Oncolytics Biotech, Inc. (USA) (NASDAQ:ONCY) announced that, following submission to the U.S. Food and Drug Administration (“FDA”) for review, the Investigational New Drug Application containing the protocol titled “A Phase Ib study of pembrolizumab (KEYTRUDA®) in combination with REOLYSIN® (pelareorep) and chemotherapy in patients with advanced pancreatic adenocarcinoma” is now active.

“This is the first study examining the effects of REOLYSIN® in combination with a checkpoint inhibitor in human patients,” said Dr. Brad Thompson, President and CEO of Oncolytics. “It builds on our previous clinical work in pancreatic cancer as well as findings from multiple clinical and preclinical studies indicating that REOLYSIN® can upregulate PD-1 and PD-L1.”

The study will enroll patients 18 years or older with histologically confirmed advanced or metastatic pancreatic adenocarcinoma who have failed, or did not tolerate, first line treatment. It is an open-label Phase Ib trial designed to determine the safety and dose-limiting toxicities of REOLYSIN® and chemotherapy (gemcitabine or irinotecan or fluorouracil, at the treating physician’s preference) in combination with pembrolizumab. Secondary endpoints include overall response rate and progression free survival by immune-related response criteria; overall survival; and effects of REOLYSIN® and pembrolizumab when administered in combination as determined by analysis of pre- and post-treatment treatment biopsies and blood based immune markers. Following an initial six to nine patient safety run-in, up to an additional 15 patients may be enrolled for further evaluation of safety and efficacy.

Oncolytics has previously conducted other clinical studies in pancreatic cancer. Mostly notably, in July 2015, the Company reported final data from a Phase 2 single-arm clinical trial using intravenous administration of REOLYSIN® in combination with gemcitabine (Gemzar®) in chemotherapy-naïve patients with advanced or metastatic pancreatic cancer (REO 017). The reported data suggested that this drug combination, when compared to gemcitabine alone (as seen in historical data), can increase median overall survival, as well as generate an approximate two-fold increase in one-year survival rates, and a five-fold increase in two-year survival rates.  The Company has received Orphan Drug Designation from the FDA and the European Medicines Agency for the use of REOLYSIN® in the treatment of pancreatic cancer. (Original Source)

Shares of Oncolytics Biotech closed yesterday at $0.44. ONCY has a 1-year high of $1.40 and a 1-year low of $0.40. The stock’s 50-day moving average is $0.52 and its 200-day moving average is $0.61.

Oncolytics Biotech Inc is a development stage biopharmaceutical company. It is engaged in the discovery and development of pharmaceutical products for the treatment of cancer.