Oncolytics Biotech Inc (ONCY) News & EventsONCYOncolytics Biotech Inc

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

Oncolytics announced that the 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 who have progressed on or were intolerant to one or more prior lines of systemic therapy.

Oncolytics Provides Update on REO 033 Clinical Progress

Oncolytics 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 and bevacizumab for the second-line treatment of patients with Rat Sarcoma-mutant, microsatellite stable 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. Based on these data, pelareorep has received Fast Track designation from the FDA for this indication. The multi-part randomized REO 033 study is designed to prospectively validate these encouraging findings against a contemporary control arm while advancing pelareorep toward a potential registration pathway. The company continues to make operational progress in Part A of REO 033, with approximately half of the planned clinical sites activated by the end of July, and more than 20 patients have been pre-identified across participating centers. The remaining sites are expected to be activated by the end of August, positioning the study for accelerated enrollment during the second half of 2026. Most recently, global lead principal investigator Sanjay Goel and his team opened enrollment at Rutgers Cancer Institute of New Jersey. The company also announced that it will hold a Type D meeting with the FDA in the first half of August to discuss the registrational design for REO 033 through the addition of Part B of the study. Building on the currently enrolling Part A of the study, this new registration-directed Part B would preserve the core design elements of REO 033 while increasing enrollment and incorporating blinded independent central review to support both a potential accelerated approval and a traditional full approval within the same study. The company intends to align with the FDA on a registrational pathway that preserves the operational efficiencies already established through REO 033 while maintaining continuity with the existing clinical program under a prospectively agreed regulatory framework. The company believes this approach provides the opportunity to generate early randomized efficacy data from Part A while simultaneously positioning Part B as a potential registrational study without the need to initiate a separate registrational trial. It also expects to report an initial tumor response update from patients enrolled in Part A by year-end 2026 and, subject to FDA feedback, initiate enrollment in Part B of the study during the first quarter of 2027.

Oncolytics Appoints Steve Glover to Board, Promotes John McAdory to COO

Oncolytics (ONCY) announced the appointment of Steve Glover to its board of directors and the promotion of John McAdory to COO. Additionally, McAdory has been promoted to COO. As COO, he will oversee the company's clinical operations and development activities, preclinical research and development efforts, and will play a key role in strategic partnerships and broader business development initiatives. McAdory joined Oncolytics earlier this year after serving as VP of Clinical Operations at CG Oncology (CGON).