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Genomically informed agent selection and testing in osteosarcoma patient-derived xenograft models

Award Number: U01CA199221
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 07/10/2015
PERIOD OF PERFORMANCE END DATE: 06/30/2026

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Genomically informed agent selection and testing in osteosarcoma patient-derived xenograft models - Project Summary/ Abstract Survival outcomes for patients with osteosarcoma have not changed since the advent of modern chemotherapy four decades ago and it has been challenging to develop new effective therapies in this disease. Our lab’s long- term mission is to identify novel molecular targets in osteosarcoma via comprehensive genomic and proteomic profiling of patient-derived cell lines and xenografts as well as human tumors with the ultimate goal of identifying and/or developing and testing therapeutics against these targets. To achieve this goal, we have a) built a robust profiling platform to identify novel targets; b) expanded our repertoire of osteosarcoma patient derived xenograft (PDX) models to reflect disease heterogeneity; and c) conducted high-throughput in vivo testing of 8-10 new agents each year both as part of Pediatric Preclinical Testing Consortium (PPTC) as well as independent of it. All of these efforts form the basis of our current research proposal and place us strongly poised to successfully achieve our goals. Our overall objective is to efficiently evaluate the efficacy of new agents with high potential to have activity in osteosarcoma based on target data from our genomic and proteomic profiling both as single agents and in rational combinations, with the vision of moving effective agents into clinical trials through the Children’s Oncology Group. We have three specific aims- 1) to select and test agents in vivo against surface targets identified by comprehensive proteomic profiling of osteosarcoma xenografts and patient tumors; 2) to select and test agents in vivo against targets identified by comprehensive genomic profiling of osteosarcoma xenografts and patient tumors; and 3) to perform testing of rationally combined agents based on target, toxicity and efficacy data of single agents. Agents from the PPTC pipeline will be selected based on either the proteomic target or genomic alteration being present in at least a subset of available osteosarcoma PDX models. The agent will be tested in selected cohorts of low/ high expressing protein target or present/ absent genomic alteration. In cases with multiple models with target expression, 3-5 mice per model will be used and in cases with few models available, 8-10 mice per model will be used for control and experiment groups with an overall n per arm per experiment of approximately 30 mice. Standard PPTC procedures will be used for tumor implantation and treatment. Tumor dimensions will be measured twice a week and response quantified as per standard PPTC definitions of complete response, maintained complete response, partial response, stable disease and progressive disease. For combination studies, three potential types of combinations will be considered based on efficacy and toxicity data- a) two surface protein targeted agents such as two antibody-drug conjugates; 2) two molecularly targeted agents and 3) a surface protein targeted agent and a molecularly targeted agent. Our results will guide the development of the next generation of clinical trials in osteosarcoma.


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 = $405,000 )
2025	2025	THE UNIVERISTY OF TEXAS M.D. ANDERSON CANCER CENTER	1515 HOLCOMBE BLVD	HOUSTON	TX	77030	HARRIS	USA	Cancer Treatment Research	000	11	6/13/2025	NON-COMPETING CONTINUATION	$405,000
														Subtotal = $405,000

Issue Date FY: 2024 ( Subtotal = $402,869 )
2024	2024	THE UNIVERISTY OF TEXAS MD ANDERSON CANCER CENTER, A COMPONENT OF THE UNIVERISTY OF TEXAS SYSTEM	1515 HOLCOMBE BLVD	HOUSTON	TX	77030	HARRIS	USA	Cancer Treatment Research	000	10	6/18/2024	NON-COMPETING CONTINUATION	$402,869
														Subtotal = $402,869

Issue Date FY: 2023 ( Subtotal = $394,769 )
2023	2023	UNIVERSITY OF TEXAS M. D. ANDERSON CANCER CENTER, THE	1515 HOLCOMBE BLVD	HOUSTON	TX	77030	HARRIS	USA	Cancer Treatment Research	000	9	6/16/2023	NON-COMPETING CONTINUATION	$394,769
														Subtotal = $394,769

Issue Date FY: 2022 ( Subtotal = $396,900 )
2022	2022	UNIVERSITY OF TEXAS M. D. ANDERSON CANCER CENTER, THE	1515 HOLCOMBE BLVD	HOUSTON	TX	77030	HARRIS	USA	Cancer Treatment Research	003	8	6/28/2022	NON-COMPETING CONTINUATION	$396,900
2022	2021	UNIVERSITY OF TEXAS M. D. ANDERSON CANCER CENTER, THE	1515 HOLCOMBE BLVD	HOUSTON	TX	77030	HARRIS	USA	Cancer Treatment Research	001	7	12/28/2021	COMPETING CONTINUATION	$2,132
2022	2021	UNIVERSITY OF TEXAS M. D. ANDERSON CANCER CENTER, THE	1515 HOLCOMBE BLVD	HOUSTON	TX	77030	HARRIS	USA	Cancer Treatment Research	000	6	12/28/2021	SUPPLEMENT FOR EXPANSION	-$2,132
2022	2021	UNIVERSITY OF TEXAS M. D. ANDERSON CANCER CENTER, THE	1515 HOLCOMBE BLVD	HOUSTON	TX	77030	HARRIS	USA	Cancer Treatment Research	002	7	6/28/2022	COMPETING CONTINUATION	$0
														Subtotal = $396,900

