Supports Advancement of GeoVax’s Phase 2 Gedeptin® Trial in Recurrent Head and Neck Cancer
ATLANTA, GA - June 24, 2025 (NEWMEDIAWIRE) - GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing multi-antigen vaccines and immunotherapies for infectious diseases and cancer, today commented on the U.S. Food and Drug Administration’s recent approval of Keytruda® (pembrolizumab) for use in resectable, locally advanced head and neck squamous cell carcinoma (HNSCC) tumors expressing PD-L1 as determined by an FDA approved test. This regulatory milestone marks a significant advancement in the curative-intent treatment landscape for head and neck cancer and affirms the therapeutic strategy underlying GeoVax’s Gedeptin® development program.
An editorial by Rosenberg and Vokes in New England Journal of Medicine (NEJM) noted that the study forming the basis of FDA’s approval represents the first demonstration of benefit for PD-1 inhibition in the curative setting for HNSCC, with implications for evolving neoadjuvant immunotherapy paradigms.
GeoVax is planning to initiate a Phase 2 clinical trial of Gedeptin® in combination with a checkpoint inhibitor, such as pembrolizumab, in patients with locally advanced HNSCC scheduled for curative-intent surgery. The trial aims to improve tumor clearance and reduce relapse by combining the immune-priming effect of Gedeptin’s targeted cytotoxicity with the systemic immune activation of checkpoint inhibition.
The Phase 2 study, expected to launch in 2026, will evaluate pathologic response, recurrence rates, and biomarker-defined immunologic changes when Gedeptin is used as neoadjuvant therapy with checkpoint inhibitors. Importantly, the NEJM editorial emphasized the need to optimize patient selection and treatment duration in the immunotherapy era, aligning with GeoVax’s biomarker-driven approach.
“The NEJM publication and FDA approval of Keytruda in resectable HNSCC signals a new era in curative-intent cancer therapy,” said David Dodd, Chairman and CEO of GeoVax. “By combining Gedeptin therapy with pembrolizumab, we aim to enhance local tumor eradication while unlocking systemic anti-tumor immunity, potentially reducing both local and distant recurrence.”
“We believe Gedeptin's tumor-targeted cytotoxicity can enhance immunotherapy efficacy, particularly in the perioperative window where anti-tumor immunity can be primed,” added Dr. Kelly McKee, GeoVax’s Chief Medical Officer. “We are excited to embark on the next phase of Gedeptin development as we attempt to build on the important advances being made in this disease."
For more information about the KEYNOTE-689 study, see the June 18, 2025 publication in the New England Journal of Medicine.
About Gedeptin
Gedeptin® is a gene-directed enzyme prodrug therapy (GDEPT) delivered intratumorally via an adenoviral vector encoding purine nucleoside phosphorylase (PNP). Upon systemic administration of fludarabine, the enzyme catalyzes the generation of a cytotoxic agent selectively within the tumor microenvironment. This mechanism provides dual cytotoxicity and immune modulation with minimal systemic exposure.
Gedeptin has been granted Orphan Drug Designation by the FDA for the treatment of oral and pharyngeal cancers and is protected by a growing intellectual property portfolio. GeoVax’s ongoing innovation in immune-sensitizing therapies supports a broader strategy to complement checkpoint inhibitors and overcome tumor immune resistance across solid tumor types.
About GeoVax
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumor cancers. The Company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax is also developing a vaccine targeting Mpox and smallpox and, based on recent regulatory guidance, anticipates progressing directly to a Phase 3 clinical evaluation, omitting Phase 1 and Phase 2 trials. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. For more information about the current status of our clinical trials and other updates, visit our website: www.geovax.com.
Forward-Looking Statements
This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.
Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.
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