FAQ on GeoVax's Gedeptin® and FDA Approval of Keytruda® for Head and Neck Cancer

What is the significance of the FDA’s approval of Keytruda® for head and neck cancer?

The FDA’s approval marks a significant advancement in the curative-intent treatment landscape for head and neck cancer, particularly for resectable, locally advanced tumors expressing PD-L1.

How does GeoVax’s Gedeptin® fit into the treatment of head and neck cancer?

GeoVax is planning a Phase 2 clinical trial to evaluate Gedeptin® in combination with a checkpoint inhibitor like pembrolizumab, aiming to improve tumor clearance and reduce relapse by combining targeted cytotoxicity with systemic immune activation.

What is the expected timeline for GeoVax’s Phase 2 trial of Gedeptin®?

The Phase 2 study is expected to launch in 2026, focusing on pathologic response, recurrence rates, and biomarker-defined immunologic changes in patients with locally advanced HNSCC.

What makes Gedeptin® unique in the treatment of cancer?

Gedeptin® is a gene-directed enzyme prodrug therapy that provides dual cytotoxicity and immune modulation with minimal systemic exposure, targeting the tumor microenvironment selectively.

Who is involved in the development of Gedeptin®?

GeoVax Labs, Inc., a clinical-stage biotechnology company, is developing Gedeptin®, with David Dodd as Chairman and CEO and Dr. Kelly McKee as Chief Medical Officer leading the efforts.

What are the potential benefits of combining Gedeptin® with checkpoint inhibitors?

The combination aims to enhance local tumor eradication and unlock systemic anti-tumor immunity, potentially reducing both local and distant recurrence in head and neck cancer patients.

Where can I find more information about the KEYNOTE-689 study mentioned in the content?

For more information about the KEYNOTE-689 study, refer to the June 18, 2025 publication in the New England Journal of Medicine.

What is the Orphan Drug Designation for Gedeptin®?

Gedeptin® has been granted Orphan Drug Designation by the FDA for the treatment of oral and pharyngeal cancers, recognizing its potential to address unmet medical needs in these areas.