GeoVax Expands Gedeptin Cancer Therapy to Multiple Solid Tumors

GeoVax Labs, Inc., a clinical-stage biotechnology company, has announced a significant expansion of its oncology development strategy to include assessments of additional solid tumor targets for Gedeptin®, its innovative gene-directed enzyme prodrug therapy (GDEPT). Building on the momentum of checkpoint inhibitors and landmark KEYNOTE-689 results, GeoVax is collaborating with the Winship Cancer Institute of Emory University to evaluate Gedeptin's combination with immune checkpoint inhibitors in preclinical models of various solid tumor types beyond head and neck cancer, including triple negative breast cancer and cutaneous malignancies. This strategic move represents a major advancement in the company's approach to cancer treatment, leveraging Gedeptin's unique mechanism of localized intratumoral cytotoxicity that simultaneously primes systemic immune responses.

The company's development pipeline includes the planned Phase 2 clinical trial AdPNP-203, which will evaluate Gedeptin combined with intravenous fludarabine and pembrolizumab as first-line treatment for head and neck squamous cell carcinoma patients eligible for curative surgery. Trial initiation is targeted for the second half of 2026, with design focused on assessing major pathological response and event-free survival over one year. GeoVax leadership, including Chairman & CEO David A. Dodd and Chief Medical Officer Dr. Kelly T. McKee, emphasized that this expansion addresses a critically important area of solid tumor cancer therapy and represents a major value-creation opportunity. The company anticipates early readouts from preclinical modeling work that will support potential clinical trials in selected solid tumor indications, while continuing potential collaborative discussions for clinical development and commercialization partnerships.

Gedeptin® represents a novel approach in cancer therapy, utilizing a non-replicating adenoviral vector to deliver the purine nucleoside phosphorylase (PNP) enzyme directly into tumors. Following administration of fludarabine, the PNP enzyme converts it into a cytotoxic compound within the tumor microenvironment, selectively destroying cancer cells while releasing antigens that enhance immune recognition. This dual mechanism of tumor debulking and immune priming positions Gedeptin as a potential force multiplier for checkpoint inhibitors like Keytruda, potentially overcoming limitations of monotherapy by enhancing immune activation within the tumor microenvironment. For more information about the company's progress and clinical trials, visit www.geovax.com.