ONCY News & Events

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).

Oncolytics announced initial data from a preclinical study evaluating pelareorep in combination with RAS inhibitor modalities in a solid tumor model, which demonstrate evidence of greater anti-tumor activity in combination than with the individual approaches alone. Pelareorep is an investigational, systemically active immunotherapy that promotes potentially protective immune responses, including the upregulation of key inflammatory cytokines resulting in the formation of tertiary lymphoid structures and the expansion of tumor-infiltrating lymphocytes. Based on these findings, the company is planning additional studies in models of pancreatic ductal adenocarcinoma and colorectal cancer designed to further evaluate the combinations' effects on immune activation, tumor response durability, and time-to-resistance. The ongoing work includes evaluations of pelareorep in combination with KRAS G12C inhibitors, pan-RAS inhibitors, and additional next-generation RAS pathway-targeting agents in RAS-mutated tumor models. Full results from the initial preclinical studies are expected to be presented in the fall or winter of 2026.

Oncolytics announced that a Type C meeting with the FDA has resulted in alignment on the design of a pivotal clinical study to support approval of pelareorep in patients with unresectable metastatic squamous cell carcinoma of the anal canal. "We want to thank the FDA for its very clear guidance and helping us create an efficient pathway for pelareorep in a disease that is desperate for new treatments," said Jared Kelly, Chief Executive Officer of Oncolytics. "While a single-arm study was possible in this setting, following a productive discussion with the FDA and in consideration of recent regulatory decisions regarding similar studies, we have aligned on a randomized controlled trial designed to potentially support both accelerated approval and full approval within the same study. This approach directly addresses relevant and rigorous evidentiary standards while allowing for approval based on multiple endpoint assessments." The company plans to incorporate FDA feedback into the final protocol, which is expected to be a single, randomized controlled trial for which accelerated approval and full approval could be applied at different points in time.