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Oncolytics Biotech Inc (2)
Symbol ONC
Shares Issued 16,915,325
Close 2018-11-23 C$ 3.20
Market Cap C$ 54,129,040
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Oncolytics treats 1st patient with pelareorep/Keytruda

2018-11-26 09:36 ET - News Release

Dr. Matt Coffey reports

ONCOLYTICS BIOTECH ANNOUNCES FIRST PATIENT TREATED IN PHASE 2 STUDY COMBINING PELAREOREP AND KEYTRUDA IN ADVANCED PANCREATIC CANCER

Oncolytics Biotech Inc. has treated its first patient in a phase 2 study combining pelareorep with Merck's Keytruda to treat advanced pancreatic adenocarcinoma. The primary objective of the study is to determine the overall response rate (ORR) by iRECIST criteria. Secondary objectives include safety of the combination immune response as determined by analysis of pretreatment and posttreatment biopsies and blood-based immune markers; determination of progression-free survival (PFS) by iRECIST criteria; and one-year, two-year and median overall survival (OS).

"We are very excited to start enrolment in this combination study, which expands upon our findings from an earlier Keytruda study in advanced pancreatic cancer," said Dr. Matt Coffey, president and chief executive officer of Oncolytics Biotech. "REO 024, our previous phase 1b study with Keytruda, showed objective response, long-term stabilization of disease and promotion of an inflamed phenotype in second-line pancreatic cancer patients. This new phase 2 study should corroborate anti-tumour activity and potentially confirm predictive biomarkers laying the groundwork towards our goal of becoming a standardized backbone for checkpoint inhibitors."

This study is a phase 2, single-arm, open-label study enrolling up to 30 patients with advanced pancreatic adenocarcinoma who experienced disease progression or did not tolerate first-line therapy. The principal investigator is Dr. Devalingham Mahalingam of Northwestern University. The first 16 patients will be enrolled in stage 1, and up to 14 additional patients will be enrolled in stage 2 if prespecified criteria are met. The predefined criteria state that, for the primary objective, three or more responses out of 16 are needed in stage 1 to continue the trial to the full 30 patients.

About pelareorep

Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumours and hematological malignancies. The compound induces selective tumour lysis and promotes an inflamed tumour phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.

About Oncolytics Biotech Inc.

Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immuno-oncolytic virus. Oncolytics is currently conducting and planning additional studies in combination with checkpoint inhibitors and targeted and IMiD (immunomodulatory imide drug) therapies in solid and hematological malignancies as it prepares for a phase 3 registration study in metastatic breast cancer.

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