Oncolytics Biotech Receives FDA Fast Track Designation for Pelareorep in Colorectal Cancer

Oncolytics Biotech Inc. (NASDAQ: ONCY) received Fast Track Designation from the FDA for its cancer treatment pelareorep in second-line microsatellite-stable metastatic colorectal cancer patients with KRAS mutations. This regulatory status can enable more frequent FDA meetings and faster potential approval timelines, and it only gets granted when a treatment shows meaningful advantages over existing options.

The designation is based on clinical data showing pelareorep combined with standard chemotherapy and Avastin achieved a 33% response rate in KRAS-mutant microsatellite-stable (MSS) colorectal cancer patients, compared to roughly 10% with chemotherapy and Avastin. Patients lived a median 27 months versus 11.2 months with standard treatment, and their cancer stayed stable for 16.6 months compared to 5.7 months. Response rate measures the percentage of patients whose tumors shrink significantly or disappear.

KRAS-mutant MSS colorectal cancer represents one of the hardest-to-treat cancer populations, with limited options after first-line treatment fails and minimal benefit from immune therapies. The global market for second-line treatment in this patient group runs between $3 billion and $5 billion annually.

The company's chief executive stated 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.

The company plans to launch a controlled study comparing standard-of-care versus standard-of-care plus pelareorep, with the first clinical site activating in March and interim data expected by year-end 2026. This marks pelareorep's second Fast Track Designation in gastrointestinal cancers, following an earlier designation for pancreatic cancer.

Pelareorep is also showing strong results in anal cancer, where third-line patients achieved a 29% response rate with responses lasting around 17 months in a setting with no FDA-approved treatments. In second-line anal cancer patients, the 30% response rate more than doubled the benchmark for available immunotherapy.

Oncolytics is building out its leadership team to handle these expanding programs. The company recently announced two critical hires: an Executive Vice President of Strategy and Operations who ran late-stage clinical trials at CG Oncology, and a Vice President, Head of Biostatistics, who led statistics at Morphic Therapeutic through its sale to Eli Lilly. The chief executive and Chief Business Officer both joined from Ambrx Biopharma, which sold to Johnson & Johnson for $2 billion in 2024.

The Fast Track announcement coincided with a sharp near term move, with a 1 day share price return of 26.99% and 7 day share price return of 22.78% taking Oncolytics Biotech to $1.06. The 1 year total shareholder return of 38.16% contrasts with weaker 3 and 5 year total shareholder returns.

Over 2,100 oncology clinical trials were initiated globally in 2024, with targeted therapies representing the fastest-growing subsegment and over 100 antibody-drug conjugates now in active clinical development. In January 2026 alone, the FDA granted orphan drug designations for agents targeting gastrointestinal cancers and myelofibrosis, as well as breakthrough therapy designations across several rare oncology indications including NSCLC, ovarian cancer, and T-cell malignancies.

Oncolytics Biotech Inc. is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent that activates the innate and adaptive immune systems and weakens tumor defense mechanisms. The company is also advancing its programs in hormone receptor-positive / human epidermal growth factor 2-negative (HR+/ HER2-) advanced and metastatic breast cancer (mBC) and metastatic pancreatic ductal adenocarcinoma (PDAC) to registration-enabled clinical studies. In addition, it is exploring opportunities for registrational programs in other gastrointestinal cancers through its GOBLET platform study.