07:54 AM EDT, 06/27/2024 (MT Newswires) -- Oncolytics Biotech Inc. ( ONCY ) on Thursday said it received "productive feedback" from its Type C meeting with the U.S. Food and Drug Administration (FDA), for its planned trial for lead candidate pelareorep in HR+/HER2- metastatic breast cancer (mBC).

The regulator supports progression-free survival as the primary endpoint of the study, with overall survival as a key secondary endpoint, Oncolytics said. The company's proposed study will enroll patients who have failed hormonal therapy and have received no more than one line of antibody-drug conjugate (ADC) therapy.

"Aligning with the FDA on key design elements and objectives of our planned registrational trial for pelareorep marks a critical step towards bringing this innovative treatment to patients," said Thomas Heineman, Chief Medical Officer.

Initiating a registration-enabling trial is a major corporate objective, the company said. Oncolytics will report survival data from the BRACELET-1 study in HR+/HER2- mBC in the second half of the year.

Oncolytics is up 1.9% to US$1.06 in US premarket trade.