Stock Gains on Regulatory Development
Oncolytics Biotech Inc. (NASDAQ:ONCY) shares rose 5.9% in premarket trading on Monday after the company announced plans to hold a Type D meeting with the U.S. Food and Drug Administration (FDA) to discuss a potential registration strategy for its REO 033 clinical trial.
The meeting is expected to take place during the first half of August.
Company Seeks Feedback on Expanded Trial Design
The clinical-stage biotechnology company intends to discuss adding a randomized Part B to the existing REO 033 study.
According to Oncolytics, the additional trial stage is designed to support both accelerated and full regulatory approval for pelareorep, its investigational immunotherapy for patients with RAS-mutant, microsatellite stable metastatic colorectal cancer.
Enrollment Progress Continues
The company also provided an update on Part A of the REO 033 trial, which is targeting enrollment of 60 patients.
Approximately half of the planned clinical sites are expected to be active by the end of July, with more than 20 patients already identified across participating centres. The remaining sites are scheduled to open before the end of August.
Part B Could Serve as Registrational Study
Oncolytics said the proposed expansion would retain the existing framework of REO 033 while increasing patient enrollment and introducing a blinded independent central review process.
Management believes this approach could deliver early randomized efficacy data from Part A while allowing Part B to function as a potential registrational study, avoiding the need to launch an entirely new clinical trial.
Key Milestones Expected Over the Next Year
The company expects to release an initial update on tumour responses from patients enrolled in Part A before the end of 2026.
Subject to FDA feedback, enrollment in Part B is anticipated to begin during the first quarter of 2027.
REO 033 builds on findings from the earlier REO 022 study. Based on previous clinical data, pelareorep has already received Fast Track designation from the FDA for this indication.
The study is evaluating pelareorep in combination with FOLFIRI and bevacizumab as a second-line treatment for patients with RAS-mutant, microsatellite stable metastatic colorectal cancer.