globenewswire news

- Findings provide mechanistic support for previously reported clinical outcomes of clinical reversal of platinum resistance/refractoriness from Phase 2 VIRO-15 trial -

- Data demonstrate Olvi-Vec–mediated modulation of the tumor microenvironment and immune activation -

- Translational analyses identify gene expression changes associated with chemotherapy sensitization, anticancer response, and favorable prognosis following Olvi-Vec-primed immunochemotherapy treatment -

WESTLAKE VILLAGE, Calif.,, June 30, 2026 (GLOBE NEWSWIRE) -- Genelux Corporation (NASDAQ: GNLX), a late clinical-stage immuno-oncology company, today announced the publication of translational and clinical findings from its Phase 1b/2 VIRO-15 trial of Olvi-Vec-primed immunochemotherapy in heavily pretreated patients with platinum-resistant/refractory ovarian cancer (PRROC). The data were presented in Gynecologic Oncology Reports, a peer-reviewed journal published by Elsevier, available here.

The publication reports data from translational analyses conducted as part of the Phase 1b/2 VIRO‑15 study in patients with PRROC, evaluating the biological effects of Olvi‑Vec on the tumor microenvironment and its impact on clinical response and survival. The clinical results are consistent with preclinical results generated by Genelux with Olvi-Vec showing in vitro viral permissivity and tumor vulnerability and the effect of Olvi-Vec primed immunochemotherapy in a mouse model of platinum-resistant ovarian cancer.

“These translational findings further support Olvi-Vec’s unique mechanism of action as a tumor-priming immunotherapy that modulates the tumor microenvironment, activates immune pathways, induces gene expression changes consistent with platinum resensitization, and demonstrates potential synergy with platinum-based therapy,” said Thomas Zindrick, President, Chairman and Chief Executive Officer of Genelux. “Importantly, these findings provide additional biological rationale supporting the ongoing registrational Phase 3 OnPrime/GOG-3076 study evaluating Olvi-Vec in PRROC and reinforce the potential role of Olvi‑Vec as a tumor-priming immunotherapy designed to induce responsiveness in recurrent and frontline settings to therapies such as cytotoxic chemotherapies, immune checkpoint inhibitors, antibody-drug conjugates, and radiotherapy.”

Key Findings

• Tumor microenvironment modulation: Olvi‑Vec treatment was associated with an influx of CD8+ tumor-infiltrating lymphocytes and immune activation within tumor tissue.
• Direct viral activity: Viral infection and killing of tumor cells were observed in patient-derived samples.
• Gene expression changes: RNA profiling identified coordinated transcriptional changes associated with immune activation, tumor cell killing, and enhanced sensitivity to subsequent platinum-based chemotherapy, supporting the potential role of Olvi-Vec as a tumor-priming immunotherapy.
• Clinical context: Translational findings provide mechanistic support for the observed restoration of platinum sensitivity following Olvi-Vec treatment, consistent with previously reported VIRO‑15 clinical outcomes demonstrating improved progression-free survival.

It is estimated that more than 70% of women newly diagnosed with ovarian cancer will not respond to or will relapse after frontline platinum-based therapy. Patients with PRROC have limited effective treatment options, and clinical outcomes under current standard of care typically decline with successive lines of therapy. Approximately 243,572 women in the United States are diagnosed with ovarian cancer (NIH Ovarian Cancer Fact Sheet 2022). Ovarian cancer is the 5^th leading cause of cancer-related death among women.

The findings presented in Gynecologic Oncology Reports suggest that Olvi‑Vec may favorably remodel the tumor microenvironment in a manner that supports renewed responsiveness to platinum-based chemotherapy, reversing the trend of diminishing progression-free survival outcomes with increased lines of treatment, and provide additional biological rationale for the ongoing registrational Phase 3 OnPrime/GOG-3076 study evaluating Olvi-Vec-primed immunochemotherapy in PRROC. Olvi-Vec is administered intraperitoneally in the Phase 3 OnPrime/GOG-3076 study.

Genelux also continues to evaluate systemic administration of Olvi‑Vec in small cell lung cancer and non-small cell lung cancer in combination with frontline standard of care therapy in patients who have failed frontline therapy. Together, these studies are intended to inform the potential for systemic use of Olvi-Vec across additional clinical settings and solid tumor types.

About Genelux Corporation

Genelux is a late clinical-stage biopharmaceutical company focused on developing next-generation oncolytic immunotherapies for patients with aggressive and/or difficult-to-treat tumor types. Olvi-Vec is currently being evaluated in two U.S.-based clinical trials: OnPrime/GOG-3076, a multi-center, randomized, open-label Phase 3 registrational trial evaluating the efficacy and safety of Olvi-Vec in combination platinum-doublet + bevacizumab compared with physician's choice of chemotherapy and bevacizumab in patients with platinum-resistant/refractory ovarian cancer. Additionally, Olvi-Vec is currently being evaluated for dose selection in VIRO-25, a multi-center open-label Phase 2 trial evaluating the efficacy and safety of Olvi-Vec & platinum-doublet + physician's choice of immune checkpoint inhibitor in non-small-cell lung cancer and in Olvi-Vec-SCLC-202, a China-based, multi-center, open-label Phase 1b/2 trial evaluating the efficacy and safety of Olvi-Vec & platinum-doublet in recurrent small-cell lung cancer. The core of Genelux's discovery and development efforts revolves around its proprietary CHOICE™ platform from which Genelux has developed an extensive library of isolated and engineered oncolytic vaccinia virus immunotherapeutic product candidates, including Olvi-Vec.

Forward-Looking Statements

This release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. “Forward-looking statements” describe future expectations, plans, results, or strategies and are generally preceded by words such as “potential,” “intended,” or “suggest.” Forward-looking statements in this release include, but are not limited to, statements related to Genelux’s future plans and prospects; safety, tolerability, activity and efficacy of Olvi-Vec, including the potential synergy of Olvi-Vec with platinum-based therapy, the potential role of Olvi-Vec as a tumor-priming immunotherapy, the ability of Olvi-Vec to remodel the tumor microenvironment, and the potential for systemic use of Olvi-Vec across clinical settings and tumor types; and continued development of Olvi-Vec. Such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements. These and other risks are identified under the caption “Risk Factors” in Genelux’s filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Genelux does not undertake any obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise.

Investor Contact

Austin Murtagh
Precision AQ
austin.murtagh@precisionaq.com

Media Contact

Ashley Murphy
Precision AQ
ashley.murphy@precisionaq.com

Source: Genelux Corporation