Oncolytics Biotech® Partner Adlai Nortye Advances to the Second Dose Escalation Cohort of the Chinese Bridging Trial Evaluating Pelareorep-Paclitaxel Combination Treatment in Breast Cancer

Enrollment in the first dose escalation is complete with no safety issues reported to date

Trial is designed to accelerate pelareorep’s development in Asian territories such as China, the world’s second-largest pharmaceutical market

Excerpt from the Press Release:

SAN DIEGO, Calif. and CALGARY, AB, Jan. 27, 2022 /PRNewswire/ — Oncolytics Biotech^® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced that its partner Adlai Nortye has advanced to the second of three dose escalation cohorts in the bridging clinical trial evaluating the safety, tolerability, and preliminary efficacy of pelareorep-paclitaxel combination therapy in Chinese patients with advanced or metastatic breast cancer. Dosing in the trial’s first dose escalation cohort is complete and no safety issues have been reported. The second dose escalation cohort is the equivalent dose that was administered in the IND-213 study, which reported a near doubling of survival in HR+/HER2- metastatic breast cancer patients.

“Initiation of the bridging trial’s second dose escalation cohort is an important advancement that reflects the positive safety findings observed in the trial to date,” said Andrew de Guttadauro, President of Oncolytics Biotech U.S. and Global Head of Business Development. “Completion of the bridging trial will allow future Chinese regulatory submissions that will include previously reported clinical data demonstrating pelareorep’s potential to substantially benefit metastatic breast cancer patients. This may accelerate pelareorep’s development in rapidly growing pharmaceutical markets such as China, which is the second largest in the world after the United States. Looking ahead, we will continue to collaborate closely with Adlai Nortye to advance pelareorep towards registration in these jurisdictions and maximize its potential therapeutic impact.”

The bridging clinical trial is designed to satisfy Chinese regulatory requirements and thereby accelerate pelareorep’s development in territories that include China, Hong Kong, and Macau. Results from the trial are expected to allow Adlai Nortye to include data from Oncolytics’ randomized North American metastatic breast cancer trials in future submissions to regulators in China and its territories.

The first of Oncolytics’ randomized North American trials, IND-213, showed a statistically significant near doubling of overall survival in patients treated with pelareorep and paclitaxel compared to those treated with paclitaxel alone. Oncolytics’ second randomized North American trial, BRACELET-1, is ongoing and evaluates pelareorep-paclitaxel combination therapy both with and without a checkpoint inhibitor. Oncolytics expects to complete enrollment in BRACELET-1 later this quarter and to report top-line data from the trial in Q4.

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