SAN DIEGO, CA — February 4, 2026 — Leads & Copy — Oncolytics Biotech Inc. (Nasdaq: ONCY) announced that the U.S. Food and Drug Administration has granted Fast Track Designation to pelareorep in combination with bevacizumab (Avastin®) and leucovorin, fluorouracil, irinotecan (“FOLFIRI”) for the treatment of patients with KRAS-mutant, microsatellite-stable metastatic colorectal cancer in the second-line setting.
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. 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.
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.
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.
The Fast Track Designation is part of the Company’s increased focus on gastrointestinal cancer and analysis of the existing colorectal data set in the fall.
According to Jared Kelly, Chief Executive Officer of Oncolytics, the designation is an important validation of the focus on pelareorep’s potential as a platform immunotherapy for gastrointestinal cancers like colorectal cancer. Kelly added that 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. Kelly also stated that pelareorep offers the potential to help a meaningful number of patients, and he looks forward to continuing to collaborate with the FDA to address this treatment gap as expeditiously as possible.
Oncolytics is a clinical-stage biotechnology company developing pelareorep, an investigational intravenously delivered double-stranded RNA immunotherapeutic agent. Pelareorep has demonstrated encouraging results in multiple first-line pancreatic cancer studies, two randomized Phase 2 studies in metastatic breast cancer, and early-phase studies in anal and colorectal cancer. It is designed to induce anti-cancer immune responses by converting immunologically “cold” tumors “hot” through the activation of innate and adaptive immune responses.
The Company is advancing pelareorep in combination with chemotherapy and/or checkpoint inhibitors in metastatic gastrointestinal cancers, where pelareorep has received Fast Track designation from the FDA for colorectal and pancreatic cancer. Oncolytics is actively pursuing strategic partnerships to accelerate development and maximize commercial impact.
Source: Oncolytics Biotech Inc.
