Host: The Japanese Society of Toxicology
Name : The 50th Annual Meeting of the Japanese Society of Toxicology
Date : June 19, 2023 - June 21, 2023
The immune system functions through the complex interaction of various immune cells. It is important to evaluate immunotoxicity in the preclinical or clinical phases of drug development because unintended immune response may cause serious adverse effects due to immunosuppression or immunoenhancement. The ICH guidelines require the evaluation of immunotoxicity, and the Immunotoxicity Guideline (ICH S8) describes considerations and test methods for the weight of evidence. Immunotoxicity evaluations, so far, have focused on immunosuppression by small molecule drugs. However, in recent years, the modality of pharmaceuticals has been diversifying, and the description of ICH S8 is not always sufficient. The modalities of pharmaceuticals include small molecule drugs, antibody drugs, cell/gene therapy products, oligonucleotide drugs. In the case of antibody drugs, the cytokine release syndrome observed in the TGN1412 clinical study has raised concerns about toxicity due to immune stimulation, and although not described in the guidelines, pharmaceutical companies and CROs have established in vitro evaluation systems using human cells, and many antibody drugs were evaluated by the assay systems. It is difficult to apply a uniform test system to immunotoxicity concerns in each modality, so assay systems are selected on a case-by-case basis. In this presentation, I will introduce the current situation and regulations, and expect that my presentation will lead to the industry-government-academia cross collaboration.
