GL-ONC1 (USAN: olvimulogene nanivacirepvec; abbreviated as Olvi-Vec) 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 (CAS Registry Number (CAS RN): 1473430-36-2) is a triple modified and attenuated vaccinia virus (Lister strain) that causes regression and elimination of a wide range of solid tumors in preclinical mouse models. [3] It was generated by insertion of three expression cassettes (encoding Renilla luciferase-Aequorea green fluorescent protein fusion, beta-galactosidase, and beta-glucuronidase) into 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, immune activation and triggering anti-tumor immune responses. [4] [5] [6]
One Phase I/II Study of intraperitoneal administration of GL-ONC1 in patients with advanced peritoneal carcinomatosis has been completed. [7] [8] A Phase II study of intraperitoneal administration of GL-ONC1 (Olvi-Vec) in heavily-pretreated patients with platinum-resistant/refractory ovarian cancer was completed. [9] [10] Positive clinical data have been reported in IGCS 2020 and ESMO 2020 conferences. [11] [12] A registration trial of Olvi-Vec(aka GL-ONC1)-primed immunochemotherapy is being planned.
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 (NSCLC), or breast cancer. [13] In this trial GL-ONC1 infection of tumor cells was identified in 6 out of 8 patients with epithelioid malignant pleural mesothelioma. [14]
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. [15] In another completed study, GL-ONC1 was given in combination with radiation therapy and cisplatin (CDDP) to patients with locoregionally advanced head and neck cancer. [16] [17]