GeoVax Labs, Inc. has announced a significant update to its Gedeptin® clinical development program, shifting focus towards evaluating Gedeptin as a neoadjuvant therapy in combination with pembrolizumab for patients with primary, resectable head and neck squamous cell carcinoma (HNSCC). This strategic revision is a direct response to the promising results of the KEYNOTE-689 Phase 3 trial, which showcased a notable improvement in event-free survival (EFS) with the addition of perioperative pembrolizumab in resectable, locally advanced HNSCC patients.

The new Phase 2 trial, AdPNP-203, aims to assess the efficacy of combining intra-tumoral Gedeptin®, intravenous fludarabine, and pembrolizumab in patients eligible for curative surgery. The trial’s primary objectives include evaluating major pathological response (MPR) and associated immunologic and biomarker outcomes, alongside monitoring event-free survival over a one-year period. GeoVax’s initiative is grounded in the belief that Gedeptin’s unique tumor-targeting and immune-sensitizing properties could enhance the effectiveness of checkpoint monotherapy by boosting immune activation within the tumor microenvironment.

Dr. Kelly McKee, Chief Medical Officer at GeoVax, emphasized the transformative potential of neoadjuvant checkpoint inhibition in head and neck cancer treatment, a perspective bolstered by the KEYNOTE-689 findings. The trial’s results, published in the New England Journal of Medicine, have not only validated the use of PD-1 inhibition in curative-intent HNSCC but also prompted a paradigm shift towards neoadjuvant immunotherapy. GeoVax’s approach seeks to leverage this shift, aiming to improve local tumor clearance and event-free survival, particularly for high-risk or PD-L1-low patients.

David Dodd, Chairman and CEO of GeoVax, highlighted the strategic nature of this shift, underscoring the potential of Gedeptin’s localized cytotoxic mechanism to enhance therapeutic outcomes when combined with systemic checkpoint inhibition for first-line treatment of resectable HNSCC. The rationale behind this combination strategy is rooted in the observed limitations of current therapies, with many patients experiencing local or distant relapse. Gedeptin’s dual mechanism of action, combining cytotoxic effects with immune-priming capabilities, positions it as an ideal complement to checkpoint inhibitors, potentially transforming ‘cold’ tumors into ‘hot’ immunogenic targets.

Gedeptin, a gene-directed enzyme prodrug therapy (GDEPT), utilizes a non-replicating adenoviral vector to deliver purine nucleoside phosphorylase (PNP) directly into tumors. Following administration of fludarabine, PNP enzymatically converts the prodrug into a cytotoxic compound, selectively targeting tumor cells while minimizing damage to healthy tissue. This targeted approach aims to reduce toxicity, enhance immune visibility, and synergize with immune checkpoint inhibitors. With Orphan Drug Designation for oral and pharyngeal cancers and a strong intellectual property portfolio, GeoVax is poised to advance its innovative immune-sensitizing therapies, offering new hope for patients with solid tumor types.

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