Walsh RE, Lannan M, Wen Y, Wang X, Moreland CA, Willency J, et al. Post-hoc assessment of the immunogenicity of three antibodies reveals distinct immune stimulatory mechanisms. mAbs. 2020;12(1):1764829.
Jenkins MK, Moon JJ. The role of naive T cell precursor frequency and recruitment in dictating immune response magnitude. J Immunol. 2012;188(9):4135–40.
Article CAS PubMed Google Scholar
Delluc S, Ravot G, Maillere B. Quantitative analysis of the CD4 T-cell repertoire specific to therapeutic antibodies in healthy donors. FASEB J. 2011;25(6):2040–8.
Article CAS PubMed Google Scholar
Hamze M, Meunier S, Karle A, Gdoura A, Goudet A, Szely N, et al. Characterization of CD4 T cell epitopes of infliximab and rituximab identified from healthy donors. Front Immunol. 2017;8:500.
Article PubMed PubMed Central Google Scholar
Ducret A, Ackaert C, Bessa J, Bunce C, Hickling T, Jawa V, et al. Assay format diversity in pre-clinical immunogenicity risk assessment: toward a possible harmonization of antigenicity assays. MAbs. 2022;14(1):1993522.
Deora A, Hegde S, Lee J, Choi CH, Chang Q, Lee C, et al. Transmembrane TNF-dependent uptake of anti-TNF antibodies. MAbs. 2017;9(4):680–95.
Article CAS PubMed PubMed Central Google Scholar
Xue L, Hickling T, Song R, Nowak J, Rup B. Contribution of enhanced engagement of antigen presentation machinery to the clinical immunogenicity of a human interleukin (IL)-21 receptor-blocking therapeutic antibody. Clin Exp Immunol. 2016;183(1):102–13.
Article CAS PubMed Google Scholar
Wen Y, Cahya S, Zeng W, Lin J, Wang X, Liu L, et al. Development of a FRET-based assay for analysis of mAbs internalization and processing by dendritic cells in preclinical immunogenicity risk assessment. AAPS J. 2020;22(3):68.
Article CAS PubMed Google Scholar
Jawa V, Terry F, Gokemeijer J, Mitra-Kaushik S, Roberts BJ, Tourdot S, et al. T-cell dependent immunogenicity of protein therapeutics pre-clinical assessment and mitigation–updated consensus and review 2020. Front Immunol. 2020;11(1301):1–23.
Murphy K, Casey W. Janeway’s Immunobiology. Ninthe. New York: Garland Science; 2017.
Wen Y, Jawa V. The impact of product and process related critical quality attributes on immunogenicity and adverse immunological effects of biotherapeutics. J Pharm Sci. 2021;110(3):1025–41.
Article CAS PubMed Google Scholar
Jarvi NL, Balu-Iyer SV. Immunogenicity challenges associated with subcutaneous delivery of therapeutic proteins. BioDrugs. 2021;35(2):125–46.
Article PubMed PubMed Central Google Scholar
Colella P, Ronzitti G, Mingozzi F. Emerging issues in AAV-mediated in vivo gene therapy. Mol Ther Methods Clin Dev. 2018;8:87–104.
Article CAS PubMed Google Scholar
Grimaldi C, Finco D, Fort MM, Gliddon D, Harper K, Helms WS, et al. Cytokine release: a workshop proceedings on the state-of-the-science, current challenges and future directions. Cytokine. 2016;85:101–8.
Article CAS PubMed Google Scholar
Shimabukuro-Vornhagen A, Gödel P, Subklewe M, Stemmler HJ, Schlößer HA, Schlaak M, et al. Cytokine release syndrome. J Immunother Cancer. 2018;6(1):56.
Article PubMed PubMed Central Google Scholar
Vessillier S, Eastwood D, Fox B, Sathish J, Sethu S, Dougall T, et al. Cytokine release assays for the prediction of therapeutic mAb safety in first-in man trials–whole blood cytokine release assays are poorly predictive for TGN1412 cytokine storm. J Immunol Methods. 2015;424:43–52.
Article CAS PubMed PubMed Central Google Scholar
Finco D, Grimaldi C, Fort M, Walker M, Kiessling A, Wolf B, et al. Cytokine release assays: current practices and future directions. Cytokine. 2014;66(2):143–55.
Article CAS PubMed Google Scholar
Vessillier S, Fort M, O’Donnell L, Hinton H, Nadwodny K, Piccotti J, et al. Development of the first reference antibody panel for qualification and validation of cytokine release assay platforms - report of an international collaborative study. Cytokine X. 2020;2(4): 100042.
Article CAS PubMed PubMed Central Google Scholar
Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, et al. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014;124(2):188–95.
