Automated plasma EV-PDL1 analysis for cancer immunotherapy
用于癌症免疫治疗的自动血浆 EV-PDL1 分析
基本信息
- 批准号:10545706
- 负责人:
- 金额:$ 39.99万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2022
- 资助国家:美国
- 起止时间:2022-09-19 至 2024-08-31
- 项目状态:已结题
- 来源:
- 关键词:AccureAlgorithmsBiological AssayBiological MarkersBiopsyCD8-Positive T-LymphocytesCancer PatientCellsClinicalClinical DataClinical TrialsColorectal CancerCombined Modality TherapyDataData AnalysesDecision MakingEnzyme-Linked Immunosorbent AssayEvaluationFDA approvedFeedbackGeneral HospitalsGoalsHealthHistologicHistologyHourImmuneImmune checkpoint inhibitorImmunohistochemistryImmunotherapyIndustryMalignant NeoplasmsMalignant neoplasm of lungMassachusettsMeasuresMonitorNeoplasm MetastasisOperative Surgical ProceduresPD-1/PD-L1Patient MonitoringPatient SelectionPatientsPerformancePharmaceutical PreparationsPhasePlasmaPopulationPrimary LesionProcessProtocols documentationRadiology SpecialtyReportingReproducibilitySamplingSecureSiteStainsStandardizationSystemTechnologyTestingTherapeuticTimeTissue SampleTissuesTreatment outcomeVariantanti-PD-1anti-PD-1/PD-L1basecancer immunotherapycancer therapycell typecheckpoint therapyclinical practicecostdetection limitdigitalextracellular vesiclesimage guidedmacrophagemedical schoolsmultiplex assayneoplastic cellpatient biomarkerspatient prognosispatient responseprogrammed cell death ligand 1prototyperesearch clinical testingsensor technologytherapeutic developmenttreatment responsetumor
项目摘要
ABSTRACT
Challenges. There are over 4000 clinical trials testing anti-PD1/PD-L1 immune checkpoint inhibitors (ICI),
either alone or in combination with other therapies. While many patients benefit, the vast amount do not, all at
a considerable cost. The most validated and FDA-approved biomarker to guide patient selection is through
immunohistochemical (IHC) staining and scoring of tissue biopsies for PD-L1 (e.g. Tumor Proportion Score,
TPS). Unfortunately, TPS is an imperfect biomarker: i) it requires surgical or image guided tissue biopsy which
is sometimes difficult to perform; ii) the site and timing of tissue acquisition and staining protocols can influence
the accuracy of TPS; iii) IHC takes days to process, delaying treatment; iv) many TPS-positive patients do not
respond to ICI treatment; and v) TPS can change during chemo, targeted and ICI therapies.
Phase I goals. Accure Health proposes to explore an alternative approach: circulating PD-L1 biomarker assay
based on Technology-integrated magneto-electronic sensing (TiMES) of extracellular vesicles (EVs).
Supported by promising clinical data, we hypothesize that circulating EV analysis integrating PD-L1 expression
from primary and metastatic lesions can be a more comprehensive marker. We propose two specific aims. Aim
1. Develop an automated TiMES assay to analyze pan EV-PDL1 and cell type-specific EV-PDL1. Aim 2.
Establish TiMES EV-PDL1 scores and correlate with TPS. We envision the automated TiMES EV-PDL1 assay
and integrated scores can be utilized in clinical trials testing anti-PD1/PD-L1 mono- or combination therapies. It
can provide a faster and more reliable solution for evaluating treatment response, and help accelerate
regulatory decision-making.
