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Hello!
We wanted to give you a quick intraday update on our new alert, Oncolytics Biotech® Inc. (Nasdaq: ONCY).
Following our alert this morning, ONCY opened at just under 0.69, so far near the high of the day of 0.71.
ONCY announced breaking news this morning that could be a big growth catalyst for the company:
“Oncolytics Biotech® Reports Accelerating Enrollment in Randomized REO 033 RAS-Mutant, MSS Colorectal Cancer Study”
Here are the highlights from this press release:
“Substantially all planned REO 033 clinical sites are now activated, with multiple patients currently on study”
“Company expects to have sufficient Part A data to provide an interim clinical update by year-end 2026”
“FDA alignment provides potential path to accelerated approval based on objective response rate and full approval based on progression-free survival”
“SAN DIEGO, Sept. 28, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) ("Oncolytics" or the "Company"), a clinical-stage immunotherapy company developing pelareorep, today announced continued clinical and operational progress in REO 033, its randomized study evaluating pelareorep in second-line RAS-mutant, microsatellite-stable ("MSS") metastatic colorectal cancer ("mCRC").”
As the company further explains:
“Nearly all planned clinical sites for Part A of REO 033 have now been activated, and multiple patients are currently enrolled (link to study on ClinicalTrials.gov). With the site activation process largely complete, the Company is focused on accelerating enrollment and generating randomized clinical data evaluating the contribution of pelareorep to the current standard-of-care regimen.”
“REO 033 is a randomized controlled study evaluating pelareorep in combination with folinic acid, fluorouracil and irinotecan ("FOLFIRI") and bevacizumab versus FOLFIRI and bevacizumab in patients with second-line RAS-mutant MSS mCRC. Part A is expected to enroll approximately 60 patients randomized between the two treatment arms, with objective response rate ("ORR") as the primary endpoint, and progression-free survival ("PFS"), overall survival ("OS"), safety, and biomarker analyses among the additional endpoints.”
Here are some of the company’s comments from this press release:
"We are seeing strong momentum in REO 033 now that substantially all of our planned sites are open and multiple patients are on study," said John McAdory, Chief Operating Officer of Oncolytics. "Given the current pace of enrollment, we expect to have the ability to report interim data from Part A by year-end, based on the number of evaluable patients enrolled by the end of October. Importantly, with site activation substantially behind us, our focus is now squarely on enrollment, execution, and generating the randomized clinical data that can inform the next stage of the program."
REO 033 Builds on Encouraging REO 022 Clinical Data
“REO 033 was designed to prospectively evaluate the efficacy signals previously observed in REO 022 in a randomized setting. In REO 022, pelareorep in combination with FOLFIRI and bevacizumab demonstrated encouraging ORR, PFS, and OS compared with historical second-line benchmarks:
Efficacy Measure | REO 022: Pelareorep + FOLFIRI + Bevacizumab1 | Historical Second-Line Benchmark |
Objective Response Rate | 33% | ~6–11%2, 3 |
Median Progression-Free Survival | 16.6 months | ~5.7 months2 |
Median Overall Survival | 27.0 months | ~11.2 months2 |
Median Duration of Response | 19.5 months | ~4–6 months4 |
“The REO 022 results were generated in a small, non-randomized study, and cross-study comparisons have inherent limitations. REO 033 is designed to test the pelareorep regimen prospectively against a concurrent control arm and determine whether the efficacy signals observed in REO 022 can be replicated in a randomized study.”
Potential Registration Path Aligned with the Food and Drug Administration
“The Company recently aligned with the U.S. Food and Drug Administration (the "FDA") on the concept for a potential pivotal Part B expansion of REO 033.
Under the proposed regulatory strategy, Part B would build directly upon the ongoing randomized REO 033 study and could support a potential accelerated approval submission based on objective response rate, with progression-free survival providing the basis for potential full approval.
The Company expects data from Part A to inform the final size and execution of the potential pivotal Part B expansion.”
We are continuing to monitor ONCY for a sustainable breakout higher.
Happy Trading!
SmallCapStocks Team
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