Dr. Matt Coffey reports

ONCOLYTICS BIOTECH(TM) FILES AMENDMENT TO INITIATE NEW PANCREATIC CANCER GOBLET COHORT SUPPORTED BY PANCAN

Oncolytics Biotech Inc. has submitted an amendment to Goblet to initiate a new phase 1/2 cohort evaluating pelareorep in combination with modified Folfirinox (mFolfirinox) with and without atezolizumab (Tecentriq) in patients with newly diagnosed metastatic pancreatic ductal adenocarcinoma (PDAC). This amendment will be reviewed by the Paul Ehrlich Institute (PEI -- Germany's regulatory body) for approval before patient enrolment can begin. The cohort, the fifth of the Goblet gastrointestinal cancer study, is being supported by the $5-million (U.S.) Therapeutic Accelerator Award from the Pancreatic Cancer Action Network (PanCAN), an innovative program established to accelerate the development of new treatments for pancreatic cancer. Evaluation of this novel treatment approach will complement Oncolytics's continuing development of pelareorep, atezolizumab, gemcitabine and nab-paclitaxel in PDAC, which is expected to advance to a registrational study later this year.

"We are enthusiastic to have the support of PanCAN to expand the evaluation of pelareorep in pancreatic cancer and explore mFolfirinox as another combination that could improve outcomes for patients. Notably, this patient population is newly diagnosed patients who are receiving first-line treatment. Chemotherapies, including either mFolfirinox or gemcitabine and nab-paclitaxel, are the backbone treatment regimens of pancreatic cancer therapy. Evaluating pelareorep in combination with these widely used regimens is an important step in our broad clinical development program," said Dr. Matt Coffey, president and chief executive officer of Oncolytics. "Last fall, we reported a 62-per-cent objective response rate for the Goblet PDAC cohort studying pelareorep in combination with the checkpoint inhibitor atezolizumab in addition to gemcitabine and nab-paclitaxel. This response is about three times that of historical controls and forms the basis of the registrational program, expected to begin this year. Therefore, we are enthusiastic about this new mFolfirinox pancreatic cancer cohort and look forward to enrolling the first patient as soon as possible."

Dirk Arnold, MD, PhD, director of Asklepios Tumorzentrum Hamburg, and primary investigator of the Goblet trial, commented: "One of the reasons for pancreatic cancer's poor survival rate is that it effectively evades the immune system and can induce an immunosuppressive tumour microenvironment (TME). Pelareorep is an attractive combination partner because of its ability to address both issues by activating the innate and adaptive immune systems, while driving the remodelling of the tumour microenvironment. Positive results from the phase 2 study evaluating pelareorep combined with atezolizumab and chemotherapy reported last fall support the potential use of these agents together. I am hopeful that the combination of pelareorep and mFolfirinox (with or without atezolizumab) will yield positive response data and advance the development of new treatment options for patients with pancreatic cancer."

"This study is designed to evaluate whether pelareorep can enhance outcomes in patients receiving mFolfirinox, one of the most commonly used metastatic pancreatic cancer treatments. Combining pelareorep with mFolfirinox represents an expansion of our existing pancreatic cancer program and maximizes the potential of pelareorep-based combination therapies to benefit pancreatic cancer patients," commented Thomas Heineman, MD, PhD, chief medical officer at Oncolytics. "The mFolfirinox cohort utilizes a screened selection design within a Simon two-stage approach that will also allow evaluation of the contribution of atezolizumab to the pelareorep/mFolfirinox combination. In addition, this study is designed to provide valuable translational assessments, such as the expansion of tumour-infiltrating lymphocytes (TILs) in the blood, which has been associated with tumour responses. We look forward to building on PanCAN's strong relationships with the pancreatic cancer community and furthering our collaboration with AIO-Studien-gGmbH (AIO) on the Goblet study."

About Goblet cohort 5

The mFolfirinox cohort of the phase 1/2 Goblet study is designed to evaluate newly diagnosed PDAC patients treated with pelareorep plus mFolfirinox, with or without atezolizumab. There will be a three-patient safety run-in to evaluate the tolerability of each treatment arm -- pelareorep plus mFolfirinox plus atezolizumab and pelareorep plus mFolfirinox. A total of 15 patients may be randomized to each arm in stage 1 of the Simon two-stage design. The co-primary end points of the cohort are objective response rate and safety. The success criteria for stage 1 is defined as six or more responses in one or both of the treatment groups. Successful completion of stage 1 will support expansion into stage 2, which can include one or both treatment regimens, and would enroll 17 additional evaluable patients. A total of 13 or more responses from stage 1 and 2 combined are required to achieve the success criteria. Translational data will also be generated.

About Goblet

The Goblet (gastrointestinal tumours exploring the treatment combinations with the oncolytic reovirus pelareorep and anti-PD-L1) study is a phase 1/2 multiple indication study in advanced or metastatic gastrointestinal tumours. The study is being conducted at 12 centres in Germany and is being managed by AIO-Studien-gGmbH. The co-primary end points of the study are objective response rate (ORR), and/or disease control rate assessed at week 16 and safety. Key secondary and exploratory end points include additional efficacy assessments and evaluation of potential biomarkers (T-cell clonality and CEACAM6). The study employs a Simon two-stage design with stage 1 comprising five treatment groups:

1. Pelareorep in combination with atezolizumab, gemcitabine and nab-paclitaxel in first-line advanced/metastatic pancreatic cancer patients;
2. Pelareorep in combination with atezolizumab in first-line MSI (microsatellite instability)-high metastatic colorectal cancer patients;
3. Pelareorep in combination with atezolizumab and TAS-102 in third-line metastatic colorectal cancer patients;
4. Pelareorep in combination with atezolizumab in second-line advanced and unresectable anal cancer patients;
5. Pelareorep in combination with mFolfirinox with and without atezolizumab in newly diagnosed metastatic PDAC patients.

Any cohort meeting prespecified efficacy criteria in stage 1 may be advanced to stage 2 and enroll additional patients.

About AIO

AIO-Studien-gGmbH emerged from the study centre of the internal oncology working group within the German Cancer Society (DKG). AIO operates with a non-profit purpose of promoting science and research with a focus on medical oncology. Since its foundation, AIO has become a successful sponsor and study management company, and has established itself both nationally and internationally.

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, both of which have received fast-track designation from the Food and Drug Administration.

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