Magnetics Business & Technology - September/October 2021 - 26

INDUSTRY NEWS
Imagion Biosystems Begins Clinical Studies on MagSense Particles for Cancer Detection
which will inform further development and commercial considerations.
Combining
biotechnology and nanotechnology, Imagion aims to
detect cancer and other diseases earlier and with higher specificity
than is currently possible. Composed of superparamagnetic
iron oxide magnetite (Fe3O4) with tight control of size, shape, and
dispersity, its particles are ideal for a wide variety of biomedical
applications, says the company. The finished particles, depicted at
top, have a protective polymer coating around the nanoparticle core
to provide stability in aqueous suspensions, then a polyethylene
glycol stealth coating for biological applications, and then antibody
conjugates to provide molecular specificity for targeting cells.
Imagion Biosystems is progressing to clinical studies of the efficacy
of its MagSense magnetic particles for early detection of cancer,
marking an important advancement for the Melbourne biotech firm
that is pioneering the application of magnetic particles beyond laboratory
studies to use in human patients. Breast cancer is the target
of the new clinical study but Imagion is also working on the potential
application of MagSense to brain cancer.
In May, it enrolled the first patient in its HER2 breast cancer Phase
I first-in-human study. Expected to enroll approximately 15 patients,
it is the first clinical investigation of the company's nanoparticle
technology. The 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 U.S. Food & Drug Administration 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. " 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. "
Based on the principles of superparamagnetic relaxometry, the tiny
magnetic nanoparticles produce a detectable magnetic signature if
attached to the targeted diseased tissue because they " relax " slowly
from a brief weak magnetic field. If there is no tumor present, the
bio-safe nanoparticles relax too quickly to be detectable and harmlessly
circulate, eventually being broken down by the liver through
normal metabolic processes.
Targeting brain cancer, Imagion recently began a collaborative
research program with another Australian biotech firm aimed at exploring
whether their combined technologies can improve imaging
and diagnosis of brain tumors. The partner is Patrys Ltd, a therapeutic
antibody development company whose novel deoxymabs are
attracted to the DNA fragments released from dying tumor cells and
are able to penetrate and kill tumor cells. The collaboration aims
to pair the targeting specificity of the deoxymabs with the imaging
capabilities of the MagSense technology to provide a highly effective
imaging agent with high specificity for hard-to-diagnose cancers
such as brain cancer.
Bob Proulx,
executive chairman
of Imagion
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
26 Magnetics Business & Technology * September/October 2021
" Initially, we are very keen to investigate the potential for brain
tumor imaging since there is such a high unmet need for differentiating
cancerous tumors in the brain, like glioblastoma, as well as
metastatic disease that has spread to the brain from other primary
tumors, " said Proulx. Preliminary research by Imagion has demonstrated
that the Patrys PAT-DX1 molecule can be conjugated
to the MagSense nanoparticles and provide bio-functionality for
targeting certain cancer cell lines. Should this further collaborative
work provide positive results, Imagion will have an exclusive option
to a future license agreement, should it elect to commercialize the
imaging agent.
For more info, see www.imagionbiosystems.com.
www.MagneticsMag.com
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Magnetics Business & Technology - September/October 2021

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