GeoVax's Gedeptin Shows Promise in Refractory Head and Neck Cancer Trial

GeoVax Labs, a clinical-stage biotechnology company, has announced the publication of a pivotal Phase 1/2 clinical trial in JCO Oncology Advances, the American Society of Clinical Oncology's open-access journal. The study evaluated Gedeptin®, the company's gene-directed enzyme prodrug therapy (GDEPT), in combination with fludarabine for patients with recurrent head and neck cancers who had exhausted all standard treatments. Key players include GeoVax's leadership team: J. Marc Pipas, MD, Executive Medical Director of Oncology; Kelly T. McKee, MD, MPH, Chief Medical Officer; and David Dodd, Chairman & CEO, all of whom emphasized the trial's significance. The core message centers on the therapy's acceptable safety profile with repeated dosing, evidence of disease stability in 37.5% of patients, and successful tumor transduction, supporting further development in earlier-stage disease and combination treatments.

The trial enrolled a highly refractory population with a median of four prior lines of therapy, administering Gedeptin via intratumoral injection followed by systemic fludarabine on a 28-day schedule. Results showed no new safety signals, with serious adverse events being uncommon and unrelated to treatment, and no deaths attributed to the therapy. Importantly, tumor biopsies confirmed robust uptake and expression of the therapeutic E. coli PNP transgene in all evaluable patients, validating the mechanistic foundation of the Gedeptin platform. The study suggests that earlier intervention, higher dosing, or combination with immune checkpoint inhibitors like pembrolizumab could enhance efficacy, aligning with GeoVax's strategy to advance into neoadjuvant studies for surgically resectable cancers.

Gedeptin's platform features a tumor-agnostic mechanism, where the adenoviral vector delivers the PNP gene into tumors, converting fludarabine into a potent cytotoxic metabolite (2-fluoroadenine) that kills cancer cells with a strong bystander effect. This approach also offers immune-sensitizing properties that may improve responses to checkpoint inhibitors. Beyond oncology, GeoVax is developing vaccines for infectious diseases, including GEO-CM04S1 for COVID-19 in immunocompromised patients. The publication underscores the scientific rationale for Gedeptin and highlights the need for new approaches in recurrent head and neck cancers, with plans to expand development into earlier settings and rational combination regimens. For more information, visit the company's website at www.geovax.com, and view the original release on www.newmediawire.com.