Imagion Biosystems (ASX:IBX) Starts Manufacturing for Phase 2 HER2+ Breast Cancer Study
Manufacturing Initiated
Imagion Biosystems has commenced manufacturing of the MagSense® HER2 Imaging Agent for its upcoming Phase 2 clinical study on HER2+ breast cancer. Production is scheduled to begin in mid-April and be completed by June, supporting the filing of an Investigational New Drug (IND) application with the US FDA by mid-2025.
Clinical Development
The Phase 2 study aims to optimise the dosage of the imaging agent and the imaging protocol to establish diagnostic performance. This follows the successful completion of the Phase 1 study, which demonstrated basic safety. The study will evaluate axillary nodal disease in over 400,000 HER2+ breast cancer patients diagnosed globally each year.
Executive Comments
Executive Chairman Bob Proulx stated, “I’m very pleased that we have managed to get the manufacturing contract in place so quickly. The receipt of funds from our recent capital raise has provided us with the resources needed to aggressively pursue our goal of filing an IND and preparing for the next phase of clinical testing of our novel imaging technology. With this key activity now in-process we are marching towards our next key development milestone.”
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