Cited by 366Monoclonal and Polyclonal Antibodies ResearchRespiratory viral infections researchBiosimilars and Bioanalytical Methods

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A Novel Investigational Fc-Modified Humanized Monoclonal Antibody, Motavizumab-YTE, Has an Extended Half-Life in Healthy Adults

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Robbie, Gabriel J., Criste, Ryan, Dall'Acqua, William F., Jensen, Kathryn, Patel, Nita K., Losonsky, Genevieve A., Griffin, M. Pamela·2013·Antimicrobial Agents and Chemotherapy

DOI 10.1128/aac.01285-13PMC PMC3837853

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Abstract

The study objective was to evaluate the pharmacokinetics (PK), antidrug antibody (ADA), and safety of motavizumab-YTE (motavizumab with amino acid substitutions M252Y/S254T/T256E [YTE]), an Fc-modified anti-respiratory syncytial virus (RSV) monoclonal antibody. Healthy adults ( n = 31) were randomized to receive a single intravenous (i.v.) dose of motavizumab-YTE or motavizumab (0.3, 3, 15, or 30 mg/kg) and followed for 240 days. Clearance of motavizumab-YTE was significantly lower (71% to 86%) and the half-life ( t 1/2 ) was 2- to 4-fold longer than with motavizumab. However, similar peak concentrations and volume-of-distribution values, indicative of similar distribution properties, were seen at all dose levels. The sustained serum concentrations of motavizumab-YTE were fully functional, as shown by RSV neutralizing activity that persisted for 240 days with motavizumab-YTE versus 90 days postdose for motavizumab. Safety and incidence of ADA were comparable between groups. In this first study of an Fc-modified monoclonal antibody in humans, motavizumab-YTE was well tolerated and exhibited an extended half-life of up to 100 days. (This study has been registered at ClinicalTrials.gov under registration no. NCT00578682.)

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Authors: Robbie, G. J., Criste, R., Dall'Acqua, W. F., Jensen, K., Patel, N. K., Losonsky, G. A., & Griffin, M. P.
Affiliations: Clinical Pharmacology and DMPK, MedImmune, Gaithersburg, Maryland, USA
Antibody Discovery and Protein Engineering, MedImmune, Gaithersburg, Maryland, USA
Biostatistics, MedImmune, Gaithersburg, Maryland, USA
Research and Development, Infectious Disease, MedImmune, Gaithersburg, Maryland, USA
Clinical Research and Development, MedImmune, Gaithersburg, Maryland, USA
ORCID: Patel, Nita K.
Griffin, M. Pamela
Venue: Antimicrobial Agents and Chemotherapy
Publisher: American Society for Microbiology
Published: 2013-12
Volume: 57
Issue: 12
Pages: 6147-6153
ISSN: 0066-4804 (ISSN-L)
1098-6596
DOI: 10.1128/aac.01285-13
PMC: PMC3837853
OpenAlex: W2148090354
Cited by: 366
References: 18
Citations by year: 2026: 31 · 2025: 26 · 2024: 33 · 2023: 37 · 2022: 47 · 2021: 22 · 2020: 20 · 2019: 26 · 2018: 26 · 2017: 38 · 2016: 19 · 2015: 25 · 2014: 14 · 2013: 1
FWCI: 15.26
Type: journal article
Language: en
Open access: green
europepmc.org
Licence: journals.asm.org/non-commercial-tdm-license (tdm)
Locations: Antimicrobial Agents and Chemotherapy (publishedVersion)
Europe PMC (PubMed Central) (publishedVersion)
PubMed Central (publishedVersion)
PubMed (publishedVersion)
Topics: Life Sciences › Immunology and Microbiology › Immunology › Monoclonal and Polyclonal Antibodies Research
Health Sciences › Medicine › Epidemiology › Respiratory viral infections research
Life Sciences › Immunology and Microbiology › Immunology › Biosimilars and Bioanalytical Methods
Keywords: respiratory syncytial virus, pharmacokinetics, extended half-life, clearance, amino acid substitutions, antidrug antibodies, drug safety, healthy volunteers
MeSH terms: Adult, Antiviral Agents, Double-Blind Method, Female, Half-Life, Humans, Immunoglobulin Fc Fragments, Injections, Intravenous, Male, Metabolic Clearance Rate, Drugs, Investigational, Antibodies, Monoclonal, Humanized

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A Novel Investigational Fc-Modified Humanized Monoclonal Antibody, Motavizumab-YTE, Has an Extended Half-Life in Healthy Adults

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