Automated plasma EV-PDL1 analysis for cancer immunotherapy

Ended Project Grant Awarded Last action

Award ID
R43CA275548
Recipient
Awarding agency
Obligated
$799,826

Award facts

Assistance listing
93.394 Cancer Detection and Diagnosis Research
Completion date
Originally
Place of performance
Cambridge, MA 02139, USA

Award details come from USAspending.gov.

Description

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.

Transactions

Action Obligated Date
Amendment $0
Amendment $399,913
Original award $399,913

Quick answers

Who received award R43CA275548?

R43CA275548 was awarded to Accure Health Inc. by National Cancer Institute (National Institutes of Health) on September 19, 2022.

How much is award R43CA275548 worth?

$799,826 has been obligated on R43CA275548.

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