Ann: First-in-human study update - First patient enrolled, page-5

Whoop there it is!

26 May 2021
First-in-human study update: First patient enrolled
MELBOURNE — Imagion Biosystems Limited (ASX: IBX), a company dedicated to improving healthcare
through the earlier detection of cancer, is pleased to announce that the first patient has been enrolled in the
MagSense® HER2 breast cancer Phase I first-in-human study.
The study, which is expected to enroll approximately 15 patients, is the first clinical investigation of Imagion
Biosystems’ MagSense® nanoparticle technology. This study investigates the use of a MagSense® imaging
agent as a means of aiding in the staging of HER2 positive breast cancer by detecting if the patient’s tumor
has spread to the lymph nodes. Current standard of care requires biopsy or surgical removal of lymph nodes
to confirm metastases. With approximately half of HER2 breast cancer patients having no nodal disease,
the MagSense® HER2 test achieved Breakthrough Device designation from the US FDA based on its
potential to provide a non-invasive way to eliminate unnecessary surgical biopsy procedures and their
resultant morbidities.
“We are very pleased to report our first patient has been enrolled in this ground-breaking study,” said Bob
Proulx, Executive Chairman of Imagion Biosystems. “Though recruiting newly diagnosed cancer patients
into a research study can be challenging, we and our investigators remain confident we will reach our
recruitment target. We are committed to explore all avenues to achieve our goal of completing this important
study.”
Each patient in the study receives an injection of the MagSense® nanoparticle imaging agent and undergoes
imaging by MRI. Additionally, a sample of the lymph node is also assessed using Imagion’s proprietary
MagSense® magnetic relaxometry technology. The primary endpoint of the study is to determine the safety
and tolerability of the MagSense® imaging agent, but the study will also explore the effectiveness of the
nanoparticles for in vivo detection which will inform further development and commercial considerations.
Full study details can be found at ANZCTR under study ID: IBI010103.