Oncolytics Biotech Inc. (NASDAQ: ONCY) announced a clinical and regulatory update on its REO 033 trial, a randomized controlled study evaluating pelareorep in combination with FOLFIRI and bevacizumab for second-line treatment of patients with RAS-mutant, microsatellite stable metastatic colorectal cancer.

The company said approximately half of the planned clinical sites for Part A of REO 033, which targets 60 patients, will be activated by the end of July 2026, with the remaining sites expected to be activated by the end of August. More than 20 patients have been pre-identified across participating centers. Enrollment at Rutgers Cancer Institute of New Jersey was recently opened by global lead principal investigator Dr. Sanjay Goel.

Oncolytics also announced it will hold a Type D meeting with the U.S. Food and Drug Administration in the first half of August 2026 to discuss adding Part B to the existing REO 033 trial design. Part B would be a randomized study incorporating blinded independent central review intended to support both potential accelerated approval and traditional full approval within the same study framework.

"Launching a global randomized study with multiple high-quality sites in a short period of time reflects the operational capabilities of our clinical organization and our investigators," said Jared Kelly, Chief Executive Officer of Oncolytics.

The company said it expects to report an initial tumor response update from patients enrolled in Part A by year-end 2026. Subject to FDA feedback, the company plans to initiate enrollment in Part B during the first quarter of 2027.

Pelareorep has received Fast Track designation from the FDA for the colorectal cancer indication. The REO 033 trial builds on the earlier REO 022 study, the results of which supported the Fast Track designation. Information in this article is based on a press release issued by Oncolytics Biotech.