ONCY News & Events

Oncolytics announced it has scheduled a Type C meeting with the FDA on April 16, to discuss a potential registrational development path for pelareorep in anal cancer. "We believe this upcoming FDA meeting is a critical step in advancing pelareorep toward a potential registration pathway in anal cancer. Our goal is to align with the FDA on the statistical analysis plan and sample size for a potential pivotal single-arm study in second-line and later SCAC," said Jared Kelly, CEO of Oncolytics Biotech. The meeting will focus on the potential to initiate a single-arm pivotal study evaluating pelareorep in combination with a checkpoint inhibitor in patients being treated with second-line and later therapy for squamous cell anal carcinoma. The company intends to discuss a study design enrolling approximately 60 to 70 patients with objective response rate as the primary endpoint to support a potential full approval.

Oncolytics announced the completion of the previously announced change in the jurisdiction of incorporation of Oncolytics from the Province of Alberta in Canada to the State of Nevada in the United States through a series of transactions in which the company first continued its existence from the Province of Alberta in Canada to the Province of British Columbia in Canada on March 17. The company will retain its office in Calgary, while the San Diego office will become the Company's new headquarters. The domestication was approved by the company's shareholders at the special meeting of shareholders held on January 15.

Oncolytics files $250M mixed securities shelf