Huons Global(084110)'s subsidiary Huons Lab is expanding the use of its subcutaneous (SC) formulation conversion technology by leveraging its in-house–developed recombinant human hyaluronidase platform.
Huons Lab said on the 31st that it completed domestic patent registration for 11 SC formulations of antibody therapeutics applying "HyDIFFUZE" and filed an international patent application under the Patent Cooperation Treaty (PCT). It plans to pursue overseas patent filings in individual countries.
The antibody therapeutics covered by the newly secured patents are 11 types: pembrolizumab, bevacizumab, obinutuzumab, ramucirumab, donanemab, isatuximab, durvalumab, dostarlimab, cetuximab, risankizumab, and dupilumab. Huons Lab applied HyDIFFUZE to each antibody and evaluated nonclinical pharmacokinetic (PK) properties.
In the evaluation, the SC dosing group with HyDIFFUZE showed higher blood drug concentrations and systemic drug exposure than the SC dosing group without it.
By antibody, the maximum blood concentration (Cmax) was about 113%–170% compared with existing SC formulations, and the area under the concentration–time curve (AUC), indicating drug exposure, was about 117%–162%. The company noted that applying HyDIFFUZE suggests the potential to increase systemic drug exposure when antibody therapeutics are administered subcutaneously.
Huons Lab is focusing on the fact that this patent is not a technology applicable to only a single antibody. Having confirmed the potential by applying the platform to 11 different antibody therapeutics, it expects to use it for SC formulation conversion of various antibody therapeutics going forward.
Using HyDIFFUZE, Huons Lab is also pursuing SC conversion for a range of biopharmaceuticals beyond antibody therapeutics, including Antibody-Drug Conjugate (ADC). Recently, it registered a patent for an ADC SC formulation applying HyDIFFUZE.
Commercialization of the platform itself is also underway. Huons Lab applied to the Ministery of Food and Drug Safety in Dec. last year for marketing authorization of a standalone finished goods product of its in-house–developed recombinant human hyaluronidase. The review is in progress, and the company is aiming to obtain authorization within the year.