Automated plasma EV-PDL1 analysis for cancer immunotherapy
Award last edited on: 4/12/2023

Sponsored Program
Awarding Agency
Total Award Amount
Award Phase
Solicitation Topic Code
Principal Investigator
Liyun (Jessica) Sang

Company Information

Accure Health Inc

Pagliuca Harvard Life Lab 127 Western Avenue
Allston, MA 02134
   (206) 790-3381
Location: Single
Congr. District: 07
County: Suffolk

Phase I

Contract Number: 1R43CA275548-01
Start Date: 9/19/2022    Completed: 8/31/2023
Phase I year
Phase I Amount
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 ata considerable cost. The most validated and FDA-approved biomarker to guide patient selection is throug himmunohistochemical (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 whichis sometimes difficult to perform; ii) the site and timing of tissue acquisition and staining protocols can influencethe accuracy of TPS; iii) IHC takes days to process, delaying treatment; iv) many TPS-positive patients do notrespond 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 assaybased 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 expressionfrom primary and metastatic lesions can be a more comprehensive marker. We propose two specific aims. Aim1. 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 assayand integrated scores can be utilized in clinical trials testing anti-PD1/PD-L1 mono- or combination therapies. Itcan provide a faster and more reliable solution for evaluating treatment response, and help accelerateregulatory decision-making.

Public Health Relevance Statement:
PROJECT NARRATIVE We will develop an automated, plasma-based TiMES EV-PDL1 assay and digital scoring system for lung cancer immunotherapy. We envision that a comprehensive analysis of PD-L1 biomarkers can help predict and evaluate treatment response, and accelerate therapeutic development.

Project Terms:

Phase II

Contract Number: ----------
Start Date: 00/00/00    Completed: 00/00/00
Phase II year
Phase II Amount