Proceedings of the 15th European immunogenicity platform open symposium on immunogenicity of biopharmaceuticals

Abstract

The European Immunogenicity Platform (EIP) celebrated the 15th edition of its Open Symposium on Immunogenicity of Biopharmaceuticals and its associated one-day workshop on 22–24 February 2024 in Lisbon. The meeting attracted experts and newcomers across industry, regulatory agencies, and academia, who actively participated in 3 days of discussion on risk assessment, monitoring, and mitigation of unwanted immunogenicity of biologics. Besides oral presentations, poster sessions were held to maximize scientific exchange and networking opportunities. Therapeutic proteins and emerging gene and cell-based therapies present promising therapeutic options for addressing unmet medical needs or when conventional treatment approaches have failed. Nonetheless, the development of an immune response against these therapeutic agents is a significant concern, as it occurs in a considerable number of cases across various products and indications. The specific anti-drug antibodies that develop can lead to adverse safety events, inhibition of drug activity, or accelerated clearance, all of which result in a loss of treatment efficacy. The EIP serves as a forum for experts and newcomers in the immunogenicity field, fostering discussion among scientists from industry and academia, encouraging interactions with regulatory agencies, and disseminating knowledge and advancements in immunogenicity sciences to the broader scientific community. This report covers the main topics discussed during the EIP 15th Open Symposium on Immunogenicity of Biopharmaceuticals, and the one-day workshop on practical aspects of immunogenicity held prior to the conference. Key topics included immunogenicity testing, clinical relevance of immunogenicity, immunogenicity risk assessment and mitigation, and current regulatory considerations.

Keywords

• immunogenicity
• anti-drug antibody
• ADA
• risk assessment
• clinical relevance