Research Published in International Journal Highlights Potential Applications to Other Protein Therapeutics
GC Biopharma has developed a new analytical method to detect drug-specific immunoglobulin E (IgE) antibodies that may trigger allergic reactions in patients receiving Hunterase, its treatment for Hunter syndrome.
The South Korean biopharmaceutical company announced on October 13 that the research had been published in the Journal of Immunological Methods, an international scientific journal indexed in the Science Citation Index Expanded (SCIE).
Hunter syndrome is a rare genetic disorder caused by a deficiency of enzymes responsible for breaking down glycosaminoglycans (GAGs) in the body. Enzyme replacement therapy (ERT), which supplies the missing enzyme, is a key treatment approach for the condition.
However, protein-based therapies can trigger immune responses in some patients, leading to the production of anti-drug antibodies (ADAs). Among these, IgE antibodies are of particular concern because they can be associated with acute allergic reactions, including breathing difficulties and a drop in blood pressure.
Accurately identifying these antibodies is therefore important for assessing potential treatment-related hypersensitivity and improving patient safety.
Conventional antibody tests generally determine whether antibodies against a therapeutic drug are present but may not distinguish specific antibody classes. Detecting IgE antibodies is particularly challenging because they circulate in the blood at very low concentrations, making it difficult to establish whether an allergic reaction is directly associated with a particular medication.
GC Biopharma's newly developed assay uses a high-sensitivity enzyme-linked immunosorbent assay (ELISA) to selectively identify IgE antibodies that specifically react with Hunterase, including those present at low concentrations in patients' blood samples.
The company expects the technology to enable more precise assessments of the relationship between Hunterase administration and potential allergic reactions. It could also support more effective monitoring of immune responses during treatment and contribute to broader patient safety management.
Beyond Hunterase, GC Biopharma sees potential for applying the analytical method to other protein-based therapeutics to detect drug-specific IgE antibodies and evaluate immunogenicity, or the ability of a drug to trigger an immune response.
Hong Jung-woon, head of the R&D Quality Management Unit at GC Biopharma, said the assay would provide a foundation for more precise evaluation of drug-specific IgE-mediated hypersensitivity in patients receiving treatment for Hunter syndrome.
He added that the company would continue strengthening its expertise in immunogenicity assessment and analytical technologies to help improve pharmaceutical safety and patient care.
