NEW YORK – Oncolytics Biotech said on Wednesday that it dosed the first patient in the Phase II IRENE study evaluating its virus-based treatment pelareorep with Incyte's investigational anti-PD-1 checkpoint inhibitor retifanlimab in triple-negative breast cancer.
The trial will take place at the Rutgers Cancer Institute of New Jersey and the Ohio State University Comprehensive Cancer Center.
Pelareorep is derived from a reovirus containing double-stranded RNA, which can trigger immune reactions to cancer cells. Research shows that pelareorep can generate autoreactive T cells, which can boost the efficacy of anti-PD-1 and anti-PD-L1 agents.
The IRENE study will investigate the safety and efficacy of the pelareorep and anti-PD-1 regimen in TNBC patients, evaluate changes in PD-L1 expression in patients' tumors, and explore correlations between treatment outcomes and peripheral T-cell clonality, which has been previously identified as a biomarker of pelareorep response.
"This is an exciting study to evaluate the role of immunomodulation in the tumor microenvironment as a treatment option," Mridula George, an oncologist at the Rutgers Cancer Institute of New Jersey and the principal investigator of IRENE, said in a statement.
In June, Oncolytics Biotech initiated a Phase II study evaluating pelareorep in combination with paclitaxel given with and without the PD-L1 checkpoint inhibitor avelumab (Merck KGaA/Pfizer's Bavencio) to hormone receptor-positive, HER2-negative breast cancer patients.
The company intends to use data from both Phase II studies to guide the design of a registration-enabling program in breast cancer for pelareorep in the next two years.