GeoVax Labs, Inc. (Nasdaq: GOVX) announced Monday it is advancing its oncology program Gedeptin toward Phase 2 clinical initiation and exploring strategic partnership opportunities, citing the growing importance of combination regimens in cancer care.
The Atlanta-based clinical-stage biotechnology company said it 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. Trial initiation is targeted for 2027.
The study will evaluate tumor response in the neoadjuvant setting, biomarker-driven immune activation, and event-free survival outcomes. GeoVax believes this trial could be a key step in establishing clinical validation for Gedeptin in combination immuno-oncology strategies.
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 also planning preclinical and translational work to evaluate Gedeptin across additional solid tumor indications. These efforts aim to identify tumor settings where combination approaches may provide the greatest clinical benefit and support expansion beyond head and neck cancer.
“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 is actively pursuing opportunities for clinical development partnerships, combination-focused collaborations, and potential licensing or co-development arrangements.
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.
According to the company, the convergence of upcoming clinical milestones and increasing industry focus on combination approaches creates a timely opportunity to advance Gedeptin’s development and strategic positioning.
GeoVax Labs 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 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 also develops GEO-CM04S1, a next-generation COVID-19 vaccine candidate.
For more information, visit www.geovax.com.
