India, April 27 -- 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 inhi...