Oncolytics Biotech Inc. (ONCY)

[justthefactsmam]

from 20-f recently released:

https://www.sec.gov/Archives/edgar/data/1129928/000112992817000003/ex151-2016mda.htm

Path #1 - Direct Tumour Lysis
Our first clinical development path focuses on direct tumour lysis and is based on the clinical data from our randomized chemotherapy combination trials. We have demonstrated a strong trend showing a two-year survival benefit in patients with pancreatic cancer in two clinical studies and are planning to take advantage of this survival data and existing orphan drug designations to seek regulatory advice in the U.S. and Europe to establish a clear path to registration in pancreatic cancer.

Path #2 - Innate Immune Response
The second path involves the combination of immune modulatory drugs (IMiDs) with REOLYSIN to enhance the innate immune response against the tumor. We expect to be able to announce collaborations in this path in the second quarter of 2017 that combine REOLYSIN with IMiDS and investigate whether the addition of REOLYSIN can enhance the benefit of this class of agents.

Path #3 - Adaptive Immune Response
Our third clinical development path focuses on the adaptive immune response, a long-term, durable and learned response. This creates a vaccination-like response that, through lysis of the tumor by the virus, educates the body’s immune cells to target and attack unique cancer antigens. We believe that REOLYSIN in combination with checkpoint inhibitors - immunological agents that enhance the adaptive immune response - will act synergistically to provide enhanced overall survival to patients. Early in 2016, we announced that the first patients had been treated in our Phase 1b study of pembrolizumab (KEYTRUDA®) in combination with REOLYSIN and chemotherapy in patients with advanced pancreatic adenocarcinoma. This study is enrolling 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 1b 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.

Our focus will be to work towards product registration via the first path of the clinical development plan. The objectives of paths two and three are to enhance the exposure of REOLYSIN to leading pharmaceutical companies working in immuno-oncology and enhance the market opportunities for our agent; that process is underway.

https://www.sec.gov/Archives/edgar/data/1129928/000112992817000003/ex442thompson.htm