On April 8, 2019 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, reported that the first patient has been treated in the AWARE-1 window of opportunity (WOO) study that is being conducted in collaboration with SOLTI, an academic research group dedicated to clinical and translational research in breast cancer (Press release, Oncolytics Biotech, APR 8, 2019, View Source [SID1234535041]). Patients will receive the appropriate intervention for their breast cancer sub-type, plus pelareorep, with or without Tecentriq (atezolizumab), followed by surgery.
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"We are pleased to have treated the first patient in our window of opportunity study that will yield important results confirming both our recently identified biomarker and pelareorep’s ability to prime an antitumor immune response," said Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech. "This short study could significantly de-risk our late-stage metastatic breast cancer program, resulting in a smaller, less expensive study with a higher likelihood of success. Beyond the biomarker data, the study will also inform whether we should add a checkpoint inhibitor arm to the phase three registration study. We look forward to initial data from this study in this highly-prevalent cancer indication later this year."
This study, which is being sponsored by Oncolytics and facilitated by SOLTI, is a WOO study in the early treatment setting for breast cancer. Patients will receive the appropriate intervention for their breast cancer sub-type plus pelareorep, with or without Tecentriq. Patients are biopsied on day one, followed immediately by treatment and a final biopsy after three weeks, on the day of their mastectomy. The study is being coordinated by Dr. Aleix Prat, Head of Medical Oncology at the Hospital Clínic of Barcelona, Associate Professor of the University of Barcelona and the Head of the Translational Genomics and Targeted Therapeutics in Solid Tumors Group at August Pi i Sunyer Biomedical Research Institute (IDIBAPS) and member of Oncolytics’ Scientific Advisory Board.
Pelareorep received FDA Fast Track Designation for the treatment of metastatic breast cancer in May 2017.
About Pelareorep
Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.