An integrated strategy using a serum and imaging biomarker for the early detection of pancreatic cancer

Ended Project Grant Awarded Last action

Award ID
R41CA265655
Recipient
Awarding agency
Obligated
$1,200,000

Award facts

Assistance listing
93.394 Cancer Detection and Diagnosis Research
Completion date
Originally
Funding
  • $800,000.00 Federal
  • $400,000.00 Non-federal
Place of performance
Charlotte, NC 28223, USA

Award details come from USAspending.gov.

Description

As the agency reported it.

Abstract
Pancreatic ductal adenocarcinoma (pdac) has a 5-year survival rate of only 6% and diagnosis at an earlier resectable stage improves survival rates: > 30% for node negative tumors < 2 CM; up to 60% for tumors < 1 CM; and, essentially curative for carcinoma in situ. Currently, at diagnosis only 20% of pancreatic cancers are resectable due to locoregional infiltration and distant metastases. Hence early detection of pdac can have a dramatic impact on survival. Tumor associated MUC1 (TMUC1) is present on over 90% of pdac examined by immunohistochemistry. Since TMUC1 is also released into circulation, given the high prevalence in pdac, the antigen can be used as both a blood based and imaging biomarker in an integrated strategy designed to detect pancreatic cancer early. We have developed a tumor specific antibody, TAB004, which specifically detects TMUC1. Variants of this antibody (murine and chimeric) have been used to develop a serum elisa test called the agkura® personal score (APS) that uses a novel patent pending process to accurately measure small increases in TMUC1 concentration which are associated with the progression of pdac. In a phase II clinical study, this test accurately differentiated patients with disease progression from those with stable disease. The TAB004 antibody has also been fully humanized (HTAB004) to develop radionuclide imaging. In this project we propose to use three novel mouse models that have human MUC1 in the entire epithelia: MUC1.TG, spontaneous PDA.MUC1.TG that spontaneously develops pdac and a non- spontaneous PDA.MUC1.TG model that requires tamoxifen injection to initiate pdac progression. The PDA.MUC1.TG models have the KRASG12D mutation and mimic the onset and progression of pancreatic cancer in humans. The mice will be maintained at uncc and be subjected to blood draws every two weeks. Blood samples will be provided to oncotab in a blinded fashion (association with mouse model will be withheld) to test the ability of the APS test to detect pdac at a carcinoma in situ stage. Mice flagged positive will be shipped to invicro for imaging with HTAB004 labeled with indium-111. To ensure the imaging study is also blinded, twice as many mice without pdac (MUC1.TG and non- spontaneous PDA.MUC.TG models) will also be shipped without model association being disclosed. The three mouse models are on the C57BL/6 background and are indistinguishable from each other. Successful demonstration of the integrated serum and imaging biomarker approach to detect pdac at a carcinoma in situ stage in the proposed blinded study will be a major breakthrough. Establishing early detection in the proposed novel mouse model that mimics human pdac progression will set the stage to conduct a clinical trial to screen people at high risk for pancreatic cancer using the APS test.

Transactions

Action Federal Non-federal Date
Amendment $0 $0
Amendment $400,000 $0
Original award $400,000 $400,000

Quick answers

Who received award R41CA265655?

R41CA265655 was awarded to Oncotab, Inc. by National Cancer Institute (National Institutes of Health) on September 21, 2021.

How much is award R41CA265655 worth?

$1,200,000 has been obligated on R41CA265655: $800,000 in federal funding and $400,000 in non-federal funding.

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