Dr. Matt Coffey reports

ONCOLYTICS ANNOUNCES THE ANAL CANCER COHORT OF THE GOBLET PHASE 1/2 STUDY OF PELAREOREP AND ATEZOLIZUMAB HAS MET THE SUCCESS CRITERIA FOR EFFICACY

Oncolytics Biotech Inc. has presented positive, interim results from the phase 1/2 Goblet study evaluating the combination of pelareorep and atezolizumab in second-line patients with unresectable squamous cell carcinoma of the anal canal (SCCA) by Dirk Arnold, MD, PhD, director of Asklepios Tumorzentrum Hamburg, and primary investigator of the Goblet trial, in an oral presentation at the second International Multidisciplinary Anal Cancer Conference (IMACC) 2023, taking place in Rome, Italy.

"The positive interim data from the anal cancer cohort of the phase 2 Goblet study presented today at the IMACC meeting is very exciting for our company and the potential of pelareorep in gastrointestinal cancers. These results met the prespecified success criteria for the cohort and exceeded the results from historical controls in similar patient populations," said Dr. Matt Coffey, president and chief executive officer of Oncolytics. "I am especially pleased to note that this is the third indication from the Goblet study in a row to meet its success criteria and the fourth indication combining pelareorep and atezolizumab to present positive data, further validating the potential clinical benefit of this combination and opening the door to another potential registrational pathway for pelareorep. Furthermore, we've seen another complete response in an indication where checkpoint inhibitor therapy alone has had limited success historically, which bodes well for the potential of pelareorep to work synergistically with multiple immunotherapies in multiple tumour types."

Dr. Arnold commented: "Current treatment options for SCCA are poor, with no defined standard of care for patients who have progressed after first-line therapy. Oncolytics is developing a solid compendium of clinical data showing consistent positive results from the combination of pelareorep and the checkpoint inhibitor atezolizumab. We are particularly pleased by the promising data presented today because they show that pelareorep may have the potential to offer the hope of a new, effective treatment option for patients with advanced SCCA."

Summary of interim data and findings from the SCCA arm of the phase 1/2 Goblet study

Tumour responses: Interim objective response rate (ORR) of 37.5 per cent based on one patient with a complete response (continuing at 12 months) and two patients with a partial response (one at week 8, one continuing at week 16).

Safety: No safety signal has been observed, consistent with previously reported cohorts from the Goblet study.

"We are very pleased by the positive data from patients with SCCA presented at IMACC. These results, which demonstrate an almost a three times improvement compared to data from like studies evaluating checkpoint inhibitors in patients with more than one prior line of therapy, provide further support for pelareorep's ability to generate an effective immune response and improve objective response rates," said Thomas Heineman, MD, PhD, chief medical officer at Oncolytics. "These data, coupled with the positive data for pancreatic and colorectal cancer, will be instrumental in defining and prioritizing the registrational pathway for pelareorep in gastrointestinal cancers."

Goblet study SCCA patient overview

Patients in the SCCA cohort, presented at IMACC 2023, are undergoing second-line or later treatment with a combination of pelareorep and atezolizumab. Ten patients are to be enrolled in the first stage of the study, eight patients were evaluable based on an Oct. 23, 2023, data cut-off date. Two or more responses out of the first 10 enrolled patients are required to satisfy the Simon two-stage success criteria.

Presentation information

The poster, titled "Goblet: A phase 1/2 multiple indication study in advanced gastrointestinal cancers treated with pelareorep and atezolizumab -- preliminary safety and efficacy results in second-line or later unresectable anal carcinoma" was presented earlier today at IMACC and a copy of the poster can be found on the Goblet media page of the Oncolytics website.

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 expected to enroll a total of approximately 55 patients: pelareorep in combination with atezolizumab, gemcitabine and nab-paclitaxel in first-line advanced/metastatic pancreatic cancer patients (n equals 12); pelareorep in combination with atezolizumab in first-line MSI (microsatellite instability) high metastatic colorectal cancer patients (n equals 19); pelareorep in combination with atezolizumab and TAS-102 in third-line metastatic colorectal cancer patients (n equals 14); and pelareorep in combination with atezolizumab in second-line advanced and unresectable anal cancer patients (n equals 10).

Any cohort showing an ORR above a prespecified threshold in Stage 1 may be advanced to Stage 2 and enroll additional patients.

About AIO

AIO-Studien-gGmbH (AIO) 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.

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