Billions Pouring Into Drugs That Could Treat Cancer Patients with High TROP2 Expressions - Seite 3

CURRENT PELAREOREP STUDIES

Back in June of 2019, Pfizer had signed a co-development agreement with both Oncolytics Biotech Inc. and Merck KGaA for what's known as the BRACELET-1 study—(BReast cAnCEr with the Oncolytic Reovirus PeLareorEp in CombinaTion with anti- PD-L1 and Paclitaxel).

Though the BRACELET-1 study pertains to HR+ breast cancer, and not TNBC, there is much anticipation over its potential. Oncolytics has already announced that it has advanced its lead breast cancer program with the dosing of the first patient in the BRACELET-1 study.

The study will take place at 20 trial sites and enroll 45 patients randomized into three cohorts: one with just paclitaxel; one with paclitaxel + pelareorep; and a third with paclitaxel + pelareorep + avelumab (Merck and Pfizer's shared immuno-oncology drug Bavencio).

As stated above, pelareorep is also being studied for its potential in treating TNBC through a study dubbed "IRENE". According to the available preclinical data, the drug shows potential in addressing the unmet needs in TNBC.

Clinical trial data suggests that the systematic administration of pelareorep shows promising outcomes in patients suffering from tumors in their breasts—helping to improve the patient count responding to what are known as checkpoint inhibitors.

Checkpoint investigators are used to target 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).

Throughout this study, RCI's 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 study is an open-label, single-arm, Phase 2 clinical trial investigating the use of INCMGA00012 and pelareorep to treat Metastatic TNBC or unresectable LA (locally advanced) TNBC. The drug combination is administered intravenously to the patients on the first, second, fifteen, and sixteenth day of the 28-day treatment program. Approximately 25 patients are enrolled for this clinical study at RCI.