Pancreatic cancer remains one of the most challenging cancers to treat, with a five-year survival rate under 10%. Oncolytics Biotech (NASDAQ: ONCY), however, is challenging that reality with its lead candidate pelareorep, a virus-based immunotherapy. In metastatic pancreatic ductal adenocarcinoma (mPDAC), this therapy has shown an encouraging 21.9% two-year survival rate, more than double the historical 9.2% benchmark. Even more remarkable is the 62% objective response rate (ORR) when combined with other treatments. These early successes are driving investor optimism and positioning ONCY as a potential game-changer in oncology.
Clinical Data That Defies the Odds
Pelareorep’s clinical trials have delivered impressive survival improvements. In the REO 017 trial, combining pelareorep with gemcitabine resulted in a 24% two-year survival, compared to 4% with gemcitabine alone. Similarly, the NCI 8601 trial showed a 20% two-year survival with pelareorep plus chemotherapy, compared to 6% without it. When Tecentriq® (atezolizumab) was added in REO 029, the trial reached a 62% ORR, far above the usual 23% with chemotherapy, along with a 45% one-year survival in first-line mPDAC patients.
What sets pelareorep apart is its ability to convert tumors from immunologically “cold” (invisible to the immune system) to “hot” (detectable and attackable). Furthermore, its safety profile is favorable, serious side effects (Grade ≥3) were rare, with only mild flu-like symptoms observed in over 1,100 patients.
Addressing a Multibillion-Dollar Market
The global pancreatic cancer therapeutics market is projected to exceed $2.5 billion by 2030, growing at a 6.5% CAGR. In the U.S. alone, approximately 50,000 new mPDAC cases emerge annually. Current treatments offer limited benefits, leaving room for a therapy like pelareorep to dominate.
Beyond pancreatic cancer, pelareorep holds Fast Track designation for metastatic breast cancer since 2017, hinting at wider applicability. In the GOBLET trial, a median progression-free survival (PFS) of 7.2 months and an interim overall survival (OS) of 10.6 months was reported, over 25% better than historical averages. This strengthens pelareorep’s positioning as a powerful addition to chemo and checkpoint inhibitors.
Accelerating Toward Approval
Pelareorep’s regulatory journey is gaining momentum:
- In 2022, it received Fast Track designation for mPDAC.
- REO 029 trial data will likely support a Biologics License Application (BLA).
- The drug enjoys Orphan Drug Designations from both the FDA and EMA, which enhance market protection.
- Presentations at ESMO 2023, including long-term survival analyses, could boost short-term investor confidence.
If approved by 2026, pelareorep could reach $500 million to $1 billion in peak sales across multiple cancer types.
Investment Case: A Conviction Buy
The investment appeal of ONCY lies in:
- Revolutionary survival data in a high-need $2.5B+ market.
- First-mover advantage in using oncolytic viruses combined with immune checkpoint inhibitors.
- Low adverse event rates and robust safety data from over 1,100 patients.
- Multiple regulatory catalysts between now and 2026.
Risks include: possible trial failures, regulatory setbacks, or rising competition from emerging biotech therapies. Still, ONCY’s upside is compelling, especially at its current $250 million market cap.
Final Word
With its ability to extend survival in one of the deadliest cancers, Oncolytics Biotech’s pelareorep represents both medical innovation and a rare investment opportunity. Backed by strong data and poised for key regulatory milestones, ONCY is a high-reward bet for those willing to ride out biotech volatility.
