Assessment of the Immunogenicity Potential for Oligonucleotide-Based Drugs

Underlying Immune Disorder May Predispose Some Transthyretin Amyloidosis Subjects to Inotersen-Mediated Thrombocytopenia

(2020) PadmaKumar Narayanan et al.   Nucleic Acid Therapeutics

Population Pharmacokinetic–Pharmacodynamic Modeling of Inotersen, an Antisense Oligonucleotide for Treatment of Patients with Hereditary Transthyretin Amyloidosis

(2020) Rosie Z. Yu et al.   Nucleic Acid Therapeutics

Immunogenicity Assessment of Inotersen, a 2′-O-(2-Methoxyethyl) Antisense Oligonucleotide in Animals and Humans: Effect on Pharmacokinetics, Pharmacodynamics, and Safety

(2020) Rosie Z. Yu et al.   Nucleic Acid Therapeutics

Clinical Pharmacology Studies Supporting Oligonucleotide Therapy Development: An Assessment of Therapies Approved and in Development Between 2012‐2018

(2020) Hobart Rogers et al.   CTS-Clinical and Translational Science

Treating Disease at the RNA Level with Oligonucleotides

(2019) Arthur A. Levin   NEW ENGLAND JOURNAL OF MEDICINE

Effective presentation of immunogenicity risk assessments and related data in regulatory dossiers

(2019) Paul Chamberlain   Bioanalysis

Volanesorsen and Triglyceride Levels in Familial Chylomicronemia Syndrome

(2019) Joseph L. Witztum et al.   NEW ENGLAND JOURNAL OF MEDICINE

Immunogenicity for antisense oligonucleotides: a risk-based assessment

(2019) Christopher C Stebbins et al.   Bioanalysis

2019 White Paper on Recent Issues in Bioanalysis: FDA Immunogenicity Guidance, Gene Therapy, Critical Reagents, Biomarkers and Flow Cytometry Validation (Part 3 – Recommendations on 2019 FDA Immunogenicity Guidance, Gene Therapy Bioanalytical Challenges, Strategies for Critical Reagent Management, Biomarker Assay Validation, Flow Cytometry Validation & CLSI H62)

(2019) Steven Piccoli et al.   Bioanalysis

RNA-Targeted Therapeutics

(2018) Stanley T. Crooke et al.   Cell Metabolism

Investigation into the Mechanism(s) That Leads to Platelet Decreases in Cynomolgus Monkeys During Administration of ISIS 104838, a 2ʹ-MOE-Modified Antisense Oligonucleotide

(2018) Padmakumar Narayanan et al.   TOXICOLOGICAL SCIENCES

Drug-induced Glomerulonephritis: The Spectre of Biotherapeutic and Antisense Oligonucleotide Immune Activation in the Kidney

(2018) Kendall S. Frazier et al.   TOXICOLOGIC PATHOLOGY

CpG Still Rocks! Update on an Accidental Drug

(2018) Arthur M. Krieg   Nucleic Acid Therapeutics

2018 White Paper on Recent Issues in Bioanalysis: focus on flow cytometry, gene therapy, cut points and key clarifications on BAV (Part 3 – LBA/cell-based assays: immunogenicity, biomarkers and PK assays)

(2018) Lauren Stevenson et al.   Bioanalysis

Oligonucleotide-based pharmaceuticals: Non-clinical and clinical safety signals and non-clinical testing strategies

(2017) Enni-Kaisa Mustonen et al.   REGULATORY TOXICOLOGY AND PHARMACOLOGY

Assay signal as an alternative to titer for assessment of magnitude of an antidrug antibody response

(2017) Marta Starcevic Manning et al.   Bioanalysis

Assessment of the Effects of 2′-Methoxyethyl Antisense Oligonucleotides on Platelet Count in Cynomolgus Nonhuman Primates

(2017) Scott P. Henry et al.   Nucleic Acid Therapeutics

The Effects of 2′-O-Methoxyethyl Containing Antisense Oligonucleotides on Platelets in Human Clinical Trials

(2017) Stanley T. Crooke et al.   Nucleic Acid Therapeutics

Integrated Safety Assessment of 2′-O-Methoxyethyl Chimeric Antisense Oligonucleotides in NonHuman Primates and Healthy Human Volunteers

(2016) Stanley T Crooke et al.   MOLECULAR THERAPY

Considerations for the Characterization and Interpretation of Results Related to Alternative Complement Activation in Monkeys Associated with Oligonucleotide-Based Therapeutics

(2016) Scott P. Henry et al.   Nucleic Acid Therapeutics

Effects of Repeated Complement Activation Associated with Chronic Treatment of Cynomolgus Monkeys with 2′-O-Methoxyethyl Modified Antisense Oligonucleotide

(2016) Lijiang Shen et al.   Nucleic Acid Therapeutics

Evaluation of Multiple Immunoassay Technology Platforms to Select the Anti-Drug Antibody Assay Exhibiting the Most Appropriate Drug and Target Tolerance

(2016) Justine Collet-Brose et al.   Journal of Immunology Research

Evaluating and Reporting the Immunogenicity Impacts for Biological Products—a Clinical Pharmacology Perspective

(2015) Yow-Ming C. Wang et al.   AAPS Journal

Comparison of immunogenicity test methods used in clinical studies of infliximab and its biosimilar (CT-P13)

(2015) Ji Soo Kim et al.   Expert Review of Clinical Immunology

Scientific and Regulatory Policy Committee Points-to-consider Paper*

(2015) Jeffery A. Engelhardt et al.   TOXICOLOGIC PATHOLOGY

Oligonucleotide-Based Drug Development

(2015) Jian Wang et al.   Therapeutic Innovation & Regulatory Science

Assessment and Reporting of the Clinical Immunogenicity of Therapeutic Proteins and Peptides—Harmonized Terminology and Tactical Recommendations

(2014) G. Shankar et al.   AAPS Journal

Immunogenicity testing strategy and bioanalytical assays for antibody–drug conjugates

(2013) Sarah A Hoofring et al.   Bioanalysis

Strategic selection and development of immunogenicity binding methods

(2012) Ana T Menendez   Bioanalysis

Complement and its role in innate and adaptive immune responses

(2009) Jason R Dunkelberger et al.   CELL RESEARCH

Immunogenicity of biologically-derived therapeutics: Assessment and interpretation of nonclinical safety studies

(2009) Rafael Ponce et al.   REGULATORY TOXICOLOGY AND PHARMACOLOGY