Shares of Oncolytics Biotech Inc (NASDAQ:ONCY) climbed 16.2% on Wednesday after the U.S. Food and Drug Administration granted Fast Track Designation to the company’s investigational therapy pelareorep for a specific colorectal cancer indication.
The Fast Track recognition applies to pelareorep administered in combination with bevacizumab and FOLFIRI for patients with KRAS-mutant, microsatellite-stable (MSS) metastatic colorectal cancer in the second-line treatment setting. The decision follows clinical data in which the pelareorep combination produced a 33% objective response rate, compared with roughly 10% typically observed with current standard-of-care options.
Alongside the higher response rate, the pelareorep regimen demonstrated materially improved survival outcomes in the reported data. Median progression-free survival for patients receiving the combination was 16.6 months, versus 5.7 months for standard care. Median overall survival measured 27 months for the pelareorep group compared with 11.2 months under existing treatments.
"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.
Fast Track status facilitates more frequent interactions with the FDA and can open pathways to Accelerated Approval and Priority Review if subsequent data support such applications. In line with that regulatory trajectory, Oncolytics intends to begin a controlled clinical study in March to compare outcomes between standard therapy alone and standard therapy plus pelareorep. The company has indicated interim data from that study are expected by year-end 2026.
This Fast Track designation is the second granted to pelareorep for gastrointestinal cancers, reinforcing the company’s positioning of the agent as a possible platform therapy in this therapeutic area. KRAS-mutant MSS metastatic colorectal cancer is highlighted in company materials as an especially difficult-to-treat subgroup, and the market for therapies addressing this population is estimated at $3-5 billion annually.
Sectors impacted:
- Biotechnology and pharmaceuticals, particularly oncology therapeutics
- Specialty medical markets focused on gastrointestinal cancers and targeted immunotherapies