Safety and immunotoxicity assessment of immunomodulatory monoclonal antibodies

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Cytokine Storm in a Phase 1 Trial of the Anti-CD28 Monoclonal Antibody TGN1412

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Adalimumab, a fully human anti–tumor necrosis factor α monoclonal antibody, for the treatment of rheumatoid arthritis in patients taking concomitant methotrexate: The ARMADA trial

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Cetuximab-Induced Anaphylaxis and IgE Specific for Galactose-α-1,3-Galactose

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NOD/SCID/γcnull mouse: an excellent recipient mouse model for engraftment of human cells

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Specificity and affinity of human Fcγ receptors and their polymorphic variants for human IgG subclasses

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Pure Red-Cell Aplasia and Antierythropoietin Antibodies in Patients Treated with Recombinant Erythropoietin

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Development of a Human Adaptive Immune System in Cord Blood Cell-Transplanted Mice

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Generation of tissue-specific and promiscuous HLA ligand databases using DNA microarrays and virtual HLA class II matrices

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Ipilimumab (anti-CTLA4 antibody) causes regression of metastatic renal cell cancer associated with enteritis and hypophysitis

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Thrombocytopenia caused by the development of antibodies to thrombopoietin

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The Linkage of Innate to Adaptive Immunity via Maturing Dendritic Cells In Vivo Requires CD40 Ligation in Addition to Antigen Presentation and CD80/86 Costimulation

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Immunostimulatory monoclonal antibodies for cancer therapy

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Efficacy and safety of adalimumab as monotherapy in patients with rheumatoid arthritis for whom previous disease modifying antirheumatic drug treatment has failed

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Generating quantitative models describing the sequence specificity of biological processes with the stabilized matrix method

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Tolerability and safety of rituximab (MabThera®)

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Pulsed monoclonal antibody treatment and autoimmune thyroid disease in multiple sclerosis

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Progressive Multifocal Leukoencephalopathy in Patients on Immunomodulatory Therapies

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Immune surveillance in multiple sclerosis patients treated with natalizumab

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Triggering of OX40 (CD134) on CD4+CD25+ T cells blocks their inhibitory activity: a novel regulatory role for OX40 and its comparison with GITR

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TGF-beta 1 prevents the noncognate maturation of human dendritic Langerhans cells.

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Preclinical safety evaluation of biotechnology-derived pharmaceuticals

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Species differences in the structure and function of the immune system

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TGF-β1 Prevents the Noncognate Maturation of Human Dendritic Langerhans Cells

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Recommendations on risk-based strategies for detection and characterization of antibodies against biotechnology products.

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Risk Assessment in Immunotoxicology II. Relationships between Immune and Host Resistance Tests

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"Cytokine Storm" in the Phase I Trial of Monoclonal Antibody TGN1412: Better Understanding the Causes to Improve PreClinical Testing of Immunotherapeutics

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Toll-like receptors (TLRs) and Nod-like receptors (NLRs) in inflammatory disorders

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Therapeutic IgG4 antibodies engage in Fab-arm exchange with endogenous human IgG4 in vivo

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Antibody therapeutics:

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An interspecies comparison of placental antibody transfer: New insights into developmental toxicity testing of monoclonal antibodies

Pentšuk, N., & van der Laan, J. W. (2009) · Birth Defects Research Part B Developmental and Reproductive Toxicology · doi:10.1002/bdrb.20201 · Cited by 287 · see citing works

Improved prediction of MHC class I and class II epitopes using a novel Gibbs sampling approach

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IMMUNOLOGICAL RELATIONSHIP BETWEEN THE MOTHER AND THE FETUS

Szekeres‐Barthó, J. (2002) · International Reviews of Immunology · doi:10.1080/08830180215017 · Cited by 255 · see citing works

Antigen-Antibody Immune Complexes Empower Dendritic Cells to Efficiently Prime Specific CD8+ CTL Responses In Vivo

Schuurhuis, D. H., Ioan‐Facsinay, A., Nagelkerken, B., Schip, J. J. V. D. P.-V., Sedlik, C., Melief, C. J. M., Verbeek, J. S., & OSSENDORP, F. A. (2002) · The Journal of Immunology · doi:10.4049/jimmunol.168.5.2240 · Cited by 238 · see citing works

Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use (1997)

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An HLA-DR1 Transgene Confers Susceptibility to Collagen-induced Arthritis Elicited with Human Type II Collagen

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Progressive Multifocal Leukoencephalopathy after Natalizumab Monotherapy

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Siglecs in innate immunity

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Loss of Siglec expression on T lymphocytes during human evolution

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Structural characterization of a human Fc fragment engineered for lack of effector functions

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Commentary on the <scp>EMA Guideline</scp> on strategies to identify and mitigate risks for first‐in‐human and early clinical trials with investigational medicinal products

van Gerven, J., & Bonelli, M. (2018) · British Journal of Clinical Pharmacology · doi:10.1111/bcp.13550 · Cited by 174 · see citing works

STP Position Paper: Best Practice Guideline for the Routine Pathology Evaluation of the Immune System

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International Conference on Harmonisation; Guidance on M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals; availability. Notice.

