On February 4, 2026 Oncolytics Biotech Inc. (Nasdaq: ONCY) ("Oncolytics" or the "Company"), a clinical-stage immunotherapy company developing pelareorep, reported that the U.S. Food and Drug Administration ("FDA") has granted Fast Track Designation to pelareorep in combination with bevacizumab (Avastin) and leucovorin, fluorouracil, irinotecan ("FOLFIRI") for the treatment of patients with KRAS ("Kirsten rat sarcoma")-mutant, microsatellite-stable ("MSS") metastatic colorectal cancer ("mCRC") in the second-line ("2L") 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.
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The Fast Track Designation is supported by clinical data demonstrating a 33% objective response rate ("ORR") for pelareorep-based therapy compared to approximately 10% ORR with standard-of-care ("SOC") in this patient population.1-2 In addition, pelareorep combination therapy was associated with a median progression-free survival ("PFS") of 16.6 months, compared to 5.7 months with SOC, and a median overall survival ("OS") of 27 months, compared to 11.2 months with SOC.1
KRAS-mutant MSS metastatic colorectal cancer represents one of the most challenging diseases in gastrointestinal oncology, as few effective treatment options exist following first-line progression, and available immune-based therapies provide little benefit. There are an estimated 2 million new colorectal cancer cases each year globally, with an annual total addressable market of approximately $3-5 billion for the 2L KRAS-mutant MSS mCRC subgroup.3-7
"This designation is an important validation of our focus on pelareorep’s potential as a platform immunotherapy for gastrointestinal cancers like colorectal cancer," said Jared Kelly, Chief Executive Officer of Oncolytics. "Adding pelareorep to the standard-of-care in this underserved segment of colorectal cancer patients results in a doubling or tripling of critical clinical endpoints, including overall survival, progression-free survival, and objective response rate in a market that is estimated to be worth several billion dollars. Pelareorep offers the potential to help a meaningful number of patients, and I look forward to continuing to collaborate with the FDA to address this treatment gap as expeditiously as possible."
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.
The Fast Track Designation enables more frequent meetings and communication with the FDA to ensure alignment on development plans and the collection of clinical data needed to support approval. Furthermore, clinical programs with Fast Track Designation may be eligible for Accelerated Approval and Priority Review if relevant criteria are met. For conditions where an available treatment exists, a candidate therapy regimen must show some advantage over the available treatment, such as superior effectiveness, to be granted Fast Track Designation.
(Press release, Oncolytics Biotech, FEB 4, 2026, View Source [SID1234662474])