The trial aims to enrol NSCLC patients who have not responded to frontline platinum-based and immune checkpoint inhibitor therapies. Credit: New Africa/Shutterstock.

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.

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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.

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The Phase II trial seeks to further validate the potential of Olvi-Vec in resensitising patients to platinum therapies across multiple tumour types.

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Genelux 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.”