Oncolytics plans FDA talks for pancreatic cancer drug trial

Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) announced it has initiated regulatory discussions with the U.S. Food and Drug Administration for a potential registration-enabled pivotal study of its drug pelareorep in first-line metastatic pancreatic ductal adenocarcinoma.

The clinical-stage immunotherapy company expects to commence study start-up activities before the end of 2025, assuming discussions with the FDA proceed as expected, according to a press release statement.

The FDA interaction will focus on finalizing a clinical trial design that leverages pelareorep's demonstrated synergy with chemotherapy with or without checkpoint inhibition, using overall survival as the primary endpoint. The company may 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."

Pelareorep has received Fast Track and Orphan Drug designations from the FDA for metastatic pancreatic ductal adenocarcinoma. The intravenously delivered immunotherapeutic agent has shown results in two randomized Phase 2 studies in metastatic breast cancer and early-phase studies in pancreatic and colorectal cancer.

The company describes pelareorep as working by converting immunologically "cold" tumors "hot" through the activation of innate and adaptive immune responses. Oncolytics is advancing the drug in combination with chemotherapy and checkpoint inhibitors in metastatic breast and pancreatic cancers.

Additional information on the study design, timelines, and next steps will be provided following regulatory feedback from the FDA.

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