GeoVax’s near-term development priority is GEO-MVA, a Modified Vaccinia Ankara (MVA) vaccine candidate for mpox, smallpox, and other poxviruses. GEO-MVA is being advanced on an expedited regulatory pathway provided by the European Medicines Agency (“EMA”; the European equivalent of the FDA) and is intended to address a significant global supply constraint for MVA-vaccine. The Company believes GEO-MVA is well-positioned to support both civilian public health needs and broader preparedness and biodefense objectives. GEO-MVA represents a near-term potential opportunity to achieve regulatory approval and subsequent commercialization. Plans include initiation of a pivotal Phase 3 clinical trial in Fourth Quarter of 2026.
CLINICAL-STAGE BIOTECH COMPANY
In addition to GEO-MVA, GeoVax’s clinical development programs include Gedeptin®, a novel oncolytic solid tumor gene-directed therapy, which recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. A Phase 2 clinical trial evaluating Gedeptin® in combination with an immune checkpoint inhibitor (ICI) as first-line treatment of patients with squamous cell head and neck cancer eligible for curative surgery, is planned to initiate during the second half of 2027.
Additional research and development programs include preventive vaccines against hemorrhagic fever viruses (Ebola Zaire, Ebola Sudan, and Marburg).
