GeoVax Labs, Inc. announced the publication of a peer-reviewed article in JCO Oncology Advances, reporting findings from a Phase 1/2 clinical trial of its Gedeptin® therapy for recurrent head and neck cancer. The study enrolled patients who had exhausted all standard treatment options and had undergone a median of four prior lines of systemic therapy, representing a highly refractory population.
The trial evaluated repeated cycles of Gedeptin, a gene-directed enzyme prodrug therapy, administered via intratumoral injection followed by systemic fludarabine. Key results included an acceptable safety profile with no new safety signals, no deaths attributed to study therapy, and clinical evidence of disease stability with three of eight patients achieving stable disease. Tumor biopsies confirmed successful tumor transduction and PNP transgene expression in all evaluable patients, supporting the mechanistic foundation of the platform.
J. Marc Pipas, MD, Executive Medical Director, Oncology of GeoVax, stated that the publication reinforces the strong scientific rationale underpinning the Gedeptin platform, noting that even in this refractory population, repeated dosing demonstrated a favorable safety profile and evidence of disease stability. Kelly T. McKee, MD, MPH, Chief Medical Officer, added that these results support continued development in settings where tumor burden is lower, patients are less heavily pretreated, or where combination strategies may amplify therapeutic benefit.
The study suggests that earlier intervention, higher vector dosing, improved tumor transduction, or combination therapy may further increase efficacy. Preclinical findings cited in the manuscript show that Gedeptin-mediated tumor destruction may sensitize tumors to checkpoint inhibitors, offering a promising path forward. GeoVax is advancing plans to evaluate Gedeptin with agents such as pembrolizumab, aiming to strengthen antitumor immune activation. For more information about clinical trials and other updates, visit https://www.geovax.com.
David Dodd, Chairman & CEO of GeoVax, stated that the publication underscores both the scientific significance of this trial and the need for new approaches to treat recurrent head and neck cancers. Gedeptin's targeted mechanism, combined with its repeat-dosing feasibility, offers a promising therapeutic option for patients. The company looks forward to expanding development into earlier disease settings and rational combination regimens.
This development is important because recurrent head and neck cancer represents a significant unmet medical need, with limited treatment options for patients who have failed standard therapies. The demonstration of safety with repeated dosing and evidence of disease stability in this challenging population provides a foundation for potentially more effective treatments in earlier-stage disease. The tumor-agnostic mechanism and immune-sensitizing properties could have broader implications for solid tumor oncology, particularly when combined with existing immunotherapies.
