Oncolytics Biotech Reports Promising Pelareorep Data Across Tumor Types

Oncolytics Biotech has presented aggregated translational data demonstrating pelareorep's effectiveness across multiple tumor types, including increased PD-L1 expression and cytotoxic T-cell activity, supporting its potential as a platform immunotherapeutic. The company is advancing towards registrational studies in metastatic breast cancer and pancreatic cancer, both with Fast Track designation from the FDA.

Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) has presented aggregated translational data that underscores the efficacy of pelareorep, its systemically delivered oncolytic virus, across multiple tumor types. The data, derived from various studies including GOBLET and AWARE-1, indicate significant immune activation signatures such as increased PD-L1 expression and enhanced cytotoxic T-cell activity, suggesting pelareorep's potential as a platform immunotherapeutic.

Key findings from the studies include:
- Viral replication and interferon signaling: Pelareorep induces viral replication and interferon signaling, activating the immune system.
- Tumor-infiltrating lymphocytes: The treatment leads to a surge in tumor-infiltrating lymphocytes, converting "cold" tumors into "hot" phenotypes.
- PD-L1 expression and T-cell activity: Pelareorep increases PD-L1 expression and boosts cytotoxic T-cell activity, making resistant tumors more responsive to checkpoint inhibitors.

The company's Chief Medical Officer, Dr. Thomas Heineman, highlighted the significance of these results, stating, "This robust data set provides definitive validation of pelareorep's immune-mediated mechanism of action" [1].

Oncolytics Biotech is advancing pelareorep towards registrational studies in metastatic breast cancer and pancreatic cancer, both of which have received Fast Track designation from the FDA. The GOBLET study continues to enroll patients with pancreatic ductal adenocarcinoma (PDAC) and anal carcinoma, with additional translational data readouts expected next year.

The data presented by Oncolytics Biotech further supports the company's focused and aggressive regulatory path. The company expects these findings to serve as the biological foundation for registration-enabled studies in immunotherapy-resistant solid tumors. As regulatory conversations progress, Oncolytics Biotech anticipates providing an updated clinical timeline by the end of the third quarter.

References:
[1] https://www.biospace.com/press-releases/oncolytics-biotech-presents-aggregated-translational-data-providing-evidence-of-pelareoreps-effectiveness-across-multiple-tumor-types
[2] https://www.biospace.com/press-releases/enhertu-plus-pertuzumab-granted-breakthrough-therapy-designation-in-the-u-s-as-first-line-therapy-for-patients-with-her2-positive-metastatic-breast-cancer