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The minimum anticipated biological effect level (MABEL) for selection of first human dose in clinical trials with monoclonal antibodies

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Structural Characterization and Immunogenicity in Wild-Type and Immune Tolerant Mice of Degraded Recombinant Human Interferon Alpha2b

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Immunotoxicity of monoclonal antibodies

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Histopathologic Approaches to Detect Changes Indicative of Immunotoxicity

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Forecasting the cytokine storm following systemic interleukin (IL)-2 administration

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Antigen‐Presenting Cells and Materno‐Fetal Tolerance: An Emerging Role for Dendritic Cells

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Infections Associated with Tumor Necrosis Factor‐α Antagonists

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Using an analogous monoclonal antibody to evaluate the reproductive and chronic toxicity potential for a humanized anti-TNFa monoclonal antibody

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Lupus-Like Syndrome Attributable to Anti—Tumor Necrosis Factor α Therapy in 14 Patients During an 8-Year Period at Mayo Clinic

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Effects of an Anti‐TNF‐α Monoclonal Antibody, Administered Throughout Pregnancy and Lactation, on the Development of the Macaque Immune System

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B-Cell-Targeted Therapy for Systemic Lupus Erythematosus

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What’s So Special about the Developing Immune System?

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Safety Assessment and Dose Selection for First-in-Human Clinical Trials With Immunomodulatory Monoclonal Antibodies

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IgG Fc Receptor III Homologues in Nonhuman Primate Species: Genetic Characterization and Ligand Interactions

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Lupus-Like Syndrome Attributable to Anti—Tumor Necrosis Factor α Therapy in 14 Patients During an 8-Year Period at Mayo Clinic

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Integrated studies of biology: multiplexed imaging assays from molecules to man and back

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Preclinical development of monoclonal antibodies

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The Trifunctional Antibody Ertumaxomab Destroys Tumor Cells That Express Low Levels of Human Epidermal Growth Factor Receptor 2

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Use of pharmacokinetic/ pharmacodynamic modelling for starting dose selection in first‐in‐human trials of high‐risk biologics

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Natalizumab and Progressive Multifocal Leukoencephalopathy

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Infusion-related and hypersensitivity reactions of monoclonal antibodies used to treat colorectal cancer--identification, prevention, and management.

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A vector driving the expression of foreign cDNAs in the MHC class II-positive cells of transgenic mice

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Developmental toxicity testing of monoclonal antibodies: An enhanced pre- and postnatal study design option

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Anti-CD40 agonist antibodies: Preclinical and clinical experience

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Constitutive expression of Bcl-xL or Bcl-2 prevents peptide antigen-induced T cell deletion but does not influence T cell homeostasis after a viral infection

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Evaluation of a surrogate antibody for preclinical safety testing of an anti-CD11a monoclonal antibody

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REVIEW ARTICLE: NK Cell Tolerance and the Maternal–Fetal Interface

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Clinical immunotoxicity of therapeutic proteins

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Preclinical development of keliximab, a Primatized™ anti-CD4 monoclonal antibody, in human CD4 transgenic mice: characterization of the model and safety studies

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Developmental immunotoxicology (DIT): windows of vulnerability, immune dysfunction and safety assessment

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Peripheral blood CD4+CD8+ lymphocytes in cynomolgus monkeys are of resting memory T lineage

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Negative and positive selection by HLA-DR3(DRw17) molecules in transgenic mice

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Risk of High-Grade Skin Rash in Cancer Patients Treated with Cetuximab – an Antibody against Epidermal Growth Factor Receptor: Systemic Review and Meta-Analysis

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Monoclonal Antibody First Dose Cytokine Release Syndromes–Mechanisms and Prediction

Wing, M. G. (2008) · Journal of Immunotoxicology · doi:10.1080/15476910801897433 · Cited by 64 · see citing works

Review of Human DC Subtypes

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The Accuracy of Extended Histopathology to Detect Immunotoxic Chemicals

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Practical considerations for nonclinical safety evaluation of therapeutic monoclonal antibodies

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Preclinical Safety Evaluation of Biopharmaceuticals

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Whole blood cytokine response as a measure of immunotoxicity

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Natalizumab and progressive multifocal leucoencephalopathy

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New Approaches to Prediction of Immune Responses to Therapeutic Proteins during Preclinical Development

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Evaluation of the Immuno-Stimulatory Potential of Stopper Extractables and Leachables by Using Dendritic Cells as Readout

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The Role of the CTLA4 Blockade in the Treatment of Malignant Melanoma

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Testing Human Biologicals in Animal Host Resistance Models

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A HUMANIZED ANTI-CD3 ANTIBODY, HuM291, WITH LOW MITOGENIC ACTIVITY, MEDIATES COMPLETE AND REVERSIBLE T-CELL DEPLETION IN CHIMPANZEES

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