Oncolytics Biotech Inc., currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, provided an update on the potential impact of COVID-19 on the company's clinical and business operations. The company's clinical and regulatory teams remain active and are working closely with our investigators to identify the most appropriate steps forward for each study. There has been no impact on the continuity of the manufacturing of pelareorep, and Oncolytics is fully capable of supplying pelareorep to all ongoing clinical studies. Although it is too early to determine the absolute effects of the outbreak on specific trial timelines, it is anticipated that COVID-19 will impact clinical trial enrollment timelines to some degree.
"Certain sites have been readied for our BRACELET-1 breast cancer trial, and absent COVID-19 we would have enrolled our first patient by now," said Dr. Matt Coffey, chief executive officer at Oncolytics. "However, COVID-19 is severely impacting global healthcare systems, and all companies are seeking adaptations to maintain aggressive clinical activities. Our focus, first and foremost, is the safety of our employees and the patients in our trials. Because cancer patients participating in clinical studies are critically ill, we and regulatory bodies will strive to minimize any delays in their treatment, and the nature of our targeted patient population may mitigate long-term impact on our clinical development program, catalysts and milestones. Indeed, we remain fully committed to advancing our clinical studies, and we will seek every legitimate and reasonable measure to deliver potentially life-saving therapies to these patients."
"The resilience and dedication of our own clinical team and our collaborators is inspiring," said Dr. Rita Laeufle, chief medical officer at Oncolytics. "We now have all twenty clinical trial sites selected for BRACELET-1, and we are expanding the number of clinical trial sites for our AWARE-1 trial. At this time, we do not expect significant enrollment delays overall and plan to have data from AWARE-1 presented at the 2020 ESMO Breast Cancer Congress, and multiple myeloma and pancreatic cancer data presented at the ASCO conference, as planned."
Oncolytics has adopted the FDA guidance issued for the COVID-19 pandemic: "FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic: Guidance for Industry, Investigators, and Institutional Review Boards" to ensure patient safety and the appropriate use of healthcare resources.
Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic dsRNA virus in development 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.