Oncolytics Biotech Inc. (ONCY), a clinical-stage immunotherapy company, announced that a Type C meeting with the U.S. Food and Drug Administration has resulted in alignment on the design of a pivotal clinical study of Pelareorep in patients with unresectable metastatic squamous cell carcinoma of the anal canal or SCAC.
Pelareorep is an investigational intravenously delivered double-stranded RNA immunotherapeutic agent. Oncolytics is advancing Pelareorep in combination with chemotherapy and/or checkpoint inhibitors in metastatic gastrointestinal cancers.
Notably, Pelareorep has received Fast Track designation from the FDA for colorectal and pancreatic cancer.
In a recent study combining Pelareorep with a checkpoint inhibitor in second-line and later SCAC, the combination achieved a median duration of response of 15.5 months versus 9.5 months, and 12-month survival of 82% versus 45.7%, each measured against the current standard of care.
The company plans to leverage the durability and survival data in second-line and later metastatic squamous cell anal carcinoma and to incorporate FDA feedback into the final protocol, which is expected to be a single, randomised controlled trial.
SCAC is a rare gastrointestinal malignancy affecting more than 10,000 patients annually in the United States.
ONCY has traded between $0.33 and $1.51 over the last year. The stock closed Friday's trade at $1.03.
ONCY is currently up 5.39% at $1.07.
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