Manufacturing, Regulatory, Clinical and Preclinical Milestones Completed in Support of Scheduled Fourth Quarter 2026 Initiation of Pivotal Immune-Bridging Study
ATLANTA, GA - August 6, 2026 (NEWMEDIAWIRE) - GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies for infectious diseases and solid tumors, today announced the completion of key manufacturing, regulatory, clinical and preclinical milestones supporting the initiation of its pivotal Phase 3 GEO-MVA immune-bridging study, scheduled to initiate in the fourth quarter of 2026.
"Completion of these milestones marks a significant inflection point for the GEO-MVA program as we prepare to initiate our pivotal immune-bridging study later this year," said David A. Dodd, Chairman and Chief Executive Officer of GeoVax. "We have systematically executed the manufacturing, regulatory, clinical and scientific activities required to support successful study completion, preparing for regulatory registration and ultimate commercialization."
Dodd continued, "Of special note, we recently completed a comparative nonclinical immunogenicity study evaluating GEO-MVA alongside the licensed MVA vaccine, Imvanex®, using both binding antibody and neutralizing antibody assays. The study demonstrated that GEO-MVA generated robust orthopoxvirus-specific immune responses. These findings further strengthen our confidence in GEO-MVA as we prepare to initiate our pivotal immune-bridging study later this year. Together with our manufacturing progress and favorable regulatory interactions, these data continue to support advancement of GEO-MVA into pivotal clinical evaluation.
“With GMP clinical product available and released, an expedited regulatory pathway established, clinical operations progressing and encouraging preclinical immunogenicity data in hand, we believe completion of these integrated milestones has substantially de-risked GEO-MVA and positions the program to advance into the Phase 3 study."
GEO-MVA is being developed to expand global manufacturing capacity for non-replicating MVA vaccine, supporting government preparedness programs and future procurement opportunities for this critically needed mpox/smallpox vaccine.
Key Development Milestones
Manufacturing Readiness: Successfully manufactured, filled, packaged and released GMP clinical product for use in the pivotal immune-bridging clinical study, completing a key requirement for clinical development.
Regulatory Alignment: Development strategy aligned with European Medicines Agency (EMA) Scientific Advice supporting an expedited immune-bridging pathway comparing GEO-MVA with the licensed MVA-BN vaccine.
Clinical Readiness: Advanced clinical operations through CRO engagement, and clinical site identification, supporting planned initiation of the targeted 500-participant study in the fourth quarter of 2026.
Preclinical Immunogenicity: A preclinical study generated neutralizing antibody data for GEO-MVA and MVA-BN that support the planned immune-bridging clinical strategy.
Commercial & Procurement Planning: In parallel with clinical development, GeoVax continues active discussions with government agencies and international preparedness organizations regarding future procurement opportunities and long-term MVA vaccine supply requirements.
GeoVax expects initiation of its targeted 500-participant immune-bridging clinical study during the fourth quarter of 2026. The study is designed to compare immune responses generated by GEO-MVA with those of the licensed MVA-BN vaccine using established neutralizing antibody endpoints. The Company expects to report results in mid-2027.
Additional CEO Commentary
GeoVax Chairman and Chief Executive Officer David Dodd provides additional context on the GEO-MVA development milestones, manufacturing readiness and planned Phase 3 study initiation. Watch the video here: https://www.youtube.com/watch?v=oxB4C1MPzm0
About GEO-MVA
GEO-MVA is GeoVax's Modified Vaccinia Ankara (MVA)-based vaccine being developed for protection against mpox and smallpox. Following Scientific Advice from the European Medicines Agency (EMA), the program is advancing under an expedited immune-bridging clinical development strategy designed to compare immune responses generated by GEO-MVA with those of the licensed MVA-BN vaccine.
GeoVax is developing GEO-MVA to expand global access to MVA vaccine supply, scalable production capabilities, and a capital-efficient regulatory pathway. The Company believes GEO-MVA has the potential to become an important strategic preparedness asset by providing governments and international public health organizations with an additional, reliable source of MVA vaccine to support biosecurity and orthopoxvirus preparedness.
About GeoVax
GeoVax Labs, Inc. is a clinical-stage biotechnology company focused on the development of vaccines and immunotherapies addressing high-consequence infectious diseases and solid tumor cancers. GeoVax’s priority program is GEO-MVA, a Modified Vaccinia Ankara (MVA)–based vaccine targeting mpox and smallpox. The program is advancing under an expedited regulatory pathway, with plans to initiate a pivotal Phase 3 clinical trial in the second half of 2026, to address critical global needs for expanded orthopoxvirus vaccine supply and biodefense preparedness. In oncology, GeoVax is developing Gedeptin®, a gene-directed enzyme prodrug therapy (GDEPT) designed to enhance immune checkpoint inhibitor activity. Gedeptin has completed a multicenter Phase 1/2 clinical trial in advanced head and neck cancer and is being advanced into combination strategies, including planned neoadjuvant and first-line settings. GeoVax maintains a global intellectual property portfolio supporting its infectious disease and oncology programs and continues to evaluate strategic partnerships and funding opportunities aligned with its development priorities. For more information, visit 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.
Company Contact:
info@geovax.com
678-384-7220
Media Contact:
Jessica Starman
media@geovax.com
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