Issue Date FY: 2021 ( Subtotal = $565,233 )
2021	2021	UNIVERSITY OF TEXAS M D ANDERSON CANCER CENTER	1515 HOLCOMBE BLVD UNIT 207	HOUSTON	TX	77030	HARRIS	USA	Cancer Treatment Research	002	7	7/1/2021	COMPETING CONTINUATION	$405,000
2021	2021	UNIVERSITY OF TEXAS M D ANDERSON CANCER CENTER	1515 HOLCOMBE BLVD UNIT 207	HOUSTON	TX	77030	HARRIS	USA	Cancer Treatment Research	000	6	1/15/2021	SUPPLEMENT FOR EXPANSION	$160,233
2021	2019	UNIVERSITY OF TEXAS M D ANDERSON CANCER CENTER	1515 HOLCOMBE BLVD UNIT 207	HOUSTON	TX	77030	HARRIS	USA	Cancer Treatment Research	001	6	6/1/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $565,233

Issue Date FY: 2020 ( Subtotal = $177,926 )
2020	2020	UNIVERSITY OF TEXAS M D ANDERSON CANCER CENTER	1515 HOLCOMBE BLVD UNIT 207	HOUSTON	TX	77030	HARRIS	USA	Cancer Treatment Research	000	6	4/1/2020	SUPPLEMENT FOR EXPANSION	$177,926
2020	2019	UNIVERSITY OF TEXAS M D ANDERSON CANCER CENTER	1515 HOLCOMBE BLVD UNIT 207	HOUSTON	TX	77030	HARRIS	USA	Cancer Treatment Research	001	6	7/29/2020	NON-COMPETING CONTINUATION	$0
														Subtotal = $177,926

Issue Date FY: 2019 ( Subtotal = $351,458 )
2019	2019	UNIVERSITY OF TEXAS M D ANDERSON CANCER CENTER	1515 HOLCOMBE BLVD UNIT 207	HOUSTON	TX	77030	HARRIS	USA	Cancer Treatment Research	000	6	7/16/2019	NON-COMPETING CONTINUATION	$351,458
														Subtotal = $351,458

Issue Date FY: 2018 ( Subtotal = $136,071 )
2018	2018	UNIVERSITY OF TEXAS M D ANDERSON CANCER CENTER	1515 HOLCOMBE BLVD UNIT 207	HOUSTON	TX	77030	HARRIS	USA	Cancer Treatment Research	000	5	8/30/2018	NON-COMPETING CONTINUATION	$136,071
														Subtotal = $136,071

Issue Date FY: 2017 ( Subtotal = $249,200 )
2017	2017	UNIVERSITY OF TEXAS M D ANDERSON CANCER CENTER	1515 HOLCOMBE BLVD UNIT 207	HOUSTON	TX	77030	HARRIS	USA	Cancer Treatment Research	003	4	8/10/2017	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$156,272
2017	2017	UNIVERSITY OF TEXAS M D ANDERSON CANCER CENTER	1515 HOLCOMBE BLVD UNIT 207	HOUSTON	TX	77030	HARRIS	USA	Cancer Treatment Research	001	4	7/10/2017	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$249,200
2017	2016	ALBERT EINSTEIN COLLEGE OF MEDICINE, INC.	1300 MORRIS PARK AVE	BRONX	NY	10461	BRONX	USA	Cancer Treatment Research	002	3	8/10/2017	NON-COMPETING CONTINUATION	-$156,272
2017	2016	ALBERT EINSTEIN COLLEGE OF MEDICINE, INC.	1300 MORRIS PARK AVE	BRONX	NY	10461	BRONX	USA	Cancer Treatment Research	000	3	7/10/2017	NON-COMPETING CONTINUATION	$0
														Subtotal = $249,200

Issue Date FY: 2016 ( Subtotal = $260,102 )
2016	2016	ALBERT EINSTEIN COLLEGE OF MEDICINE INC	111 E 210TH ST	BRONX	NY	10467	BRONX	USA	Cancer Treatment Research	002	3	6/9/2016	NON-COMPETING CONTINUATION	$260,103
2016	2015	ALBERT EINSTEIN COLLEGE OF MEDICINE OF YESHIVA UNIV	1300 MORRIS PARK AVENUE	BRONIX	NY	10461		USA	Cancer Treatment Research	001	1	4/30/2016	NEW	$17,383
2016	2015	ALBERT EINSTEIN COLLEGE OF MEDICINE INC	111 E 210TH ST	BRONX	NY	10467	BRONX	USA	Cancer Treatment Research	000	2	4/29/2016	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	-$17,384
														Subtotal = $260,102

Issue Date FY: 2015 ( Subtotal = $260,103 )
2015	2015	ALBERT EINSTEIN COLLEGE OF MEDICINE INC	111 E 210TH ST	BRONX	NY	10467	BRONX	USA	Cancer Treatment Research	001	2	9/18/2015	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$260,103
2015	2015	ALBERT EINSTEIN COLLEGE OF MEDICINE OF YESHIVA UNIV	1300 MORRIS PARK AVENUE	BRONIX	NY	10461		USA	Cancer Treatment Research	000	1	7/10/2015	NEW	$260,103
2015	2015	ALBERT EINSTEIN COLLEGE OF MEDICINE OF YESHIVA UNIV	1300 MORRIS PARK AVENUE	BRONIX	NY	10461		USA	Cancer Treatment Research	002	1	9/18/2015	NEW	-$260,103
														Subtotal = $260,103

Grand Total All Awards = $3,599,631

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Genomically informed agent selection and testing in osteosarcoma patient-derived xenograft models

Award Number: U01CA199221

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 07/10/2015

PERIOD OF PERFORMANCE END DATE: 06/30/2026

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