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Novel assay to monitor Tacrolimus levels at the point of care

Award Number: R44AI140931
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 06/15/2018
PERIOD OF PERFORMANCE END DATE: 07/31/2023

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Novel assay to monitor Tacrolimus levels at the point of care - SUMMARY/ABSTRACT In 2016, over 33,000 organ transplants were performed in the United States, an increase of 20% over the past 5 years. Organ transplantation requires lifelong immunosuppression to prevent rejection of the transplant. Tacrolimus, a macrolide antibiotic, is one of the most effective immunosuppressants, with >90% of solid organ transplant recipients receiving it as part of their maintenance immunosuppression. Tacrolimus has a narrow therapeutic window, with sub-therapeutic levels putting patients at risk for rejection and supra-therapeutic levels leading to toxicity. In addition to significant pharmacokinetic variability, it is also estimated that >25% of patients are non-adherent to their immunosuppressant regimen, significantly increasing graft rejection and failure rates and increasing the financial burden on the US healthcare system. Because transplant recipients require a lifetime of immunosuppression, any methods that facilitate improved dosing and rapid detection of non-adherence are of great clinical utility. Because tacrolimus levels cannot be ascertained at the point of care, detection of non-therapeutic levels in the outpatient setting is challenging. Patients must either attend a separate lab appointment ahead of their routine follow-up visits or they have levels drawn on the day of their visit. In the former, an extra burden is placed on the patient to attend an additional appointment while the latter precludes analysis of levels prior to the patient’s appointment. Delays in medication management or identification of patient non-compliance place the patient at risk for graft rejection (sub-therapeutic levels) or drug-associated toxicities (supra-therapeutic levels). To address this technical hurdle, Affinergy plans to develop a point-of-care lateral flow assay that will enable frequent, accurate and affordable monitoring of tacrolimus levels. We have already generated a proprietary capture reagent and identified several detection reagent candidates that bind with nanomolar affinity to tacrolimus. At the conclusion of Phase I, we will have a prototype lateral flow assay with established limits of quantitation. In Phase II, we will scale up production of our assay, optimize performance characteristics, establish storage conditions, determine stability and evaluate our assay using transplant recipient blood specimens. Successful completion of this project will lead to improved long-term maintenance of patients receiving tacrolimus for immunosuppression and ease the burden on both patients and providers.


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	2021	AFFINERGY, LLC	104 TW ALEXANDER DRIVE, BLDG. 20	DURHAM	NC	27709	DURHAM	USA	Allergy and Infectious Diseases Research	000	4	4/24/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $735,018 )
2021	2021	AFFINERGY, LLC	601 KEYSTONE PARK DR STE 100	MORRISVILLE	NC	27560	WAKE	USA	Allergy and Infectious Diseases Research	000	4	6/24/2021	NON-COMPETING CONTINUATION	$735,018
														Subtotal = $735,018

Issue Date FY: 2020 ( Subtotal = $734,099 )
2020	2020	AFFINERGY, LLC	601 KEYSTONE PARK DR STE 100	MORRISVILLE	NC	27560	WAKE	USA	Allergy and Infectious Diseases Research	000	3	6/26/2020	NON-COMPETING CONTINUATION	$734,099
														Subtotal = $734,099

Issue Date FY: 2019 ( Subtotal = $759,336 )
2019	2019	AFFINERGY, LLC	601 KEYSTONE PARK DR STE 100	MORRISVILLE	NC	27560	WAKE	USA	Allergy and Infectious Diseases Research	001	2	7/29/2019	EXTENSION WITH OR WITHOUT FUNDS	$759,336
2019	2018	AFFINERGY, LLC	601 KEYSTONE PARK DR STE 100	MORRISVILLE	NC	27560	WAKE	USA	Allergy and Infectious Diseases Research	000	1	6/4/2019	NEW	$0
														Subtotal = $759,336

Issue Date FY: 2018 ( Subtotal = $300,000 )
2018	2018	AFFINERGY, LLC	601 KEYSTONE PARK DR STE 100	MORRISVILLE	NC	27560	WAKE	USA	Allergy and Infectious Diseases Research	000	1	6/15/2018	NEW	$300,000
														Subtotal = $300,000

Grand Total All Awards = $2,528,453

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Novel assay to monitor Tacrolimus levels at the point of care

Award Number: R44AI140931

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 06/15/2018

PERIOD OF PERFORMANCE END DATE: 07/31/2023

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