Oncolytics Biotech Accelerates Enrollment in Key Colorectal Cancer Study — Oncolytics Biotech Inc.

Event summary

Oncolytics Biotech has activated nearly all planned clinical sites for its REO 033 study, with multiple patients already enrolled.
The company expects to report interim data from Part A of the study by year-end 2026.
REO 033 is evaluating pelareorep in combination with FOLFIRI and bevacizumab for second-line RAS-mutant, MSS metastatic colorectal cancer.
The study aims to replicate encouraging efficacy signals observed in the earlier REO 022 study in a randomized setting.

The big picture

Oncolytics Biotech is advancing its pelareorep immunotherapy in a pivotal study for metastatic colorectal cancer, a market with significant unmet needs. The company's alignment with the FDA on a potential registration path underscores the strategic importance of this trial. Success in REO 033 could position pelareorep as a key player in the treatment of RAS-mutant, MSS colorectal cancer, a challenging subset of the disease.

What we're watching

Clinical Data: Whether the interim data from Part A of REO 033 will confirm the efficacy signals observed in the REO 022 study.
Regulatory Pathway: The potential for accelerated approval based on objective response rate and full approval based on progression-free survival.
Enrollment Pace: The pace at which Oncolytics can complete enrollment and generate randomized clinical data to inform the next stage of the program.