Oncolytics Biotech Initiates Phase 2 Trial for Colorectal Cancer Immunotherapy

Oncolytics Biotech Inc. announced the initiation of a Phase 2 study in metastatic colorectal cancer, designated REO 033, designed to confirm previous efficacy results with preliminary data expected by the end of 2026. The pelareorep-based treatment regimen recently received Fast Track Designation from the U.S. Food & Drug Administration in second-line KRAS-mutant, microsatellite-stable metastatic colorectal cancer.

In the trial, second-line RAS-mutated (which includes KRAS), microsatellite-stable metastatic colorectal cancer patients will be randomized to a control arm of bevacizumab (Avastin) and fluorouracil, leucovorin, irinotecan (FOLFIRI) or an experimental arm of pelareorep, bevacizumab, and FOLFIRI. The study is powered for statistical significance, with each study arm expected to enroll 30 patients. All participants will have failed their initial treatment with platinum-based chemotherapy. The primary endpoint of the study is objective response rate, with progression-free survival, overall survival, safety, and biomarker analysis as other endpoints.

The trial will be sponsored by Oncolytics with a professor of medicine at Rutgers Cancer Institute of New Jersey as the Lead Investigator. The Company is expecting to initiate the first study site later this month and provide preliminary data by year-end.

The previous REO 022 clinical study of pelareorep, bevacizumab, and FOLFIRI in this population demonstrated a median overall survival of 27 months and a median progression-free survival of 16.6 months, both of which substantially exceed the median 11.2- and 5.7-month overall survival and progression-free survival, respectively, observed for standard-of-care therapy. Similarly, objective response rate in the same study was 33% for pelareorep-containing therapy compared to approximately 10% for standard-of-care treatment.

Oncolytics is a clinical-stage biotechnology company developing pelareorep, an investigational intravenously delivered double-stranded RNA immunotherapeutic agent. Pelareorep has demonstrated encouraging results in multiple first-line pancreatic cancer studies, two randomized Phase 2 studies in metastatic breast cancer, and early-phase studies in anal and colorectal cancer. It is designed to induce anti-cancer immune responses by converting immunologically "cold" tumors "hot" through the activation of innate and adaptive immune responses.

The Company is advancing pelareorep in combination with chemotherapy and/or checkpoint inhibitors in metastatic gastrointestinal cancers, where pelareorep has received Fast Track designation from the FDA for colorectal and pancreatic cancer.