Oncolytics Biotech® to Engage FDA for Potential Registration-Enabled Study in First-Line Pancreatic Cancer with Goal to Launch Trial Activities by Year-End

Core Insights - Oncolytics Biotech Inc. is initiating regulatory discussions with the FDA for a pivotal study in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC), aiming to start study activities by the end of 2025 [1][4] - The company believes in the differentiated mechanism of action of pelareorep and its potential to improve survival rates in mPDAC, a highly lethal cancer [2][3] - Oncolytics is considering an adaptive study design that may involve collaboration with a third party, focusing on overall survival as the primary endpoint [2][4] Company Overview - Oncolytics is a clinical-stage biotechnology company developing pelareorep, an immunotherapeutic agent that has shown promising results in metastatic breast cancer and early-phase studies in pancreatic and colorectal cancer [5][6] - Pelareorep works by converting "cold" tumors into "hot" tumors, activating both innate and adaptive immune responses [5] - The company has received Fast Track and Orphan Drug designations for pelareorep in mPDAC, positioning it well for strategic partnerships in gastrointestinal oncology [4][6] Strategic Goals - The CEO of Oncolytics emphasizes the importance of execution and focus in moving down a clear regulatory path, with the goal of enhancing shareholder value and attracting pharmaceutical partnerships [3][4] - The upcoming regulatory discussions and trial initiation are seen as major catalysts for collaboration and long-term value creation [4] - Oncolytics aims to leverage its clinical promise in mPDAC and other gastrointestinal cancers to engage potential partners looking to enhance their oncology pipelines [3][4]