Article CAS PubMed PubMed Central Google Scholar
Quarmby V, Phung QT, Lill JR. MAPPs for the identification of immunogenic hotspots of biotherapeutics; an overview of the technology and its application to the biopharmaceutical arena. Expert Rev Proteomics. 2018;15(9):733–48.
Article CAS PubMed Google Scholar
Kropshofer H, Singer T. Overview of cell-based tools for pre-clinical assessment of immunogenicity of biotherapeutics. J Immunotoxicol. 2006;3(3):131–6.
Paul S, Lindestam Arlehamn CS, Scriba TJ, Dillon MB, Oseroff C, Hinz D, et al. Development and validation of a broad scheme for prediction of HLA class II restricted T cell epitopes. J Immunol Methods. 2015;422:28–34.
Article CAS PubMed PubMed Central Google Scholar
Zinsli LV, Stierlin N, Loessner MJ, Schmelcher M. Deimmunization of protein therapeutics - recent advances in experimental and computational epitope prediction and deletion. Comput Struct Biotechnol J. 2021;19:315–29.
Article CAS PubMed Google Scholar
Moise L, Song C, Martin WD, Tassone R, De Groot AS, Scott DW. Effect of HLA DR epitope de-immunization of factor VIII in vitro and in vivo. Clin Immunol. 2012;142(3):320–31.
Article CAS PubMed Google Scholar
Ridker PM, Tardif JC, Amarenco P, Duggan W, Glynn RJ, Jukema JW, et al. Lipid-reduction variability and antidrug-antibody formation with Bococizumab. N Engl J Med. 2017;376(16):1517–26.
Article CAS PubMed Google Scholar
Hua F, Comer GM, Stockert L, Jin B, Nowak J, Pleasic-Williams S, et al. Anti-IL21 receptor monoclonal antibody (ATR-107): safety, pharmacokinetics, and pharmacodynamic evaluation in healthy volunteers: a phase I, first-in-human study. J Clin Pharmacol. 2014;54(1):14–22.
Article CAS PubMed Google Scholar
Welt S, Ritter G, Williams C Jr, Cohen LS, John M, Jungbluth A, et al. Phase I study of anticolon cancer humanized antibody A33. Clin Cancer Res. 2003;9(4):1338–46.
Stern LJ, Santambrogio L. The melting pot of the MHC II peptidome. Curr Opin Immunol. 2016;40:70–7.
Article CAS PubMed PubMed Central Google Scholar
Jiskoot W, Kijanka G, Randolph TW, Carpenter JF, Koulov AV, Mahler HC, et al. Mouse models for assessing protein immunogenicity: lessons and challenges. J Pharm Sci. 2016;105(5):1567–75.
Article CAS PubMed PubMed Central Google Scholar
Wickramarachchi D, Steeno G, You Z, Shaik S, Lepsy C, Xue L. Fit-for-purpose validation and establishment of assay acceptance and reporting criteria of dendritic cell activation assay contributing to the assessment of immunogenicity risk. AAPS J. 2020;22:114.
Wullner D, Zhou L, Bramhall E, Kuck A, Goletz TJ, Swanson S, et al. Considerations for optimization and validation of an in vitro PBMC derived T cell assay for immunogenicity prediction of biotherapeutics. Clin Immunol. 2010;137(1):5–14.
Article CAS PubMed Google Scholar
Jawa V, Cousens LP, Awwad M, Wakshull E, Kropshofer H, De Groot AS. T-cell dependent immunogenicity of protein therapeutics: preclinical assessment and mitigation. Clin Immunol. 2013;149(3):534–55.
Article CAS PubMed Google Scholar
Bertolini TB, Shirley JL, Zolotukhin I, Li X, Kaisho T, Xiao W, et al. Effect of CpG depletion of vector genome on CD8(+) T cell responses in AAV gene therapy. Front Immunol. 2021;12: 672449.
Article CAS PubMed PubMed Central Google Scholar
Konkle BA, Walsh CE, Escobar MA, Josephson NC, Young G, von Drygalski A, et al. BAX 335 hemophilia B gene therapy clinical trial results: potential impact of CpG sequences on gene expression. Blood. 2021;137(6):763–74.
Article CAS PubMed PubMed Central Google Scholar
Wright JF. Codon modification and PAMPs in clinical AAV vectors: the tortoise or the hare? Mol Ther. 2020;28(3):701–3.
Article CAS PubMed PubMed Central Google Scholar
Verdera HC, Kuranda K, Mingozzi F. AAV vector immunogenicity in humans: a long journey to successful gene transfer. Mol Ther. 2020;28(3):723–46.
Article CAS PubMed PubMed Central Google Scholar
Mingozzi F, High KA. Immune responses to AAV vectors: overcoming barriers to successful gene therapy. Blood. 2013;122(1):23–36.
留言 (0)