Dr. Matt Coffey reports

THE PANCREATIC CANCER ACTION NETWORK SELECTS ONCOLYTICS BIOTECH(TM) INC. TO RECEIVE $5 MILLION THERAPEUTIC ACCELERATOR AWARD TO DEVELOP LEADING-EDGE TREATMENTS

In an effort to continue accelerating new treatment options for people with pancreatic cancer, the Pancreatic Cancer Action Network (PanCAN) has named Oncolytics Biotech Inc. as the recipient of its second annual PanCAN Therapeutic Accelerator Award. Oncolytics received this award in recognition of its promising work on pelareorep, an investigational immunotherapy treatment that introduces double-stranded RNA into cancer cells, which stimulates anti-cancer inflammatory effects, including innate and adaptive immune responses, and the activation and recruitment of T cells into the tumour. This $5-million grant will enable Oncolytics to continue the next stage of its research focused on a clinical trial with Oncolytics's proprietary reovirus pelareorep in combination with modified Folfirinox chemotherapy, with or without an immune checkpoint inhibitor. If results are encouraging, the treatment combination may be advanced to late-stage clinical development through the PanCAN Precision Promise adaptive clinical trial platform.

The combination of pelareorep, gemcitabine, nab-paclitaxel and atezolizumab was granted fast-track designation by the FDA (United States Food and Drug Administration) last year and has already been selected for inclusion in the Precision Promise clinical trial platform, which is anticipated to open in early 2024. Testing pelareorep in combination with Folfirinox expands the approach so all patients with advanced pancreatic cancer could have the opportunity to benefit from this innovative immunotherapeutic approach.

The announcement of the Therapeutic Accelerator Award is being made in advance of PanCAN's annual Scientific Summit in Boston, which brings together PanCAN's Community for Progress, including research grant recipients, scientific and medical advisers, industry partners and special guests to share ideas and build collaboration. Oncolytics was selected to receive the 2023 PanCAN Therapeutic Accelerator Award for $5-million through a rigorous, competitive process involving scientific, business and programmatic review from leading experts in the field.

Pancreatic cancer is notoriously aggressive and hard to treat. Current estimates suggest that the disease will be the second leading cause of cancer-related deaths in the United States before 2030. Most people with pancreatic cancer are diagnosed at a late stage when their tumour is inoperable, leaving these patients with few treatment options. And because the disease is significantly more resistant to chemotherapy than other cancers, it can even be difficult to treat in its earliest stages. Despite the fact that there is an urgent need for better outcomes for pancreatic cancer, research is often not prioritized because pancreatic cancer affects a relatively small population compared with other cancers, and clinical research can be risky and expensive.

"Today's five-year survival rate of 12 per cent is too low and we need new treatment options now," said Lynn Matrisian, PhD, MBA, PanCAN chief science officer. "PanCAN launched our own clinical program to derisk companies' investment through both the Therapeutic Accelerator Award and the Precision Promise platform to facilitate rapid advances in this disease."

PanCAN continues to take bold actions to improve the lives of everyone impacted by pancreatic cancer, including the investment of more than $208-million since 2003 to advance scientific research. PanCAN created the multimillion-dollar Therapeutic Accelerator Award in 2022 as a research investment focused on supporting companies working on new pancreatic cancer therapies that plan to conduct early-stage (phase 1 and 2) clinical trials for these therapies.

"Oncolytics is so pleased to receive this innovative award and have the opportunity to work with PanCAN," said Dr. Matt Coffey, president and chief executive officer of Oncolytics Biotech. "This generous grant will enable early- and late-stage patients with pancreatic cancer to potentially benefit from another commonly employed chemotherapy backbone, as Folfirinox and gemcitabine plus nab-paclitaxel are the most frequently used chemotherapy standards of care in both the first- and second-line setting. By teaming up with PanCAN, we believe we may be able to expedite development and provide pancreatic cancer patients with a bespoke immunotherapeutic treatment option."

Oncolytics plans to utilize the grant funding to study pelareorep in combination with modified Folfirinox chemotherapy in patients with metastatic pancreatic cancer who have not received prior cancer treatment. In addition, a separate group of patients will receive this combination along with a checkpoint inhibitor to verify synergies previously observed in this patient population. The goal of this research is to evaluate the safety and efficacy of these combination therapies. Efficacy will be assessed by measuring the effect of the treatments on tumour size, progression-free survival and overall survival. In addition, immune responses to treatment will be assessed.

The funding offered through the PanCAN Therapeutic Accelerator Award represents an innovative and groundbreaking way for a non-profit to accelerate drug development. If the result of the clinical trial is positive, the hope is that the selected investigational treatment combination will be incorporated into the PanCAN Precision Promise adaptive clinical trial. While Precision Promise provides an effective approach for late-stage research on new pancreatic cancer therapies, many companies are not investing in the early-stage research necessary for late-stage studies and potential drug approval in this disease.

About Oncolytics Biotech Inc.

Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in phase 2 studies in breast and pancreatic cancers. It acts by inducing 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.