Clinical collaboration announced for window of opportunity study into breast cancer

Biotechnology company, Oncolytics Biotech, has announced a clinical collaboration with an academic research group dedicated to clinical and translational research in breast cancer, SOLTI.

This clinical collaboration, which is being sponsored by Oncolytics and facilitated by SOLTI, is a window of opportunity study (WOO) in the neoadjuvant setting for breast cancer. Within the study, patients will receive the appropriate standard of care for their cancer subtype plus pelareorep with or without the anti-PD-L1 cancer immunotherapy atezolizumab (Tecentriq).

Data generated from this study is intended to confirm that the virus is acting as a novel immunotherapy and to provide comprehensive biomarker data by breast cancer subtype, to support Oncolytics’ phase III study in metastatic breast cancer — expected in mid 2019.

“We are thrilled to enter into this collaboration with SOLTI and sponsor this window of opportunity study. We expect that this study will provide additional biomarker and immunological data to support our planned phase three study in metastatic breast cancer,” said Matt Coffey, president and CEO of Oncolytics Biotech. “This data should confirm the findings of our phase II study and generate a robust biomarker plan designed to potentially enhance our phase three programme. Importantly, it will also generate additional data demonstrating how the promotion of a virally induced inflamed phenotype should synergise with checkpoint inhibitors targeting PD-L1 like atezolizumab.”

The study will be facilitated by SOLTI with 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 — coordinating.

Final study design and other details will be announced upon enrolment of the first patient, expected around the end of 2018 or very early 2019.

“It has been demonstrated that when reovirus infects a tumour, it promotes the release of immuno-stimulatory signals. This in turn results in the upregulation of PD-L1 on tumour cells and the recruitment of inflammatory immune cells like NK-cells and cytotoxic T-cells to the tumour, which are required prerequisites for checkpoint inhibitors to function effectively. In short, it turns cold tumours hot,” added Prat. “We believe pelareorep can demonstrate the necessary inflamed tumour phenotype to prime tumours for PD-L1 blockade, which could potentially represent a promising form of cancer immunotherapy combination with atezolizumab. Results from this study will seek to establish the virus as an important immuno-oncology agent in breast cancer, which could ultimately support the expansion of pelareorep beyond metastatic breast cancer into first-line therapy.”