GeoVax Labs' CEO David Dodd Discusses Pipeline, Trials, and Upcoming Milestones

GeoVax Labs is a clinical-stage biotech company developing vaccines and therapies for infectious diseases and solid tumor cancers. Their pipeline includes ongoing trials for a next-gen COVID-19 vaccine and therapy for advanced head and neck cancer. The company has received positive Scientific Advice from the European Medicines Agency for its MVA-based vaccine for Mpox and smallpox prevention, allowing for a streamlined Phase 3 trial and potentially accelerated regulatory approval.

ATLANTA, GA - July 24, 2025 - GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company focused on developing immunotherapies and vaccines against cancers and infectious diseases, has announced a strategic shift in its Gedeptin® clinical development program. The new strategy aims to evaluate Gedeptin as a neoadjuvant therapy in combination with pembrolizumab for patients with primary, resectable head and neck squamous cell carcinoma (HNSCC).

The revised strategy follows the landmark results of the KEYNOTE-689 Phase 3 trial, which demonstrated a significant improvement in event-free survival (EFS) with the addition of perioperative pembrolizumab in resectable, locally advanced HNSCC patients [1]. This data represents the first validated use of PD-1 inhibition in curative-intent HNSCC and has catalyzed a major shift in treatment paradigms toward neoadjuvant immunotherapy.

GeoVax's new Phase 2 trial (AdPNP-203) will evaluate the addition of intra-tumoral Gedeptin®, intravenous fludarabine, and pembrolizumab in patients eligible for curative surgery. The trial is designed to assess major pathological response (MPR) and associated immunologic and biomarker outcomes following two pre-surgical cycles of therapy as well as event-free survival over a one-year period. Trial initiation is planned for 2026.

Dr. Kelly McKee, Chief Medical Officer at GeoVax, stated, "The KEYNOTE-689 results support our view that neoadjuvant checkpoint inhibition can transform the treatment of head and neck cancer. By integrating Gedeptin into this emerging standard, we hope to improve both local tumor clearance and event-free survival, especially for high-risk or PD-L1-low patients."

David Dodd, Chairman and CEO of GeoVax, added, "This is a strategic shift in our program. We believe Gedeptin's localized cytotoxic mechanism, when combined with systemic checkpoint inhibition for first-line treatment, can meaningfully improve therapeutic outcomes in patients with resectable HNSCC."

Gedeptin is a gene-directed enzyme prodrug therapy (GDEPT) using a non-replicating adenoviral vector encoding purine nucleoside phosphorylase (PNP). Once delivered directly into tumors and followed by fludarabine, PNP enzymatically converts the prodrug into a cytotoxic compound, selectively targeting tumor cells while sparing healthy tissue. This localized approach aims to reduce toxicity, enhance immune visibility, and enable immune checkpoint synergy.

GeoVax Labs is also making progress with its MVA-based vaccine for Mpox and smallpox prevention. The company has received positive Scientific Advice from the European Medicines Agency, allowing for a streamlined Phase 3 trial and potentially accelerated regulatory approval.

References:
[1] https://www.nasdaq.com/press-release/geovax-advance-gedeptinr-first-line-therapy-neoadjuvant-combination-trial-following