An overview of immune safety avatar: mimicking the effects of immunomodulatory therapies on the immune system

Innovative therapeutics like biologicals that modulate the immune system are on the rise. However, their advantage can also harbor risks in terms of the induction of adverse effects. Due to the complexity and target-specificity of such therapeutics, these drug-induced adverse events are often overlooked or remain undetected during non-clinical development and only emerge in clinical development when tested in humans. To identify adverse effects on the human immune system at an early stage, new approaches, assays, and technologies are needed. The IMI cooperation Immune Safety Avatar (imSAVAR) project aims to develop a standard for integrated nonclinical safety assessment for immune-modulatory new therapeutic drugs and clinical trial applications. To achieve this goal, imSAVAR has relied on the Adverse Outcome Pathway (AOPs) framework to gather knowledge in a structured approach in order to design, select or develop, when needed, appropriate test systems for prediction of the immune-related adverse outcomes. The imSAVAR work described in this special issue of The Journal of Immunopharmacology and Immunotoxicology supports our understanding of immune-mediated adverse effects and their early discovery during development to improve the safety of innovative biomedicals.

NEUHAUS Vanessa;  CLERBAUX Laure-Alix;  SEWALD Katherina; 

2025-01-10

TAYLOR & FRANCIS LTD

JRC134505

0892-3973 (online),   

https://www.tandfonline.com/doi/full/10.1080/1547691X.2024.2354213#abstract,    https://publications.jrc.ec.europa.eu/repository/handle/JRC134505,   

10.1080/1547691X.2024.2354213 (online),