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Human on a chip systems to investigate disease comorbidities common in the aged population

Award Number: R44AG059511
ORGANIZATION: NATIONAL INSTITUTE ON AGING
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 04/01/2018
PERIOD OF PERFORMANCE END DATE: 04/30/2025

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Human on a chip systems to investigate disease comorbidities common in the aged population - Project Summary Both older adults and the pharmaceutical industry would benefit from the development of human-on-a-chip systems to be able to systematically investigate disease comorbidities and their response to drug candidates in the aged population at the preclinical stage due to the lack of good multimodal models of disease combinations. We will investigate diseases that are most prevalent in the aged population including non- alcoholic fatty liver disease (NAFLD), cardiomyopathy, cachexia/sarcopenia and type II diabetes. The influence of metabolic diseases, especially type II diabetes, on aged and diseased patients is well known, but little studied at the preclinical level. This proposal will build upon the expertise at Hesperos and their current collaborations with UCF and the Center for Pharmacodynamics at the University of Florida branch, located in Orlando. We will use Hesperos’ patented multi-organ functional systems to investigate multiple disease phenotypes to determine how other deficits in organs or modalities enhance or cause disease, hasten progression or limit treatment options in each organ. It is also unclear how normal aging is affected by metabolic disorders, although some correlations have been observed. Human-on-a-chip models composed of multiple organs in recirculating media will provide a controlled reproducible system to evaluate responses to drugs. In addition, by comparing acute to chronic effects, the model will enable prediction of clinical trial success using models to inform clinical disease trial design based on these preclinical studies. We will build on ongoing initiatives to expand PBPK/PD modeling and simulation platforms to geriatrics by accounting for changes in the underlying pathophysiology with age. These models may also serve as screening tools during early stages of drug development and facilitate decision-making with respect to selecting the compound with a more favorable PK and formulation properties. To construct a well-defined system, we will use a common serum free medium with functional readouts using microelectrode arrays and cantilevers that are integrated on chip that allow for noninvasive electronic and mechanical readouts for acute drug responses in Phase I and chronic drug tests in Phase II. The Phase I portion of this proposal will show that three organs can be linked together - liver, cardiac and muscle- and that their response to therapeutics can reproduce responses in clinical trials. Drug and drug combinations will then be tested in the multiplexed disease models acutely for altered efficacy and toxicity compared to healthy or non-comorbidity systems. After the quantitative milestones for Phase I have been achieved, the acute studies will be extended to chronic applications in Phase II. We will also establish a type II diabetic phenotype in the system by utilizing different concentrations of insulin and glucose in a five-organ system developed by integrating the system in Aim 1 with adipose and pancreas. The disease phenotypes introduced into the system in Phase I and the combined effect of metabolic diseases will be used to evaluate therapeutics in the system.


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 = $0 )
2024	2022	HESPEROS, INC	12501 RESEARCH PKWY STE 100	ORLANDO	FL	32826	ORANGE	USA	Aging Research	000	5	6/25/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $1,483,966 )
2022	2022	HESPEROS, INC.	12501 RESEARCH PKWY STE 100	ORLANDO	FL	32826	ORANGE	USA	Aging Research	000	5	5/17/2022	NON-COMPETING CONTINUATION	$1,483,966
														Subtotal = $1,483,966

Issue Date FY: 2021 ( Subtotal = $1,483,966 )
2021	2021	HESPEROS, INC.	12501 RESEARCH PKWY STE 100	ORLANDO	FL	32826	ORANGE	USA	Aging Research	001	4	5/6/2021	NON-COMPETING CONTINUATION	$1,483,966
2021	2019	HESPEROS, INC.	12501 RESEARCH PKWY STE 100	ORLANDO	FL	32826	ORANGE	USA	Aging Research	000	2	2/1/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $1,483,966

Issue Date FY: 2020 ( Subtotal = $1,483,966 )
2020	2020	HESPEROS, INC.	12501 RESEARCH PKWY STE 100	ORLANDO	FL	32826	ORANGE	USA	Aging Research	001	3	5/8/2020	EXTENSION WITH OR WITHOUT FUNDS	$1,483,966
2020	2019	HESPEROS, INC.	12501 RESEARCH PKWY STE 100	ORLANDO	FL	32826	ORANGE	USA	Aging Research	000	2	5/5/2020	NON-COMPETING CONTINUATION	$0
														Subtotal = $1,483,966

Issue Date FY: 2019 ( Subtotal = $224,999 )
2019	2019	HESPEROS, INC	3259 PROGRESS DR, # 158	ORLANDO	FL	32826	ORANGE	USA	Aging Research	000	2	3/18/2019	NON-COMPETING CONTINUATION	$224,999
														Subtotal = $224,999

Issue Date FY: 2018 ( Subtotal = $224,999 )
2018	2018	HESPEROS, INC	3259 PROGRESS DR, # 158	ORLANDO	FL	32826	ORANGE	USA	Aging Research	000	1	3/28/2018	NEW	$224,999
														Subtotal = $224,999

Grand Total All Awards = $4,901,896

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Human on a chip systems to investigate disease comorbidities common in the aged population

Award Number: R44AG059511

ORGANIZATION: NATIONAL INSTITUTE ON AGING

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 04/01/2018

PERIOD OF PERFORMANCE END DATE: 04/30/2025

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