The MHC Associated Peptide Proteomics assay is a useful tool for the non-clinical assessment of immunogenicity

Frontiers in Immunology

Immunology

Edward Cloake¹  Campbell Bunce¹  Ricardo Resende¹  Zuben E. Sauna²  Wojciech Jankowski²  Christopher Kidchob² 

[1] Abzena, Cambridge, United Kingdom;Hemostasis Branch 1, Division of Hemostasis, Office of Plasma Protein Therapeutics, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD, United States;

关键词: therapeutic protein;    immunogenicity;    MAPPS;    HLA;    protein engineering;    anti-drug antibodies;   

DOI  :  10.3389/fimmu.2023.1271120

 received in 2023-08-01, accepted in 2023-09-13,  发布年份 2023

来源: Frontiers

【 摘 要 】

The propensity of therapeutic proteins to elicit an immune response, poses a significant challenge in clinical development and safety of the patients. Assessment of immunogenicity is crucial to predict potential adverse events and design safer biologics. In this study, we employed MHC Associated Peptide Proteomics (MAPPS) to comprehensively evaluate the immunogenic potential of re-engineered variants of immunogenic FVIIa analog (Vatreptacog Alfa). Our finding revealed the correlation between the protein sequence affinity for MHCII and the number of peptides identified in a MAPPS assay and this further correlates with the reduced T-cell responses. Moreover, MAPPS enable the identification of “relevant” T cell epitopes and may contribute to the development of biologics with lower immunogenic potential.

【 授权许可】

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Copyright © 2023 Jankowski, Kidchob, Bunce, Cloake, Resende and Sauna