Oncolytics Biotech Inc. (ONCY), a clinical-stage immunotherapy company, on Monday announced that it has scheduled a Type C meeting with the U.S. Food and Drug Administration FDA on April 16, 2026, to discuss a potential registrational development path for its lead investigational candidate, Pelareorep, in anal cancer.
Pelareorep is an intravenously delivered double-stranded RNA immunotherapeutic agent designed for cancer indications.
The meeting will focus on the potential to initiate a single-arm pivotal study evaluating Pelareorep in combination with a checkpoint inhibitor in patients receiving second-line and later therapy for squamous cell anal carcinoma, meaning that all enrolled patients would have no approved alternative therapies available at this stage of treatment.
Oncolytics intends to discuss a study design enrolling approximately 60 to 70 patients with an objective response rate as the primary endpoint.
Earlier in Cohort 4 of the GOBLET study, the combination achieved approximately 30% ORR, with a median duration of response of 17 months in late-line patients.
"We believe this upcoming FDA meeting is a critical step in advancing pelareorep toward a potential registration pathway in anal cancer," said Jared Kelly, Chief Executive Officer of Oncolytics.
Pelareorep has demonstrated encouraging results in first-line pancreatic cancer studies, two randomised Phase 2 studies in metastatic breast cancer, and early-phase studies in anal and colorectal cancer.
Squamous cell anal carcinoma is a rare cancer, and the World Health Organisation estimates that there are approximately 54,000 cases of anal cancer globally each year, and the anal cancer market is expected to double to $2.3 billion from 2025 to 2035.
ONCY has traded between $0.33 and $1.51 in the last year. The stock closed Thursday's trade at $0.96.
ONCY is currently trading at $0.97,up 1.33%.
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