Oncolytics Biotech, Inc. (NASDAQ:ONCY) begins TNBC (triple-negative breast cancer) study, which is sponsored by the investigator. New Jersey-based Rutgers Cancer Institute (RCI) will manage this clinical trial in patients with unresectable metastatic or locally advanced TNBC. In Phase 2 clinical trial, the company will investigate using pelareorep and retifanlinmab, an anti-PD-1 checkpoint inhibitor.
A principal investigator at RCI, Mridula George, said she is pleased to investigate the use of pelareorep in patients suffering from TNBC. According to the available preclinical data, the drug shows potential in addressing the unmet needs in TNBC.
Checkpoint investigators are used to targetting the interactions between PD-1 and PD-L1. Commercially proven checkpoint investigators only achieve 20% success in patients with TNBC because of an ITM (immunosuppressive tumor microenvironment). However, they are beneficial for the patients, who suffer from the upregulation of PD-L1 expression in tumors.
Pelareorep unregulates PD-L1 expression in the tumors
According to the clinical trial data, the systematic administration of pelareorep shows promising outcomes in patients suffering from tumors in their breasts. It will help to improve the patient count responding to the checkpoint inhibitors.
Mridula said the team targets to evaluate induced adaptive responses of pelareorep that interacts with inhibition of PD-1 in patients suffering from TNBC. The IRENE study is an extension of the lead breast cancer program of Oncolytics into TNBC, a subtype of the new disease.
In this study, the investigators will evaluate the efficacy and safety of pelareorep in TNBC patients in an anti-PD-1 combination cure. It will study the changes in the PD-L1 expression in this trial, along with peripheral T-Cell Clonality and correlations between the treatments’ outcomes. The IRENE clinical trial will be conducted at RCI and Cancer Center of the Ohio State University. It is co-sponsored by Incyte, RCI, and Oncolytics.
It is an open-label, single-arm, Phase 2 clinical trial investigating the use of INCMGA00012 and pelareorep to cure Meta TNBC or unresectable LA (locally advanced) TNBC. Around 25 patients are enrolled for this clinical study at RCI. The drug combination is administered intravenously to the patients on the first, second, fifteen, and sixteenth day of the 28-day treatment program.
The main endpoints of this study are objective response and safety. In the secondary endpoint, the teams will study the overall survival and progression-free survival of the patients.