Oncolytics Biotech disclosed that 4 of 14 evaluable third‑line squamous cell anal carcinoma patients achieved objective responses, giving a 29% objective response rate, a marked improvement over the historically <10% rate in this heavily pre‑treated population.
The cohort’s median duration of response was 17 months, with two complete responses and two partial responses, underscoring the durability of the benefit. This data was presented in a release issued on January 12, 2026, and represents a new milestone for the company’s pelareorep platform.
The results support Oncolytics’ strategy to pursue accelerated approval in an indication with no FDA‑approved therapies, potentially opening a new revenue stream. The company will discuss the data with the FDA in a Type C meeting scheduled for Q1 2026, a key regulatory step toward approval.
Oncolytics is a clinical‑stage biotech with no current revenue and a net loss of $31.7 million for 2024. Cash on hand was $15.942 million as of December 31 2024, providing runway through Q3 2025. The clinical milestone therefore carries significant importance for the company’s financial outlook and future funding needs.
CEO Jared Kelly said, “When you isolate to anal cancer patients with two prior lines of treatment and see a strong signal like this, it points the arrow in a direct line to a registration study in an indication where there are no FDA‑approved therapies.” The comment highlights the strategic focus on translating the data into a registration program that could secure the first‑to‑market position in this niche.
Pelareorep has Fast Track designation for metastatic pancreatic and breast cancer, and the GOBLET study is part of a broader Phase 1/2 program evaluating the agent in combination with checkpoint inhibitors across gastrointestinal cancers. The third‑line anal cancer data adds to the growing evidence of the platform’s systemic activity and its potential to convert “cold” tumors into “hot” tumors.
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