Huons Lab has secured a patent for a groundbreaking platform technology that converts antibody-drug conjugates (ADCs) into subcutaneous (SC) injections, bolstering its position in next-generation biopharmaceutical formulation technology.
Huons Lab, a subsidiary of Huons Group, announced on Monday that it has successfully patented an ADC subcutaneous injection formulation using its proprietary human-derived hyaluronidase-based platform technology, HyDIFFUZE™.
ADCs, which combine antibodies and drugs to target specific cells such as cancer cells, have seen rapid growth in the global pharmaceutical market. With most approved ADC products currently administered intravenously, there’s a growing interest in subcutaneous injection formulations to improve patient convenience and healthcare efficiency.
The patent covers the application of HyDIFFUZE to ADC subcutaneous injection formulations, focusing on enhancing stability and drug delivery efficiency in high-concentration ADC formulations.
Through extensive formulation research, Huons Lab has demonstrated that their HyDIFFUZE-enhanced ADC subcutaneous injection formulation maintains physical and chemical stability even at high concentrations.
Non-clinical pharmacokinetic studies have shown impressive results, with drug exposure (AUC) improving by up to 126% and maximum plasma concentration (Cmax) increasing by up to 149% compared to formulations without HyDIFFUZE.
The company anticipates that this technology will significantly enhance the initial absorption rate and overall drug exposure for ADC subcutaneous injection formulations. These promising findings were presented at the American Society for Clinical Pharmacology and Therapeutics (ASCPT) conference in March.
A spokesperson for Huons Lab emphasized the significance of this patent, stating that this breakthrough not only validates the applicability of the HyDIFFUZE platform for ADCs but also expands its potential applications. It’s committed to further refining the platform technology and extending its use to various next-generation biopharmaceuticals, with the ultimate goal of global commercialization.
In a related development, Huons Lab is pioneering technology to transform intravenous (IV) antibody drugs into subcutaneous (SC) injections. This innovative approach utilizes hyaluronidase, an enzyme that facilitates drug dispersion by breaking down hyaluronic acid (HA) in subcutaneous tissue.