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Evaluation of efficacy and safety of gene-manufacturing silkworm-derived human alpha-iduronidase to a Japanese monkey affected by mucopolysaccharidosis type I

Silkworm is a traditionally domesticated and sustainable insect for the industrial production of silk. Based on the remarkable ability of silkworms to overproduce silk proteins in silk glands and recent transgenic technology, gene-manufacturing (GM) silkworm strains have been developed to produce large amounts of drug substances for antibody pharmaceuticals and enzyme replacement therapy at a lower cost. Also, silkworms can be utilized for drug screening and efficacy evaluation due to the similarity in pharmacokinetics and drug response between humans and silkworms. In addition, silkworms, out of a target of animal welfare, are expected as substitution models for animal experiments. In this symposium, we introduce the recent advance in developing GM-silkworm overproducing glycoproteins available for biomedicine as GMP-grade pharmaceutical base materials. The safety and efficacy of glycol-engineered human lysosomal enzymes (CTSA and IDUA) for the disease model animals with the genetic enzyme deficiency will be presented. Furthermore, an application case of silkworms as human disease model reflecting cytokine storm pathology will be introduced.

The forefront of drug discovery utilizing silkworms - Application for production of human biologics and disease models

The 142nd Annual Meeting of the Pharmaceutical Society of Japan (Nagoya)

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[S12-4]Evaluation of efficacy and safety of gene-manufacturing silkworm-derived human alpha-iduronidase to a Japanese monkey affected by mucopolysaccharidosis type I

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