Oncolytics Biotech's Pelareorep Shows Promising Results in Metastatic Breast Cancer Treatment

Oncolytics Biotech Inc. (NASDAQ: ONCY) is making strides in the fight against metastatic breast cancer with its leading immunotherapeutic agent, pelareorep. Recent clinical trials have shown promising results, potentially offering new hope for patients facing this aggressive form of cancer.

Metastatic breast cancer, which affects approximately one in three women diagnosed with breast cancer, presents significant challenges in treatment. With a five-year survival rate of only 29% for distant metastatic breast cancer, the need for effective therapies is critical. Pelareorep, an intravenously delivered immunotherapeutic agent, has demonstrated the ability to induce anti-cancer immune responses and transform "cold" tumors into "hot" ones, making them more susceptible to immune attack.

In Phase 1 and 2 studies, pelareorep has shown remarkable potential. When added to standard metastatic breast cancer treatment, it nearly doubled overall survival rates in a randomized study of patients with HR+/HER2- breast cancer. The agent works by generating, recruiting, and training immune cells to recognize and kill cancer cells while remodeling the tumor microenvironment to facilitate immune cell access.

The BRACELET-1 randomized Phase 2 trials have further solidified pelareorep's promise, demonstrating meaningful improvements in overall response rate and progression-free survival. These trials, along with the AWARE-1 study, consistently showed that pelareorep produces an expansion of T cell clones and increases in CelTIL scores and peripheral tumor-infiltrating lymphocyte counts. Importantly, the trials also revealed a manageable safety profile consistent with prior studies.

Wayne Pisano, interim CEO and chair of the board of Oncolytics, expressed confidence in the data, stating, "We believe this data will further bolster our compelling data package and underscores the therapeutic potential of pelareorep." The company remains committed to improving the standard of care for metastatic breast cancer patients.

Pelareorep's potential has not gone unnoticed by regulatory authorities. The Food and Drug Administration (FDA) has granted fast track designation to the agent, allowing for expedited review. Recently, Oncolytics participated in a productive Type C meeting with the FDA to support the planned potential registration-enabling trial for pelareorep in HR+/HER2- metastatic breast cancer.

The FDA has supported progression-free survival as the primary endpoint of the study, with overall survival as a key secondary endpoint. This alignment on key design elements and objectives marks a critical step towards bringing pelareorep to patients. Dr. Thomas Heineman, Chief Medical Officer at Oncolytics, emphasized the significance of this development, stating, "We are now well-positioned to deliver on our mission of making pelareorep available to breast cancer patients in need of better treatment options."

As the metastatic breast cancer treatment market is forecast to grow at a CAGR of 10.4% from 2021 to 2030, reaching $41.74 billion, the potential impact of pelareorep is substantial. With its ability to extend survival times and expand existing and new T cell clones in the blood, pelareorep could significantly improve outcomes for patients with metastatic breast cancer.

The upcoming registrational trial for pelareorep in HR+/HER2- metastatic breast cancer will enroll patients for whom hormonal therapy hasn't worked and who have received no more than one line of antibody-drug conjugate (ADC) therapy. This trial builds on the compelling data and key learnings from the BRACELET-1 and IND-213 studies, which demonstrated clinically meaningful benefits in patients receiving pelareorep and paclitaxel compared to paclitaxel alone.

As Oncolytics Biotech continues to advance its research and development efforts, the potential of pelareorep to transform