GC Biopharma develops precise test for antibodies linked to allergic reactions to Hunter syndrome treatment

[Financial News] GC Biopharma has developed a test to precisely identify the causes of allergic reactions that may occur after treatment for Hunter syndrome. The technology detects antibodies that react specifically to the treatment and is expected to be used to help manage patient safety.
GC Biopharma said on the 13th that it had developed an assay to detect IgE antibodies that react specifically to Hunterase, a treatment for Hunter syndrome. 
Hunter syndrome is a rare disease caused by a deficiency of an enzyme that breaks down glycosaminoglycans (GAGs), a particular type of carbohydrate in the body. The main treatment is enzyme replacement therapy (ERT), which periodically replenishes the deficient enzyme.
However, some patients’ immune systems may recognize protein-based treatments as foreign substances and produce antibodies. Among these, immunoglobulin E (IgE) antibodies can trigger acute allergic reactions, such as difficulty breathing or a drop in blood pressure, making it important to identify them accurately.
Although existing tests could determine whether antibodies reacting to a treatment were present, they had limitations in distinguishing between antibody types. In particular, the tests struggled to detect the extremely small amounts of IgE antibodies in the blood, limiting the assessment of whether an allergic reaction was linked to a specific drug.
GC Biopharma developed an assay that uses enzyme-linked immunosorbent assay (ELISA) to sensitively detect Hunterase-specific IgE antibodies in the blood. The company expects this will make it possible to assess more precisely whether allergic reactions occurring after treatment are related to the drug.
The company plans to consider using the technology not only to detect drug-specific IgE antibodies for Hunterase, but also for other protein-based treatments, and to assess their immunogenicity. Immunogenicity refers to a treatment’s ability to trigger an immune response in the body.
Hong Jeong-un, head of GC Biopharma’s R&D QM Unit, said, “This assay will provide a basis for precisely assessing drug-specific IgE hypersensitivity reactions in patients being treated for Hunter syndrome,” adding, “We will continue to build our capabilities in assessing the immunogenicity of medicines and in analytical technologies, and contribute to improving patient safety.”
The findings were published in the international journal Journal of Immunological Methods.

[email protected] Sang-hee Jeong Reporter