Imagion Biosystems (ASX: IBX) is moving its MagSense® HER2 Imaging Agent Phase 1b/2 clinical trial towards patient enrolment, with key study partners now engaged and the investigational product ready for distribution. This impending trial takes the company a step closer to developing a more precise cancer imaging offering that fills a key gap in clinical analysis, particularly in HER2-positive breast cancer, where accurate assessment of whether cancer has spread to regional lymph nodes can help inform treatment decisions.
Accelerates trial preparation
Imagion Biosystems has executed work orders with its primary contract research organisation (CRO), along with other CROs responsible for imaging and pathology activities. The company says these agreements support study start-up activities including site selection, onboarding, data management, investigator training and participant recruitment planning.
“We have been making tremendous progress towards study start-up and look forward to opening the Clinical Trial for enrolment as quickly as possible,” said Imagion Biosystems, Inc. President Ward Detwiler.
The company has begun initiation activities with seven prospective clinical trial sites, while negotiations are underway with the first site after its clinical team confirmed an intention to participate.
Delivery of distribution logistics for MagSense®
Manufacturing of the MagSense® HER2 investigational product has now been completed, with the product passing its required stability testing and distribution logistics established.
This means the imaging agent can be delivered to engaged clinical sites ahead of patient enrolment, while remaining study start-up work continues.
Imagion Biosystems has also finalised the study imaging protocol, incorporating advanced quantitative MRI techniques developed through its previous research engagement with Wayne State University and validated for clinical adoption through its collaboration with Siemens Healthineers.
MagSense® targets an unmet diagnostic need
The Phase 1b/2 trial will focus on MagSense® HER2 Imaging Agent in HER2-positive breast cancer. According to Breast Cancer Research Foundation data, approximately 450,000 women receive a HER2-positive breast cancer diagnosis globally each year.
HER2-positive breast cancer is considered an aggressive subtype, with a high rate of recurrence and metastasis. Following diagnosis, nodal staging is used to assess whether cancer has spread to nearby regional lymph nodes.
Ultrasound is currently the most commonly used method for nodal assessment, but the company notes challenges around sensitivity and specificity, as well as limitations in assessing the extent of disease spread.
The design of the Phase 1b/2 trial
Imagion Biosystems’ completed Phase 1 study found that independent radiologists could identify a change in MRI images produced by the MagSense® HER2 Imaging Agent, allowing differentiation between tumour-involved and non-involved lymph nodes.
The upcoming Phase 1b/2 trial is designed to establish the optimised dose and imaging timing while assessing diagnostic performance.
The trial will run across three parts. Part A will collect additional safety data, Part B will evaluate a reduced dosing regimen and optimised imaging protocol, and Part C will involve a larger cohort to establish diagnostic performance.
Building toward broader applications
All up, the Phase 1b/2 trial is expected to take 18–24 months to complete, with interim analyses anticipated following Parts A and B. Alongside diagnostic performance, the study is expected to provide insight into potential impacts on cost of care, patient outcomes and overall clinical value.
The incorporation of quantitative imaging techniques is also intended to generate data that can support the development and training of AI diagnostic tools.
Imagion Biosystems’ MagSense® platform uses targeted magnetic nanoparticles with MRI to provide molecular specificity without radioactive tracers or ionising radiation. The company has developed agents targeting three cancer types, with the lead HER2+ breast cancer program now advancing into Phase 1b/2, while prostate and ovarian cancer agents could progress into IND-enabling studies as resources become available.
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