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ONCYF: REOLYSIN Clinical Development Plan

By John Vandermosten, CFA


On April 12, 2017, Oncolytics Biotech, Inc. (OTC:ONCYF) provided an outline of their path forward for developing REOLYSIN, their proprietary oncolytic virus used in the treatment of several cancers.  The company’s primary goal is to obtain regulatory approval for REOLYSIN in metastatic breast cancer based on the data presented at the American Academy of Cancer Research (AACR) Annual Meeting in early April.  Oncolytics will also develop REOLYSIN for other indications and in combination with other agents, such as checkpoint inhibitors and immunomodulatory imide drugs (IMiDs).

REOLYSIN is currently being used in an open-label, Phase Ib trial in combination with checkpoint inhibitor, pembrolizumab (Keytruda).  This study (REO 024) is a dose-limiting toxicity study in patients with advanced metastatic pancreatic adenocarcinoma who failed first line treatment.  Safety data from this trial is expected in 2017.  

REOLYSIN is also being used in conjunction with Celgene’s (NASDAQ: CELG) IMiDs: pomalidomide (Imnovid) and lenalidomide (Revlimid).  This is being done in the MUK eleven clinical trial which was launched March 2017.  The dose escalation trial will be used as a rescue treatment in relapsing myeloma patients and will recruit 44 participants in the United Kingdom.  

In the recent Phase II trial (IND 213) presentation at AACR, the Canadian Cancer Trials Group presented overall survival data for patients on REOLYSIN and paclitaxel vs. paclitaxel alone for metastatic breast cancer.  As a reminder, the trial results showed that there was a statistically significant improvement in median OS from 10.4 months on the control arm to 17.4 months on the test arm at a p-value of 10%.  Efficacy was even greater in the p53 subset of patients.  This subgroup of mutated p53 tumors made up 82% of the trial population and had a median OS of 20.9 months versus 10.4 months in patients treated only with paclitaxel.  P-value for this group was 3%.  

Oncolytics will present this data to regulators to obtain advice and support for a regulatory pathway.  The subsequent trial is expected to employ overall survival as a primary endpoint and seek other exploratory endpoints that will identify important surrogate markers.  Fast track and accelerated approval may be possible; however, our valuation target does not rely on this eventuality.

Please refer to our initiation for an in-depth explanation of REOLYSIN’s mechanism of action.  

Several pillars support our favorable view of Oncolytics, including statistically significant results that show a seven month or greater benefit from the use of REOLYSIN combination therapy in metastatic breast cancer, and an indication that can address a large population with an unmet need.  A strong pipeline with other cancer indications is also a plus as is a favorable environment for biologics exclusivity and low manufacturing costs compared to others in the class.  


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