ONCY News & Events

Oncolytics Biotech announced the initiation of a metastatic colorectal cancer, mCRC, Phase 2 study that will be referred to as REO 033. In this trial, second-line RAS-mutated, microsatellite-stable mCRC patients will be randomized to a control arm of bevacizumab and fluorouracil, leucovorin, irinotecan or an experimental arm of pelareorep, bevacizumab, and FOLFIRI. The study is powered for statistical significance, with each study arm expected to enroll 30 patients. All participants will have failed their initial treatment with platinum-based chemotherapy. The primary endpoint of the study is objective response rate, with progression-free survival, overall survival , safety, and biomarker analysis as other endpoints.

Oncolytics Biotech announced that the U.S. Food and Drug Administration has granted Fast Track Designation to pelareorep in combination with bevacizumab and leucovorin, fluorouracil, irinotecan for the treatment of patients with KRAS mutant, microsatellite-stable metastatic colorectal cancer in the second-line setting. As part of the Company's increased focus on gastrointestinal cancer and analysis of the existing colorectal data set in the fall, the Company applied for and has now received Fast Track Designation. The Fast Track Designation is supported by clinical data demonstrating a 33% objective response rate for pelareorep-based therapy compared to approximately 10% ORR with standard-of-care in this patient population. In addition, pelareorep combination therapy was associated with a median progression-free survival of 16.6 months, compared to 5.7 months with SOC, and a median overall survival of 27 months, compared to 11.2 months with SOC. Oncolytics expects to initiate a controlled clinical study in second-line KRAS-mutant MSS mCRC comparing standard-of-care therapy alone versus standard-of-care plus pelareorep. The first clinical site is expected to be activated in March, with up to 10 additional sites anticipated to open shortly thereafter. Interim data from the study are expected by year-end. Further details regarding the study design and milestones are forthcoming.

Oncolytics Biotech (ONCY) announced the appointment of John McAdory as Executive Vice President of Strategy and Operations and Yujun Wu as Vice President, Head of Biostatistics. McAdory will oversee clinical development execution, operational strategy, and regulatory readiness across the Company's portfolio. Most recently, Mr. McAdory served as Vice President, Clinical Operations at CG Oncology (CGON). Most recently, Wu served as Head of Biostatistics at Morphic Therapeutic.