Dr. Matt Coffey reports

ONCOLYTICS BIOTECH'S(TM) PELAREOREP SELECTED FOR INCLUSION IN PRECISION PROMISESM PIVOTAL PHASE 3 PLATFORM TRIAL

Oncolytics Biotech Inc.'s pelareorep has been selected for inclusion as a new investigational treatment in Precision Promise, an innovative adaptive phase 3 clinical trial. The Precision Promise study is designed to evaluate pelareorep in combination with a checkpoint inhibitor and the chemotherapeutic agents gemcitabine and nab-paclitaxel. If successful, the clinical study is expected to support approval of the studied combination as a treatment for first-line metastatic pancreatic ductal adenocarcinoma (PDAC).

Precision Promise has a primary end point of overall survival and can include multiple investigational treatments as well as control arms evaluating: (1) gemcitabine plus nab-paclitaxel or (2) mFOLFIRINOX. Each investigational therapy is subject to prespecified interim analyses prior to proceeding to the registrational portion of the trial. This design, which was developed with guidance from the U.S. Food and Drug Administration, minimizes the number of participants needed to generate licensure-enabling data, thereby accelerating late-stage development by up to two years and reducing costs compared with non-platform trials.

"We are delighted at being selected by the Precision Promise panel of experts," said Dr. Matt Coffey, president and chief executive officer of Oncolytics Biotech. "Our next step is to engage with stakeholders to finalize the protocol for Precision Promise's pelareorep-containing investigational treatment so that we can enter into this study. We are thrilled to have the opportunity to leverage Precision Promise, which we expect will allow us to reduce the time and costs needed to reach a potential approval."

Julie Fleshman, JD, MBA, president and CEO of PanCAN, commented: "With a five-year survival rate of 12 per cent, pancreatic cancer patients cannot afford to wait for new treatment options. This urgent unmet need was the driving inspiration behind the Precision Promise platform trial, which was designed specifically to identify, accelerate and derisk the development of promising pancreatic cancer treatments. We are thrilled to be bringing pelareorep into Precision Promise as a new investigational therapy to study against the current standard of care."

Dr. Thomas Heineman, chief medical officer of Oncolytics Biotech, commented: "Prior trials in pancreatic cancer show pelareorep-based combinations outperforming historical controls on key metrics such as one- and two-year survival and objective response rate. In addition, mechanistic data from these studies highlight how pelareorep's immunologic mechanism of action allows it to synergize with chemotherapy and checkpoint inhibition in this indication. I look forward to working with the Precision Promise team of investigators to seek to confirm the therapeutic value of pelareorep in a randomized setting so that we can potentially provide pancreatic cancer patients with a new treatment option."

Oncolytics expects to finalize the definitive agreements within the next 90 days and open the Precision Promise investigational treatment of pelareorep, checkpoint inhibitor, gemcitabine and nab-paclitaxel in early 2024.

Pelareorep in pancreatic cancer

Pelareorep's inclusion in Precision Promise is supported by prior clinical data in pancreatic cancer that suggest it synergizes with checkpoint inhibition and chemotherapy. These prior data include phase 1/2 results showing a 69-per-cent objective response rate (ORR) in a cohort of first-line advanced/metastatic PDAC patients treated with pelareorep combined with atezolizumab, gemcitabine and nab-paclitaxel. This compares with an average ORR of approximately 25 per cent reported in relevant historical control trials. In addition, a phase 2 study of pelareorep plus gemcitabine that included 29 evaluable chemotherapy-naive pancreatic cancer patients showed a median overall survival (mOS) of 10.2 months and a one-year survival rate of 45 per cent, compared with historical control trials showing mOS of approximately 6.7 months and one-year survival rates of approximately 20 to 22 per cent, respectively. A subsequent phase 2 study of pelareorep plus checkpoint inhibition without chemotherapy in pancreatic cancer patients who progressed after first-line treatment showed a 42-per-cent disease control rate, posttreatment increases in PD-L1+ cells, and a correlation between clinical response and increased activation of anti-cancer CD8+ T cells.

About Oncolytics Biotech Inc.

Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. This compound induces anti-cancer immune responses and promotes an inflamed tumour phenotype -- turning cold tumours hot -- through innate and adaptive immune responses to treat a variety of cancers.

Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid and hematological malignancies as it advances toward registrational studies in metastatic breast cancer and pancreatic cancer.

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