Oncolytics Biotech Achieves 33% Response Rate in KRAS-Mutant Colorectal Cancer
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 16 2025
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Source: Newsfilter
- Clinical Breakthrough: Oncolytics Biotech has achieved a 33% objective response rate in KRAS-mutant metastatic colorectal cancer, significantly surpassing the historical benchmark of 6-11%, indicating its potential to transform treatment paradigms in this area.
- Market Outlook: The total addressable market for colorectal cancer is projected to reach $20 billion by 2033, positioning Oncolytics' pelareorep as a potentially transformative treatment option that addresses the needs of underserved patients.
- FDA Support: The company has secured FDA alignment on the pivotal Phase 3 study design for pelareorep in first-line metastatic pancreatic cancer, signaling the imminent launch of its registration trial and further solidifying its market position.
- Strategic Advisory: Oncolytics has established a Gastrointestinal Tumor Scientific Advisory Board to guide its registration strategy across pancreatic, colorectal, and anal cancers, ensuring expert support and market recognition in future clinical trials.
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Analyst Views on ONCY
Wall Street analysts forecast ONCY stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for ONCY is 5.50 USD with a low forecast of 3.00 USD and a high forecast of 10.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
6 Analyst Rating
5 Buy
1 Hold
0 Sell
Strong Buy
Current: 1.110
Low
3.00
Averages
5.50
High
10.00
Current: 1.110
Low
3.00
Averages
5.50
High
10.00
About ONCY
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. This improves the ability of the immune system to fight cancer, making tumors more susceptible to a broad range of oncology treatments. It acts by inducing anti-cancer immune responses and promotes an inflamed tumor phenotype, turning cold tumors hot through innate and adaptive immune responses to treat a variety of cancers. 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.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Oncolytics Biotech Strengthens Leadership Amid Oncology Market Surge
- Executive Appointments: Oncolytics Biotech has appointed John McAdory as Executive Vice President of Strategy and Operations and Yujun Wu as Vice President, Head of Biostatistics, both bringing extensive experience in late-stage oncology trial execution and regulatory strategy to advance the company's registration-directed programs in gastrointestinal cancers.
- Clinical Data Breakthrough: The company reported that pelareorep achieved a 33% objective response rate in second-line KRAS-mutant microsatellite stable metastatic colorectal cancer patients when combined with standard chemotherapy, tripling the historical response rate of 6-11%, demonstrating significant efficacy in this difficult-to-treat population.
- FDA Alignment Success: Oncolytics has secured FDA alignment on its Phase 3 study design for pelareorep in first-line metastatic pancreatic cancer, positioning it to launch the only immunotherapy registration trial currently planned for this challenging therapeutic area, further solidifying its market position.
- Strategic Expansion: The company has also expanded its Scientific Advisory Board with globally recognized experts from Memorial Sloan Kettering Cancer Center and MD Anderson Cancer Center, aiming to accelerate clinical development across multiple indications and enhance overall R&D capabilities.
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Oncolytics Biotech Strengthens Leadership to Advance Clinical Programs
- Leadership Enhancement: Oncolytics Biotech has appointed John McAdory as Executive Vice President of Strategy and Operations and Yujun Wu as Vice President, Head of Biostatistics, both bringing extensive experience in late-stage oncology trial execution and regulatory strategy to advance the company's registration-directed programs in gastrointestinal cancers.
- Breakthrough Efficacy Data: The company reported that pelareorep achieved a 33% objective response rate in second-line KRAS-mutant microsatellite stable metastatic colorectal cancer patients when combined with standard chemotherapy, significantly surpassing the historical 6-11% response rate, indicating its potential in difficult-to-treat patient populations.
- FDA Designation Approval: Oncolytics secured FDA alignment on its Phase 3 study design for pelareorep in first-line metastatic pancreatic cancer, marking the initiation of the only immunotherapy registration trial planned for this challenging area, further solidifying its market position.
- Advisory Board Expansion: The company has expanded its Scientific Advisory Board by adding globally recognized experts from Memorial Sloan Kettering Cancer Center and MD Anderson Cancer Center, laying the groundwork for accelerated clinical development across multiple indications.
Continue Reading