Imagion Biosystems Limited (ASX: IBX) reports that the first phase of manufacturing of the MagSense HER2 nanoparticle formulation under Good Manufacturing Practice (GMP) conditions has proceeded uninterrupted by the pandemic, and has been completed on time.
The second phase of manufacturing the nanoparticle material is expected to continue on schedule as the Company makes ready for its first human study.
“Saying we are pleased with the progress would be an understatement,” said Bob Proulx, Executive Chairman of Imagion Biosystems.
“We took great care in our preparations before commencing manufacturing and that has paid off. The first step of the production process is the trickiest, so completing this step on schedule is encouraging.”
While manufacturing proceeds, Imagion continues to work on regulatory requirements and clinical site readiness for its upcoming in-human study.
The company is also monitoring the potential impact of the global pandemic, particularly as it relates to possible delays that may arise if the intended study sites are unable to initiate a new clinical study. At present, it appears likely the availability of clinical sites will coincide with the availability of the nanoparticle material later this year.
Imagion Biosystems is developing a new non-radioactive and safe diagnostic imaging technology. Combining biotechnology and nanotechnology the company aims to detect cancer and other diseases earlier and with higher specificity than is currently possible.
The company recently entered into a collaboration agreement with Siemens Healthcare Pty Ltd of Australia (Siemens Healthineers) to further explore the utility of Imagion’s MagSense nanoparticles as an MRI contrast agent.
The collaboration will see Siemens Healthineers work with Imagion to identify optimal MRI scanning protocols for the MagSense HER2 targeted nanoparticles. Siemens Healthineers in-kind contribution of expertise and provision of technical support to clinical sites will be valuable should Imagion undertake a study in Australia which includes MRI scans.
Imagion has previously announced that it is planning for its first clinical study of the MagSense technology in HER2 breast cancer patients.
The MagSense nanoparticles are designed to be detectable only when attached to cancer cells providing a specific means of cancer imaging, and has a received Breakthrough Device designation from the US Food and Drug Administration (FDA).