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1. 10 th European immunogenicity platform open symposium on immunogenicity of biopharmaceuticals.

Author

Tourdot S, Abdolzade-Bavil A, Bessa J, Broët P, Fogdell-Hahn A, Giorgi M, Jawa V, Kuranda K, Legrand N, Pattijn S, Pedras-Vasconcelos JA, Rudy A, Salmikangas P, Scott DW, Snoeck V, Smith N, Spindeldreher S, and Kramer D

Subjects
Animals, Europe, Humans, Antibodies immunology, Biological Products immunology
Abstract

Therapeutic proteins and emerging gene and cell-based therapies are attractive therapeutic tools for addressing unmet medical needs or when earlier conventional treatment approaches failed. However, the development of an immune response directed against therapeutic agents is a significant concern as it occurs in a substantial number of cases across products and indications. The specific anti-drug antibodies that develop can lead to safety adverse events as well as inhibition of drug activity or accelerated clearance, both phenomena resulting in loss of treatment efficacy. The European Immunogenicity Platform (EIP) is a meeting place for experts and newcomers to the immunogenicity field, designed to stimulate discussion amongst scientists across industry and academia, encourage interactions with regulatory agencies and share knowledge and the state-of-the-art of immunogenicity sciences with the broader scientific community. Here we report on the main topics covered during the EIP 10th Open Symposium on Immunogenicity of Biopharmaceuticals held in Lisbon, 26-27 February 2019, and the 1-d training course on practical and regulatory aspects of immunogenicity held ahead of the conference. These main topics included immunogenicity testing, clinical relevance of immunogenicity, immunogenicity prediction, regulatory aspects, tolerance induction as a mean to mitigate immunogenicity and immunogenicity in the context of gene therapy.

Published
2020
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2. Long-term exposure to Myozyme results in a decrease of anti-drug antibodies in late-onset Pompe disease patients.

Author

Masat E, Laforêt P, De Antonio M, Corre G, Perniconi B, Taouagh N, Mariampillai K, Amelin D, Mauhin W, Hogrel JY, Caillaud C, Ronzitti G, Puzzo F, Kuranda K, Colella P, Mallone R, Benveniste O, and Mingozzi F

Subjects
Adult, Age of Onset, Aged, Case-Control Studies, Dendritic Cells immunology, Enzyme Replacement Therapy methods, Female, Humans, Immunoglobulin G blood, Interleukin-2 blood, Male, Middle Aged, T-Lymphocytes immunology, Treatment Outcome, alpha-Glucosidases administration & dosage, Antibodies blood, Enzyme Replacement Therapy adverse effects, Glycogen Storage Disease Type II drug therapy, Glycogen Storage Disease Type II immunology, alpha-Glucosidases adverse effects, alpha-Glucosidases immunology
Abstract

Immunogenicity of recombinant human acid-alpha glucosidase (rhGAA) in enzyme replacement therapy (ERT) is a safety and efficacy concern in the management of late-onset Pompe disease (LOPD). However, long-term effects of ERT on humoral and cellular responses to rhGAA are still poorly understood. To better understand the impact of immunogenicity of rhGAA on the efficacy of ERT, clinical data and blood samples from LOPD patients undergoing ERT for >4 years (n = 28) or untreated (n = 10) were collected and analyzed. In treated LOPD patients, anti-rhGAA antibodies peaked within the first 1000 days of ERT, while long-term exposure to rhGAA resulted in clearance of antibodies with residual production of non-neutralizing IgG. Analysis of  T cell responses to rhGAA showed detectable T cell reactivity only after in vitro restimulation. Upregulation of several cytokines and chemokines was detectable in both treated and untreated LOPD subjects, while IL2 secretion was detectable only in subjects who received ERT. These results indicate that long-term ERT in LOPD patients results in a decrease in antibody titers and residual production of non-inhibitory IgGs. Immune responses to GAA following long-term ERT do not seem to affect efficacy of ERT and are consistent with an immunomodulatory effect possibly mediated by regulatory T cells., Competing Interests: Pascal Laforet has received grants and honoraria from Genzyme Company, and honoraria from BioMarin and Amicus Therapeutics and all the other authors declare no competing financial interests.

Published
2016
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