GeoVax Advances Gedeptin Toward Phase 2 Initiation and Strategic Partnership Opportunities

GeoVax Labs, Inc. (Nasdaq: GOVX) has outlined near-term development milestones and strategic priorities for its oncology program, Gedeptin, as the company advances toward Phase 2 clinical initiation and potential partnership opportunities. The clinical-stage biotechnology company is focusing on integrating Gedeptin into combination treatment regimens, particularly alongside immune checkpoint inhibitors (ICIs) and other established oncology backbones, aligning with the evolving treatment landscape.

GeoVax is preparing to initiate a Phase 2 clinical trial evaluating Gedeptin in combination with an ICI as a first-line neoadjuvant treatment in patients with resectable locally advanced head and neck cancer, with trial initiation targeted for 2027. The study is designed to evaluate tumor response in the neoadjuvant setting, biomarker-driven immune activation, and event-free survival outcomes. This trial is expected to represent a key step in establishing clinical validation for Gedeptin in combination immuno-oncology strategies.

In parallel with its lead clinical program, GeoVax is planning to advance preclinical and translational work evaluating Gedeptin across additional solid tumor indications. These efforts are intended to identify tumor settings where combination approaches may provide the greatest clinical benefit, support expansion beyond head and neck cancer, and inform future clinical development strategies.

GeoVax is actively pursuing opportunities to advance Gedeptin through clinical development partnerships, combination-focused collaborations, and potential licensing or co-development arrangements. David A. Dodd, Chairman and Chief Executive Officer of GeoVax, stated, "We are entering an important phase of development for Gedeptin, with a focus on clinical execution and advancing discussions around potential partnerships. As combination therapy becomes more common across oncology, we believe Gedeptin is well positioned to be integrated into these regimens and contribute to improved treatment outcomes."

GeoVax has established a clinical and scientific foundation to support Gedeptin's advancement, including completed Phase 1/2 clinical experience in advanced head and neck cancer, engagement of an Oncology Advisory Board with deep immuno-oncology expertise, and expanded intellectual property supporting combination use with checkpoint inhibitors. This foundation is intended to support both continued clinical progression and engagement with potential partners.

Gedeptin is a gene-directed enzyme prodrug therapy (GDEPT) delivered intratumorally using a non-replicating viral vector encoding purine nucleoside phosphorylase (PNP). Following administration of a systemically delivered prodrug, the encoded enzyme converts the prodrug into a cytotoxic agent directly within the tumor microenvironment. For more information, visit www.geovax.com.