FDA Gives Oncolytics Nod on Metastatic Breast Cancer Trial Framework

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Thursday, May 10, 2018

Heading into Thursday, Oncolytics Biotech (TSX:ONC)(OTCQX:ONCYF) was having a good week, trading ahead almost 9 percent to close Wednesday at 74 cents. The increase in value added to a gain of 8 percent in the week prior. In early Thursday trading, shares are climbing even higher following news that an agreement was reached with the the U.S. Food and Drug Administration for a late-stage study of the company's metastatic breast cancer treatment.
Under what is known as a Special Protocol Assessment, or SPA, Oncolytics and the FDA agreed upon the trial's design, endpoints and statistical analysis for a Phase 3 study of Reolysin (pelareorep) for the indication. A SPA is a bit of a comfort blanket, letting a biotech know that the FDA won't have an issue with a pivotal trial's design should the company subsequently file a new drug application seeking marketing approval.
Oncolytics is developing Reolysin, a proprietary isolate of the unmodified reovirus, for metastatic breast cancer under a FDA "Fast Track" designation received last May. The immunotherapy works by inducing selective tumor lysis and promoting an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of solid and liquid cancers. Reolysin only replicates in cancer cells - it is unable to do so in healthy cells for a number or reasons - causing the release of inflammatory cytokines, triggering the immune system to unleash natural killer cell and T-cells in the tumor microenvironment, eliciting cancer cell death.
With the SPA agreement in tow, the Calgary-based company can finalize the work to advance Reolysin into the Phase 3 study.
Shares of Toronto-listed ONC have shot ahead 8.1% to 80 cents just after Thursday's opening bell. U.S.-listed shares of ONCYF are doing even a bit better, up 12.3% at 64 cents ten minutes into the trading session.

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