 Dr. Peng Li
Associate Director, Global Safety Headquarters
Eisai
Japan |
Title:
Data-Driven Immunogenicity Risk Assessment to Guide Antibody Therapeutic Development
Abstract:
Antibody therapeutic development requires early control of immunogenicity risks, as most protein drugs can elicit anti drug antibodies that impact efficacy, safety, and pharmacokinetics. This presentation introduces an integrated immunogenicity risk assessment (IRA) approach combining in silico T cell epitope prediction with in vitro DC:T cell assays and biophysical analyses. Together, these methods provide rapid sequence level risk screening and functional measurement of CD4⁺ T cell activation—via proliferation, stimulation above background, and Response Index (RI)—to sensitively identify potential T cell epitopes in antibody candidates.
A case study in collaboration with ProImmune illustrates how these complementary platforms can be operationalized within preclinical programs to inform lead candidate selection. Integrating in silico scoring, DC:T cell assay data, pharmacodynamic profiles, and biophysical properties supports a holistic, data driven decision making framework. Importantly, such integration also provides financial and strategic value: early risk visibility enables developers to better quantify the overall liability of a molecule, reduce late stage failures, and accelerate go/no go decisions—ultimately improving the efficiency and cost effectiveness of program progression.
This talk summarizes practical strategies, assay principles, and key learnings from applying an integrated immunogenicity assessment approach to real world candidate optimization, highlighting both scientific and economic advantages of early, data rich immunogenicity evaluation.
Biography:
Dr. Peng Li was born in Xi’an, China, and relocated to Japan in 2010 to pursue advanced studies. He earned his Ph.D. from the University of Tokyo in 2017, conducting immunology research on inflammatory bowel disease within the Department of Applied Biological Chemistry.
In 2016, during his doctoral program, he served as a visiting research fellow at the University of Nottingham Medical School, where he focused on chronic obstructive pulmonary disease (COPD).
Upon completing his doctorate, Dr. Li joined the Graduate School of Medicine at Kyoto University as a postdoctoral researcher in the laboratory of Prof. Tasuku Honjo—recipient of the 2018 Nobel Prize in Physiology or Medicine—where he engaged in cutting-edge cancer immunology research.
In 2019, Dr. Li began his industry career at Eisai as a scientist specializing in cancer immunology and led several antibody drug development programs. He currently holds the position of Director at Eisai’s Global Safety Headquarters.
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