ArticlePharmaceutics2022
Validation of a Dendritic Cell and CD4+ T Cell Restimulation Assay Contributing to the Immunogenicity Risk Evaluation of Biotherapeutics.
Article in Pharmaceutics, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
20 citing papers in PubMed, 26 citations in OpenAlex.
- Article
- Optimisation of in vitro assays for accurate risk assessment of T-cell responses to biologics with potential immune liabilities.Archives of toxicology · 2026Article
- First step towards predicting clinical immunogenicity of biologics using in vitro based readouts as animal trial alternatives.Journal of pharmaceutical sciences · 2026Article
- Immunogenicity Publication Bias and Its Consequences for Predictive Models: A Call for Transparent Reporting.CPT: pharmacometrics & systems pharmacology · 2026Article
- A universal monoallelic human leukocyte antigen class II immunopeptidomic platform for defining the immunogenicity potential of therapeutic proteins.Communications biology · 2025Article
- T cell assays for non-clinical immunogenicity risk assessment: best practices recommended by the European Immunogenicity Platform.Frontiers in immunology · 2025Review
- A single point mutation on FLT3L-Fc protein increases the risk of immunogenicity.Frontiers in immunology · 2025Article
- Elucidation of B-cell specific drug immunogenicity liabilities via a novelFrontiers in immunology · 2025Article
- Imaging of tumor-associated macrophage dynamics during immunotherapy using a CD163-specific nanobody-based immunotracer.Proceedings of the National Academy of Sciences of the United States of America · 2024Article
- Specific imaging of CD8 + T-Cell dynamics with a nanobody radiotracer against human CD8β.European journal of nuclear medicine and molecular imaging · 2024Article
- Immunogenicity risk assessment and mitigation for engineered antibody and protein therapeutics.Nature reviews. Drug discovery · 2024Review
- Reducing Immunogenicity by Design: Approaches to Minimize Immunogenicity of Monoclonal Antibodies.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2024Review
- Development and characterization of dendritic cell internalization and activation assays contributing to the immunogenicity risk evaluation of biotherapeutics.Frontiers in immunology · 2024Article
- Preclinical immunogenicity risk assessment of biotherapeutics using CD4 T cell assays.Frontiers in immunology · 2024Article
- The Editorial Position on 'Recent Advances in Multifunctional Antimicrobial Peptides as Preclinical Therapeutic Studies and Clinical Future Applications'.Pharmaceutics · 2023Article
- Expanding the MAPPs Assay to Accommodate MHC-II Pan Receptors for Improved Predictability of Potential T Cell Epitopes.Biology · 2023Article
- Therapeutically targeting type I interferon directly to XCR1+ dendritic cells reveals the role of cDC1s in anti-drug antibodies.Frontiers in immunology · 2023Article
- Characterization and root cause analysis of immunogenicity to pasotuxizumab (AMG 212), a prostate-specific membrane antigen-targeting bispecific T-cell engager therapy.Frontiers in immunology · 2023Article
- Review
- Review
Corrections and comments
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Authors and funding
13 authors at 3 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Immunogenicity, defined as the ability to provoke an immune response, can be either wanted (i.e., vaccines) or unwanted. The latter refers to an immune response to protein or peptide therapeutics, characterized by the production of anti-drug antibodies, which may affect the efficacy and/or the safety profiles of these drugs. Consequently, evaluation of the risk of immunogenicity early in the development of biotherapeutics is of critical importance for defining their efficacy and safety profiles. Here, we describe and validate a fit-for-purpose FluoroSpot-based in vitro assay for the evaluation of drug-specific T cell responses. A panel of 24 biotherapeutics with a wide range of clinical anti-drug antibody response rates were tested in this assay. We demonstrated that using suitable cutoffs and donor cohort sizes, this assay could identify most of the compounds with high clinical immunogenicity rates (71% and 78% for sensitivity and specificity, respectively) while we characterized the main sources of assay variability. Overall, these data indicate that the dendritic cell and CD4+ T cell restimulation assay published herein could be a valuable tool to assess the risk of drug-specific T cell responses and contribute to the selection of clinical candidates in early development.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.