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Drug-Loaded Nanobubbles for Ultrasound Enhanced Delivery to Colon Cancer Liver Metastasis

Award Number: R01EB028144
ORGANIZATION: NATIONAL INSTITUTE Of BIOMEDICAL IMAGING & BIOENGINEERING
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/30/2019
PERIOD OF PERFORMANCE END DATE: 06/30/2025

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Drug-Loaded Nanobubbles for Ultrasound Enhanced Delivery to Colon Cancer Liver Metastasis - PROJECT SUMMARY Drug-Loaded Nanobubbles for Ultrasound Enhanced Delivery to Colon Cancer Liver Metastasis Most advanced cancers can spread to the liver including those of the breast, esophagus, stomach, pancreas, colon, lungs, kidneys and even melanoma. Liver metastases (also referred to as secondary liver cancer) cannot be cured in the majority of cases, and most patients presenting with liver metastases will die of the disease. The problem is most pronounced in colorectal cancer, where nearly 85% of the 150,000 patients diagnosed in the United States each year will eventually develop metastatic disease in the liver due to the shared blood supply between the intestine and the liver. Effective treatment options at this stage are severely limited, and most cases are treated with oral or intravenous chemotherapy. The median survival for patients receiving systemic chemotherapy is still only 21 months due primarily to low drug uptake in the tumor, serious systemic toxicity and heterogeneous drug distribution at tumor sites. To meet the urgent need for more effective treatment options for liver metastases, we plan to develop a hybrid theranostic nanobubble which is inherently ultrasound visible and ultrasound-deployable on demand in real time at the region of interest. Our exciting preliminary data demonstrate that even after a single application of ultrasound immediately following particle injection, ultrasound-triggered delivery leads to significantly higher drug concentration in tumors and results in more homogeneous distribution within tumor compared to free drug and non-triggered particles. This suggests that, especially after parameters are optimized, treatment of tumors with the proposed construct has the potential to maximize drug dose at the tumor site and should lead to improved survival. Within the scope of this project we thus propose to optimize formulation and treatment parameters essential to the success of this approach. Some aspects that distinguish our technology from others include 1) nanoparticles used in the study are 100-300 nm in diameter and yet have strong ultrasound response making them visible at clinically relevant frequencies of 3- 12 MHz; 2) nanoparticles have augmented cargo capacity to enable simple and efficient drug loading directly into the particle; 3) payload release can be triggered with the imaging transducer using standard pulse sequences already available on clinical scanners; 4) nanoparticle is self-assembled and thus easily formulated and scaled up. The project will be carried out in four aims with Aims 1 and 2 being dedicated to in vitro characterization and optimization of the construct and Aims 3 and 4 evaluating in vivo performance. The ultimate goal of this work is to develop and optimize an image-guided drug delivery strategy that will maximize drug accumulation in tumors and lead to augmented, homogeneous drug distribution within the tumor volume while minimizing systemic accumulation compared to free drug. The outcome of this research will be a more effective strategy to improve delivery of chemotherapeutic agents to metastatic liver tumors. Impact: We are confident that the advantages and unique aspects of our nanoparticles will enable successful completion of this objective. These nanoparticles will overcome the drug transport challenges and will improve the effectiveness of chemotherapy regimens used in treating secondary liver cancer with ultimate goal to translate this research to the clinic.


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 = -$27,239 )
2026	2023	CASE WESTERN RESERVE UNIVERSITY	10900 EUCLID AVE	CLEVELAND	OH	44106	CUYAHOGA	USA	Discovery and Applied Research for Technological Innovations to Improve Human Health	000	4	12/15/2025	NON-COMPETING CONTINUATION	-$27,239
														Subtotal = -$27,239

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2023	CASE WESTERN RESERVE UNIVERSITY	10900 EUCLID AVE	CLEVELAND	OH	44106	CUYAHOGA	USA	Discovery and Applied Research for Technological Innovations to Improve Human Health	000	4	6/5/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $463,093 )
2023	2023	CASE WESTERN RESERVE UNIVERSITY	10900 EUCLID AVE	CLEVELAND	OH	44106	CUYAHOGA	USA	Discovery and Applied Research for Technological Innovations to Improve Human Health	000	4	7/19/2023	NON-COMPETING CONTINUATION	$463,093
														Subtotal = $463,093

Issue Date FY: 2022 ( Subtotal = $463,093 )
2022	2022	CASE WESTERN RESERVE UNIVERSITY	10900 EUCLID AVE	CLEVELAND	OH	44106	CUYAHOGA	USA	Discovery and Applied Research for Technological Innovations to Improve Human Health	000	3	9/2/2022	NON-COMPETING CONTINUATION	$463,093
														Subtotal = $463,093

Issue Date FY: 2021 ( Subtotal = $471,119 )
2021	2021	CASE WESTERN RESERVE UNIVERSITY	10900 EUCLID AVE	CLEVELAND	OH	44106	CUYAHOGA	USA	Discovery and Applied Research for Technological Innovations to Improve Human Health	000	2	9/16/2021	NON-COMPETING CONTINUATION	$471,119
														Subtotal = $471,119

Issue Date FY: 2020 ( Subtotal = $378,024 )
2020	2020	CASE WESTERN RESERVE UNIVERSITY	10900 EUCLID AVE	CLEVELAND	OH	44106	CUYAHOGA	USA	Discovery and Applied Research for Technological Innovations to Improve Human Health	001	1	9/8/2020	SUPPLEMENT FOR EXPANSION	$378,024
2020	2019	CASE WESTERN RESERVE UNIVERSITY	10900 EUCLID AVE	CLEVELAND	OH	44106	CUYAHOGA	USA	Discovery and Applied Research for Technological Innovations to Improve Human Health	000	1	7/30/2020	NEW	$0
														Subtotal = $378,024

Issue Date FY: 2019 ( Subtotal = $513,175 )
2019	2019	CASE WESTERN RESERVE UNIVERSITY	10900 EUCLID AVE	CLEVELAND	OH	44106	CUYAHOGA	USA	Discovery and Applied Research for Technological Innovations to Improve Human Health	000	1	9/16/2019	NEW	$513,175
2019	2019	CASE WESTERN RESERVE UNIVERSITY	10900 EUCLID AVE	CLEVELAND	OH	44106	CUYAHOGA	USA	Discovery and Applied Research for Technological Innovations to Improve Human Health	001	1	9/25/2019	NEW	$0
														Subtotal = $513,175

Grand Total All Awards = $2,261,265

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Drug-Loaded Nanobubbles for Ultrasound Enhanced Delivery to Colon Cancer Liver Metastasis

Award Number: R01EB028144

ORGANIZATION: NATIONAL INSTITUTE Of BIOMEDICAL IMAGING & BIOENGINEERING

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/30/2019

PERIOD OF PERFORMANCE END DATE: 06/30/2025

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