Huonslab scores positive result in nonclinical trial of drug co-formulated with Hydiffuze

Huonslab is accelerating the development of a drug that uses Hydiffuze to enhance patient convenience in subcutaneous injections (SC).

[Huonslab]

Huonslab is accelerating the development of a drug that uses Hydiffuze to enhance patient convenience in subcutaneous injections (SC).

The research subsidiary of the biopharmaceutical firm Huons Global announced on Wednesday that animal testing of an antibody drug co-formulated with the recombinant human hyaluronidase confirmed its nonclinical efficacy through a Korean contract research organization.

The tests involved an injection of the antibody drug Herceptin IV/Hydiffuze into the subcutaneous fat under the skin to compare the effects to those of Herceptin SC/Enhanze. The test concluded that the pharmacokinetic effects and diffusion rates were identical.

Comparison tests of Hydiffuze against Mabthera co-formulated with Enhanze in February and October of 2023 confirmed the efficacy of Huonslab’s product, with the biopharmaceutical firm explaining that all three trials demonstrated that its drug’s efficacy in diffusion equals that of Enhanze, as well as the company’s technological capacity to switch the injection route from intravenous to subcutaneous with its new product.

Huonslab will submit the research abstracts of the three nonclinical trials to this year’s meeting of the American Association for Cancer Research, one of the three major professional associations on oncology in the world, where it will present on the efficacy of Hydiffuze.

In July, Huonslab secured a process patent from the Korean Intellectual Property Office for its innovative production method of Hydiffuze and rHuPh20. This method cultivates animal cells with genetic recombination and applies Hydiffuze technology to generate human hyaluronidase in its fullest form, allowing a high yield and purity in the final product.

According to a Freedom-to-Operate analysis by the law firm PADO IP Law PLLC, the patent on rHuPH20 owned by Halozyme will expire in September of 2027 in the United States, having already expired for the rest of the world in March of 2024. As such, Huonslab will register its own process patent for Hidiffuze, which the company is confident will avoid any infringement claims with the Halozyme expiration.

The Korean pharmaceutical will carry out clinical trials of the hyaluronidase HLB3-002 — approved in August by the Ministry of Food and Drug Safety — on 243 healthy adults. A single subcutaneous dose will be given to evaluate the drug’s safety and tolerance.

“Upon completing the clinical study and obtaining Biologics License Applications approval from the Drug Safety Ministry, we expect to secure global competitiveness, and market the drug in the fields of aesthetics and pain management,” said Lim Chae-Young, the chief technology officer of Huonslab Bio Research Institute.

“We also plan to broaden the scope of application to various fields such as antibodies, bispecific antibodies, and antibody drug conjugates, driving the development of SC drugs that offer great convenience and innovation.”

BY KIM YEONSOO [kim.yeonsoo1@joongang.co.kr]