07:29 AM EDT, 04/11/2024 (MT Newswires) -- Oncolytics Biotech ( ONCY )(r) Inc. (ONC.TO), specializing in immunotherapeutics for oncology, has submitted a Type C meeting request to the FDA, to discuss its planned registration-enabling trial for pelareorep in HR+/HER2- metastatic breast cancer (mBC).

Oncolytics hopes to secure a meeting with the agency in Q2 2024.

"A key focus for Oncolytics in 2024 is defining the regulatory path for pelareorep in breast cancer treatment. We are optimistic that pelareorep, in combination with paclitaxel, could significantly enhance clinical outcomes for patients with HR+/HER2- metastatic breast cancer," said CEO Dr Matt Coffey.

Coffey added that "encouraging" data from two randomized studies (BRACELET-1 and IND-213) and the AWARE-1 study, are paving the way for the next phase of pelareorep's development and its registration. Overall survival results from the randomized HR+/HER2- metastatic breast cancer BRACELET-1 trial are expected in H2 2024.