- Trial startup underway with seven prospective US sites
- MagSense HER2 imaging agent manufactured and ready for distribution
- Contract negotiations underway with first prospective trial site
Special Report: Imagion Biosystems is progressing towards the start of a Phase 1b/2 clinical trial of its MagSense HER2 Imaging Agent, with work orders signed with key contract research organisations (CROs) and trial initiation activities underway at seven prospective US sites.
Imagion Biosystems (ASX:IBX) announced in June it had received clearance from the US Food and Drug Administration (FDA) to proceed with the trial in HER2-positive breast cancer patients.
Imagion has now executed work orders with its primary study CRO, as well as CROs responsible for imaging and pathology activities for the trial.
The company said these relationships would support the integrity and clinical compliance of the study while allowing it to accelerate trial startup activities.
These include site selection and onboarding, data management, site and investigator training and participant recruitment strategies.
Imagion has kicked off study initiation activities with seven prospective trial sites, with contract negotiations underway with its first site after receiving confirmed intent to participate from the site’s clinical team.
Manufacturing of the MagSense HER2 investigational product has also been completed, with the product passing required stability testing and distribution logistics in place.
While working towards finalisation of trial site contracting, Imagion and its study partners will proceed with the remaining startup activities required before the study can formally open for enrolment.
These activities include relevant Institutional Review Board approvals, registration with ClinicalTrials.gov, investigator training and shipment of the investigational product.
‘Laser focused on trial initiation activities’
The trial’s imaging protocol has also been finalised, incorporating advanced quantitative imaging techniques developed through a previous research engagement with Wayne State University.
The techniques were validated for clinical adoption through Imagion’s collaboration with Siemens Healthineers.
“Since receiving our IND clearance and Study May Proceed notice from the US FDA in June, the Imagion team and its key Trial partners have been laser focused on Trial initiation activities,” President Ward Detwiler said.
“We have been making tremendous progress towards study start-up and look forward to opening the clinical trial for enrolment as quickly as possible.”
Watch: Imagion extends Siemens partnership for breast cancer trial
Potential to improve detection of cancer spread
Imagion said about 450,000 women receive a HER2-positive (HER2+) breast cancer diagnosis globally each year.
HER2-positive breast cancer is considered an aggressive subtype with a high rate of recurrence and metastasis, making precise nodal staging an essential part of treatment planning.
Nodal staging assesses whether cancer has spread to nearby lymph nodes and currently relies on a combination of clinical assessment and radiographic imaging.
Imagion said ultrasound was the most used method for nodal staging but faced diagnostic challenges that can result in variability in sensitivity and specificity and limit assessment of the extent of disease spread.
The MagSense HER2 Imaging Agent uses targeted magnetic nanoparticles designed to add molecular specificity to MRI imaging without using radioactivity.
In a successfully completed Phase I study, independent radiologists found the MagSense HER2 Imaging Agent produced a readily identifiable change in MRI images that differentiated between tumour-involved and non-involved nodes.
Building on Phase I trial
Imagion said the Phase 1b/2 study will establish the optimised dose of the imaging agent and optimum imaging timing while assessing its diagnostic performance.
The trial is designed in three parts as agreed with the FDA, with Part A involving an initial cohort to collect additional safety data.
The reduced dosing regimen and optimised imaging protocol will then be evaluated in a second group of subjects in Part B.
Part C will use a larger cohort to establish the diagnostic performance of MagSense.
Dr Eghtedari at City of Hope hospital in Los Angeles, California, will be the principal investigator for the trial.
Eghtedari is section chief, Women’s Imaging, in the Department of Diagnostic Radiology at the hospital and participated as an independent reviewer of the MagSense HER2 Phase 1 study.
The trial is expected to be completed in 18-24 months, with interim analyses anticipated after Parts A and B.
Imagion said the trial would also provide data on the potential impact of MagSense on cost of care, patient outcomes and overall clinical value.
Integration of quantitative imaging techniques into the protocol is also expected to generate data for the development and training of AI diagnostic tools.
This article was developed in collaboration with Imagion Biosystems, a Stockhead advertiser at the time of publishing.
This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.
