Canadian-based biotechnology company Oncolytics has initiated the Phase II trial of Reolysin (pelareorep) in combination with FOLFOX6, bevacizumab and pembrolizumab in female patients with KRAS-mutant colorectal cancer (CRC) metastatic to the liver.

The announcement follows the company’s submission of its Investigational New Drug Application (IND) for the US Food and Drug Administration review.

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Reolysin is the company’s patented variant of reovirus, which stands for respiratory enteric orphan virus and acts as a cancer therapeutic agent.

Around 30 patients will be enrolled in this multicentre, single arm Phase II trial designed to evaluate the safety and efficacy of Reolysin in combination with chemotherapy (FOLFOX6), bevacizumab (Avastin) and pembrolizumab (Keytruda).

"This study is intended to confirm the encouraging objective overall and liver metastases response rates in female patients that we saw in a sponsored randomised Phase II study conducted in Canada."

Oncolytics president and CEO Dr Brad Thompson said: "This study is intended to confirm the encouraging objective overall and liver metastases response rates in female patients that we saw in a sponsored randomised Phase II study conducted in Canada.

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"We are adding a checkpoint inhibitor to the treatment regimen based on our evolving understanding of how Reolysinupregulates immune responses and how the combination may make cancer cells more susceptible to attack by the immune system."

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The trial is primarily focused on determining the overall response rate (ORR) based on the Immune-related Response Evaluation Criteria in Solid Tumours (irRECIST).

The trial’s secondary objective is to assess disease response in liver metastases and overall survival.

Oncolytics also intends to measure the effect of the treatment on immune-related cells and biomarkers triggering immune response and genetic biomarkers displaying a positive response during the study.