GeoVax Labs(US:GOVX) Newsfilter·2024-07-31 14:15Core Viewpoint - GeoVax Labs, Inc. is advancing its Gedeptin® cancer therapy into an expanded Phase 2 clinical trial, focusing on its efficacy and safety in combination with an immune checkpoint inhibitor for treating first-recurrence head and neck cancer [1][2][4]. Group 1: Clinical Development Plans - The company plans to initiate a novel Phase 2 clinical trial to evaluate the combination of Gedeptin and an immune checkpoint inhibitor, aiming to support neoadjuvant therapy [2][4]. - The trial will focus on squamous cell head and neck cancer, with the primary endpoint being the pathologic response rate in approximately 36 patients [13]. - The trial activation is anticipated during the first half of 2025, with necessary planning activities already underway [13]. Group 2: Funding and Regulatory Status - The current study is partially funded by the FDA through its Orphan Products Clinical Trials Grants Program, and Gedeptin has received orphan drug status for treating specific oral and pharyngeal cancers [3]. - The therapy has demonstrated acceptable safety and efficacy in previous trials, supporting its continued development [9]. Group 3: Technology Overview - Gedeptin utilizes a gene therapy strategy known as Gene-Directed Enzyme Prodrug Therapy (GDEPT), which selectively targets tumor cells to convert a non-toxic prodrug into an active antitumor compound [5]. - The therapy has shown sufficient tumor stabilization and reduction activity in heavily pretreated patients, indicating its potential effectiveness [9][10]. Group 4: Company Background - GeoVax Labs, Inc. is a clinical-stage biotechnology company focused on developing immunotherapies and vaccines for cancer and infectious diseases [6][14]. - The company has a strong intellectual property portfolio and a leadership team with extensive experience in life sciences [14].