Saturday, August 23, 2025 8/23/2025

A Circulating Biomarker for use in Monitoring Metastatic Breast Cancer

Award Number: R44CA210817
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 03/15/2017
PERIOD OF PERFORMANCE END DATE: 08/31/2025

Group Awards By:

View Award Description

A Circulating Biomarker for use in Monitoring Metastatic Breast Cancer - Cost-effective and minimally invasive monitoring of metastatic breast cancer (MBC) patients for disease progression or response to therapy is an unmet need in the clinical management of the disease. Imaging technologies are currently the gold standard of such monitoring. However, there is controversy regarding the type & frequency of imaging required. Imaging is expensive, time consuming, slow to detect disease changes and raises concern about repeated radiation exposure and costs are not always covered by insurance. Complementary approaches to imaging such as circulating tumor cells and biomarkers are used in the Standard of Care (SOC), although their application remains limited. A simple, cost-effective blood test to measure the level of biomarkers which are drivers of the disease aggressiveness should provide novel solutions for real-time monitoring of therapy response and reduce dependency on imaging in the MBC population. The PI has identified an 88kDa glycoprotein GP88 (progranulin), elucidated its biological activity as an autocrine growth & survival factor. GP88 is secreted from cancer cells and measurable in biological fluids at higher levels in breast cancer patients, compared to healthy individuals. Based on these characteristics, an innovative diagnostic test (Enzyme Immunoassay – EIA) to measure GP88 in circulation was established. Our SBIR Phase 1 retrospective study demonstrated a statistical association between serum GP88 levels measured by the EIA test and objective measures of disease, i.e. RECIST 1.1 in 101 MBC patients. We established that a serum GP88 level of 56ng/mL was a stratification point below which patients have improved overall survival while patients with GP88>56 ng/ml have a poor outcome. We showed that serum GP88 levels were statistically correlated to response to therapy in addition to progression of disease unlike the SOC biomarker CA15-3 which is only associated to progression of disease. Based on these promising data, we are proposing an SBIR Phase 2 prospective longitudinal study over a 15-month period enrolling 120 MBC patients at two clinical sites by measuring serum GP88 level every month with imaging performed every 3 months. The objectives are to validate the findings of phase 1 and establish the predictive use of the GP88 test in monitoring MBC patients for disease progression/ response as an adjunct to imaging and aid in the clinical management of such patients. Specifically, we will (1) Validate that serum GP88 levels are correlated to disease response/ progression as defined by imaging results; (2) Examine the impact of successive high (>56ng/mL) and low (<56ng/mL) GP88 blood levels on future response/ progression and time to progression as defined by imaging results; (3) Validate that patients with consistent low (<56ng/mL) GP88 blood levels, have improved survival compared with patients with consistently high (>56ng/mL) GP88 blood levels. The outcomes of this phase 2 will be to establish clinical data to support commercialization of GP88 EIA as an integral part of clinical management of MBC patients that will contribute to improved care of MBC patients at reduced cost.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2024 ( Subtotal = -$99,823 )
2024	2022	A&G PHARMACEUTICAL, INC.	9130 RED BRANCH RD STE U	COLUMBIA	MD	21045	HOWARD	USA	Cancer Detection and Diagnosis Research	001	4	2/1/2024	NON-COMPETING CONTINUATION	$0
2024	2022	A&G PHARMACEUTICAL, INC.	9130 RED BRANCH RD STE U	COLUMBIA	MD	21045	HOWARD	USA	Cancer Detection and Diagnosis Research	002	4	9/18/2024	NON-COMPETING CONTINUATION	$0
2024	2022	A&G PHARMACEUTICAL, INC.	9130 RED BRANCH RD STE U	COLUMBIA	MD	21045	HOWARD	USA	Cancer Detection and Diagnosis Research	000	4	10/1/2023	NON-COMPETING CONTINUATION	-$99,823
														Subtotal = -$99,823

Issue Date FY: 2022 ( Subtotal = $70,818 )
2022	2022	A&G PHARMACEUTICAL, INC.	9130 RED BRANCH RD STE X	COLUMBIA	MD	21045	HOWARD	USA	Cancer Detection and Diagnosis Research	001	4	8/23/2022	NON-COMPETING CONTINUATION	$70,818
2022	2021	A&G PHARMACEUTICAL, INC.	9130 RED BRANCH RD STE X	COLUMBIA	MD	21045	HOWARD	USA	Cancer Detection and Diagnosis Research	000	3	10/29/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $70,818

Issue Date FY: 2021 ( Subtotal = $141,660 )
2021	2021	A&G PHARMACEUTICAL, INC.	9130 RED BRANCH RD STE X	COLUMBIA	MD	21045	HOWARD	USA	Cancer Detection and Diagnosis Research	000	3	8/30/2021	NON-COMPETING CONTINUATION	$141,660
														Subtotal = $141,660

Issue Date FY: 2020 ( Subtotal = $0 )
2020	2018	A&G PHARMACEUTICAL, INC.	9130 RED BRANCH RD STE X	COLUMBIA	MD	21045	HOWARD	USA	Cancer Detection and Diagnosis Research	000	2	8/26/2020	COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2019 ( Subtotal = $0 )
2019	2018	A&G PHARMACEUTICAL, INC.	9130 RED BRANCH RD STE X	COLUMBIA	MD	21045	HOWARD	USA	Cancer Detection and Diagnosis Research	000	2	9/10/2019	COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2018 ( Subtotal = $1,101,350 )
2018	2018	A&G PHARMACEUTICAL, INC.	9130 RED BRANCH RD STE X	COLUMBIA	MD	21045	HOWARD	USA	Cancer Detection and Diagnosis Research	000	2	8/23/2018	COMPETING CONTINUATION	$1,101,350
														Subtotal = $1,101,350

Grand Total All Awards = $1,214,005

Top

All Categories

About

Search

Reports

Data Submission

Award Information

A Circulating Biomarker for use in Monitoring Metastatic Breast Cancer

Award Number: R44CA210817

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 03/15/2017

PERIOD OF PERFORMANCE END DATE: 08/31/2025

Federal Websites

Department of Health & Human Services

HHS Operating Divisions

HHS Staff Divisions

Download A Document Viewer