GeoVax Advances Gedeptin Toward Phase 2 Trial, Secures Emory License for ICI Combination
GeoVax is advancing Gedeptin toward a Phase 2 trial in head and neck cancer and has secured an exclusive license from Emory University for Gedeptin-ICI combination technology. The therapy has Orphan Drug Designation for oral and pharyngeal cancers.
GeoVax Labs, Inc. (Nasdaq: GOVX) is advancing its oncology asset Gedeptin toward a Phase 2 clinical trial initiation targeted for 2027, while also securing an exclusive worldwide license from Emory University for intellectual property covering the use of Gedeptin in combination with immune checkpoint inhibitors (ICIs). The planned Phase 2 trial will evaluate Gedeptin in combination with an ICI as a first-line neoadjuvant treatment in patients with resectable locally advanced head and neck cancer.
The exclusive license agreement with Emory University, announced in February 2026, provides GeoVax with global rights to patent applications and associated know-how covering the combination of Gedeptin with ICIs within a defined field of use. The licensed technology was developed in collaboration with investigators at Emory University and Children's Healthcare of Atlanta. Financial terms of the agreement were not disclosed.
Gedeptin is a gene-directed enzyme prodrug therapy (GDEPT) delivered intratumorally using a non-replicating viral vector encoding purine nucleoside phosphorylase (PNP). Following administration of a systemically delivered prodrug, the encoded enzyme converts the prodrug into a cytotoxic agent directly within the tumor microenvironment. The therapy is designed to selectively destroy both proliferating and non-proliferating tumor cells while promoting immune recognition and minimizing systemic toxicity.
Preclinical in vivo tumor models of metastasis have demonstrated that treatment of a single lesion can sensitize tumors to checkpoint blockade inhibitors, presumably by destroying tumor tissue, exposing neoantigens, and enhancing immune response and activity of ICIs at distant untreated lesions. GeoVax has generated preclinical, clinical and translational data supporting Gedeptin's ability to induce localized tumor cell death while promoting immune activation within the tumor microenvironment.
Gedeptin has received Orphan Drug Designation for oral and pharyngeal cancers. The therapy has completed a multicenter Phase 1/2 clinical trial in advanced head and neck cancer.
In parallel with its lead clinical program, GeoVax is planning to advance preclinical and translational work evaluating Gedeptin across additional solid tumor indications. The Company is actively pursuing opportunities to advance Gedeptin through clinical development partnerships, combination-focused collaborations, and potential licensing or co-development arrangements.
GeoVax's broader pipeline includes GEO-MVA, a Modified Vaccinia Ankara (MVA)-based vaccine targeting mpox and smallpox, which is advancing under an expedited regulatory pathway with plans to initiate a pivotal Phase 3 clinical trial in the second half of 2026, and GEO-CM04S1, a next-generation COVID-19 vaccine candidate being evaluated in immunocompromised and other patient populations.