Genelux Corporation has commenced its Phase 2 VIRO-25 clinical trial, dosing the first patient to evaluate Olvi-Vec as a systemic treatment for recurrent non-small cell lung cancer (NSCLC). This open-label, randomized trial aims to address the unmet needs of NSCLC patients who have progressed following frontline platinum-based chemotherapy and immune checkpoint inhibitor (ICI) therapies.
The VIRO-25 trial (NCT06463665) is designed to assess the efficacy and safety of Olvi-Vec, an intravenously delivered oncolytic vaccinia virus, in combination with platinum-doublet chemotherapy and a physician's choice of ICI. This regimen will be compared to docetaxel in patients with advanced or metastatic NSCLC who have experienced disease progression after initial treatment with platinum-doublet chemotherapy and ICI. The primary endpoint is to determine if Olvi-Vec can resensitize tumors to platinum-based therapies.
Olvi-Vec: A Novel Oncolytic Virus
Olvi-Vec (olvimulogene nanivacirepvec) is a modified oncolytic vaccinia virus engineered to selectively infect and kill tumor cells while stimulating an anti-tumor immune response. Preclinical studies have demonstrated its ability to target a broad spectrum of tumor cell types both in vitro and in vivo. To date, Olvi-Vec has been administered to over 150 patients across seven clinical trials, exhibiting a manageable safety profile and indications of clinical benefit.
Addressing Unmet Needs in NSCLC
NSCLC remains a significant challenge, with a substantial portion of patients developing resistance or experiencing disease progression after initial treatments. The VIRO-25 trial seeks to validate Olvi-Vec's potential in resensitizing patients to platinum therapies, offering a new treatment avenue for those with limited options. Interim data from the trial is anticipated in mid-2025.
Management Perspective
"Today’s milestone holds profound significance for patients with recurrent non-small cell lung cancer who face limited therapeutic options," stated Thomas Zindrick, President, CEO and Chairman of Genelux. "This Phase 2 trial, in addition to our ongoing Phase 1b/2 trial evaluating intravenous delivered Olvi-Vec in patients with recurrent small cell lung cancer, co-sponsored with Newsoara Biopharma Co. Ltd., signifies the key advancement of Olvi-Vec to potentially be an important systemically administered oncolytic virus treatment option, setting the stage for the future of this promising field."
