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Development of class-IIa HDAC targeting PET probes for molecular imaging of disorders of the CNS

Award Number: R56AG067417
ORGANIZATION: NATIONAL INSTITUTE ON AGING
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 04/15/2020
PERIOD OF PERFORMANCE END DATE: 08/31/2026

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Development of class-IIa HDAC targeting PET probes for molecular imaging of disorders of the CNS - Summary The aim of this application is to validate a novel class-IIa histone deacetylase (class-IIa HDAC) positron emission tomography (PET) imaging probe, to obtain IRB approval and an exploratory IND for translational research in Alzheimer's disease (AD) and other diseases, in order to test this radiopharmaceutical to human volunteers. Despite decades of intensive research and a large financial investment in clinical trials, AD is a fast-growing public health problem. The development of novel diagnostic tools to guide the development of an efficacious pharmacological treatment of AD is still an unmet and urgent need. Therefore, we plan to validate a novel class- IIa HDACs PET probe to bridge the gap that exists between postmortem studies and the need for real time non- invasive and longitudinal quantification of class-IIa HDAC expression in human AD. If successful, our novel probe may provide information on AD progression and early detection of AD. The success of our imaging studies may delineate a novel role for class-IIa HDAC in the pathophysiology and progression of AD and may identify class- IIa HDAC as druggable target for AD, which potentially will incentivize the development and deployment of class- IIa HDAC targeting drugs. We propose three specific aims to facilitate the clinical translation of a novel class-IIa HDAC targeting radioligand named [18F]NT311D. In aim1, we plan to optimize and automate the radiosynthesis of [18F]NT311D and to perform PET imaging in rats. In aim2 we plan to validate class-IIa HDACs in AD human tissues using in vitro autoradiography and immunohistochemistry (IHC) and in aim3, we plan to perform PET imaging, biodistribution, metabolism, kinetic modeling, and radiation dosimetry with [18F]NT311D in pigs. We will also perform the studies needed for translation to humans. With completion of this proposal, we will seek IRB approval and file an IND application with the FDA for first in human studies for PET imaging of AD and other diseases.


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 = $1,731,604 )
2025	2025	THE RESEARCH FOUNDATION FOR THE STATE UNIVERSITY OF NEW YORK	W5510 FRANKS MELVILLE MEMORIAL LIBRARY	STONY BROOK	NY	11794	SUFFOLK	USA	Aging Research	000	4	2/26/2025	COMPETING CONTINUATION	$778,247
2025	2025	THE RESEARCH FOUNDATION FOR THE STATE UNIVERSITY OF NEW YORK	W5510 FRANKS MELVILLE MEMORIAL LIBRARY	STONY BROOK	NY	11794	SUFFOLK	USA	Aging Research	001	5	8/26/2025	NON-COMPETING CONTINUATION	$778,247
2025	2024	THE RESEARCH FOUNDATION FOR THE STATE UNIVERSITY OF NEW YORK	W5510 FRANKS MELVILLE MEMORIAL LIBRARY	STONY BROOK	NY	11794	SUFFOLK	USA	Aging Research	000	4	2/26/2025	COMPETING CONTINUATION	$175,110
														Subtotal = $1,731,604

Issue Date FY: 2024 ( Subtotal = $794,129 )
2024	2024	THE RESEARCH FOUNDATION FOR THE STATE UNIVERSITY OF NEW YORK	W5510 FRANKS MELVILLE MEMORIAL LIBRARY	STONY BROOK	NY	11794	SUFFOLK	USA	Aging Research	000	4	9/25/2024	COMPETING CONTINUATION	$794,129
														Subtotal = $794,129

Grand Total All Awards = $2,525,733

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Development of class-IIa HDAC targeting PET probes for molecular imaging of disorders of the CNS

Award Number: R56AG067417

ORGANIZATION: NATIONAL INSTITUTE ON AGING

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 04/15/2020

PERIOD OF PERFORMANCE END DATE: 08/31/2026

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