FAQ on GeoVax's Strategic Shift in Gedeptin® Clinical Development Following KEYNOTE-689 Results

What is the main focus of GeoVax’s revised clinical development program for Gedeptin®?

The revised program focuses on evaluating Gedeptin as a neoadjuvant therapy in combination with pembrolizumab for patients with primary, resectable head and neck squamous cell carcinoma (HNSCC).

Why did GeoVax decide to shift its strategy for Gedeptin®?

The shift was inspired by the landmark results of the KEYNOTE-689 Phase 3 trial, which demonstrated significant improvement in event-free survival with perioperative pembrolizumab in resectable, locally advanced HNSCC patients.

What will GeoVax’s new Phase 2 trial (AdPNP-203) evaluate?

The trial will evaluate the addition of intra-tumoral Gedeptin®, intravenous fludarabine, and pembrolizumab in patients eligible for curative surgery, assessing major pathological response and event-free survival over a one-year period.

How does Gedeptin® work in combination with checkpoint inhibitors?

Gedeptin’s tumor-targeting, immune-sensitizing mechanism may help overcome the limitations of checkpoint monotherapy by enhancing immune activation within the tumor microenvironment.

When is the trial initiation planned?

Trial initiation is planned for 2026.

What is the significance of the KEYNOTE-689 trial results?

The results represent the first validated use of PD-1 inhibition in curative-intent HNSCC and have catalyzed a major shift in treatment paradigms toward neoadjuvant immunotherapy.

What are the potential benefits of combining Gedeptin® with pembrolizumab?

The combination aims to improve both local tumor clearance and event-free survival, especially for high-risk or PD-L1-low patients, by converting ‘cold’ tumors into ‘hot’ immunogenic targets.

What is Gedeptin®?

Gedeptin is a gene-directed enzyme prodrug therapy (GDEPT) using a non-replicating adenoviral vector encoding purine nucleoside phosphorylase (PNP), designed to selectively target tumor cells while sparing healthy tissue.

Who is leading the clinical development program at GeoVax?

Dr. Kelly McKee, Chief Medical Officer at GeoVax, is leading the clinical development program, with strategic oversight from David Dodd, Chairman and CEO of GeoVax.