Oncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage immunotherapy company developing pelareorep, today announced updates on enrollment progress, U.S. site expansion, and expected data readouts from the ongoing GOBLET trial evaluating pelareorep in gastrointestinal cancers. The study is supported in part by a grant from the Pancreatic Cancer Action Network (PanCAN).
“The GOBLET trial is designed to rigorously evaluate pelareorep’s potential across gastrointestinal cancers,” said Dr. Dirk Arnold, Director of Asklepios Tumorzentrum Hamburg and Primary Investigator of the GOBLET study. “The strong early efficacy signals give us confidence that pelareorep may become a foundational immunotherapy for these difficult-to-treat tumors, and expanding enrollment into the U.S. will broaden the scope and impact of these data.”
Cohort 4 (Second-Line or later Squamous Cell Carcinoma of the Anal Canal, “SCAC”)
Pelareorep is being studied in combination with atezolizumab in the rare but deadly relapsed, unresectable SCAC indication. In January, the Company released efficacy data showing a 33% overall response rate (ORR) in 12 patients. This nearly triples the ORR achieved by retifanlimab in second-line or later SCAC patients. Enrollment is currently at 20 evaluable patients and is expected to be completed by the end of 2025.
The Company expects to provide an efficacy update regarding ORR in Cohort 4 in the fourth quarter of 2025.
Cohort 5 (First-Line Metastatic Pancreatic Ductal Adenocarcinoma, “mPDAC”)
In a randomized two-arm cohort, pelareorep is being evaluated in combination with modified FOLFIRINOX with or without atezolizumab to gain greater clarity regarding the contribution of the checkpoint inhibitor to the efficacy achieved in GOBLET Cohort 1. In that cohort, pelareorep combined with gemcitabine/nab-paclitaxel and atezolizumab achieved a 62% ORR in 13 evaluable patients. Enrollment into Cohort 5 is approximately 40% complete and is expected to be fully enrolled by the end of 2026.
The Company anticipates providing a Cohort 5 interim efficacy update, including overall survival, in the first quarter of 2026.
GOBLET Expansion to U.S. Sites
The Company recently submitted a protocol amendment to allow the GOBLET study to open U.S. clinical sites within the next few months. Upon approval, Northwestern University and other academic institutions are expected to serve as U.S. sites for GOBLET.
“We are pleased to bring this important study to U.S. patients with pancreatic cancer, a population urgently in need of novel immunotherapy strategies,” said Dr. Devalingam Mahalingham, who is expected to lead the Cohort 5 study at Northwestern University. “The combination of pelareorep and a checkpoint inhibitor with chemotherapy has shown early signs of durability, and I am excited to be part of advancing this program toward registration.”
“We expect to build on this clinical momentum to lay the foundation for our regulatory strategy,” said Jared Kelly, Chief Executive Officer of Oncolytics. “It’s imperative that we leverage our clinical data to obtain regulatory clarity and position pelareorep as a platform immunotherapy in these gastrointestinal tumors where patients desperately need treatment options.”
