GL-ONC1 is an investigational therapeutic product consisting of the clinical grade formulation of the laboratory strain GLV-1h68, an oncolytic virus developed by Genelux Corporation. GL-ONC1 is currently under evaluation in Phase I/II human clinical trials in the United States and Europe.
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GL-ONC1 is an attenuated vaccinia virus (Lister strain) that causes regression and elimination of a wide range of solid tumors in preclincal mouse models. GLV-1h68 (GL-ONC1) was generated by insertion of three expression cassettes (encoding Renilla luciferase-Aequorea green fluorescent protein fusion, beta-galactosidase, and beta-glucuronidase) replacing the F14.5L, J2R (encoding thymidine kinase) and A56R (encoding hemagglutinin) loci of the parental viral Lister strain genome, respectively. The oncolytic virus specifically infects and kills tumor cells which leads to oncolysis, which is thought to trigger an anti-tumor immune response.
Regional (Cavity) Administration
One Phase I/II Study of intraperitoneal administration of GL-ONC1 in patients with advanced peritoneal carcinomatosis has been completed at the University of Tübingen. A Phase Ib study of intraperitoneal administration of GL-ONC1 in patients with recurrent ovarian cancer is ongoing at the Florida Hospital Cancer Institute.
In a Phase I study at the Memorial Sloan Kettering Cancer Center intra-pleural administration of GL-ONC1 is evaluated in patients with malignant pleural effusion, which is caused by cancer from malignant pleural mesothelioma, non-small cell lung cancer (NSCLC), or breast cancer. In this trial GL-ONC1 infection of tumor cells was identified in 6 out of 8 patients with epithelioid malignant pleural mesothelioma.
Systemic Administration
Systemic administration of GL-ONC1 via intravenous injection is under investigation in two different clinical trials:
In one study at the Royal Marsden Hospital GL-ONC1 is administered to patients with advanced solid organ tumors as a monotherapy. In another completed study at the Moores UC San Diego Cancer Center GL-ONC1 was given in combination with radiation therapy and cisplatin (CDDP) to patients with locoregionally advanced head and neck cancer. Both studies showed that GL-ONC1 was well tolerated, and evidence of tumor colonization was observed.