Oncolytics Biotech announced the launch of its Phase 2 colorectal cancer study, REO 033, targeting second‑line RAS‑mutant microsatellite‑stable metastatic colorectal cancer. The trial will enroll 60 patients, 30 in each arm, and will evaluate the combination of pelareorep with bevacizumab and FOLFIRI versus bevacizumab and FOLFIRI alone. The primary endpoint is objective response rate, with progression‑free and overall survival as secondary endpoints.
The trial design builds on the promising results of the earlier REO 022 study, which reported a 33% objective response rate for pelareorep‑containing therapy compared with roughly 10% for standard care in a similar patient population. The new study will confirm whether the observed efficacy can be replicated in a larger, randomized setting and will provide data that could support a registration application.
Pelareorep, an intravenously delivered double‑stranded RNA immunotherapeutic, has received FDA Fast Track designation for second‑line KRAS‑mutant microsatellite‑stable metastatic colorectal cancer. The Fast Track status reflects the agency’s recognition of the unmet need in this difficult‑to‑treat subgroup, which represents a $12.5 billion market with a 4.7% CAGR through 2033.
Oncolytics’ strategic focus has shifted toward registration‑enabling studies in anal and colorectal cancer, following the completion of enrollment in its GOBLET study. The company plans to meet with the FDA in mid‑April to align on a registrational study design for anal cancer, underscoring its intent to pursue regulatory approval efficiently.
Management emphasized the significance of the new trial. Dr. Sanjay Goel said, "I am honored to lead this study as I have a long track record working with pelareorep and have witnessed its ability to improve patient outcomes in a meaningful way. The colorectal cancer data we recorded in the REO 022 study continues to be compelling to this day, as evidenced by the Fast Track Designation, and I hope we can generate additional exciting data in this new trial to support registration." Dr. Van Morris added, "An immunotherapy with the potential to improve outcomes would improve treatment options in colorectal cancer and would be highly welcomed, especially as we are seeing more and more younger patients being diagnosed with colorectal cancer." CEO Jared Kelly noted, "GOBLET has done its job successfully. We now know where pelareorep can make the greatest impact for patients and where we can pursue approval most efficiently. Our disciplined strategy is to run registrational or registration‑enabling studies with ruthless efficiency that can create maximum shareholder value without unnecessary dilution."
The company currently reports zero revenue and ongoing losses, typical for a development‑stage biopharma. Its high debt‑to‑equity ratio reflects reliance on external funding, although recent insider buying suggests confidence among insiders. The launch of REO 033 represents a critical milestone that could accelerate the path to regulatory approval and, ultimately, revenue generation.
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