Imagion Biosystems (ASX:IBX) has partnered with ChemConnection to produce MagSense™ nanoparticle formulations for its planned HER2 breast cancer human clinical studies.
ChemConnection is a development and manufacturing company based in the Netherlands, with extensive experience in producing nanoparticle-based products and medicines.
Imagion’s MagSense bio-imaging detection technology uses disease specific targeting nanoparticles and detectors to locate tumours and other diseased cells by their molecular signature.
The manufacturing procedures for the MagSense™ HER2 breast cancer test formulation will be as per current good manufacturing practices (cGMP), a regulatory requirement for human testing.
The method transfer of the proprietary nanoparticle formulation will commence immediately.
ChemConnection will initially produce a pilot lot of material which will be used for stability and toxicity studies that are needed before first-in-human testing can begin.
The safety toxicology studies are expected to commence in the first quarter of 2018.
Imagion commenced trading on the ASX in June 2017 after raising $12 million.
The company’s shares are trading circa 7% higher intra-day, at $0.145.