Host: The Japanese Society of Toxicology
Name : The 49th Annual Meeting of the Japanese Society of Toxicology
Date : June 30, 2022 - July 02, 2022
Regenerative medical products (cellular and tissue-based products/gene therapeutic products) including chimeric antigen receptor (CAR)-modified T cells, adeno-associated virus vector, and oncolytic virus have been approved one after another. Some of the new products have been under research and development by academic institutions in Japan, which would facilitate not only curative potential but also great economic success. To promote the clinical application and further commercialization of Japanese -made regenerative medical products in international markets, we need to clear the product-specific safety concerns. Cell- or virus-based products can often induce immunotoxicity. Therefore, the toxicity data obtained by the non-clinical studies using rodents, which critically different have immune system and/or antigen homology from humans, would be insufficient to ensure the safety of those products.
In order to clear the safety concerns, we have developed a standardized non-clinical safety evaluation system and infrastructure for studies using non-human primates (NHP) with the support of AMED. First, we established two methods to evaluate non-clinical safety of CAR-T cells using cynomolgus monkeys (autologous model, Morokawa et al. Clin Transl Immunology 2020); xenograft model, Yagyu et al. Clin Transl Immunology 2021), leading to first-in-human (FIH) trials of a novel CAR-T cells. Second, we set up an open research facility for non-clinical study using NHP, Center for Advanced Research of Gene and Cell Therapy in Shinshu University (CARS) Ina Research lab in 2019. We have already performed 8 types of non-clinical safety studies using cynomolgus monkeys there, and moreover strengthened the equipment under the Cartagena Protocol on biosafety to be able to handle viral vectors in 2022. In this meeting, I will introduce our development in CARS.
