EQS-News: GeoVax Presents Gedeptin(R) Clinical Data at the American Association for Cancer Research Annual Meeting

Advancing Gene-Directed Prodrug Therapy: Data Presented at AACR Supports Gedeptin’s Potential in Solid Tumors

ATLANTA, GA - April 29, 2025 (NEWMEDIAWIRE) - GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced the presentation of new clinical data on its gene-directed enzyme prodrug therapy, Gedeptin®, at the American Association for Cancer Research (AACR) Annual Meeting 2025, being held April 25–30 in Chicago, IL.

The presentation, titled “Viral-Vectored, Gene-Directed Prodrug Therapy (Gedeptin) in Needle-Accessible Solid Tumors,” was delivered by J. Marc Pipas, M.D., Executive Medical Director, Oncology at GeoVax, during the Phase II Clinical Trials 1 Poster Session on April 29, 2025. The session drew significant interest from researchers and clinicians, underscoring the growing recognition of Gedeptin’s therapeutic potential. The corresponding abstract was published in the AACR journal Cancer Research.

Key Findings from the Clinical Study

The study, conducted in collaboration with researchers from Stanford Cancer Center, Emory University School of Medicine, Vanderbilt University, and Thomas Jefferson University, evaluated the safety and efficacy of repeated cycles of Gedeptin in patients with advanced head and neck cancer (H&N Ca).

• Trial Design: Up to five treatment cycles were administered, each consisting of intratumoral (IT) injection of Gedeptin followed by intravenous (IV) administration of fludarabine.
• Patient Population: Eight heavily pretreated patients (median four prior lines of systemic therapies) were enrolled, including those with squamous cell carcinoma, nasopharyngeal carcinoma, and lymphoepithelial carcinoma.
• Efficacy & Safety:
• Several patients achieved stable disease (SD) despite extensive prior therapy.
• Median progression-free survival (PFS) and overall survival (OS) were both 7.0 months.
• No dose-limiting toxicities (DLTs) were reported.
• Treatment-related adverse events (AEs) were minimal, with injection site pain being the most common.
• Serious adverse events (SAEs) observed in five patients were mostly attributed to the underlying disease.

Next Steps: Phase 2 Combination Therapy Trial

Following these encouraging results, GeoVax is advancing preparations for a Phase 2 clinical trial evaluating Gedeptin in combination with pembrolizumab (Keytruda®) as a neoadjuvant therapy for primarily relapsed squamous cell H&N Ca. Preclinical evidence supports the hypothesis that Gedeptin sensitizes tumors to immune checkpoint inhibitors, potentially enhancing clinical response.

“These clinical results reinforce the potential of Gedeptin as a tumor-targeted therapy for patients with advanced, refractory cancers,” said Kelly T. McKee, Jr., M.D., Chief Medical Officer of GeoVax. “We are excited about the upcoming Phase 2 trial integrating Gedeptin with immunotherapy to leverage the immune system more effectively against solid tumors.”

About Gedeptin®

Gedeptin is a viral-vectored gene therapy that uses a non-replicating adenoviral vector encoding E. coli purine nucleoside phosphorylase (PNP). When administered directly into tumors and followed by IV fludarabine, PNP enzymatically converts the prodrug into a cytotoxic compound (fluoroadenine), selectively killing cancer cells by disrupting RNA and protein synthesis. Gedeptin’s mechanism enables the targeting of quiescent tumor cells within the tumor microenvironment, offering a novel approach for treating hard-to-manage solid tumors.

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. The Company is also developing GEO-MVA, a vaccine targeting Mpox and smallpox. 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. 

Company Contact:                 
info@geovax.com
678-384-7220                           

Investor Relations Contact:
geovax@precisionaq.com
212-698-8696

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