences. “The BioGENEius Challenge is critical because it provides students with a platform to apply cutting-edge science to real-world problems, while also strengthening the future workforce that will drive breakthroughs in healthcare, biotechnology, and beyond.” The Georgia BioGENEius Challenge is part of Georgia Life Sciences’ broader commitment to advancing workforce development and fostering innovation across the state’s rapidly growing life sciences ecosystem. Judging the 2026 Georgia BioGENEius Challenge: Ian Biggs; Ralph Cordell, CDC; Alex Harvey, ViaMune; Jamie Graham, Smith Gambrell Russell; and Evan Scullin, LuminiSci.

Georgia Life Science's Feature in Very First Atlanta Edition of Inside Medicine

March 24, 2026
Georgia Life Sciences is thrilled to be featured in the very first Atlanta edition of Inside Medicine . This inaugural issue represents something truly special. Atlanta’s healthcare and life sciences community is driven by innovation, collaboration, and outstanding leadership—and we’re honored to be part of this exciting launch. Also in the issue, GLS's Kennedy Dumas is featured, sharing her journey on how observation and research evolved into a powerful practice of journaling. As the founder of Stationery Black, she creates notebooks designed to showcase, uplift, and inspire people of color. Read the full article here.
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