GeoVax's Gedeptin® Shows Favorable Safety and Disease Stability in Recurrent Head & Neck Cancer Trial

GeoVax Labs, Inc. announced the publication of a peer-reviewed article in JCO Oncology Advances, reporting findings from a multi-center clinical trial evaluating repeated cycles of Gedeptin®, a gene-directed enzyme prodrug therapy, in patients with recurrent head and neck cancers. The Phase 1/2 trial enrolled patients who had exhausted all standard treatment options and had undergone a median of four prior lines of systemic therapy, making this a highly refractory population. Patients received therapy on a 28-day schedule, each consisting of intratumoral Gedeptin injections followed by intravenous fludarabine.

Key results from the publication include an acceptable safety profile with no new safety signals, where serious adverse events were uncommon and generally unrelated to treatment, and no deaths were attributed to study therapy. Clinical evidence of disease stability was observed, with three of eight patients achieving stable disease in this cohort of patients with end-stage disease. Successful tumor transduction and PNP transgene expression were confirmed through tumor biopsies, supporting the mechanistic foundation of the Gedeptin platform. These findings suggest that earlier intervention, higher vector dosing, improved tumor transduction, or combination therapy may further increase efficacy.

J. Marc Pipas, MD, Executive Medical Director, Oncology of GeoVax, stated that this publication reinforces the strong scientific rationale underpinning the Gedeptin platform, noting that even in a highly refractory patient population, repeated intratumoral dosing demonstrated a favorable safety profile and evidence of disease stability. Kelly T. McKee, MD, MPH, Chief Medical Officer of GeoVax, added that these results support continued development in settings where tumor burden is lower, patients are less heavily pretreated, or where combination strategies, particularly with immune checkpoint inhibitors, may amplify therapeutic benefit. This aligns with the strategy to advance Gedeptin into neoadjuvant studies for surgically resectable recurrent head and neck cancers.

David Dodd, Chairman & CEO of GeoVax, emphasized that the publication in the ASCO journal underscores both the scientific significance of this trial and the need for new approaches to treat recurrent head and neck cancers, highlighting Gedeptin’s targeted mechanism and repeat-dosing feasibility as promising for patients. The Gedeptin platform is a non-replicating adenoviral vector delivering the E. coli purine nucleoside phosphorylase gene directly into tumor tissue, with key characteristics including a tumor-agnostic mechanism of action, strong bystander effect, immune-sensitizing properties, and a favorable safety profile. Gedeptin is now progressing toward combination-therapy in a neoadjuvant clinical program, with plans to evaluate it with agents such as pembrolizumab to strengthen antitumor immune activation, as detailed on the company's website at https://www.geovax.com.