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Pharmacology & human Phase 1 safety & dose escalation studies using anti-GP88 in aggressive breast cancer

Award Number: R44CA224718
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/01/2018
PERIOD OF PERFORMANCE END DATE: 02/28/2026

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Pharmacology & human Phase 1 safety & dose escalation studies using anti-GP88 in aggressive breast cancer - In 2017, ~200,000 new cases of breast cancer (BC) and ~40,000 related deaths are expected in the US. ~30,000 of these are patients with aggressive triple negative BC (TNBC) or anti-estrogen/aromatase inhibitor resistant (AE/AI) BC that do not have targeted therapy and rely on radiotherapy and aggressive chemotherapy. A new approach that benefits these patients and provides increased life expectancy needs to be developed. We have identified GP88, a glycoprotein that is produced by cancer cells and stimulates their growth and survival leading to formation of more aggressive tumors. GP88 is found in BC but not in normal breast tissue. There is compelling biological and clinical evidence to suggest that GP88 can be used to develop novel targeted therapy with companion diagnostics that could impact treatment and improve survival of TNBC and AE/AI BC patients. We have developed a tissue test to identify patients with tumors expressing GP88 and an anti-GP88 (AG1) to block the action of GP88 on tumor tissues to a) inhibit tumor growth and b) increase the efficacy of current BC drugs. We have safety and efficacy data in animals and will in our Phase 1 develop a dosing strategy in mice before moving into human studies as part of the Phase 2. Additionally, a blood test has been developed to monitor patients while on treatment. Using AG1 as the therapy with two companion diagnostic tests, we will carry out a phase IA/B clinical trial in humans to determine safety of AG1 manufactured under GMP in the Phase 2 and will collect tumor tissue and blood on all patients to evaluate for GP88 expression (tissue) and concentration (blood).


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: 2025 ( Subtotal = $0 )
2025	2022	A&G PHARMACEUTICAL, INC.	9130 RED BRANCH RD STE U	COLUMBIA	MD	21045	HOWARD	USA	Cancer Treatment Research	000	3	2/13/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2022	A&G PHARMACEUTICAL, INC.	9130 RED BRANCH RD STE U	COLUMBIA	MD	21045	HOWARD	USA	Cancer Treatment Research	000	3	4/3/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2022	A&G PHARMACEUTICAL, INC.	9130 RED BRANCH RD	COLUMBIA	MD	21045	HOWARD	USA	Cancer Treatment Research	000	3	6/30/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $826,939 )
2022	2022	A&G PHARMACEUTICAL, INC.	9130 RED BRANCH RD STE X	COLUMBIA	MD	21045	HOWARD	USA	Cancer Treatment Research	000	3	3/24/2022	NON-COMPETING CONTINUATION	$826,939
														Subtotal = $826,939

Issue Date FY: 2021 ( Subtotal = $0 )
2021	2020	A&G PHARMACEUTICAL, INC.	9130 RED BRANCH RD STE X	COLUMBIA	MD	21045	HOWARD	USA	Cancer Treatment Research	001	2	9/7/2021	EXTENSION WITH OR WITHOUT FUNDS	$0
2021	2020	A&G PHARMACEUTICAL, INC.	9130 RED BRANCH RD STE X	COLUMBIA	MD	21045	HOWARD	USA	Cancer Treatment Research	002	2	9/8/2021	EXTENSION WITH OR WITHOUT FUNDS	$0
2021	2018	A&G PHARMACEUTICAL, INC.	9130 RED BRANCH RD STE X	COLUMBIA	MD	21045	HOWARD	USA	Cancer Treatment Research	000	1	3/19/2021	NEW	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $1,062,115 )
2020	2020	A&G PHARMACEUTICAL, INC.	9130 RED BRANCH RD STE X	COLUMBIA	MD	21045	HOWARD	USA	Cancer Treatment Research	001	2	9/1/2020	EXTENSION WITH OR WITHOUT FUNDS	$1,062,115
2020	2018	A&G PHARMACEUTICAL, INC.	9130 RED BRANCH RD STE X	COLUMBIA	MD	21045	HOWARD	USA	Cancer Treatment Research	000	1	3/2/2020	NEW	$0
														Subtotal = $1,062,115

Issue Date FY: 2019 ( Subtotal = $0 )
2019	2018	A&G PHARMACEUTICAL, INC.	9130 RED BRANCH RD STE X	COLUMBIA	MD	21045	HOWARD	USA	Cancer Treatment Research	000	1	8/28/2019	NEW	$0
														Subtotal = $0

Issue Date FY: 2018 ( Subtotal = $159,365 )
2018	2018	A&G PHARMACEUTICAL, INC.	9130 RED BRANCH RD STE X	COLUMBIA	MD	21045	HOWARD	USA	Cancer Treatment Research	000	1	8/31/2018	NEW	$159,365
														Subtotal = $159,365

Grand Total All Awards = $2,048,419

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Pharmacology & human Phase 1 safety & dose escalation studies using anti-GP88 in aggressive breast cancer

Award Number: R44CA224718

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/01/2018

PERIOD OF PERFORMANCE END DATE: 02/28/2026

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