On July 29, 2025 Oncolytics Biotech Inc. (Nasdaq: ONCY) (TSX: ONC) ("Oncolytics" or the "Company"), a clinical-stage immunotherapy company developing pelareorep, reported it has initiated regulatory discussions with the U.S. Food and Drug Administration (FDA) for a potential registration-enabled pivotal study in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC) (Press release, Oncolytics Biotech, JUL 29, 2025, View Source [SID1234654603]). Assuming discussions with the FDA go as expected, the Company expects to commence study start-up activities before the end of 2025.
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This milestone reflects Oncolytics’ conviction in pelareorep’s differentiated mechanism of action and its encouraging survival signal in one of the most lethal and underserved solid tumors. The FDA interaction will focus on finalizing a clinical trial design that leverages pelareorep’s demonstrated synergy with chemotherapy with or without checkpoint inhibition, and overall survival as the primary endpoint. Among the potential options, Oncolytics will consider proposing an adaptive study in collaboration with a third party.
"We expect to move quickly and decisively down a clear regulatory path," said Jared Kelly, Chief Executive Officer of Oncolytics. "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."
Oncolytics’ recent Key Opinion Leader event reinforced the clinical promise of pelareorep in mPDAC and other gastrointestinal (GI) cancers, including KRAS-mutated colorectal cancer, and validated its ability to transform "cold" tumors into immunologically active ones. Experts emphasized the scarcity of innovation in pancreatic cancer and the urgent demand for new immunotherapies that can deliver a survival benefit in this setting.
With Fast Track and Orphan Drug designations in mPDAC and translational data supporting pelareorep’s immunologic activity, the Company believes it is well-positioned to engage potential partners seeking to bolster their GI oncology pipelines. The upcoming regulatory discussions and planned trial initiation represent major catalysts for strategic collaboration and long-term value creation.
Additional information on the study design, timelines, and next steps will be provided following regulatory feedback.