Imagion Biosystems (ASX:IBX) has updated investors on its planned Phase 2 HER2 breast cancer clinical trial to be conducted in the US.
The company stated that its clinical team has been in communication with the US FDA regarding plans to submit an Investigational New Drug (IND) application for its MagSense HER2 imaging agent. It said it has recently received formal written feedback from the FDA, which included positive feedback and constructive input regarding the study plan and outcomes.
“I’m very pleased with the trajectory of our communications with the FDA,” said Imagion Executive Chairman, Bob Proulx. “We view the feedback from the FDA as very encouraging and can now confidently press forward with the formal submission and plans for undertaking the Phase 2 clinical study knowing we are in good shape regarding the regulatory path.” The company expects to file the Investigational New Drug (IND) application for the Phase 2 study in the third quarter of the 2025 calendar year.