ONCY

Yeh

 

Updating the market on its flagship immunotherapeutic agent pelareorep, Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC) laid out its primary breast cancer achievements in 2021, as well as its 2022 program to come in its latest letter to shareholders.

For breast cancer patients treated with pelareorep Oncolytics has witnessed a more-than-doubling of overall survival in metastatic HR+/HER2- in IND-213--as seen from study results delivered in 2017.

Through a series of data analysis, Oncolytics chose to focus on the three achievable objectives put in place by regulators and the company's pharma partners, representing important steps towards a registrational study. This included: 1. Confirming that pelareorep works through an immunotherapeutic mechanism of action; 2. Determining whether pelareorep synergizes with immune checkpoint inhibitors; and 3. Identifying a biomarker to select patients who are likely to have better clinical outcomes.

In the shareholders letter, Dr. Matt Coffey, President & CEO of Oncolytics Biotech, wrote: "I am pleased to report that we are well on our way to achieving these three objectives."

Back in April 2021, Oncolytics presented cohort data from its AWARE-1 study, being conducted with Roche, showing that the first two objectives referenced above had been achieved.

By December at the 2021 San Antonio Breast Cancer Symposium (SABCS), Oncolytics presented a positive safety update from its IRENE Phase 2 Triple-Negative Breast Cancer Trial evaluating the safety and efficacy of pelareorep in combination with the anti-PD-1 checkpoint inhibitor retifanlimab from Incyte for second- or third-line treatment of patients with metastatic triple-negative breast cancer (TNBC).

"Prior clinical studies have shown that pelareorep upregulates tumor PD-L1 expression and reverses immunosuppressive TMEs," said Mridula George, M.D., Medical Oncologist, Rutgers Cancer Institute of New Jersey, Assistant Professor of Medicine, Rutgers Robert Wood Johnson Medical School, and principal investigator of the trial. "These findings suggest that pelareorep can address a pressing unmet need in TNBC by synergizing with PD-1 inhibition to increase the proportion of patients responding to therapy. We look forward to evaluating this hypothesis through the IRENE study's continued advancement and are pleased that the pelareorep-retifanlimab combination has been well-tolerated in each of the patients enrolled in the trial."

Safety data from the trial showed the combination was well-tolerated, with no safety concerns noted in any of the patients enrolled in the trial at the time of reporting. The IRENE study remains ongoing and will continue to enroll patients at the Rutgers Cancer Institute of New Jersey and the Ohio State University Comprehensive Cancer Center.