Oncolytics Biotech Inc. announced 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). This move reflects the company's conviction in pelareorep's differentiated mechanism of action and its encouraging survival signal in one of the most lethal solid tumors.
Assuming positive feedback from the FDA, Oncolytics 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 will target overall survival as the primary endpoint. The company is considering proposing an adaptive study in collaboration with a third party.
This program is expected to create significant value for shareholders and position Oncolytics as an attractive partner for pharmaceutical companies seeking to enter the immunotherapy landscape in mPDAC and other GI tumors. Pelareorep has already received Fast Track and Orphan Drug designations in mPDAC, further supporting this accelerated development strategy.
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