Monday, December 29, 2025 12/29/2025

Immunoengineering Next-Generation Cancer Therapies with Focused Ultrasound

Award Number: DP5OD031846
ORGANIZATION: OFFICE OF THE DIRECTOR, NIH
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/14/2021
PERIOD OF PERFORMANCE END DATE: 08/31/2026

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Immunoengineering Next-Generation Cancer Therapies with Focused Ultrasound - Project Abstract Metastatic breast cancer (BrCa) is the 2nd most prevalent cause of cancer mortality in women in the United States, with a 5-year overall survival of only 22%. Though cancer immunotherapies are capable of generating durable responses across a variety of cancer types, immunologic rejection of BrCa is rare and spontaneous regression unusual. Thus, there exists a strong precedent for allied combinatorial therapy paradigms that potentiate immunotherapy (ITx) by boosting tumor immunogenicity and/or curbing immunosuppressive mechanisms. In this proposal, we will systematically assess the capacity of focused ultrasound (FUS) - a technique for non-invasive, non-ionizing acoustic energy deposition into tumors – to potentiate adaptive immunity against BrCa metastases and synergize with selected immunotherapies. UVA is a world leader in FUS ITx research, with two “first-in-human” clinical trials underway to evaluate combinations of FUS with PD1 blockade in solid tumors (including metastatic BrCa) and a third trial pending approval to evaluate FUS and gemcitabine for immune-mediated control of BrCa tumors. These trials are accompanied by a companion imaging trial designed to evaluate CD8+ T cell infiltration in patients’ tumor deposits via PET/CT, an approach that will also be integrated into our pre-clinical studies. To this end, this proposal leverages these clinical trials as well as a robust pre-clinical program to fortify a highly translational research pipeline rooted in the domains of immunology, molecular imaging, liquid biopsy and radiogenomics. With this toolkit, we intend to design and implement FUS+ITx combinations that offer the potential for quantum improvements in metastatic BrCa therapy. This is achieved in three Specific Aims. In Specific Aim 1, we will expand on intriguing early clinical and pre-clinical findings to identify FUS regimens that, when combined with myeloid-targeted therapies, augment the efficacy of chimeric antigen receptor (CAR) T cell therapy against primary and disseminated BrCa tumors (e.g. brain metastases). In Specific Aim 2, we will engineer FUS-based theranostic technologies for liquid biopsy in BrCa in order to (i) discover novel biomarkers of response to FUS and ITx (ii) enable liquid biopsy in settings with low basal levels of circulating tumor biomarkers. Finally, in Specific Aim 3, we will construct machine learning frameworks that integrate radiological data with genomic data from liquid biopsy specimens (e.g. radiogenomics) to advance BrCa precision care with FUS and ITx. The highly innovate aims of this proposal lend to a systematic approach for advancing the role of FUS in CAR T cell therapy, cancer biomarker discovery and personalized ITx, thereby promising to improve the lives of metastatic breast cancer patients.


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: 2026 ( Subtotal = $0 )
2026	2025	RECTOR & VISITORS OF THE UNIVERSITY OF VIRGINIA	1001 EMMET ST N	CHARLOTTESVILLE	VA	22903	CHARLOTTESVILLE CITY	USA	Trans-NIH Research Support	000	5	12/17/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2025 ( Subtotal = $395,430 )
2025	2025	RECTOR & VISITORS OF THE UNIVERSITY OF VIRGINIA	1001 EMMET ST N	CHARLOTTESVILLE	VA	22903	CHARLOTTESVILLE CITY	USA	Trans-NIH Research Support	000	5	8/15/2025	NON-COMPETING CONTINUATION	$395,430
														Subtotal = $395,430

Issue Date FY: 2024 ( Subtotal = $395,712 )
2024	2024	RECTOR & VISITORS OF THE UNIVERSITY OF VIRGINIA	1001 EMMET ST N	CHARLOTTESVILLE	VA	22903	CHARLOTTESVILLE CITY	USA	Trans-NIH Research Support	000	4	8/14/2024	NON-COMPETING CONTINUATION	$395,712
														Subtotal = $395,712

Issue Date FY: 2023 ( Subtotal = $395,984 )
2023	2023	RECTOR & VISITORS OF THE UNIVERSITY OF VIRGINIA	1001 EMMET ST N	CHARLOTTESVILLE	VA	22903	CHARLOTTESVILLE CITY	USA	Trans-NIH Research Support	000	3	8/31/2023	NON-COMPETING CONTINUATION	$395,984
														Subtotal = $395,984

Issue Date FY: 2022 ( Subtotal = $403,750 )
2022	2022	RECTOR & VISITORS OF THE UNIVERSITY OF VIRGINIA	1001 N EMMET ST	CHARLOTTESVILLE	VA	22903	CHARLOTTESVILLE CITY	USA	Trans-NIH Research Support	001	2	8/30/2022	NON-COMPETING CONTINUATION	$403,750
2022	2021	RECTOR & VISITORS OF THE UNIVERSITY OF VIRGINIA	1001 N EMMET ST	CHARLOTTESVILLE	VA	22903	CHARLOTTESVILLE CITY	USA	Trans-NIH Research Support	000	1	11/26/2021	NEW	$0
														Subtotal = $403,750

Issue Date FY: 2021 ( Subtotal = $403,750 )
2021	2021	RECTOR & VISITORS OF THE UNIVERSITY OF VIRGINIA	1001 N EMMET ST	CHARLOTTESVILLE	VA	22903	CHARLOTTESVILLE CITY	USA	Trans-NIH Research Support	000	1	9/14/2021	NEW	$403,750
														Subtotal = $403,750

Grand Total All Awards = $1,994,626

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Immunoengineering Next-Generation Cancer Therapies with Focused Ultrasound

Award Number: DP5OD031846

ORGANIZATION: OFFICE OF THE DIRECTOR, NIH

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/14/2021

PERIOD OF PERFORMANCE END DATE: 08/31/2026

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