Huonslab secures Korean patent for HyDIFFUZE applications in 11 antibody therapeutics

[Min Ji-Son, Edaily Reporter] Huonslab, the R&D subsidiary of Huons Global, has secured intellectual property rights to expand the application scope of its recombinant human hyaluronidase-based formulation conversion platform.

The company said on Aug. 31 that it has secured domestic patent registration and completed PCT international patent filing for 11 pharmaceutical formulation for subcutaneous(SC) injection comprising therapeutic antibody and hyaluronidase, its proprietary human-derived hyaluronidase-based platform technology, HyDIFFUZE. The company plans to proceed with patent applications in individual overseas countries in the future.

Huonslab applied HyDIFFUZE to different antibody therapeutics—Pembrolizumab, Bevacizumab, Obinutuzumab, Ramucirumab, Donanemab, Isatuximab, Durvalumab, Dostarlimab, Cetuximab, Risankizumab, and Dupilumab—and evaluated their pharmacokinetic characteristics.

In non-clinical pharmacokinetic(PK) evaluations, the SC administration group treated with HyDIFFUZE demonstrated a peak plasma concentration (Cmax) and systemic drug exposure (Area Under the Curve, AUC) for each antibody of approximately 113% to 170%, and 117% to 162%, respectively, compared to the SC administration group without HyDIFFUZE.

The results showed that applying HyDIFFUZE to subcutaneous antibody therapeutics could improve systemic drug exposure.

With these findings, Huonslab expects to be able to develop SC formulation-converted drugs using HyDIFFUZE across a variety of antibodies, not limited to specific ones.

In the recent global biopharmaceutical market, interest in SC formulations continues to rise as they enhance patient convenience and shorten administration time in medical institutions. As efforts are growing to convert antibody therapeutics traditionally administered via intravenous(IV) injection into SC formulations, SC drug delivery platforms capable of effectively delivering high-dose antibody therapeutics subcutaneously are gaining attention.

Lim Chae-young, Chief Technical Officer at Huonslab, stated, “This patent registration is significant in that we have confirmed the applicability of HyDIFFUZE to various antibody therapeutics, rather than a specific antibody, and secured our intellectual property rights.” He added, “We plan to expand the application scope of HyDIFFUZE to diverse biotherapeutics, including antibody therapeutics, while continuously strengthening our intellectual property rights and commercialization foundation.”

Based on HyDIFFUZE, Huonslab is promoting R&D and commercialization for the SC conversion of various biotherapeutics, including Antibody-Drug Conjugates (ADCs). The company has recently expanded its platform application scope and IP portfolio by registering patents for ADC applications using hyaluronidase.

Meanwhile, Huonslab is undergoing regulatory review by South Korea‘s Ministry of Food and Drug Safety(MFDS) to secure marketing authorization for HYDIZYME Injection, its standalone recombinant hyaluronidase product, within this year.