Huons Lab announced on the 5th that it has confirmed the potential to convert antibodies and antibody-drug conjugates (ADCs) into subcutaneous (SC) injection formulations by using recombinant human-derived hyaluronidase.

On the 4th (local time), at the annual meeting of the American Society for Clinical Pharmacology and Therapeutics held in Colorado, United States, Huons Lab presented preclinical study results evaluating the applicability of its human-derived hyaluronidase platform “HyDIFFUSE” to antibodies and ADCs.

Hyaluronidase is an enzyme that promotes the diffusion and absorption of drugs and infusion fluids. In the study, pharmacokinetic tests were conducted comparing HyDIFFUSE-applied formulations with existing formulations for 11 monoclonal antibodies (mAbs) and 3 ADCs. In tests conducted on laboratory mice, HyDIFFUSE-based high-concentration formulations showed a 116–162% increase in drug exposure (AUCt) and a 113–170% increase in maximum plasma drug concentration (Cmax) compared with existing substances.

The company also explained that even under conditions where the antibody dose was reduced by approximately 25% in the HyDIFFUSE formulation, AUCt and Cmax levels similar to those of existing high-concentration formulations were observed.

Based on these results, Huons Lab expects that when antibody therapeutics are administered subcutaneously, it may be possible to reduce the dose while maintaining a similar level of efficacy.

The company further stated that the platform has potential applicability not only to antibody therapeutics but also to various next-generation biopharmaceuticals, including nucleic acid therapeutics, bispecific antibodies, and proteolysis-targeting chimeras (PROTACs).

A company representative said, “We plan to continue research and development to expand the application scope of HyDIFFUSE-based formulation technology.”

Huons Lab filed for domestic marketing authorization in December last year for “HyDIzyme Inj.,” a recombinant human hyaluronidase using HyDIFFUSE technology. Following approval, the company plans to launch it as a standalone product in fields such as cosmetic surgery, dermatology, and treatment of pain and edema, according to the company.

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