- Oncolytics Biotech (TSX:ONC) has initiated regulatory discussions with the U.S. Food and Drug Administration (FDA) to advance pelareorep, its lead immunotherapeutic candidate
- The FDA discussions will focus on finalizing a clinical trial design that leverages pelareorep’s demonstrated synergy with chemotherapy—with or without checkpoint inhibitors—and will use overall survival as the primary endpoint
- The company expects to move quickly and decisively down a clear regulatory path
- Oncolytics Biotech stock (TSX:ONC) opened trading at C$1.47
A clinical-stage immunotherapy company announced that it has initiated regulatory discussions with the U.S. Food and Drug Administration (FDA) to advance its lead immunotherapeutic candidate.
Oncolytics Biotech (TSX:ONC) wants to move pelareorep into a potential registration-enabled pivotal study for first-line metastatic pancreatic ductal adenocarcinoma (mPDAC).
Assuming productive engagement with the FDA, Oncolytics anticipates beginning study start-up activities before the end of 2025. This milestone underscores the company’s confidence in pelareorep’s differentiated mechanism of action and its promising survival signal in one of the most aggressive and underserved solid tumors.
This content has been prepared as part of a partnership with Oncolytics Biotech Inc. and is intended for informational purposes only.
The FDA discussions will focus on finalizing a clinical trial design that leverages pelareorep’s demonstrated synergy with chemotherapy—with or without checkpoint inhibitors—and will use overall survival as the primary endpoint. Among the trial design options under consideration is an adaptive study model, potentially in collaboration with a third-party partner.
The announcement follows a recent event hosted by Oncolytics, where leading experts highlighted pelareorep’s potential not only in mPDAC but also in other gastrointestinal cancers, including KRAS-mutated colorectal cancer. The event reinforced the urgent need for innovative immunotherapies in pancreatic cancer, a field that has seen limited progress in recent decades.
“We expect to move quickly and decisively down a clear regulatory path,” Jared Kelly, Chief Oncolytics’ CEO said in a media statement. “This is about execution and focus. Our goal is to win on survival—and this pivotal study is how we do it. We believe this program not only creates significant value for shareholders but also positions Oncolytics as a highly attractive partner for pharma companies seeking to break open the immunotherapy landscape in mPDAC and other GI tumors.”
Pelareorep has already received both fast track and orphan drug designations from the FDA for mPDAC, and translational data continue to support its immunologic activity. These regulatory advantages, combined with compelling clinical data, position Oncolytics as an attractive partner for companies seeking to expand their GI oncology pipelines.
Oncolytics Biotech is a clinical-stage biotechnology company developing immunotherapies against breast, anal and pancreatic cancer.
Oncolytics Biotech stock (TSX:ONC) opened 0.66 per cent lower trading at C$1.47, but it has climbed 20.38 per cent since the year began and is up 4.76 per cent since this time last year.
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