GeoVax Highlights Gedeptin as Immune-Sensitizing Platform Amid Growing Industry Investment in In Vivo Cancer Therapies

ATLANTA, GA – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today highlighted the strategic positioning of its oncology asset, Gedeptin® (Ad/PNP), in the context of accelerating industry investment in next-generation in vivo cancer therapies. Recent high-profile transactions and investments across the biopharmaceutical sector underscore a growing focus on therapies designed to simplify delivery, improve scalability, and expand therapeutic reach. As these approaches advance, a central challenge remains: many tumors are immunologically 'cold,' limiting the effectiveness of even the most advanced therapeutic modalities. GeoVax believes Gedeptin is uniquely positioned to address this challenge.

'While the industry is investing heavily in next-generation cell and gene therapies, the ability to positively modify the local tumor environment is believed to be one of the critical determinants of clinical success,' said David A. Dodd, Chairman and Chief Executive Officer of GeoVax. 'Gedeptin is designed to directly destroy both proliferating and non-proliferating tumors, while also demonstrating high bystander activity due to the ability of the in situ generated cytotoxic agent to diffuse into neighboring tumor cells.'

Gedeptin is a gene-directed enzyme prodrug therapy (GDEPT), delivered intratumorally, designed to generate PNP, selectively destroy both proliferating and non-proliferating tumor cells within the treated tumor. In vivo preclinical experiments have shown PNP treatment to be additive or synergistic with checkpoint blockade–type agents. For example, studies in preclinical in vivo tumor models of metastasis have demonstrated that treatment of a single lesion can robustly sensitize tumors to checkpoint blockade inhibitors, presumably by destroying tumor tissue (including the tumor microenvironment), exposing neoantigens, and enhancing immune response and activity of immune checkpoint inhibitors (ICIs) at distant PNP-untreated lesions. This dual mechanism—localized cytotoxicity combined with enhancing the immune response and activity of immune checkpoint inhibitors against both Gedeptin-treated and untreated tumors—has the potential to offer an improved therapeutic approach to addressing solid tumor metastatic disease.

GeoVax has generated preclinical, clinical and translational data supporting Gedeptin’s ability to induce localized tumor cell death against both proliferating and non-proliferating tumors while minimizing systemic toxicity, and to potentially improve response rates when combined with immune checkpoint inhibitors. As checkpoint inhibitors continue to move earlier in treatment paradigms, including neoadjuvant and first-line settings, the need for complementary approaches that enhance response rates is becoming increasingly evident. GeoVax is advancing Gedeptin in combination with checkpoint inhibition in a planned Phase 2 clinical trial in first-line head and neck cancer therapy, with additional solid tumor indications under evaluation.

'Checkpoint inhibitors have transformed cancer care, but many patients still do not achieve durable responses,' said Kelly T. McKee, M.D., Chief Medical Officer of GeoVax. 'We believe Gedeptin is well positioned as a combination-enabling platform designed to enhance therapeutic response across checkpoint inhibitors and other emerging oncology modalities.'

Gedeptin has received Orphan Drug Designation for oral and pharyngeal cancers. The Company continues to evaluate strategic partnerships and collaborations to advance the clinical development and potential commercialization of Gedeptin-based combination therapies. For more information about GeoVax and its programs, visit www.geovax.com.