Personalized precision dosing of anti-TNF biologic therapies

抗 TNF 生物疗法的个性化精确剂量

基本信息

  • 批准号:
    9888300
  • 负责人:
  • 金额:
    $ 84.11万
  • 依托单位:
  • 依托单位国家:
    美国
  • 项目类别:
  • 财政年份:
    2018
  • 资助国家:
    美国
  • 起止时间:
    2018-02-01 至 2021-02-28
  • 项目状态:
    已结题

项目摘要

Biologics are increasingly used in the treatment of autoimmune and inflammatory diseases. Monoclonal antibody (mAb) drugs that target tumor necrosis factor alpha (TNF-a), such as Remicade (infliximab), are blockbuster drugs—global sales of infliximab were close to $6B in 2016. However, post-approval studies have revealed inefficiencies in the use of these anti-TNF-a biologics; some patients do not respond to mAb therapies upon induction, whereas others lose response over time. Primary causes of dosing inefficiency include a rigid dosing schedule and the frequent development of anti-drug antibody (ADA) responses in treated patients. The clinical data strongly point to the need for therapeutic dose monitoring of mAb drugs to ensure an optimal therapeutic window in every patient. While laboratory-based test methods are available, there are no point-of-care tests for measuring the concentration of either infliximab or ADAs. The goal of this project is to develop lateral flow immunoassays (LFAs) for rapid measurement of free infliximab and ADA levels in finger-stick blood samples. Our proprietary technology uses small peptide mimetics (Veritopes™) of the antigen as a specific capture reagent. Our tests are based on ligand-binding activity, and are thus expected to detect the parent mAb drug (infliximab), as well as new biosimilars (infliximab-dyyb, infliximab-abda). We previously qualified the technical feasibility of Veritope-based LFAs for the detection of rituximab concentration in patient serum. The objectives of this project are to: 1) generate Veritope specific for infliximab and implement the peptide in a LFA for the measurement of free infliximab levels in blood at the point-of-care, 2) Demonstrate ADA detection for infliximab using a complement point-of-care LFA that incorporates an initial acid dissociation step, and 3) validate free drug and ADA LFA using patient samples. These innovative products will fulfill of an unmet clinical need for a rapid, cost effective, and accurate dose monitoring assay. Precision dosing through data-driven, personalized regimens will improve treatment outcomes and maximize the efficient use of infliximab.
生物制剂越来越多地用于自身免疫性疾病和炎症性疾病的治疗。单克隆抗体

项目成果

期刊论文数量(1)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)

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BRADLEY T MESSMER其他文献

BRADLEY T MESSMER的其他文献

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{{ truncateString('BRADLEY T MESSMER', 18)}}的其他基金

Personalized precision dosing of biologic therapies in oncology
肿瘤学生物疗法的个性化精确剂量
  • 批准号:
    9984616
  • 财政年份:
    2017
  • 资助金额:
    $ 84.11万
  • 项目类别:
Novel Materials for Viral Purification
用于病毒纯化的新型材料
  • 批准号:
    9408588
  • 财政年份:
    2017
  • 资助金额:
    $ 84.11万
  • 项目类别:
Activin A antagonist for treatment of cancer-associated cachexia
激活素 A 拮抗剂用于治疗癌症相关恶病质
  • 批准号:
    9046615
  • 财政年份:
    2015
  • 资助金额:
    $ 84.11万
  • 项目类别:
Cleavage Coupled Lateral Flow Immunoassay for Rapid Endotoxin Testing
用于快速内毒素检测的裂解偶联侧向层析免疫分析
  • 批准号:
    8905383
  • 财政年份:
    2015
  • 资助金额:
    $ 84.11万
  • 项目类别:
Multiplexed DeNAno Protein Assay and Quantitation: Sequencing Based Proteomics
多重 DeNAno 蛋白质测定和定量:基于测序的蛋白质组学
  • 批准号:
    8855369
  • 财政年份:
    2015
  • 资助金额:
    $ 84.11万
  • 项目类别:
Lateral Flow Immunoassay for Therapeutic Monoclonal Antibody Quality Assurance
用于治疗性单克隆抗体质量保证的侧流免疫分析
  • 批准号:
    8648070
  • 财政年份:
    2014
  • 资助金额:
    $ 84.11万
  • 项目类别:
HMGB1-Derived Peptides As Vaccine Adjuvants
HMGB1 衍生肽作为疫苗佐剂
  • 批准号:
    8435590
  • 财政年份:
    2012
  • 资助金额:
    $ 84.11万
  • 项目类别:
Molecular Evolution of Multifunctional DNA Nanoparticles
多功能DNA纳米颗粒的分子进化
  • 批准号:
    8293019
  • 财政年份:
    2011
  • 资助金额:
    $ 84.11万
  • 项目类别:
Molecular Evolution of Multifunctional DNA Nanoparticles
多功能DNA纳米颗粒的分子进化
  • 批准号:
    8472338
  • 财政年份:
    2011
  • 资助金额:
    $ 84.11万
  • 项目类别:
Molecular Evolution of Multifunctional DNA Nanoparticles
多功能DNA纳米颗粒的分子进化
  • 批准号:
    8035223
  • 财政年份:
    2011
  • 资助金额:
    $ 84.11万
  • 项目类别:

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