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Oncolytics Biotech(R) Announces Preliminary AWARE-1 Trial Data Demonstrating Viral Replication and Promotion of Inflammation Following Systemic Administration of Pelareorep When Combined with Tecentriq(R)
Favorable Steering Committee Recommendation for AWARE-1 Early data indicate...
About this update from Oncolytics Biotech Inc.
[{"type":"text","content":"\nOncolytics Biotech(R) Announces Preliminary AWARE-1 Trial Data Demonstrating Viral Replication and Promotion of Inflammation Following Systemic Administration of Pelareorep When Combined with Tecentriq(R)Favorable Steering Committee Recommendation for AWARE-1Early data indicate that T cell clonality may support the development of a biomarker in breast cancerSAN DIEGO, CA and CALGARY, AB / ACCESSWIRE / July 23, 2019 / Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, today announced completion of the three patient run-in for the AWARE-1 study in early-stage breast cancer combining pelareorep and Tecentriq® (atezolizumab). All three patients demonstrated immunohistochemically positive viral replication in the tumor mass - two of the three patients showed greater than 50% of the tumor cells infected - following intravenous administration, generating inflammation and T cell recruitment at the tumor site. Increases in PD-L1 expression on tumor cells were noted in all patients, and early data suggest a correlation between T cell clonality and viral replication with highly infected tumors. Importantly, no additional side effects were observed with the combination of pelareorep and atezolizumab beyond those observed for each agent individually.“Data from the Tecentriq safety run-in support our hypothesis that pelareorep can enhance tumor inflammation not only in HR+/HER2- patients but also in triple-negative breast cancer patients, and we are pleased with the favorable recommendation from the Steering Committee to advance into the next phase of the AWARE-1 study,” said Rita Laeufle, Chief Medical Officer of Oncolytics Biotech. “Importantly, our previously identified biomarker of higher peripheral T cell clonality appears to correlate with patients having the most productive viral infection. As the study continues, we expect data will provide further evidence of the role of pelareorep enhancing the inflammatory process and synergizing with checkpoint blockade.”“These observations are supportive of our previous findings of improved survival in metastatic breast cancer patients which will allow us to further refine our phase three registration study,” said Dr. Matt Coffey, President, and CEO of Oncolyt...