Oncolytics Biotech, Roche, AIO Initiate Gastrointestinal Cancer Trial

Oncolytics Biotech® announced a new multi-indication gastrointestinal (GI) cancer study to be managed by AIO. The phase 1/2 trial, known as GOBLET, will investigate the use of pelareorep, in combination with Roche's anti-PD-L1 checkpoint inhibitor atezolizumab (Tecentriq®), in patients with metastatic pancreatic, metastatic colorectal and advanced anal cancers.

"We are very excited for the opportunity to treat patients with pelareorep, which has the potential to address significant unmet needs across multiple challenging indications with poor prognoses in the GI cancer space," said Dirk Arnold M.D., Ph.D., Director of the Asklepios Tumorzentrum Hamburg, and principal investigator of the newly announced trial. "Despite the great commercial success of checkpoint inhibitors, as many as four in five patients do not respond to these therapies in most GI malignancies, often due to an immunosuppressive tumor microenvironment (TME). We believe that pelareorep treatment may substantially increase the proportion of patients who are eligible for, and respond to, checkpoint inhibitor therapy. Prior clinical data in breast, hematological, and also some early data in gastrointestinal cancers have shown that systemic pelareorep administration reverses immunosuppressive TMEs by increasing tumor immune cell infiltration and PD-L1 expression."

"In this trial, we aim to demonstrate that the great potential shown by pelareorep in our lead breast cancer program can be extended to other advanced malignancies for which new treatments are needed,” Thomas Heineman, M.D., Ph.D., Global Head of Clinical Development and Operations at Oncolytics, said. “Pelareorep's potential in GI cancers is supported by the encouraging early clinical data we previously reported in pancreatic and colorectal cancer, which showed that pelareorep-based combination treatments stimulated an adaptive immune response and led to a greater than 90% clinical benefit rate in KRAS-mutated colorectal cancer patients (link to PR, link to study), and a greater than 80% increase in progression-free survival in pancreatic cancer patients with low levels of CEACAM6 expression (link to PR, link to poster). We hope the GOBLET study, in addition to providing positive safety and efficacy data, will also support our previously identified predictive blood-based biomarkers CEACAM6 and T cell clonality. This will allow us to select the most appropriate patients for future registration studies, thereby increasing their likelihood of success."

The GOBLET study will make use of a new master clinical supply agreement between Oncolytics and Roche. Per the agreement, Roche will supply atezolizumab for use in Oncolytics' clinical development plan.

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.