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Oncolytics Biotech Inc.
Video analysis: ONCY
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News: ONCY
Oncolytics Biotech® Announces Positive Preclinical Results Combining Pelareorep with a Pan-RAS Inhibitor in Colorectal Cancer
Oncolytics announced positive preclinical results evaluating pelareorep in combination with a pan-RAS inhibitor in a RAS-driven colorectal cancer model.
Oncolytics Biotech® Aligns with FDA on Registrational Path for Second-Line RAS-Mutant MSS Colorectal Cancer
FDA written feedback provides alignment on a potential pivotal Part B expansion of the ongoing REO 033 study Proposed pathway offers potential accelerated approval based on objective response rate and progression-free survival supporting full approval Pivotal expansion to follow initial clinical data from the ongoing randomized Part A SAN DIEGO, Aug. 18, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage immunotherapy company developing pelareorep, today announced that it has received written feedback from the U.S. Food and Drug Administration (“FDA”) regarding the design of a potential pivotal Part B expansion of REO 033, the Company's ongoing randomized study evaluating pelareorep in second-line RAS-mutant, microsatellite stable (“MSS”) metastatic colorectal cancer (“REO 033”). The Company submitted a Type D meeting request to the FDA regarding the potential expansion of REO 033 into a pivotal study.
Oncolytics Biotech® Receives Fast Track Designation for Pelareorep in Second-Line and Later Anal Cancer
Designation supports development in an estimated $1 billion market where there are no FDA-approved therapies for patients whose disease progresses following first-line standard of care therapy Third Fast Track designation in gastrointestinal cancers strengthens Oncolytics' regulatory momentum and continues to advance the Company's path toward registration SAN DIEGO, July 20, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage immunotherapy company, today announced that the U.S. Food and Drug Administration (“FDA”) has granted Fast Track designation to pelareorep in combination with a checkpoint inhibitor for the treatment of patients with inoperable, locally recurrent or metastatic squamous cell carcinoma of the anal canal (“SCAC”) who have progressed on or were intolerant to one or more prior lines of systemic therapy. Fast Track designation is intended to facilitate the development and expedite the review of therapies that treat serious diseases and address significant unmet medical needs.
Oncolytics Biotech® Reports FDA Regulatory Milestone and Strong Clinical Progress in Randomized RAS-Mutant MSS Colorectal Cancer Trial
Half of planned clinical sites will be activated this month; more than 20 patients have been pre-identified across participating centers Company to hold Type D meeting with FDA to discuss a potential registrational pathway through the addition of Part B to the existing REO 033 trial design Part B will be a randomized study designed to support potential accelerated and full approval SAN DIEGO, July 13, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage company developing pelareorep, an investigational, systemically active immunotherapy that promotes potentially protective immune responses, including the upregulation of key inflammatory cytokines resulting in the formation of tertiary lymphoid structures and the expansion of tumor-infiltrating lymphocytes, today provided a clinical and regulatory update on REO 033, the Company's randomized controlled study evaluating pelareorep in combination with folinic acid, fluorouracil and irinotecan (“FOLFIRI”) and bevacizumab for the second-line treatment of patients with Rat Sarcoma (“RAS”)-mutant, microsatellite stable (“MSS”) metastatic colorectal cancer. REO 033 builds upon the previously reported REO 022 study, which more than doubled historical standard-of-care benchmarks across progression-free survival, overall survival, duration of response, and objective response rate.1 -4 Based on these data, pelareorep has received Fast Track designation from the U.S. Food and Drug Administration (“FDA”) for this indication.
Oncolytics Biotech® Secures New U.S. Patent Protecting Commercial Manufacturing of Pelareorep into 2044
Intellectual property update confirms pelareorep's unique manufacturing process and scalability Previously filed method-of-use patent application expected to provide protection into 2046 Additional patent filings planned in 2026 to further expand the pelareorep intellectual property estate SAN DIEGO, June 16, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage company developing pelareorep, an investigational, systemically active immunotherapy that promotes potentially protective immune responses, including the upregulation of key inflammatory cytokines resulting in the formation of tertiary lymphoid structures and the expansion of tumor-infiltrating lymphocytes, today announced that the United States Patent and Trademark Office (“USPTO”) has issued a new patent broadly protecting the Company's proprietary manufacturing process for pelareorep. The newly issued patent covers key aspects of the methods used to manufacture pelareorep and is expected to provide intellectual property protection into 2044.
