Genelux Corporation Announces Publication of Phase I Trial Results of Intrapleural Administration of Olvi-Vec in Patients with Malignant Pleural Effusion from Mesothelioma, Lung or Breast Cancers in Frontiers in Immunology

• Phase 1 trial conducted at Memorial Sloan Kettering Cancer Center, New York, investigated the safety, feasibility and immune activating effects of Olvi-Vec by intrapleural administration.
  
  
• Documented Olvi-Vec infection of tumor cells, which was also associated with reduction in tumor cell density and increase in immune cell density, confirming the mechanism of action of both direct cytotoxic and immune-activating effects.
  
  
• Among all patients, median overall survival (OS) was 19.5 months. The median OS among patients who had malignant pleural mesothelioma (MPM) was 22 months.
  
  
• There were no dose-limiting toxicities or dose de-escalations, and the maximally tolerated dose was not reached. Therefore, a recommended dose was not established.
  

WESTLAKE VILLAGE, Calif., July 10, 2023 (GLOBE NEWSWIRE) -- Genelux Corporation (NASDAQ: GNLX), a late clinical-stage immuno-oncology company, today announced the publication in Frontiers in Immunology of positive results from a Phase 1 trial exploring intrapleural delivered Olvi-Vec in patients with malignant pleural effusion (MPE) due to either MPM or metastatic disease (non-small cell lung cancer or breast cancer). The study was completed at Memorial Sloan Kettering Cancer Center, and the published article is available here.

“We are delighted to announce the publication of the Phase 1 trial data in Frontiers in Immunology, which further highlights the extensive range of tumor types that may benefit from Olvi-Vec treatment. These published results contribute significantly to the growing body of evidence that underscores the meaningful activity and safety of Olvi-Vec in a clinical setting," said Thomas Zindrick, President, Chairman and CEO of Genelux. “We commend Memorial Sloan Kettering for the comprehensive translational analyses conducted in this study. The results were robust and we believe they are quite telling of the mechanism of action of Olvi-Vec for tumor cell killing and immune activation, and match well with what we have observed in previous clinical studies in ovarian cancer.”

Palliative interventions have traditionally been relied upon for alleviating symptoms and preventing the recurrence of MPE, which can disrupt cancer treatments for MPE patients. However, the effectiveness of systemic immune checkpoint inhibitor therapy, chemotherapy, or a combination of therapies in MPE patients has shown limited success. This Phase 1 clinical trial enrolled eighteen MPE patients [MPM (n=15), and metastatic breast or lung diseases (n=3)], who underwent a dose escalating method of intrapleural administration of Olvi-Vec following drainage of MPE. The primary objective of this trial was to determine a recommended dose. The secondary objectives were to assess feasibility, safety and tolerability; evaluate viral presence in the tumor and serum as well as viral shedding in pleural fluid, sputum, and urine; and evaluate anti-vaccinia virus immune response.