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Oncolytics Biotech® Announces Key Progress and Upcoming Studies for Breast and Pancreatic Cancer Treatments, Prepares for FDA Accelerated Approval Path
Recent clinical efficacy results from the BRACELET-1 trial in HR+/HER2- breast cancer pave the way for a clinical study designed to support an accelerated
About this update from Oncolytics Biotech Inc.
[{"type":"text","content":"Recent clinical efficacy results from the BRACELET-1 trial in HR+/HER2- breast cancer pave the way for a clinical study designed to support an accelerated approval\nKey milestones in gastrointestinal cancer clinical trials expected in 2025, with potential for new registration-enabling studies\nSAN DIEGO and CALGARY, AB, Oct. 4, 2024 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, is issuing a corporate update to provide investors with a deeper understanding of recent data and what is expected for 2025. \n\n \n \n \n \n \n \n\n \n\"We're excited by the recent BRACELET-1 results, which exceeded our expectations and substantiate the strong efficacy signal previously observed in breast cancer patients treated with pelareorep,\" said Wayne Pisano, Interim CEO and Chair of Oncolytics' Board of Directors. \"Having treated well over 100 HR+/HER2- metastatic breast cancer patients in multiple clinical studies, these results provide the basis for a development path leading to an accelerated approval. The BRACELET-1 results, combined with recent feedback from the FDA, give us confidence in our development approach, and we look forward to initiating a clinical trial designed to support the approval of pelareorep as a novel breast cancer therapeutic.\"\nMr. Pisano continued, \"The gastrointestinal cancer data also supports making pancreatic cancer a major priority for the company. To advance this development, we've established a collaboration with the Global Coalition for Adaptive Research (GCAR), and The Pancreatic Cancer Action Network (PanCAN) has provided us with the funding to further investigate pelareorep in pancreatic cancer through our GOBLET study. Having demonstrated pelareorep's efficacy across multiple cancer indications and with important data readouts and future studies on the horizon, I'm looking forward to these next few years of Oncolytics' growth and development.\" \nPlanned HR+/HER2- metastatic breast cancer study could open the door to an accelerated approval\nThe strong efficacy results from BRACELET-1 provide the foundation for a large Phase 2 study designed to support an accelerated approval. Early in 2025, we plan to submit to the FDA a pelareorep + paclitaxel combination therapy breast cancer trial. The study will enroll...