Oncolytics Biotech (ONCY) H.C. Wainwright 26th Annual Global Investment Conference 2024 summary

Lead candidate and mechanism of action

• Pelareorep (pela) is a naturally occurring, intravenously delivered oncolytic virus in late-stage oncology development.

• Pela targets and kills cancer cells while sparing healthy cells, inducing both innate and adaptive immune responses and altering the tumor microenvironment.

• IV administration enables targeting of both primary and metastatic disease, offering a commercial advantage over intratumoral approaches.

• Pela's mechanism draws T-cells to the tumor site, enhancing immune-mediated cancer cell destruction.

Clinical development and data highlights

• Statistically significant survival data observed in breast and pancreatic cancer led to the initiation of BRACELET-1 and GOBLET studies.

• BRACELET-1 phase II in HR-positive, HER2-negative metastatic breast cancer is nearing overall survival data readout, expected imminently.

• GOBLET platform study in pancreatic cancer showed strong response rates, especially with the addition of atezolizumab.

• A new cohort using modified FOLFIRINOX in pancreatic cancer began this year, with safety data expected late this year or early next.

Regulatory and approval pathways

• FDA meetings in 2023 and May 2024 confirmed the phase II design and patient population for breast cancer, supporting a path to accelerated approval if endpoints are met.

• The FDA accepted PFS as a primary endpoint and OS as a secondary endpoint for the breast cancer program.

• For pancreatic cancer, collaboration with GCAR aims to use an adaptive phase III design with standard of care plus pela and tislelizumab, targeting full approval.

• Submission to the FDA for the pancreatic cancer program is planned for Q4 this year or early next year.