Oncolytics Biotech Inc. released two poster presentations recently to the European Society for Medical Oncology 2017 Congress on the development of Reolysin, an immune-oncolytic virus that activates the innate and adaptive immune systems.
Reolysin is a non-pathogenic, proprietary isolate of the unmodified reovirus for the treatment of solid tumours and hematological malignancies. The compound induces selective tumour lysis and promotes an inflamed tumour phenotype through innate and adaptive immune responses to treat a variety of cancers.
The first poster pooled data that analyzed the safety and tolerability of intravenous Pelareorep in combination with chemotherapy in over five hundred patients. The significant information gathered from the safety pooled data included adverse events by Reolysin treated patients were reversible in grade I/II, and that Reolysin did not modify or increase chemotherapy adverse events in grade III/IV. The data did point out that certain treatment-emergent adverse events (TEAEs) were more common in the Reolysin-treated arms, however the incidences of serious TEAEs due to febrile neutropenia and/or infection were similar in each group.
“Our poster on pooled data outlines the largest safety database available to date for on oncolytic virus and demonstrates that Reolysin is safe and well tolerated when administered in combination with chemotherapy,” said Dr. Matt Coffey, president and CEO of Oncolytics Biotech.
In the IND 213 randomized phase II study in metastatic breast cancer, conducted by the Canadian Cancer Trials Group, patients indicated that the test arm of Reolysin/paxlitaxel more than doubled median overall survival from 10.8 months on the control arm to 21.8 months from just paxlitaxel alone. The intent-to-treat group (ITT) and genetic subtypes improved overall survival from 10.4 months on the control arm to 17.4 months on the test arm.
“Regarding the metastatic breast cancer data presented within this pooled safety data, further analysis of our phase II study highlights a doubling of overall survival benefit for patients with hormone receptor double-positive, HER2-negative breast cancer – a major genetic subgroup – when treated with Reolysin/paclitaxel combination treatment versus paclitaxel alone,” stated Coffey. “The poster demonstrates a strong safety profile and statistically significant efficacy as we continue to advance towards regulatory approval for Reolysin in this indication.”
The United States Food and Drug Administration (FDA) recently granted Oncolytics a fast track designation after their meeting addressing registration pathways for Reolysin in the treatment of metastatic breast cancer.
The second poster highlighted the mechanism of pelareorep-mediated cell death with the combination of Reolysin and irinotecan/fluorouracial/leucovorin/bevacizumab (FOLFIRI/B) in patients with KRAS mutant metastatic colorectal cancer.
The study showed that Reolysin compromises cancer cell integrity and is safe and tolerated in combination with FOLFIRI/B.