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A Circulating Biomarker for use in Monitoring Metastatic Breast Cancer

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R43CA210817-01A1
Agency Tracking Number: R43CA210817
Amount: $152,589.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: NCI
Solicitation Number: PA16-302
Timeline
Solicitation Year: 2016
Award Year: 2017
Award Start Date (Proposal Award Date): 2017-03-15
Award End Date (Contract End Date): 2018-03-14
Small Business Information
9130 RED BRANCH RD STE U
Columbia, MD 21045-2006
United States
DUNS: 963442723
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 GINETTE SERRERO
 (410) 706-7515
 gserrero@agpharma.com
Business Contact
 GINETTE SERRERO
Phone: (410) 884-4100
Email: gserrero@agpharma.com
Research Institution
N/A
Abstract

Significance Despite decreases in the overall number of new breast cancer BC cases reported in the US
annually there are still about BC deaths annually from metastatic breast cancer MBC Thus the
ability to monitor MBC is important to determine disease status and therapy response While the gold standard
imaging is expensive time consuming and slow to detect disease response or progression circulating
biomarkers such as CA CA and CEA also used to monitor MBC have limitations due to low specificity
and sensitivity Thus providing better safe inexpensive non invasive specific and sensitive tests for new
biomarkers to monitor disease is a key component in improving MBC patient care Strategy Measurement of
critical biological drivers as biomarkers of the disease will provide a clearer understanding of current disease
state and improve proactive clinical management The PI has characterized a proprietary target biomarker GP
expressed in BC tissue secreted in BC patients blood and playing a key role in BC tumorigenesis GP IHC
and EIA tests to measure GP tumor expression and circulating levels in BC patients were developed and
clinically validated Supporting Evidence Pathological studies have established GP tumor expression as a
predictive marker for recurrence Clinical studies have shown BC patients with progressive disease have
elevated GP serum levels compared to patients with no evidence of disease or healthy individuals Patients
with poor outcome had a significantly higher GP serum levels ng ml range ng ml than alive patients
ng ml range ng ml p These data indicate that if GP blood levels are maintained below a yet
to be established cut off level then a patient can be expected to have a longer survival than patients with
elevated GP Hypothesis Measuring serum GP level could provide an ideal approach for monitoring
disease status in MBC patients as adjunctive to imaging This hypothesis will be investigated by measuring GP
levels in sequential retrospective serum samples collected from MBC patients enrolled in an IRB approved
study at UMGCCC and correlate such levels with objective measures of clinical outcome determined using
RECIST criteria Specific Aims we will a establish by Kaplan Meier survival graphs a GP threshold
value that stratify BC patients for survival and clinical outcomes b determine if changes in GP serum level
correlate with changes in RECIST criteria collected at the same time points using receiver operating
characteristics curves identify GP cutoff values that effectively stratify patients by their clinical outcome
using multivariate analysis and logistic regression evaluate if combining GP and CA results can improve
upon and enhance the predictive performance of CA Overall Impact Since GP is a driver of the
disease the use of the GP EIA test has the potential to provide real time evaluation of the disease state
making GP a better biomarker to monitor MBC than those currently available This will provide clinicians with
a new assay to assess disease status to increase predictive values of existing techniques such as imaging Of breast cancer BC related deaths are where BC has spread outside the breast MBC even
though at time of primary diagnosis there is often no evidence of tumor spread Thus the ability to detect and
monitor MBC is important in the management of BC Provision of safe inexpensive non invasive specific and
sensitive tests for monitoring of disease is key in disease management The PI has characterized a biomarker
called GP Biological and clinical studies have established the importance of GP in BC aggressiveness and
as a predictive marker for recurrence Published studies demonstrated GP is present in BC tissue but not in
corresponding normal breast tissue elevated levels of GP in BC tumor tissue are associated with poor
outcome and compared to healthy individuals elevated GP blood levels can be found in BC patients with
progressive disease Thus using blood tests to detect and quantify GP during treatment could provide an ideal
target for monitoring disease progression in BC patients undergoing therapy This SBIR Phase I study will
measure GP levels in sequential blood samples collected from MBC patients enrolled in an IRB approved
study and correlate such levels with objective measures of clinical outcome This application will explore this
relationship and determine the best cutoff level for GP when examining sequential data in comparison to
disease status If we can establish a relationship between the GP level in blood and the disease state the
information will be useful for disease management of MBC patients

* Information listed above is at the time of submission. *

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