Oncolytics Biotech Inc.·Healthcare

Translational data demonstrate induction of both innate and adaptive antiviral and anti-tumor specific immune responses capable of controlling tumor growth

Oncolytics Biotech, Inc. (NASDAQ:ONCY) shares are up on Monday as the company reported promising durability data for its investigational immunotherapy, pelareorep, in treating metastatic colorectal cancer.

2L KRAS-Mutant MSS mCRC Demonstrates ~3–4x Improvement in Duration of Response vs. Historical 4–6 Month Benchmark Company Engaged with FDA to Support Potential Accelerated Approval Pathway in 2L RAS-Mutant MSS mCRC SAN DIEGO, May 04, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage company developing pelareorep, an investigational, systemically delivered immunotherapy that has been shown to activate innate immune-sensing pathways, today announced new durability data in metastatic colorectal cancer (“mCRC”), demonstrating meaningful and sustained clinical benefit in patients with RAS-mutant, microsatellite-stable (“MSS”) disease.

Company to leverage strong durability and survival data in second-line and later metastatic squamous cell anal carcinoma Pivotal study expected to focus on patients in a post-standard-of-care patient population with no FDA-approved therapies SAN DIEGO, April 27, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage immunotherapy company developing pelareorep, an investigational, systemically delivered immunotherapy that has been shown to activate innate immune-sensing pathways, today announced that a Type C meeting with the U.S. Food and Drug Administration (“FDA”) has resulted in alignment on the design of a pivotal clinical study to support approval of pelareorep in patients with unresectable metastatic squamous cell carcinoma of the anal canal (“SCAC”). “We want to thank the FDA for its very clear guidance and helping us create an efficient pathway for pelareorep in a disease that is desperate for new treatments,” said Jared Kelly, Chief Executive Officer of Oncolytics.

Oncolytics is narrowing Pelareorep development toward anal cancer and metastatic colorectal cancer, making its bull case more concrete. Pelareorep may turn “cold” tumors “hot,” potentially improving chemotherapy and checkpoint inhibitor responses across GI cancers. CRC data showed an unusually high 33% ORR versus 6%-11% historical SoC. This is why it received the FDA's Fast Track designation.

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Oncolytics Biotech Inc., a development-stage biopharmaceutical company, focuses on the discovery and development of pharmaceutical products for the treatment of cancer. Its lead product is pelareorep, an intravenously delivered immunotherapeutic agent for the treatment of solid tumors and hematological malignancies. Oncolytics Biotech Inc. has a co-development agreement with Merck KGaA and Pfizer Inc. to co-develop pelareorep in combination with paclitaxel and avelumab, a human anti-PD-L1 antibody for the treatment of hormone receptor-positive/human epidermal growth factor 2-negative metastatic breast cancer; and PrECOG LLC. The company was incorporated in 1998 and is headquartered in Calgary, Canada.
Healthcare
Biotechnology
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2001-10-05
1.03