Oncolytics Biotech® Provides Positive Safety Update on the Third-Line Metastatic Colorectal Cancer Cohort of its Multi-Indication Phase 1/2 Gastrointestinal Cancer Trial

Independent review identified, no safety concerns in trial’s final safety run-in

Cohort supported by prior clinical data showing a pelareorep-based combination driving a 90% clinical benefit rate in KRAS-mutated colorectal cancer patients

Multi-indication trial being conducted in collaboration with Roche and AIO also includes pancreatic and advanced anal cancer cohorts

Excerpt from the Press Release:

SAN DIEGO, Calif. and CALGARY, AB, March 31, 2022 /PRNewswire/ — Oncolytics Biotech^® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced the successful completion of the three-patient safety run-in for the third-line metastatic colorectal cancer (mCRC) cohort of the phase 1/2 GOBLET study, following an independent review by the study’s Data Safety Monitoring Board (DSMB). The DSMB noted no safety concerns in these patients and has recommended that the study proceed to full enrollment pending clearance by the Paul Ehrlich Institute (PEI; Germany’s medical regulatory body). The PEI recently cleared the study’s pancreatic cancer cohort for full enrollment following a similar recommendation by the DSMB. The trial’s anal cancer and first-line mCRC cohorts do not include safety run-ins and are proceeding as planned.

The GOBLET study is designed to evaluate the safety and efficacy of pelareorep in combination with Roche’s anti-PD-L1 checkpoint inhibitor atezolizumab in patients with metastatic pancreatic, metastatic colorectal, and advanced anal cancers. The study includes 14 clinical trial sites across Germany and is being managed by AIO, a leading academic cooperative medical oncology group.

“The successful completion of GOBLET’s final safety run-in underscores the trial’s strong momentum and supports the ability of pelareorep to be safely combined with checkpoint inhibitors,” said Thomas Heineman, M.D., Ph.D., Chief Medical Officer of Oncolytics. “This achievement positions us to continue building on prior clinical data that demonstrate the potential of pelareorep to provide a clinical benefit in colorectal and other gastrointestinal (GI) cancers. Existing data suggest this clinical benefit likely results from the stimulation of protective immune responses that may be enhanced by the addition of checkpoint inhibition. Given the high prevalence of GI malignancies, including colorectal and pancreatic cancer, and the fact that most cases do not respond to checkpoint inhibition, we view GOBLET as an important opportunity to evaluate a novel therapeutic approach that may address a pressing unmet medical need.”

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