GeoVax Presents Promising Clinical Data for Gedeptin® Gene Therapy in Head and Neck Cancer Treatment

GeoVax Labs revealed clinical trial results for Gedeptin®, a novel gene-directed prodrug therapy showing potential in treating advanced head and neck cancers with minimal side effects and stability in patient outcomes.

April 29, 2025
GeoVax Presents Promising Clinical Data for Gedeptin® Gene Therapy in Head and Neck Cancer Treatment

Biotechnology company GeoVax Labs presented new clinical data for its innovative cancer therapy Gedeptin® at the American Association for Cancer Research (AACR) Annual Meeting, demonstrating promising results for treating advanced head and neck cancers.

The phase I/II clinical study evaluated Gedeptin®, a viral-vectored gene therapy designed to selectively target and kill cancer cells, in eight heavily pretreated patients with various head and neck cancer subtypes. Researchers administered up to five treatment cycles, combining intratumoral Gedeptin® injections with intravenous fludarabine.

Key findings revealed several patients achieved stable disease despite extensive prior treatments. The study reported a median progression-free and overall survival of 7.0 months, with minimal treatment-related adverse events. Notably, no dose-limiting toxicities were observed, and injection site pain was the most common side effect.

The encouraging results have prompted GeoVax to plan a Phase 2 clinical trial combining Gedeptin® with pembrolizumab (Keytruda®) as a neoadjuvant therapy for relapsed squamous cell head and neck cancers. Preclinical evidence suggests the combination could enhance immune system response against solid tumors.

Gedeptin®'s unique mechanism involves using a non-replicating adenoviral vector to deliver an enzyme that converts a prodrug into a cytotoxic compound, potentially offering a novel approach to targeting difficult-to-treat solid tumors. This innovative strategy could represent a significant advancement in personalized cancer treatment, particularly for patients with limited therapeutic options.