摘要
挑战有超过4000项临床试验测试抗PD 1/PD-L1免疫检查点抑制剂(ICI),
单独或与其它疗法联合使用。虽然许多患者受益,但大量患者并没有受益,
相当大的代价。最有效和FDA批准的指导患者选择的生物标志物是通过
组织活检的免疫组织化学(IHC)染色和PD-L1评分(例如肿瘤比例评分,
TPS)。不幸的是,TPS是一种不完美的生物标志物:i)它需要手术或图像引导的组织活检,
有时难以执行; ii)组织采集和染色方案的部位和时间可能影响
TPS的准确性; iii)IHC需要几天的时间来处理,延迟治疗; iv)许多TPS阳性患者不需要
对ICI治疗有反应;和v)TPS可以在化疗、靶向和ICI治疗期间改变。
第一阶段的目标。Accure Health建议探索一种替代方法:循环PD-L1生物标志物检测
基于细胞外囊泡(EV)的技术集成磁电传感(TiMES)。
在有希望的临床数据的支持下,我们假设循环EV分析整合PD-L1表达
可以作为一个更全面的标志物。我们提出两个具体目标。目的
1.开发自动化TiMES检测试剂盒,以分析泛EV-PDL 1和细胞类型特异性EV-PDL 1。目标二。
建立TiMES EV-PDL 1评分并与TPS相关。我们设想自动化的TiMES EV-PDL 1测定
并且综合评分可用于测试抗PD 1/PD-L1单一或组合疗法的临床试验。它
可以为评估治疗反应提供更快、更可靠的解决方案,
监管决策。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
数据更新时间:{{ journalArticles.updateTime }}
{{
item.title }}
{{ item.translation_title }}
- DOI:
{{ item.doi }} - 发表时间:
{{ item.publish_year }} - 期刊:
- 影响因子:{{ item.factor }}
- 作者:
{{ item.authors }} - 通讯作者:
{{ item.author }}
数据更新时间:{{ journalArticles.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ monograph.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ sciAawards.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ conferencePapers.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ patent.updateTime }}
Liyun Jessica Sang其他文献
Liyun Jessica Sang的其他文献
{{
item.title }}
{{ item.translation_title }}
- DOI:
{{ item.doi }} - 发表时间:
{{ item.publish_year }} - 期刊:
- 影响因子:{{ item.factor }}
- 作者:
{{ item.authors }} - 通讯作者:
{{ item.author }}
相似海外基金
DMS-EPSRC: Asymptotic Analysis of Online Training Algorithms in Machine Learning: Recurrent, Graphical, and Deep Neural Networks
DMS-EPSRC:机器学习中在线训练算法的渐近分析:循环、图形和深度神经网络
- 批准号:
EP/Y029089/1 - 财政年份:2024
- 资助金额:
$ 39.99万 - 项目类别:
Research Grant
CAREER: Blessing of Nonconvexity in Machine Learning - Landscape Analysis and Efficient Algorithms
职业:机器学习中非凸性的祝福 - 景观分析和高效算法
- 批准号:
2337776 - 财政年份:2024
- 资助金额:
$ 39.99万 - 项目类别:
Continuing Grant
CAREER: From Dynamic Algorithms to Fast Optimization and Back
职业:从动态算法到快速优化并返回
- 批准号:
2338816 - 财政年份:2024
- 资助金额:
$ 39.99万 - 项目类别:
Continuing Grant
CAREER: Structured Minimax Optimization: Theory, Algorithms, and Applications in Robust Learning
职业:结构化极小极大优化:稳健学习中的理论、算法和应用
- 批准号:
2338846 - 财政年份:2024
- 资助金额:
$ 39.99万 - 项目类别:
Continuing Grant
CRII: SaTC: Reliable Hardware Architectures Against Side-Channel Attacks for Post-Quantum Cryptographic Algorithms
CRII:SaTC:针对后量子密码算法的侧通道攻击的可靠硬件架构
- 批准号:
2348261 - 财政年份:2024
- 资助金额:
$ 39.99万 - 项目类别:
Standard Grant
CRII: AF: The Impact of Knowledge on the Performance of Distributed Algorithms
CRII:AF:知识对分布式算法性能的影响
- 批准号:
2348346 - 财政年份:2024
- 资助金额:
$ 39.99万 - 项目类别:
Standard Grant
CRII: CSR: From Bloom Filters to Noise Reduction Streaming Algorithms
CRII:CSR:从布隆过滤器到降噪流算法
- 批准号:
2348457 - 财政年份:2024
- 资助金额:
$ 39.99万 - 项目类别:
Standard Grant
EAGER: Search-Accelerated Markov Chain Monte Carlo Algorithms for Bayesian Neural Networks and Trillion-Dimensional Problems
EAGER:贝叶斯神经网络和万亿维问题的搜索加速马尔可夫链蒙特卡罗算法
- 批准号:
2404989 - 财政年份:2024
- 资助金额:
$ 39.99万 - 项目类别:
Standard Grant
CAREER: Efficient Algorithms for Modern Computer Architecture
职业:现代计算机架构的高效算法
- 批准号:
2339310 - 财政年份:2024
- 资助金额:
$ 39.99万 - 项目类别:
Continuing Grant
CAREER: Improving Real-world Performance of AI Biosignal Algorithms
职业:提高人工智能生物信号算法的实际性能
- 批准号:
2339669 - 财政年份:2024
- 资助金额:
$ 39.99万 - 项目类别:
Continuing Grant