Genelux Announces Interim Results from SCLC and NSCLC Trials

Genelux announced interim results from two ongoing trials - Phase 1b/2 SCLC and Phase 2 VIRO-25 - evaluating systemic administration of Olvi-Vec in patients with progressive small cell lung cancer and progressive non-small cell lung cancer, respectively, after failure of prior platinum-based regimens. Together, the open-label studies are designed to demonstrate that the Olvi-Vec-primed immunochemotherapy mechanism of resensitizing tumors to platinum-based chemotherapy can extend beyond intraperitoneal delivery into a systemic delivery setting across multiple solid tumor types. Platinum-relapsed or platinum-refractory advanced SCLC: The open-label Phase 1b/2 SCLC trial is evaluating a single intravenous cycle with multiple doses of Olvi-Vec administered in combination with platinum and etoposide chemotherapy in SCLC patients with platinum-relapsed or platinum-refractory disease after failing previous treatment with platinum and etoposide chemotherapy. The trial is being conducted by the Company's licensing partner, Newsoara HYK Biopharmaceuticals. As of the data review cutoff date of December 23, 2025, systemic administration of Olvi-Vec in the initial dose escalation cohorts achieved the following preliminary results: 9 evaluable patients; Overall response rate of 33%, including three PRs; Two of the three PRs occurred in Cohort 4, the highest dose cohort tested as of the data review cutoff date, with tumor shrinkage of approximately 55% and 85% from baseline, representing an ORR of 67% in Cohort 4 and potentially suggesting a dose-response trend; Disease control rate of 67%; Tumor shrinkage of 24-85% among the six DCR patients, all of whom experienced a reduction in all target lesions from baseline; Olvi-Vec generally well tolerated; Exploratory durability signals: Two PR patients across different cohorts have been evaluated in long-term follow-up: A patient with 1 prior line, at last scan, achieved a PR with an ongoing progression-free survival of 12.1 months; A patient with 4 prior lines had a PFS of 7.7 months, which exceeds the PFS in the immediately preceding line in the same patient by 5.8 months. Notably, this SCLC trial is primarily evaluating safety and tolerability and, as such, patients who achieved objective responses from Olvi-Vec immunochemotherapy in this trial do not receive any subsequent standard maintenance immunotherapy to extend durability of response. Advanced or metastatic recurrent NSCLC: The open-label Phase 2 VIRO-25 trial is evaluating a single intravenous cycle with multiple doses of Olvi-Vec in combination with platinum chemotherapy and an immune checkpoint inhibitor in patients with advanced or metastatic recurrent NSCLC who failed standard frontline treatment of platinum chemotherapy and an ICI. The trial is being conducted in the United States. As of the data review cutoff date of December 31, 2025, systemic administration of Olvi-Vec in the initial dose escalation cohorts achieved the following preliminary results: 5 evaluable patients; DCR of 60%; Tumor size changes among the three DCR patients were 8.9%, -18.9%, and -22.7%, respectively, as compared to baseline; Olvi-Vec generally well tolerated. Upcoming Milestones: The Phase 1b/2 SCLC trial and Phase 2 VIRO-25 trial are actively enrolling in dose escalation cohorts with an aim to optimize efficacy, safety, and tolerability of Olvi-Vec. The trials are being conducted to align a systemic dosing regimen to support future multi-regional registrational clinical trials. Additional interim data readouts expected throughout 2026 in Phase 1b/2 SCLC trial and Phase 2 VIRO-25 trial; Topline data from the Phase 3 platinum-resistant/refractory ovarian cancer trial expected in second half of 2026.