ONCY · Oncolytics Biotech Inc.

Oncolytics Biotech reported significant clinical durability data from its REO 022 study in metastatic colorectal cancer (mCRC). The pelareorep-based combination therapy achieved a median duration of response of 19.5 months in second-line KRAS-mutant MSS mCRC patients, representing a three- to four-fold improvement over the historical benchmark of 4-6 months for this setting. Additionally, the objective response rate of 33% marks a substantial increase over the 6-11% typically observed with standard of care. These findings are critical for investors as they suggest a potential competitive advantage in a difficult-to-treat patient population with high unmet medical need. The Company is actively engaging with the FDA to establish a regulatory strategy for accelerated approval based on these durability and response metrics. A randomized Phase 2 study is currently enrolling to support this pathway. Pelareorep has previously received Fast Track designation from the FDA for colorectal and pancreatic cancer, which may facilitate the development timeline.