Oncolytics Biotech Inc., a development-stage biopharmaceutical company, focuses on the discovery and development of pharmaceutical products for the treatment of cancer. Its lead product is pelareorep, an intravenously delivered immunotherapeutic agent for the treatment of solid tumors and hematological malignancies. Oncolytics Biotech Inc. has a co-development agreement with Merck KGaA and Pfizer Inc. to co-develop pelareorep in combination with paclitaxel and avelumab, a human anti-PD-L1 antibody for the treatment of hormone receptor-positive/human epidermal growth factor 2-negative metastatic breast cancer; and PrECOG LLC. The company was incorporated in 1998 and is headquartered in Calgary, Canada.
Oncolytics Biotech® Receives Fast Track Designation for Pelareorep in Second-Line and Later Anal Cancer
Oncolytics Biotech received Fast Track designation from the FDA for pelareorep in combination with a checkpoint inhibitor for second-line anal cancer.
The designation is supported by GOBLET study data showing a 30% objective response rate and a 12-month overall survival rate of 82%, both significantly exceeding historical rates of 9.5 months duration and 45.7% survival.
This is the third Fast Track designation for pelareorep in gastrointestinal cancers, targeting a market with an estimated $1 billion annual opportunity where no FDA-approved therapies currently exist.