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Oncolytics’ (ONCYF) End of Phase II Meeting

09/20/2017
By John Vandermosten, CFA

OTC:ONCYF
TSX:ONC.V

Oncolytics Biotech (OTC:ONCYF) (TSX:ONC.TO) announced a successful end of Phase II meeting with the FDA in a September 18 press release.  The purpose of the broadly promulgated meeting was to discuss the path forward for REOLYSIN in combination with paclitaxel, for the treatment of hormone receptor positive, HER2 receptor negative (HR+/HER2-) metastatic breast cancer.  The focus of the meeting centered on the proposed design of a Phase III registrational trial that is expected to launch in mid-2018.  

Based on the feedback from the meeting, there are several takeaways of the trial design, which we list below:

➢ Target population will be hormone receptor positive, HER2 receptor negative (HR+/HER2-) metastatic breast cancer (mBC) patients
o This group comprises 73% of mBC cases that have limited treatment options that offer survival benefit
o This patient group showed evidence of extending survival from 10.8 months to 21.0 months using REOLYSIN
➢ Trial size is expected to include 400 patients based on statistical analyses
➢ Primary endpoint for trial will be Overall Survival (OS)

At this early stage, based on company commentary, our broad estimate for enrollment duration will be from 18 to 24 months; however, it is still not clear how many sites will be established which will impact how rapidly enrollment will take place.  The duration of treatment measurement remains 18 months, as this provides sufficient time for the Kaplan-Meier curves to separate.  Oncolytics will be in discussions with European regulatory authorities, key opinion leaders, clinical experts and potential partners to continue to refine trial design details.  

Importantly, we highlight that this meeting with the FDA was not intended to determine whether or not Oncolytics will qualify for Breakthrough Therapy Designation (BTD).  As a reminder BTD is intended to provide closer collaboration with the FDA and shorten the development process for drugs that show signs of extraordinary benefit at early stages of the clinical development process.  On this front, the next steps for Oncolytics are for the company to review their notes from the end of Phase II meeting and then request approval for BTD.  Following the request, the FDA has 60 days to respond.  If, as anticipated, Oncolytics makes the request in the next several weeks, we should see a response in the fourth quarter.  

Key Milestones

➢ End of Phase II Meeting with the FDA (completed)
➢ MUK Eleven study first patient treated (September 2017)
➢ File for BTD with FDA (September/October 2017)
➢ Final analysis of REO 024 (REOLYSIN with Pembrolizumab) for pancreatic cancer
➢ Pursue collaboration for Phase III trial for metastatic breast cancer
➢ Launch Phase III trial for HR+/HER2- mBC (mid-2018)

Summary


Oncolytics continues to achieve its announced milestones and has provided additional detail on the design of its Phase III trial which we expect will launch in mid-2018.  We anticipate that the company will file in the next few weeks for BTD, which along with the guidance from the FDA in the end of Phase II meeting will provide a clear path forward that should attract additional interest from potential collaborators.  Based on the company’s financial position with sufficient cash on the balance sheet to begin its Phase III trial, compelling data and clarity from the FDA, Oncolytics is in a strong negotiating position with potential partners who may seek to develop REOLYSIN outside of North America.

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