On July 16, 2025 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, reported its biomarker and translational data for pelareorep, the Company’s systemically delivered oncolytic virus (Press release, Oncolytics Biotech, JUL 16, 2025, View Source [SID1234654410]). The data support pelareorep’s mechanism of action and further strengthen the unique biological rationale and therapeutic potential for pelareorep as a platform immunotherapeutic. These include its ability to replicate in cancer cells, activate immune pathways, and drive T cell expansion and tumor infiltration in immunotherapy-resistant cancers.
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The translational research included the analysis of blood and tumor samples from patients in the GOBLET (pancreatic ductal adenocarcinoma (PDAC) and other gastrointestinal cancers) and AWARE-1 (breast cancer) studies. Analyses revealed consistent immune activation signatures, including:
•Upregulation of interferons, CXCL9/10/11, and PD-L1
•Conversion of immunologically ‘cold’ tumors into ‘hot’ phenotypes
•Expansion and mobilization of tumor-infiltrating lymphocyte (TIL) clones in the blood, which correlates with a reduction in tumor size
•Modulation of the tumor microenvironment (TME) to enhance responsiveness to immune therapies
"This robust data set, amassed from several studies in cancers that have historically resisted immunotherapeutic approaches, provides definitive validation of pelareorep’s immune-mediated mechanism of action," said Dr. Thomas Heineman, Chief Medical Officer of Oncolytics. "We observed tumor biopsy-confirmed virus replication, immune cell activation, and the recruitment of cytotoxic T cells into the TME – all consistent with the durable responses observed in patients with metastatic PDAC and HR+/HER2- breast cancer who were treated with pelareorep."
"The collection of data here show that pelareorep works how a cancer immunotherapy should work," said Jared Kelly, Chief Executive Officer of Oncolytics. "Pelareorep is a versatile product candidate with strong platform potential to enhance immunological responses in multiple indications, including hard-to-treat cancers. Such compelling findings should be exciting to strategic partners focused on finding a platform immunotherapy in large indications with high unmet medical needs."
The GOBLET study continues to enroll PDAC and anal carcinoma patients, and additional translational data readouts are expected next year. The Company expects these and its other clinical data to support its focused and aggressive regulatory path and serve as the biological foundation for registration-enabled studies in immunotherapy-resistant solid tumors. As regulatory conversations progress throughout the summer, the Company expects to provide an updated clinical timeline before the end of the third quarter.