Genelux has dosed the first subject in the Phase II VIRO-25 clinical trial in the US, designed to assess the systemic administration of Olvi-Vec, an oncolytic vaccinia virus, to treat recurrent non-small cell lung cancer (NSCLC).
The open-label, randomised trial aims to enrol NSCLC patients who have not responded to frontline platinum-based and immune checkpoint inhibitor (ICI) therapies.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
It will assess the efficacy and safety of Olvi-Vec, followed by platinum-doublet chemotherapy and a physician’s choice of ICI.
This regimen will be compared against docetaxel in patients with advanced or metastatic NSCLC, who have experienced disease progression with front-line or maintenance ICI therapy after initial treatment with platinum-doublet chemotherapy and ICI.
In previous studies, Olvi-Vec is said to have demonstrated a manageable safety profile.
The Phase II trial seeks to further validate the potential of Olvi-Vec in resensitising patients to platinum therapies across multiple tumour types.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataGenelux anticipates reporting interim data from the trial mid-next year.
Olvi-Vec is being developed as a potential treatment for a variety of cancers, based on preclinical studies that suggest its ability to infect and kill a broad spectrum of tumour cells, both in vitro and in vivo, while also stimulating an anti-tumour immune response.
To date, Olvi-Vec has been administered to over 150 patients across seven trials.
In these trials, the therapy was found to be well tolerated, with data indicating a clinical benefit in patients.
Genelux president, CEO and chairman Thomas Zindrick said: “The milestone holds profound significance for patients with recurrent non-small cell lung cancer who face limited therapeutic options.
“This Phase II trial, in addition to our ongoing Phase Ib/II trial evaluating intravenous delivered Olvi-Vec in patients with recurrent small cell lung cancer, co-sponsored with Newsoara Biopharma, 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.”
