Dr. Matt Coffey reports

ONCOLYTICS BIOTECH(TM) INITIATES ENROLLMENT EXPANSION OF GOBLET ANAL CANCER COHORT

Oncolytics Biotech Inc. has expanded enrolment for the anal cancer cohort of the Goblet study evaluating pelareorep in combination with atezolizumab (Tecentriq) in patients with second-line or later unresectable squamous cell carcinoma of the anal canal (SCCA). The study was expanded based on positive data from stage 1 of the study, presented at the second International Multidisciplinary Anal Cancer Conference (IMACC) in November, 2023.

"These exciting clinical data, which exceed the Simon two-stage success criteria, provide strong support to expand the evaluation of pelareorep in patients with advanced anal cancer. The results reported at IMACC 2023 showed that the combination of pelareorep and atezolizumab provided a 37.5-per-cent objective response rate, including one patient with a long-lasting complete response, and good overall tolerability. These data represent a meaningful contrast to recent clinical trial results which show that patients with second-line or later anal carcinoma treated with checkpoint inhibitor therapy experienced response rates of 10 to 14 per cent," said Dr. Matt Coffey, president and chief executive officer of Oncolytics.

"We begin the stage 2 expansion with substantial optimism for patients and the potential of pelareorep, especially considering the initial efficacy signal observed for pelareorep-based therapy in pancreatic cancer. There is currently no established standard therapy for patients with anal carcinoma who have failed first-line treatment. Continued positive results could potentially expand the opportunity for pelareorep beyond the lead indications of breast cancer and pancreatic cancer and open the door to a rapid regulatory pathway in this rare and significantly underserved patient population," continued Dr. Coffey.

Dr. Dirk Arnold, MD, PhD, director of Asklepios Tumorzentrum Hamburg, and primary investigator of the Goblet trial, commented: "One of the most difficult challenges in my practice is the limited number of treatment options that are available for patients with advanced anal cancer who have progressed on first-line therapy. I am enthusiastic about the expansion of this cohort because it will enable the continued evaluation of the pelareorep/atezolizumab combination and could provide important confirmatory data that may lead to better treatment options for patients with this late-stage disease."

"We look forward to building on the oncology community's enthusiastic reception of the IMACC 2023 data by expanding enrolment in the anal carcinoma cohort and incorporating additional sites into the study," commented Dr. Thomas Heineman, MD, PhD, chief medical officer at Oncolytics. "Careful consideration of recently published clinical trial results indicates that a modest expansion of fewer than 20 patients will be sufficient to solidify the efficacy signal we have observed to date and lay the groundwork for a potential future registrational study in this population. We look forward to continuing our excellent collaboration with the clinical sites and investigators at AIO and hope to report additional results in 2025."

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) 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 four treatment groups:

• Pelareorep in combination with atezolizumab, gemcitabine and nab-paclitaxel in first-line advanced/metastatic pancreatic cancer patients;
• Pelareorep in combination with atezolizumab in first-line MSI-high (microsatellite instability) metastatic colorectal cancer patients;
• Pelareorep in combination with atezolizumab and TAS-102 in third-line metastatic colorectal cancer patients;
• Pelareorep in combination with atezolizumab in second-line advanced and unresectable anal cancer patients.

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

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.

We seek Safe Harbor.