Oncolytics Biotech Announces Clinical And Translational Findings Supporting Development Of Pelareorep In Second-Line mCRC, Specifically In Patients With KRAS- MSS Disease

33% ORR achieved in second-line KRAS-mutant MSS colorectal cancer—triple historical response rates for Avastin + FOLFIRI of 6-11%

Translational analysis shows pelareorep enhances KRAS-mutant–specific T-cell activity, providing mechanistic support for clinical responses

Data strengthen pelareorep's potential to transform a multi–billion dollar underserved colorectal cancer market

Oncolytics Biotech® Inc. (NASDAQ:ONCY) ("Oncolytics" or the "Company"), a clinical-stage immunotherapy company developing pelareorep, today announced clinical and translational findings supporting the development of pelareorep in second-line metastatic colorectal cancer ("mCRC"), specifically in patients with KRAS-mutant, microsatellite-stable ("MSS") disease. This represents one of the most difficult-to-treat and least responsive subgroups within colorectal cancer.

In a previously completed clinical study evaluating pelareorep in combination with standard-of-care therapy, 33% of KRAS-mutant MSS patients achieved an objective response, compared to the well-established historical objective response rate ("ORR") of approximately 6–11% for Avastin® (bevacizumab) + FOLFIRI in second-line mCRC.1, 2 In that same study, patients receiving the pelareorep, bevacizumab, and FOLFIRI treatment regimen more than doubled progression-free survival and overall survival compared to those receiving bevacizumab and FOLFIRI (click here for the PR).

In addition to the clinical activity, a separate translational analysis of paired tumor biopsies revealed that treatment with pelareorep led to a notable increase in KRAS-mutant–specific T-cell populations, indicating that pelareorep may directly enhance anti-tumor immune recognition in this genetically defined subgroup. These findings provide strong biological support for pursuing pelareorep as a precision immunotherapy capable of addressing a patient population that rarely benefits from checkpoint inhibitors or other immunotherapies. A complete analysis of the translational data will be presented at an upcoming medical meeting.