GENELUX CORPORATION

FDA Signals Potential Traditional Approval Pathway for Genelux's Olvi-Vec in Platinum-Resistant Ovarian Cancer

2 months ago

• FDA indicates that Genelux's ongoing Phase 3 OnPrime/GOG-3076 trial could potentially support traditional approval for Olvi-Vec in platinum-resistant/refractory ovarian cancer without requiring a separate confirmatory study. • The regulatory guidance represents a significant milestone for Genelux, potentially accelerating the approval timeline if the trial demonstrates clinically meaningful progression-free survival advantage without compromising overall survival. • Topline safety and efficacy data from the registrational trial are expected in the first half of 2026, addressing an urgent unmet need for innovative treatments in this difficult-to-treat patient population.

Genelux Advances Olvi-Vec Trials in Lung and Ovarian Cancer, Anticipates Key Data Readouts

6 months ago

• Genelux is actively enrolling patients in a Phase 3 trial for platinum-resistant/refractory ovarian cancer, with topline results expected in the latter half of 2025. • A Phase 2 trial is underway for recurrent non-small cell lung cancer, combining Olvi-Vec with chemotherapy and immune checkpoint inhibitors, with interim data anticipated by mid-2025. • Interim results from a Phase 1b/2 trial in recurrent small cell lung cancer, conducted in collaboration with Newsoara BioPharma, are projected by the end of 2024. • Genelux's cash and investments of $35.1 million are expected to fund operations into the first quarter of 2026, supporting ongoing clinical development programs.

Genelux Doses First Patient in Phase 2 Trial of Olvi-Vec for Recurrent NSCLC

7 months ago

• Genelux has dosed the first patient in a Phase 2 clinical trial (VIRO-25) evaluating Olvi-Vec for recurrent non-small cell lung cancer (NSCLC). • The trial will assess Olvi-Vec's efficacy and safety in combination with platinum-doublet chemotherapy and an immune checkpoint inhibitor (ICI) versus docetaxel. • Olvi-Vec is an oncolytic vaccinia virus being developed as a potential treatment for various cancers, demonstrating a manageable safety profile in prior studies. • Interim data from the Phase 2 trial is expected in mid-2025, potentially offering a new systemic treatment option for NSCLC patients with limited options.