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City of Hope Begins Oncolytic Virus Trial in Triple-Negative Breast Cancer

NEW YORK – City of Hope on Friday began a Phase I trial of an oncolytic virus therapy, CF33-hNIS-antiPDL1, in metastatic triple-negative breast cancer patients.

The trial will enroll up to 78 patients with recurrent metastatic triple-negative breast cancer who had progressed after standard-of-care therapies. The researchers will monitor safety, determine an optimal dose, and measure response rate, progression-free survival, clinical benefit rate, event-free survival, duration of response, and overall survival.

The researchers will also assess certain biomarker expression changes by immunohistochemistry in this study, including changes in PD1, PD-L1, and CTLA-4 expression, and CD8 cell quantification. If there is an increased expression of these targets, the researchers will know that CF33-hNIS-antiPDL1 has activated the immune system against breast cancer.

"The study is designed to determine the safety and optimal biological dose that may induce an immune response in triple-negative breast cancer tumors," Yuan Yuan, principal investigator of the trial, said in a statement. "Current approved therapies do not offer a cure for this aggressive type of breast cancer, which often becomes resistant to chemotherapy. Clinical trials like this one seek durable responses and better quality of life for patients."

In preclinical research, CF33-hNIS-antiPDL1 has shown activity in several cancers, including pancreatic, stomach, lung, ovarian, and colon. The patents to CF33-hNIS-antiPDL1 previously were out-licensed to Sydney-based cancer drug developer Imugene.