On May 16, 2019 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, reported the publication of an abstract highlighting additional immune-based biomarker data used to help predict patient response to pelareorep in combination with checkpoint inhibitor therapy (Press release, Oncolytics Biotech, MAY 16, 2019, View Source [SID1234536425]). The abstract was published online as part of the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in the Meeting Proceedings, an online supplement of ASCO (Free ASCO Whitepaper)’s Journal of Clinical Oncology.

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The abstract, titled, "Prediction of response to pelareorep plus pembrolizumab in pancreatic ductal adenocarcinoma (PDAC)," describes further immune analysis of the peripheral blood of patients from REO 024, a completed phase 1b study of pelareorep and Keytruda (pembrolizumab) in combination with chemotherapy in patients with advanced (second-line) pancreatic cancer. A phase 2 trial of pelareorep plus pembrolizumab in advanced PDAC is currently ongoing.

"The gene expression and cytokine data analysis, as well as TCR-sequencing, provides further insight into the immune environment prior to and during treatment with pelareorep and pembrolizumab," said Dr. Rita Laeufle, Chief Medical Officer of Oncolytics Biotech. "These additional findings further highlight pelareorep’s ability to create an inflamed phenotype, resulting in a primed immune system that we believe supports combination treatment with immune checkpoint inhibitors. It also builds on our discovery that T cell clonality can serve as a predictive and prognostic biomarker for clinical benefit when used to identify patients who may respond well to this therapeutic combination. This new biomarker data supports the potential selection of patients in future clinical studies, giving these studies a higher likelihood of success."

Key data and conclusions:

•Clonal T cell diversity was expanded during therapy, broadening the potential repertoire of T cells that can target tumor cells.
•~30% of expanded clones at day eight of pelareorep therapy were durable after one cycle of treatment suggesting a refinement of T cell clones that target the best tumor cell antigens.
•Gene expression analysis in peripheral blood mononuclear cells (PBMCs) helps to validate the changes in T cell diversity, where responding patients had higher levels of pro-inflammatory cytokines expressed by activated T cells, compared to non-responders. Importantly, there was a statistically significant upregulation of genes that aid in the recruitment and activation of T cells including IL17F, CCL7, and ICOS (raw p < 0.05).
•Gene expression analysis in PBMCs may serve as a separate and independent biomarker, and helps to corroborate our previously published blood-based T cell clonality biomarker for pelareorep therapy.

The abstract was authored by Dr. Christos Fountzilas, Assistant Professor, Dept. of Medicine – GI Medical Oncology, Roswell Park Comprehensive Cancer Center and his colleagues, in collaboration with Oncolytics Biotech, Northwestern University, UT Health San Antonio, and Adaptive Biotechnologies. The publication of the abstract can be found on the Posters & Publications page of Oncolytics’ website, View Source

About Pelareorep

Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.