GeoVax Completes Enrollment for Gedeptin Phase 1/2 Trial in Advanced HNC Patients

GeoVax Labs, a biotechnology firm, has completed patient recruitment for a Phase 1/2 clinical trial of Gedeptin, a novel immunotherapy for advanced head and neck cancer. The company's Chief Medical Officer, Dr. Kelly McKee, highlighted the significance of this trial in advancing the Gedeptin program, with expectations to conclude by the third quarter of 2024. Discussions are underway with advisors to develop a protocol for subsequent trials, aiming to discuss the possibility of an expedited approval pathway with the FDA.

Dr. McKee emphasized the potential of Gedeptin to treat not only advanced head and neck cancer but also other solid tumors, given its demonstrated safety and efficacy in stabilizing or reducing tumor sizes. David Dodd, Chairman and CEO of GeoVax, expressed confidence in the product's potential, based on previous trials and investigations. The company plans to adjust the treatment regimen and explore combinations with immune checkpoint inhibitors for broader applications.

Gedeptin operates on the Gene-Directed Enzyme Prodrug Therapy (GDEPT) principle, where a vector introduces a nonhuman gene into tumor cells, enabling them to convert a harmless prodrug into a potent anti-cancer compound. The current trial, identified by ClinicalTrials.gov as NCT03754933, involves up to five cycles of Gedeptin treatment for patients with recurrent head and neck squamous cell carcinoma, with no curative treatment options available. The treatment protocol includes multiple injections of Gedeptin followed by fludarabine phosphate infusions.

Interim data from the trial showed no dose-limiting toxicities or serious adverse events directly attributable to Gedeptin treatment. Furthermore, no adverse events above grade 3 severity were reported, and tumor growth stabilization was observed in a majority of the patients. The FDA has partially funded the study through its Orphan Products Clinical Trials Grants Program and has granted Gedeptin orphan drug status for specific oral and pharyngeal cancers.

GeoVax is also developing GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patients, currently in multiple Phase 2 clinical trials. The company's leadership has a track record of value creation in the life sciences sector.