Oncolytics Biotech Inc. announced a strategic update, emphasizing its compelling clinical data and a sharpened focus on advancing pelareorep into registration-enabling studies. The company stated it is no longer funding proof-of-concept studies, but rather moving directly into pivotal trials based on meaningful clinical data. This strategic shift aims to leverage pelareorep's Fast Track designations for an efficient regulatory path.
The company highlighted strong and consistent efficacy signals in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC), with pooled data from over 100 patients across two studies showing rare 2-year overall survival rates of 21.9% compared to a 9.2% historical benchmark. A single-arm study also observed a 62% objective response rate with pelareorep in combination with chemotherapy and a checkpoint inhibitor, more than double historical results.
In HR+/HER2- metastatic breast cancer, pelareorep demonstrated a median overall survival benefit of greater than 10 months compared to standard-of-care chemotherapy in two randomized Phase 2 studies. The BRACELET-1 study showed a 12.1-month median progression-free survival versus 6.4 months in the control arm. Data from over 1,100 patients across tumor types also affirm pelareorep's favorable and well-understood safety profile, with common adverse events being transient flu-like symptoms.
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