Near-Term Clinical Milestones and Combination Strategy Position Program for Next Stage of Value Creation
ATLANTA, GA - April 29, 2026 (NEWMEDIAWIRE) - GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today outlined near-term development milestones and strategic priorities for its oncology program, Gedeptin®, as the Company advances toward Phase 2 clinical initiation and potential partnership opportunities.
With oncology treatment increasingly defined by combination regimens, the ability to integrate into established therapeutic backbones is becoming a key factor in clinical and commercial success. GeoVax believes the convergence of upcoming clinical milestones and increasing industry focus on combination approaches creates a timely opportunity to advance Gedeptin’s development and strategic positioning.
Advancing Toward Phase 2 Clinical Execution
GeoVax is advancing Gedeptin with a focus on integration into combination treatment regimens, particularly alongside immune checkpoint inhibitors (ICIs) and other established oncology backbones. The Company believes this approach aligns with the evolving treatment landscape and may support broader applicability across multiple tumor types. GeoVax is preparing to initiate a Phase 2 clinical trial evaluating Gedeptin, in combination with an ICI, as a first-line neoadjuvant treatment in patients with resectable locally advanced head and neck cancer, with trial initiation targeted for 2027.
The study is designed to evaluate:
- Tumor response in the neoadjuvant setting
- Biomarker-driven immune activation
- Event-free survival outcomes
This trial is expected to represent a key step in establishing clinical validation for Gedeptin in combination immuno-oncology strategies.
Expanding Development Across Additional Solid Tumors
In parallel with its lead clinical program, GeoVax is planning to advance preclinical and translational work evaluating Gedeptin across additional solid tumor indications. These efforts are intended to (a) identify tumor settings where combination approaches may provide the greatest clinical benefit, (b) support expansion beyond head and neck cancer and, (c) inform future clinical development strategies.
Positioned for Strategic Collaboration
GeoVax is actively pursuing opportunities to advance Gedeptin through clinical development partnerships, combination-focused collaborations and potential licensing or co-development arrangements.
“We are entering an important phase of development for Gedeptin, with a focus on clinical execution and advancing discussions around potential partnerships,” said David A. Dodd, Chairman and Chief Executive Officer of GeoVax. “As combination therapy becomes more common across oncology, we believe Gedeptin is well positioned to be integrated into these regimens and contribute to improved treatment outcomes.”
Supported by an Established Clinical and Scientific Foundation
GeoVax has established a clinical and scientific foundation to support Gedeptin’s advancement into its next stage of development, including:
- Completed Phase 1/2 clinical experience in advanced head and neck cancer
- Engagement of an Oncology Advisory Board with deep immuno-oncology expertise
- Expanded intellectual property supporting combination use with checkpoint inhibitors
This foundation is intended to support both continued clinical progression and engagement with potential partners.
About Gedeptin®
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.
About GeoVax
GeoVax Labs, Inc. is a clinical-stage biotechnology company focused on the development of vaccines and immunotherapies addressing high-consequence infectious diseases and solid tumor cancers. GeoVax’s priority program is GEO-MVA, a Modified Vaccinia Ankara (MVA)-based vaccine targeting mpox and smallpox. The program is advancing under an expedited regulatory pathway, with plans to initiate a pivotal Phase 3 clinical trial in the second half of 2026, to address critical global needs for expanded orthopoxvirus vaccine supply and biodefense preparedness. In oncology, GeoVax is developing Gedeptin®, a gene-directed enzyme prodrug therapy (GDEPT) designed to enhance immune checkpoint inhibitor activity. Gedeptin has completed a multicenter Phase 1/2 clinical trial in advanced head and neck cancer and is being advanced into combination strategies, including planned neoadjuvant and first-line settings. GeoVax’s broader pipeline includes the development of GEO-CM04S1, a next-generation COVID-19 vaccine candidate being evaluated in immunocompromised and other patient populations. GeoVax maintains a global intellectual property portfolio supporting its infectious disease and oncology programs and continues to evaluate strategic partnerships and funding opportunities aligned with its development priorities. For more information, visit 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
Media Contact:
Jessica Starman
media@geovax.com
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