GeoVax Labs, Inc.
Filed Sep 17, 2026.
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period unavailable · Filed Sep 17, 2026
Contents
Overview and Recent Developments
GeoVax is a clinical-stage biotechnology company developing human vaccines and immunotherapies against infectious diseases and cancers using novel proprietary platforms.
Our corporate strategy is to advance, protect, and strategically leverage our proprietary vaccine and immunotherapy platforms to develop differentiated preventive and therapeutic solutions for infectious diseases and solid tumors. We aim to efficiently progress our product candidates through clinical development and pursue regulatory approval and commercialization through internal development and selective external licensing and partnership arrangements. We also work collaboratively with academic, governmental, and industry partners to validate our technologies, support development efforts and enhance the strategic value of our pipeline.
GeoVax’s primary near-term strategic development priority is GEO-MVA, an MVA-based vaccine candidate for mpox and smallpox. GEO-MVA is being advanced on an expedited regulatory pathway in Europe and. is intended to address a documented global supply constraint for orthopoxvirus vaccines. The Company believes GEO-MVA is well-positioned to support both civilian public health needs and broader preparedness and biodefense objectives. The advancement of GEO-MVA represents the Company’s most near-term opportunity to achieve regulatory approval and potential commercialization.
Our programs are in various stages of development. Key updates for our lead programs are outlined below:
| ● | GEO-MVA – mpox/smallpox Vaccine Candidate: | |
|---|---|---|
| o | GEO-MVA is a MVA vaccine candidate intended for protection against mpox and smallpox. MVA is the strain recommended by both the World Health Organization (“WHO”) and CDC for these indications and is currently used in the U.S. Strategic National Stockpile. | |
| o | Following scientific advice from the EMA, in May 2025, we intend to proceed directly to a Phase 3 trial, bypassing traditional Phase 1 and 2 studies, subject to final protocol and regulatory alignment. The Phase 3 study is expected to initiate in late 2026. | |
| o | A cGMP clinical drug product batch of GEO-MVA has been successfully produced to support clinical development. | |
| ● | Gedeptin® -- Gene-Directed Enzyme Prodrug Therapy: | |
| o | Gedeptin has successfully completed a Phase 1/2 clinical trial (NCT03754933) in patients with advanced HNSCC. This trial was funded in part by the FDA pursuant to its Orphan Products Clinical Trials Grants Program. | |
| o | Planning activities are underway for a Phase 2 trial to evaluate the addition of intra-tumoral Gedeptin and intravenous fludarabine to recently approved neoadjuvant pembrolizumab as first-line treatment of patients with head and neck squamous cell carcinoma eligible for curative surgery. Trial initiation is targeted for initiation in late 2027. | |
| o | The Gedeptin manufacturing platform has been upgraded to use the CAP Ad™ suspension cell line, optimal for adenovirus-based gene therapies, and is in late phase development and poised for manufacturing clinical trial material. | |
| ● | Manufacturing Platform – Continuous Avian Cell Line: | |
| o | GeoVax is developing a continuous avian cell line manufacturing platform for production of its MVA-based vaccines. This platform will enable scalable, high-yield production of vaccine candidates under current cGMP conditions in the continental U.S. Thus far, initial process development steps in support of cGMP production of GEO-MVA in the continuous avian cell line have been achieved. Unlike traditional egg-based production methods, continuous cell line manufacturing offers greater efficiency, reproducibility and flexibility, supporting rapid response capabilities for emerging infectious diseases and biothreats. This approach is aligned with U.S. and international priorities for modernizing vaccine manufacturing, onshoring the production and ensuring supply chain resilience. |
On May 26, 2026, the Company announced a strategic reprioritization of its development portfolio to concentrate resources on its lead programs, GEO-MVA and Gedeptin®, reflecting increasing clinical, regulatory, and market alignment across these programs. As part of this decision, the Company elected to discontinue active development activities related to its GEO-CM04S1 COVID-19 vaccine candidate. This decision was not related to any safety or efficacy concerns with the vaccine but reflects the continued evolution and contraction of the global COVID-19 vaccine market, and GeoVax’s focus on programs with clearer regulatory pathways, stronger demand visibility, and more immediate commercialization potential.
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