Genelux Starts Phase 2 Trial of Olvi-Vec for Non-Small Cell Lung Cancer

Genelux Corporation has announced the commencement of a Phase 2 clinical trial, named VIRO-25, in the United States. This trial aims to evaluate the efficacy and safety of the drug Olvi-Vec in patients suffering from recurrent non-small cell lung cancer (NSCLC), who have not responded to initial platinum-based and immune checkpoint inhibitor (ICI) therapies.

Thomas Zindrick, the President, CEO, and Chairman of Genelux, emphasized the importance of this development for patients with recurrent NSCLC who have limited treatment options. He noted that this Phase 2 trial, along with an ongoing Phase 1b/2 trial co-sponsored with Newsoara Biopharma Co. Ltd., marks significant progress in the potential of Olvi-Vec as a systemically administered oncolytic virus treatment.

The VIRO-25 trial is an open-label, randomized study designed to assess the effectiveness and safety of Olvi-Vec, an intravenously delivered oncolytic vaccinia virus. The trial will compare the performance of Olvi-Vec followed by platinum-doublet chemotherapy and the physician's choice of immune checkpoint inhibitor against the current standard treatment, docetaxel. This study targets patients with advanced or metastatic NSCLC who have experienced disease progression after initial treatment with platinum-doublet chemotherapy and ICI. Previous data on Olvi-Vec indicate a manageable safety profile, and this trial aims to confirm whether Olvi-Vec can resensitize tumors to platinum-based treatments across multiple cancer types. Genelux anticipates an interim data readout by mid-2025.

Olvi-Vec is a proprietary, modified oncolytic vaccinia virus engineered by Genelux. Preclinical studies have demonstrated that Olvi-Vec has the potential to infect and destroy a wide range of tumor cells while also eliciting an anti-tumor immune response. To date, more than 150 patients have been treated with Olvi-Vec across seven clinical trials, which have shown the virus to be generally well tolerated with evidence of clinical benefit.

Genelux Corporation is a late-stage clinical biopharmaceutical company dedicated to developing next-generation oncolytic immunotherapies for patients with aggressive or difficult-to-treat solid tumors. Olvi-Vec, their most advanced product candidate, is currently being evaluated in a Phase 3 trial (OnPrime/GOG-3076) for platinum-resistant or refractory ovarian cancer. The company's research and development efforts are centered around their proprietary CHOICE™ platform, from which they have developed an extensive library of oncolytic vaccinia virus immunotherapeutic candidates, including Olvi-Vec.

Genelux's ongoing commitment to advancing the field of oncolytic virus therapy holds promise for patients with limited treatment options, offering hope for more effective cancer therapies in the future. With the VIRO-25 trial underway, the company is poised to make significant strides in the fight against recurrent non-small cell lung cancer.