Oncolytics Biotech? announced the first patient has been dosed in the Company's investigator-sponsored phase 2 study of pelareorep-anti-PD-1 combination therapy in unresectable locally advanced or metastatic triple-negative breast cancer (TNBC). The study, known as IRENE, is co-sponsored by Oncolytics, the Rutgers Cancer Institute of New Jersey, and Incyte. Participants in the multi-center study receive pelareorep in combination with Incyte's anti-PD-1 checkpoint inhibitor retifanlimab (INCMGA00012).

The recently announced IRENE study builds on prior clinical data showing pelareorep-induced priming of an adaptive immune response in multiple breast cancer subtypes. In addition to investigating the safety and efficacy of pelareorep-anti-PD-1 combination treatment in TNBC patients, the study will also evaluate changes in PD-L1 expression and correlations between treatment outcomes and peripheral T cell clonality, a previously identified biomarker of pelareorep response that may enable the success of future registrational trials by facilitating study design and patient selection. The trial will take place at the Rutgers Cancer Institute of New Jersey and The Ohio State University Comprehensive Cancer Center.

"The paucity of treatment options in metastatic triple-negative breast cancer combined with its aggressive clinical behavior results in a poorer prognosis when compared to other subtypes of breast cancer. This is an exciting study to evaluate the role of immunomodulation in the tumor microenvironment as a treatment option. I'm looking forward to getting this study underway to potentially make an impact in the lives of patients affected with metastatic triple-negative breast cancer," Principal investigator Mridula George, M.D., Medical Oncologist, Rutgers Cancer Institute of New Jersey and Assistant Professor of Medicine, Rutgers Robert Wood Johnson Medical School, said.