Oncolytics to Meet FDA on Registrational Pathway for REO 033 Colorectal Cancer Trial

Oncolytics Biotech provided a clinical and regulatory update for its REO 033 study, which evaluates its drug pelareorep for second-line metastatic colorectal cancer. The company will hold a Type D meeting with the U.S. FDA in August 2026 to discuss a registrational pathway for the drug by adding a new part to the existing trial, which could support both accelerated and full approval.

Key Details

• FDA Meeting: A Type D meeting with the FDA is scheduled for the first half of August 2026 to discuss adding a registration-directed "Part B" to the REO 033 study.
• Clinical Progress: Part A of the study (n=60 patients) is advancing rapidly, with all clinical sites expected to be activated by the end of August 2026. Over 20 patients have been pre-identified.
• Upcoming Milestones: The company expects to report an initial tumor response update from Part A by year-end 2026 and, subject to FDA feedback, initiate enrollment in Part B during Q1 2027.