Oncolytics reports HPV immune activity data for pelareorep in anal cancer

Oncolytics Biotech announced on November 4, 2026 new translational findings from an ongoing study of pelareorep in second-line or later squamous cell anal cancer (SCAC), presented at the Society for Immunotherapy of Cancer 2026 Annual Meeting. The data show pelareorep's ability to increase human papillomavirus-16-specific T cell clones and tumor-infiltrating lymphocyte clones in this patient population.¹

The company said when pelareorep was combined with a checkpoint inhibitor, the combination showed efficacy signals including a more than doubled objective response rate and a 50% longer median duration of response relative to the currently approved therapy for this group.¹

Specific biomarker results included: in seven of eight evaluable patients, immune-activation markers CXCL10, IFN-γ, and soluble PD-L1 more than doubled after one treatment cycle.¹ After three cycles, all four evaluable patients showed expansion of TIL clones in peripheral blood, correlating with tumor shrinkage, including two complete and two partial responses.¹ Those four responding patients also showed meaningful growth of at least one HPV-16-specific T cell clone.¹ Among 14 patients assessed for HPV-16-specific immune activity, six had clonal expansion, and four of those six saw their tumors shrink.¹

The trial is a Phase 1/2, Simon 2-stage study evaluating pelareorep plus a checkpoint inhibitor in unresectable second-line or later SCAC.¹

Oncolytics CEO Jared Kelly said the company views HPV-related cancers, including anal, oropharyngeal, and cervical cancer, as a potential business development opportunity worth an estimated $3 to 5 billion based on the company's internal projections.¹ Pelareorep has also received FDA Fast Track designation for colorectal, anal, and pancreatic cancer indications.¹ Oncolytics said it is pursuing strategic partnerships to advance pelareorep's development.¹