ArticlemAbs2018
Linear pharmacokinetic parameters for monoclonal antibodies are similar within a species and across different pharmacological targets: A comparison between human, cynomolgus monkey and hFcRn Tg32 transgenic mouse using a population-modeling approach.
Article in mAbs, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 68 papers.
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Who cites it
68 citing papers in PubMed, 103 citations in OpenAlex.
- A phase I/II study of preoperative letrozole, everolimus, and carotuximab in stage 2 and 3 hormone receptor-positive and Her2-negative breast cancer.Breast cancer research and treatment · 2023Trial
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- Quantitative Systems Pharmacology Model Predicts Enhanced Antitumor Efficacy of Combined Cytotoxic T‑Lymphocyte-Associated Protein 4 (CTLA-4) and Programmed Cell Death Protein 1 (PD-1) Blockade in a Syngeneic Mouse Model of Breast Cancer.ACS pharmacology & translational science · 2026Article
- Human Pharmacokinetic Prediction of Antibody-Drug Conjugates Using Human FcRn Transgenic Mice.Clinical and translational science · 2026Article
- Preclinical assessment of broadly neutralizing HIV-1 antibody BNT351 with optimized pharmacokinetics and potent antiviral activity.iScience · 2026Article
- Application of Allometric Scaling and Translational Modeling to Predict Human Pharmacokinetics of mRNA-Encoded Antibodies.Molecular pharmaceutics · 2026Article
- A Tutorial on the Development of a Physiologically Inspired PKRO Model for Monoclonal Antibodies.CPT: pharmacometrics & systems pharmacology · 2026Article
- Regulatory-Driven Pharmacokinetic and Immunogenicity Study of Siltartoxatug, a Recombinant Native Human Monoclonal Antibody Against Tetanus Toxin, in Cynomolgus Monkeys.Advances in pharmacological and pharmaceutical sciences · 2026Article
- Translational strategy to support the first-in-human study of a TCR-like T cell bispecific with anFrontiers in immunology · 2026Article
- Clinical Pharmacology Perspective on Direct-To-Subcutaneous Dosing of T Cell Engagers in Oncology First-In-Human Studies.Clinical and translational science · 2026Review
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- Immunoglobulin G Fc engineering for localized therapy: Eliminating neonatal Fc receptor interactions and ensuring purification using protein A.Protein science : a publication of the Protein Society · 2025Article
- N-Glycosylation of Antibodies: Biological Effects During Infections and Therapeutic Applications.Antibodies (Basel, Switzerland) · 2025Review
- Population pharmacokinetics of weight-based compared with fixed dosing of CAP256V2LS, a broadly neutralizing antibody for HIV prevention in women.The Journal of antimicrobial chemotherapy · 2025Article
- First-in-human phase I open-label study of the anti-TIM-3 monoclonal antibody INCAGN02390 in patients with select advanced or metastatic solid tumors.The oncologist · 2025Article
- A Novel B7-H4xCD3 Bispecific T-cell Engager (PF-07260437) Synergizes with Breast Cancer Standard of Care and Immune Checkpoint Therapies.Molecular cancer therapeutics · 2025Article
- Development and in vitro characterization of humanized antibodies for blocking human TRPM4 channel.Scientific reports · 2025Article
8 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The linear pharmacokinetics (PK) of therapeutic monoclonal antibodies (mAbs) can be considered a class property with values that are similar to endogenous IgG. Knowledge of these parameters across species could be used to avoid unnecessary in vivo PK studies and to enable early PK predictions and pharmacokinetic/pharmacodynamic (PK/PD) simulations. In this work, population-pharmacokinetic (popPK) modeling was used to determine a single set of 'typical' popPK parameters describing the linear PK of mAbs in human, cynomolgus monkey and transgenic mice expressing the human neonatal Fc receptor (hFcRn Tg32), using a rich dataset of 27 mAbs. Non-linear PK was excluded from the datasets and a 2-compartment model was applied to describe mAb disposition. Typical human popPK estimates compared well with data from comparator mAbs with linear PK in the clinic. Outliers with higher than typical clearance were found to have non-specific interactions in an affinity-capture self-interaction nanoparticle spectroscopy assay, offering a potential tool to screen out these mAbs at an early stage. Translational strategies were investigated for prediction of human linear PK of mAbs, including use of typical human popPK parameters and allometric exponents from cynomolgus monkey and Tg32 mouse. Each method gave good prediction of human PK with parameters predicted within 2-fold. These strategies offer alternative options to the use of cynomolgus monkeys for human PK predictions of linear mAbs, based on in silico methods (typical human popPK parameters) or using a rodent species (Tg32 mouse), and call into question the value of completing extensive in vivo preclinical PK to inform linear mAb PK.
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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 OpenQuestion graph.