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. GL-ONC1 is currently under evaluation in Phase I/II human clinical trials in the United States and Europe.
GL-ONC1 is a triple modified and attenuated vaccinia virus that causes regression and elimination of a wide range of solid tumors in preclinical mouse models. It was generated by insertion of three expression cassettes into the F14.5L, J2R and A56R loci of the parental viral Lister strain genome, respectively. The oncolytic virus specifically infects and kills tumor cells which leads to oncolysis, immune activation and triggering anti-tumor immune responses.

Clinical trials

Regional (cavity) administration

One Phase I/II Study of intraperitoneal administration of GL-ONC1 in patients with advanced peritoneal carcinomatosis has been completed. A Phase II study of intraperitoneal administration of GL-ONC1 in patients with platinum-resistant/refractory ovarian cancer has completed enrollment with follow-up ongoing.
In a Phase I study, intra-pleural administration of GL-ONC1 is being evaluated in patients with malignant pleural effusion, which is caused by cancer from malignant pleural mesothelioma, non-small cell lung cancer, 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 (intravenous) administration

Systemic administration of GL-ONC1 via intravenous injection was under investigation in multiple clinical trials:
In one study, GL-ONC1 was administered to patients with advanced solid organ tumors as a monotherapy. In another completed study, GL-ONC1 was given in combination with radiation therapy and cisplatin to patients with locoregionally advanced head and neck cancer.