GeoVax Labs, Inc. (Nasdaq: GOVX) announced today the advancement of its oncology program, Gedeptin, toward a Phase 2 clinical trial and potential strategic partnerships. The company is preparing to initiate a Phase 2 trial evaluating Gedeptin in combination with an immune checkpoint inhibitor (ICI) as a first-line neoadjuvant treatment for patients with resectable locally advanced head and neck cancer, with trial initiation targeted for 2027.
The study will assess tumor response in the neoadjuvant setting, biomarker-driven immune activation, and event-free survival outcomes. This trial is expected to provide key clinical validation for Gedeptin in combination immuno-oncology strategies. GeoVax believes that the convergence of upcoming clinical milestones and the increasing industry focus on combination approaches creates a timely opportunity to advance Gedeptin's development and strategic positioning.
In parallel with its lead program, GeoVax is planning to advance preclinical and translational work evaluating Gedeptin across additional solid tumor indications. These efforts aim 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. "We are entering an important phase of development for Gedeptin, with a focus on clinical execution and advancing discussions around potential partnerships," said David A. Dodd, Chairman and Chief Executive Officer of GeoVax. "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."
The company 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.
GeoVax is a clinical-stage biotechnology company focused on vaccines and immunotherapies for infectious diseases and solid tumor cancers. Its priority program is GEO-MVA, a Modified Vaccinia Ankara (MVA)-based vaccine targeting mpox and smallpox, which is advancing under an expedited regulatory pathway with plans to initiate a pivotal Phase 3 clinical trial in the second half of 2026. The company's broader pipeline includes GEO-CM04S1, a next-generation COVID-19 vaccine candidate being evaluated in immunocompromised and other patient populations. For more information, visit www.geovax.com.
The company 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.
