EQS-News: GeoVax Announces Major Gedeptin Milestone With Plans of Phase 2 Trial

Represents a Key Step Toward Validating Gedeptin Potential in Solid Tumor Therapy

ATLANTA, GA - January 15, 2025 (NEWMEDIAWIRE) - GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing innovative immunotherapies and vaccines for cancer and infectious diseases, announced significant progress in advancing Gedeptin as a cancer therapy. Gedeptin, based on a Gene-Directed Enzyme Prodrug Therapy (GDEPT) platform, employs a targeted approach to deliver therapeutic agents directly to tumor sites. The result of this approach is the localized production of a potent anti-cancer agent(s) within the tumor microenvironment, while minimizing systemic exposure and the potential for associated side effects. 

Following a review of the data from the completed Phase 1 single-cycle and Phase 1/2 multi-cycle Gedeptin trials among patients with advanced Head & Neck (H&N) tumors, GeoVax has decided to initiate a Phase 2 clinical study, evaluating neoadjuvant Gedeptin therapy in combination with an approved immune check point inhibitor (ICI) in 1st recurrent H&N cancer scheduled for resection with curative intent.

Therapy Potential and Market Opportunity

Gedeptin has been granted Orphan Drug Designation by the U.S. FDA for the intratumoral treatment of anatomically accessible oral and pharyngeal cancers, underscoring its potential to address significant unmet medical needs.

"Preclinical data suggest that Gedeptin/fludarabine can enhance the activity of ICIs in treatment of solid tumors.  Our upcoming Phase 2 trial will investigate this approach as a neoadjuvant therapy for patients with first recurrence head and neck cancer. We believe this will lead to increased tumor response and decreased recurrence rates in these patients," said David Dodd, Chairman and CEO of GeoVax. "Based on the data generated to date, this combination has the potential to address multiple solid tumor indications, and represents a significant medical and commercial opportunity, if approved."

David Dodd added, "We are entering an exciting phase of clinical development with Gedeptin, and our team remains committed to advancing this innovative therapy to deliver life-changing benefits for cancer patients worldwide."

Advancing Clinical Development

The upcoming Phase 2 trial will evaluate the efficacy of Gedeptin in combination with ICIs in patients with first-recurrence head and neck cancer. Key endpoints will include pathologic response rates and overall treatment outcomes. GeoVax plans to initiate trial activities mid-year and partner with leading academic oncology centers.

A Transformative Year Ahead

GeoVax projects significant milestones in 2025, with Gedeptin expected to play a key role in delivering transformative cancer therapies. Beyond head and neck cancers, the company plans to explore Gedeptin's potential applications across other solid tumor types.

GeoVax's CEO, David Dodd, will present the Company's 2024 progress and outlook for 2025 at the Emerging Growth Conference: January 16, 2025, at 2:35 PM ET.

For more information on GeoVax's portfolio and developments, please visit www.geovax.com.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines for many of the world’s most threatening infectious diseases and therapies for solid tumor cancers. The company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine for which GeoVax was recently awarded a BARDA-funded contract to sponsor a 10,000-participant Phase 2b clinical trial to evaluate the efficacy of GEO-CM04S1 versus an approved COVID-19 vaccine. In addition, GEO-CM04S1 is 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. A Phase 2 clinical trial in first recurrent head and neck cancer, evaluating Gedeptin combined with an immune checkpoint inhibitor is planned to initiate during the first half of 2025. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. The Company has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. 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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