Imagion Biosystems (ASX:IBX) has taken another step toward starting its MagSense HER2 Phase 1b/2 clinical trial, with key CRO work orders signed and startup activities now underway.
The MagSense investigational product has also completed manufacturing and stability testing and is ready for distribution to trial sites.
Seven sites in the mix
Imagion has started trial initiation activities with seven prospective sites, while contract negotiations are underway with the first US clinical site.
The company has also finalised the imaging protocol, including advanced quantitative MRI techniques developed through its Wayne State University work and validated through its collaboration with Siemens Healthineers.
That brings the study closer to the point that matters most: patient enrolment.
From clearance to execution
Imagion received FDA clearance and a “Study May Proceed” notice in June.
Since then, the focus has shifted from regulatory approval to practical trial setup.
Remaining work includes site contracting, IRB approvals, ClinicalTrials.gov registration, investigator training and shipping the MagSense agent to participating sites.
President Ward Detwiler said the company is focused on opening the study for enrolment as quickly as possible.
Figure 1: Imagion Biosystems timeline.
Why this trial matters
The Phase 1b/2 study is designed to optimise dose and imaging timing before moving into a larger cohort to assess diagnostic performance in HER2-positive breast cancer.
The trial is expected to run for 18 to 24 months, with interim analyses planned after Parts A and B.
The bigger opportunity is whether MagSense can improve nodal staging using MRI without radioactive tracers.
What’s next
Finalise the first site, complete study startup, then Imagion can open enrolment.
IBX has the agent ready, now it needs patients in the trial.
