Oncolytics Biotech Inc. ONCY
Oncolytics Biotech Inc. (Nasdaq: ONCY) is an oncology drug developer. Its lead program, Pelareorep, is in Phase 2 for Second-line RAS-mutated MSS metastatic colorectal cancer (randomized Phase 2 REO 033); also anal and pancreatic cancers.
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| Pelareorep + bevacizumab + FOLFIRI (REO 033) | Second-line RAS-mutated MSS mCRC (randomized Phase 2, site activation under way) | biologic-other | Phase 2 |
| Pelareorep + atezolizumab (GOBLET Cohort 4) | Relapsed unresectable squamous cell carcinoma of the anal canal (enrollment complete) | biologic-other | Phase 2 |
| Pelareorep + checkpoint inhibitor (planned pivotal) | Second-line or later SCAC (Fast Track July 2026; FDA aligned on pivotal design April 2026) | biologic-other | Phase 2 |
| Pelareorep | Metastatic pancreatic cancer (partnering sought) | biologic-other | Phase 2 |
| Pelareorep + RAS inhibitors | RAS-mutated solid tumors (preclinical) | biologic-other | Pre-clinical |
Recent results and decisions
- Oct 27, 2026positive GOBLET Cohort 4 updated data show approximately 15-month median duration of response with pelareorep plus atezolizumab in second-line anal cancer, exceeding historical checkpoint inhibitor monotherapy results.
Although median overall survival has not yet been reached, the median duration of response is approximately 15 months, which compares favorably with historical results of 9.5 months for U.S. Food and Drug Administration ("FDA")-approved retifanlimab monotherapy in a similar patient population.
Filing - Oct 27, 2026positive FDA granted Fast Track Designation for pelareorep in anal cancer following recent regulatory interactions.
Following recent FDA interactions and receipt of Fast Track Designation, Oncolytics plans to explore additional clinical studies with a potential checkpoint inhibitor partner to support registrational development in SCAC.
Filing - Oct 20, 2026started Oncolytics presents trial-in-progress abstract for REO 033 Phase 2 randomized study of pelareorep plus FOLFIRI/bevacizumab in second-line RAS-mutant MSS metastatic colorectal cancer.
The randomized, controlled, open-label study will evaluate patients with RAS-mutated, MSS mCRC who have progressed on first-line oxaliplatin-based therapy.
Filing
2 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
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Other phase 2 oncology companies
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Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.