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Oncolytics Biotech Receives FDA Fast Track Designation for Pelareorep in Anal Cancer


First-in-Class Immunotherapy Platform –Pelareorep is an investigational, first-in-class intravenous dsRNA immunotherapeutic agent with a safety profile demonstrated across more than 1,300 patients to date, and it holds FDA Fast Track Designation for advanced pancreatic cancer and second-line and later anal cancer.
Validated Pharmaceutical Partnerships – Roche supplies its checkpoint inhibitor atezolizumab for use in Oncolytics-sponsored studies, and the company also collaborates with Pfizer, Merck Serono, Incyte, and Adlai Nortye to evaluate pelareorep in combination with their therapies.
Strong Early Data Across Three GI Cancers – In metastatic pancreatic cancer, pelareorep combined with chemotherapy and atezolizumab produced a 45% one-year survival rate and a 62% objective response rate in the GOBLET Cohort 1 study. In KRAS-mutant, microsatellite-stable metastatic colorectal cancer, the REO 022 trial reported a median overall survival of 27 months versus 11.2 months for standard treatment. In anal cancer, pelareorep combined with atezolizumab produced objective response rates of roughly 29 to 30 percent, compared with 13.8% for the only FDA-approved immunotherapy in that setting.
Extended Patent Protection to 2044– A new U.S. patent secured in June 2026 extends commercial manufacturing protection for pelareorep to 2044, part of a portfolio of 137 patents including 11 U.S. and 7 Canadian patents. The company also filed a $250 million mixed securities shelf registration in April 2026 to help fund ongoing clinical development.
New Leadership and Corporate Redomestication– Oncolytics completed a corporate domestication from Alberta, Canada to Nevada, USA in April 2026 and relocated its headquarters to San Diego, California, while retaining an office in Calgary. New leadership includes CEO Jared Kelly, and the company recently strengthened its team with the June 2026 promotion of John McAdory to Chief Operating Officer and the addition of board member Steve Glover, who previously chaired Ambrx Biopharma through its roughly $2 billion acquisition by Johnson & Johnson.
Oncolytics Biotech Inc.


Platform Immunotherapy for Gastrointestinal Cancers


Operational Momentum and Scaling


Positioning for Long-Term Growth




Jared Kelly
Chief Executive Officer & Director
Jared Kelly serves as Chief Executive Officer and Director of Oncolytics Biotech Inc., leading the company's strategic focus on pelareorep, its investigational platform immunotherapy for gastrointestinal cancers. Under his leadership, Oncolytics has advanced pelareorep through partner sponsored and academic collaborations, secured Fast Track Designation from the FDA for two indications, completed the company's corporate domestication from Alberta, Canada to Nevada, USA, and relocated its headquarters to San Diego, California. He oversees the company's clinical development partnerships with organizations including Roche, Pfizer, Merck Serono, Incyte, and Adlai Nortye, as well as its capital markets strategy as a clinical stage biopharmaceutical company.


Kirk Look, CA, MSJ
Chief Financial Officer
Kirk Look serves as Chief Financial Officer of Oncolytics Biotech Inc. He oversees the company's financial operations as a clinical stage biopharmaceutical company funding its trials through equity and other securities offerings, including the company's $250 million mixed securities shelf registration filed with the SEC in April 2026. He works closely with the company's auditor, Ernst & Young LLP, and supports the finance and reporting functions tied to the company's SEC filings, including its 10-Q and 10-K disclosures.
During his tenure, Oncolytics has strengthened its balance sheet through capital markets activity, advanced pelareorep across three gastrointestinal cancer indications in partnership with Roche, Pfizer, Merck Serono, Incyte, and Adlai Nortye, and supported the company's transition to its new Nevada domicile and San Diego headquarters.


Thomas C. Heineman, MD, PhD
Chief Medical Officer
Thomas C. Heineman, MD, PhD serves as Chief Medical Officer of Oncolytics Biotech Inc. He leads the clinical development strategy for pelareorep, the company's investigational dsRNA immunotherapeutic, across its three target gastrointestinal cancer indications: metastatic pancreatic ductal adenocarcinoma, KRAS mutant microsatellite stable metastatic colorectal cancer, and unresectable squamous cell anal carcinoma. He works closely with the company's academic and institutional collaborators, including Mayo Clinic, Duke University, and the Rutgers Cancer Institute of New Jersey, and supports the company's regulatory interactions with the FDA, including its Fast Track Designations and its pursuit of a Type C meeting to discuss an accelerated approval pathway.
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Sources
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