Advances in immunogenicity risk assessment, monitoring and mitigation of biologics - Volume II

This Research Topic is the second volume of https://www.frontiersin.org/research-topics/65424/advances-in-immunogenicity-risk-assessment-monitoring-and-mitigation-of-biologicsThe field of biologic therapeutics is experiencing rapid evolution, with an expanding array of protein-based drugs and advanced modalities such as gene, cell, and nucleic acid-based therapies revolutionizing the management of serious and life-threatening diseases. Despite these advancements, the immune system’s recognition of biologics as foreign can trigger undesirable immune responses, notably the development of anti-drug antibodies and cellular immunity. These responses may compromise therapy durability, reduce efficacy, and lead to adverse patient outcomes. While progress has been made in non-clinical risk assessment, in silico modeling, and clinical immunogenicity monitoring, the prediction and management of immunogenicity remain formidable challenges due to the interplay of product, patient, and treatment variables. Emerging machine learning strategies and integrative modeling are showing promise, but the field continues to face obstacles as new molecular formats and delivery technologies further complicate assessment paradigms. Persistent gaps include the ability to predict immunogenicity liabilities with confidence, translate preclinical findings into clinical outcomes, and enable proactive mitigation across increasingly complex therapeutic landscapes.This Research Topic aims to highlight state-of-the-art advancements and persistent challenges in the immunogenicity risk assessment, monitoring, and mitigation of biologic therapies. The main objectives are to disseminate new findings on integrative non-clinical and clinical risk prediction, innovative monitoring technologies, and best practices in immunogenicity management throughout the drug development continuum. Particular focus will be placed on translational research that bridges novel in silico, in vitro, and in vivo approaches with practical clinical monitoring strategies and intervention pathways. The topic will also explore the repercussions of immunogenicity on safety, efficacy, and business decision-making, while shedding light on novel, patient-centric initiatives and the growing application of artificial intelligence. Contributors are encouraged to address how advances in this multifaceted field are shaping next-generation therapeutic platforms and optimizing patient outcomes.The scope of this Research Topic encompasses both foundational and applied research on immunogenicity assessment and management for biologic therapies, with an emphasis on innovation and translational value across modalities. Submissions focusing solely on traditional biologics are still encouraged, so long as they contribute new insights or methodologies relevant to current challenges. To gather further insights in immunogenicity risk, boundaries include preclinical evaluations through to clinical impact and molecular and business considerations. We welcome articles addressing, but not limited to, the following themes:-Non-clinical immunogenicity risk assessment, including advances in in silico protein engineering models and high-throughput/autonomous risk profiling-Interpretation of preclinical immunogenicity findings in the design and implementation of clinical trial protocols-Innovative clinical immunogenicity monitoring strategies, including retrospective analyses and novel analytical technologies-Clinical consequences of immunogenicity on patient safety and efficacy, including mechanistic insights, predictive approaches, and management of adverse events-Patient-centric strategies to improve understanding, anticipation, and clinical impact of immunogenicity-The influence of immunogenicity risk assessments on business and regulatory decisions during drug development-Integration of artificial intelligence and machine learning in immunogenicity prediction, monitoring, and mitigationArticle types may include original research, reviews, perspectives, methodological advances, case reports, and policy or regulatory analysis. Sophie Tourdot is a full employee of Pfizer Inc.; might hold shares of the company, Lydia Michaut is a full employee of Novartis AG; might hold shares of the company Topic editors: Sophie Tourdot, Tim Hickling, Lydia Michaut Source: https://www.frontiersin.org/research-topics/78641/advances-in-immunogenicity-risk-assessment-monitoring-and-mitigation-of-biologics---volume-ii