Shares of Oncolytics Biotech Inc rose 5.9% in premarket trading Monday after the clinical-stage company said it had scheduled a Type D meeting with the U.S. Food and Drug Administration to discuss the registrational pathway for its REO 033 trial.
The company said the meeting is planned for the first half of August and will cover a proposal to add a randomized Part B to the existing REO 033 design. The proposed Part B would be intended to support potential accelerated and full approvals for pelareorep, the companys investigational oncolytic immunotherapy being developed for patients with RAS-mutant, microsatellite stable (MSS) metastatic colorectal cancer.
Oncolytics provided an operational update on Part A of REO 033, which is set to enroll 60 patients. The company reported that roughly half of the planned clinical sites should be activated by the end of July, and that more than 20 patients have been pre-identified across participating centers. Remaining sites are expected to be activated by the end of August.
According to Oncolytics, the suggested Part B would keep the core design features of REO 033 while expanding enrolment and adding a blinded independent central review. The company said this approach could allow for early randomized efficacy data to emerge from Part A and position Part B as a potential registrational study without the need to start a separate trial.
Oncolytics outlined a timetable tied to FDA feedback: it expects to report an initial tumor response update from patients enrolled in Part A by year-end 2026 and, contingent on the agencys guidance, to begin enrollment in Part B during the first quarter of 2027.
REO 033 follows on the earlier REO 022 study. Based on prior data, pelareorep has received Fast Track designation from the FDA for this indication. The REO 033 trial is testing pelareorep in combination with FOLFIRI and bevacizumab as a second-line treatment for patients with RAS-mutant, MSS metastatic colorectal cancer.
This regulatory and operational update highlights the companys effort to align a single-trial strategy that could yield randomized efficacy data and, potentially, a pathway toward regulatory submissions for pelareorep pending FDA feedback.
Context note: The information above reflects Oncolytics public statements about the REO 033 clinical program and the planned interaction with the FDA. Timelines for data readouts and initiation of Part B are conditional on regulatory feedback.