On August 6, 2015 Oncolytics Biotech Inc. (TSX:ONC, NASDAQ:ONCY) ("Oncolytics" or the "Company") reported its financial results and operational highlights for the second quarter ended June 30, 2015 (Press release, Oncolytics Biotech, AUG 6, 2015, View Source [SID:1234507069]).
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"Subsequent to quarter end we announced compelling overall, one- and two-year survival data from the REO 017 study in patients with advanced pancreatic cancer treated with gemcitabine and REOLYSIN," said Dr. Brad Thompson, President and CEO of Oncolytics. "During the quarter we also added to our growing body of evidence that REOLYSIN contributes to the upregulation of PD-1 and PD-L1 and so may play a role in immunotherapeutic treatment of cancer."
Selected Highlights
Since April 1, 2015, selected highlights announced by the Company include:
Clinical Program
Presentation of final data from a single arm clinical study examining the use of REOLYSIN in combination with gemcitabine in patients with advanced pancreatic cancer (REO 017), which showed an increase in median overall survival, as well as an approximate two-fold increase in one-year survival rates, and a five-fold increase in two-year survival rates when compared to gemcitabine therapy alone as seen in historical data;
An update on the planned registration program for REOLYSIN including an initial focus on two indications: the neoadjuvant treatment of muscle-invasive bladder cancer and the treatment of glioblastoma;
Activation of an Investigational New Drug Application containing the protocol titled "MC1472: Phase 1 Study of Replication Competent Reovirus (REOLYSIN) in Combination with GM-CSF in Pediatric Patients with Relapsed or Refractory Brain Tumors";
Presentation of data showing up regulation of PD-1 and PD-L1 from a single arm clinical study examining the use of REOLYSIN in patients with primary glioblastomas or brain metastases (REO 013b) at the Royal Society of Medicine’s Immuno-oncology: Using the Body’s Own Weapons conference, held in London, UK;
Regulatory
Granting of Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for REOLYSIN in the treatment of gastric cancer and malignant gliomas;
Granting of Orphan Drug Designation by the European Medicines Agency for REOLYSIN in the treatment of pancreatic cancer;
Basic Research
Presentation of preclinical data at the 9th International Conference on Oncolytic Virus Therapeutics in Boston, MA, including findings around REOLYSIN’s mechanism of action and its potential in new indications including chronic lymphocytic leukemia;
Presentation of clinical and preclinical data at the 2015 Immune Checkpoint Inhibitors meeting in Boston, MA, including content showing the combination of REOLYSIN, GM-CSF, anti-PD-1 and anti-CTLA-4 improved survival in immune competent mice versus REOLYSIN and GM-CSF alone, and REOLYSIN and GM-CSF plus either one of the checkpoint inhibitors alone;
A series of presentations made by the Company’s research collaborators at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting held in Philadelphia, PA covering preclinical research in a range of indications, with a variety of treatment combinations including REOLYSIN;
Corporate
Linda Hohol resigned from the Board of Directors of the Company effective August 5, 2015. Ms. Hohol has served as a Director since June 2014; and
Financial
At June 30, 2015 the Company reported $32.1 million in cash, cash equivalents and short-term investments. At August 5, 2015, the Company had approximately $31.6 million in cash, cash equivalents and short-term investments.