GL-ONC1
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.[1] GL-ONC1 is currently under evaluation in Phase I/II human clinical trials in the United States and Europe.[2]
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.[3] 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.[1] The oncolytic virus specifically infects and kills tumor cells which leads to oncolysis, which is thought to trigger an anti-tumor immune response.[4][5][6]
Contents
Clinical trials
Local 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.[7]
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.[8] In this trial GL-ONC1 infection of tumor cells was identified in 6 out of 8 patients with epithelioid malignant pleural mesothelioma.[9]
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.[10] 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.[11] Both studies showed that GL-ONC1 was well tolerated, and evidence of tumor colonization was observed.[12][13]
References
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- University Hospital Tübingen
- Memorial Sloan Kettering Cancer Center
- Royal Marsden Hospital
- Moores UC San Diego Cancer Center
- Genelux website
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