Oncolytics Biotech Receives FDA Fast Track Designation for Pelareorep in Colorectal Cancer

Oncolytics Biotech Inc. has received Fast Track Designation from the U.S. Food and Drug Administration for its pelareorep therapy for the treatment of KRAS-mutant, microsatellite-stable metastatic colorectal cancer in combination with bevacizumab and FOLFIRI chemotherapy. The designation is based on clinical data showing a 33% objective response rate for the pelareorep-based therapy, significantly higher than the 10% achieved with standard care. Additionally, the therapy demonstrated a median progression-free survival of 16.6 months and a median overall survival of 27 months, compared to 5.7 months and 11.2 months, respectively, with standard treatments.

This marks pelareorep's second Fast Track Designation in gastrointestinal cancers, following an earlier designation for pancreatic cancer. The regulatory status can enable more frequent FDA meetings and faster potential approval timelines, and it only gets granted when a treatment shows meaningful advantages over existing options.

The company plans to launch a controlled study comparing standard-of-care versus standard-of-care plus pelareorep, with the first clinical site activating in March and interim data expected by year-end 2026. Oncolytics has also initiated a Phase 2 study, named REO 033, for metastatic colorectal cancer. This trial will focus on patients with RAS-mutated, microsatellite-stable cancer who have not responded to initial platinum-based chemotherapy.

The Phase 2 study will enroll second-line RAS-mutated, microsatellite-stable metastatic colorectal cancer patients who have failed initial platinum-based chemotherapy treatment. The study will randomize 60 patients into two arms of 30 participants each. The control arm will receive bevacizumab and FOLFIRI chemotherapy, while the experimental arm will receive pelareorep combined with bevacizumab and FOLFIRI. The primary endpoint is objective response rate, with progression-free survival, overall survival, safety, and biomarker analysis as secondary endpoints.

Pelareorep is also showing strong results in anal cancer, where third-line patients achieved a 29% response rate with responses lasting around 17 months in a setting with no FDA-approved treatments. In second-line anal cancer patients, the 30% response rate more than doubled the benchmark for available immunotherapy.

The company recently completed its reincorporation from Alberta, Canada to Nevada on March 31, 2026. The reincorporation was approved by shareholders at a special meeting held on January 15, 2026. The company will retain its Calgary office while its San Diego location becomes the new headquarters. Oncolytics' common stock continues to trade on Nasdaq under the ticker symbol ONCY.

Oncolytics is building out its leadership team to handle these expanding programs. The company recently announced two critical hires: an Executive Vice President of Strategy and Operations who ran late-stage clinical trials at CG Oncology, and a Vice President, Head of Biostatistics who led statistics at Morphic Therapeutic through its sale to Eli Lilly.