Oncolytics engaging FDA for registration-enabled pancreatic cancer trial

Oncolytics (ONCY) has initiated regulatory discussions with the FDA for a potential registration-enabled pivotal study in first-line metastatic pancreatic ductal adenocarcinoma, or mPDAC. Assuming discussions with the FDA go as expected, the company expects to commence study start-up activities before the end of 2025. 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. 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.