WESTLAKE VILLAGE, Calif. — January 05, 2026 — Leads & Copy —
Genelux Corporation (NASDAQ: GNLX) announced interim results from its Phase 1b/2 SCLC and Phase 2 VIRO-25 trials, which are evaluating systemic administration of Olvi-Vec in patients with progressive small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC) after previous platinum-based treatments failed. The company reported positive anti-tumor activity and tolerability in lung cancer patients.
The trials are open-label and are designed to demonstrate Olvi-Vec’s mechanism of resensitizing tumors to platinum-based chemotherapy, extending its potential beyond intraperitoneal delivery to systemic delivery across multiple solid tumor types.
According to Thomas Zindrick, President, CEO, and Chairman of Genelux, the data, while preliminary, reinforces the company’s commitment to advancing registration-path trials in progressive lung cancers. Zindrick noted the company’s focus on establishing Olvi-Vec as an immunotherapeutic agent to modify the tumor microenvironment and resensitize tumors to platinum-based chemotherapy across various cancer types. Topline data from the Phase 3 registration trial in ovarian cancer is expected in the second half of 2026, with additional lung cancer trial readouts anticipated throughout the year.
The Phase 1b/2 SCLC trial (NCT07136285) is evaluating intravenous doses of Olvi-Vec with platinum and etoposide chemotherapy in SCLC patients with platinum-relapsed or platinum-refractory disease. Genelux’s licensing partner, Newsoara HYK Biopharmaceuticals Co., Ltd. (Newsoara), is conducting the trial in China.
Data from the initial dose escalation cohorts, with a cutoff date of December 23, 2025, showed systemic administration of Olvi-Vec achieved the following:
In platinum-relapsed or platinum-refractory advanced SCLC, two of three partial responses (PRs) occurred in the highest dose cohort tested. The company observed durable response signals and treatment tolerability in the Phase 1b/2 SCLC trial.
The open-label Phase 2 VIRO-25 trial (NCT06463665) is evaluating intravenous doses of Olvi-Vec with platinum chemotherapy and an immune checkpoint inhibitor (ICI) in patients with advanced or metastatic recurrent NSCLC who failed frontline treatment. The trial is being conducted in the United States.
Data from the initial dose escalation cohorts, with a cutoff date of December 31, 2025, showed that in advanced or metastatic recurrent NSCLC, the company observed anti-tumor activity in the initial dose cohort and that Olvi-Vec was generally well tolerated in the Phase 2 VIRO-25 trial.
The trials are actively enrolling in dose escalation cohorts to optimize the efficacy, safety, and tolerability of Olvi-Vec, aiming to align a systemic dosing regimen for future registrational clinical trials. The company expects additional data readouts throughout 2026 from both the Phase 1b/2 SCLC trial and Phase 2 VIRO-25 trial.
Olvi-Vec (olvimulogene nanivacirepvec) is Genelux’s lead investigational asset, an oncolytic immunotherapy being evaluated for its mechanism of action to directly kill cancer cells, stimulate a tumor-specific immune response, remodel the tumor microenvironment, and resensitize tumors to platinum-based chemotherapy with or without ICIs. It has been administered to more than 150 patients across seven completed clinical trials, demonstrating clinically meaningful benefits. Genelux has granted Newsoara an exclusive license to develop and commercialize Olvi-Vec in greater China.
Genelux is a late clinical-stage biopharmaceutical company focused on developing oncolytic immunotherapies for solid tumor types. The company’s CHOICE™ platform has facilitated the development of an extensive library of oncolytic vaccinia virus immunotherapeutic product candidates, including Olvi-Vec.
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Source: Genelux Corporation
