- Imagion Biosystems (IBX) is ready to start manufacturing its MagSense nanoparticle formula for a HER2 breast cancer study
- HER2 is a gene in the human body that can play a role in the development of breast cancer and tends to be more aggressive than other types
- Imagion has spent the past quarter making sure its partners are ready to begin production of the MagSense, which will be used in the study
- MagSense uses highly sensitive detectors to locate tumours and other diseased cells in the body
- Imagion has bought equipment and supplies to begin the study, and has already completed the necessary qualifications
- With these steps completed the company can now begin manufacturing
- Imagion's share price is currently grey with shares trading for 2.8 cents apiece
Imagion Biosystems (IBX) is ready to begin manufacturing its MagSense cancer treatment nanoparticle formula.
The company told shareholders of the manufacturing progress in a business update this morning. The MagSense particles are a core part of Imagion's first study for detecting HER2 metastatic breast cancer.
HER2 (human epidermal growth factor receptor 2) is a gene in the human body that can play a role in the development of breast cancer and tends to be more aggressive than other types of cancer.
The primary operational focus for the company this past quarter has been ensuring the readiness of its partners to begin manufacturing MagSense, which will be used in the study.
Imagion's MagSense technology uses disease-specific targeting nanoparticles and highly sensitive detectors to find tumours and other diseased cells.
According to Imagion, MagSense does not use radiation, radioactive tracers or strong magnetic fields like other cancer detecting technologies. Rather, it works by using tiny bio-safe nanoparticles coated with tumour targeting antibodies.
These nanoparticles produce a detectable magnetic signature which enables MagSense to locate the particles which become attached to cancer cells.
If there are no tumours present, the nanoparticles circulate the body until being eventually broken down by the liver.
Imagion has purchased equipment and supplies to begin the study and has already completed the necessary qualifications to confirm compliance with Good Manufacturing Practice (GMP).
These qualifications are required for the manufacturing of medical and pharmaceutical devices and products that will be used in clinical human studies.
With these steps completed, Imagion will now begin manufacturing.
"With this being the first time our nanoparticle product is to be used in a human study, we have taken great care in our preparations to ensure we could move forward with confidence into manufacturing and achieve the exacting standards required of GMP manufacturing processes," Executive Chairman Bob Proulx said.
While manufacturing proceeds, Imagion will continue to work on other key areas needed to support a study which is expected later this year once manufacturing is completed.
This includes establishing and preparing clinical sites for subject enrolment and receiving necessary regulatory authorisations such as from the U.S. FDA.
Imagion's share price is currently grey with shares trading for 2.8 cents apiece at 12:47 pm AEDT.