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Development of PTI-125-DX, a blood-based diagnostic for Alzheimer's disease

Award Number: R44AG057329
ORGANIZATION: NATIONAL INSTITUTE ON AGING
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/30/2018
PERIOD OF PERFORMANCE END DATE: 12/31/2021

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Development of PTI-125-DX, a blood-based diagnostic for Alzheimer's disease - Abstract PTI is developing PTI-125-DX, a novel, quantitative blood-based diagnostic candidate for Alzheimer's disease (AD). A non-invasive and inexpensive AD diagnostic is sorely needed, particularly one with the ability to detect early pathological changes that precede cognitive symptoms. PTI-125-DX measures the ratio of two protein fragments in plasma and is a companion diagnostic/biomarker for our therapeutic candidate PTI-125. PTI-125 disrupts and prevents filamin A (FLNA)'s association with the α7-nicotinic acetylcholine receptor (α7nAChR), which amyloid beta 1-42 (Aβ42) hijacks to hyperphosphorylate tau protein. We have tested over 220 plasma samples and show two orders of magnitude significant differences between patients with AD diagnoses (confirmed by imaging or CSF markers) and age-matched normal controls. These two groups are distinguished with 98-100% accuracy. In one of two blinded studies, PTI- 125-DX distinguished MCI with confirmed AD pathology (MCI-AD) from MCI with suspected non- amyloid pathology (MCI-SNAP) with 92% accuracy; in the other, this distinction needs confirmation by imaging. In this proposal, we will compare additional MCI-AD and MCI-SNAP samples and determine disease specificity of the assay by testing archived plasma samples from patients with dementia with Lewy bodies, Frontotemporal Dementia and Parkinson's disease alongside AD, MCI-AD, MCI-SNAP, early-onset familial AD (FAD), cancer and elderly or young controls. As PTI-125-DX is currently in Western blot format, we will develop an ELISA assay and compare it to an automated Western blot format using ProteinSimple's Wes™. In Phase II, we will generate proprietary antibodies by immunizing with carefully selected peptides and recombinant proteins; these polyclonal antibodies will be screened and tested to determine optimal combinations. The corresponding immunogens will then be used to develop monoclonal antibodies. The sandwich ELISA we envision will capture all fragments of interest and separately detect two specific protein fragments. With final monoclonal antibodies and a final ELISA (or Wes) format selected, we will perform a new blinded study of up to 250 de-identified plasma samples from the AIBL study. At the conclusion of this work, PTI-125-DX will be ready for commercialization or partnering.


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: 2022 ( Subtotal = $0 )
2022	2020	CASSAVA SCIENCES, INC.	7801 N CAPITAL OF TEXAS HWY STE 260	AUSTIN	TX	78731	TRAVIS	USA	Aging Research	000	3	10/15/2021	NON-COMPETING CONTINUATION	$0
2022	2020	CASSAVA SCIENCES, INC.	7801 N CAPITAL OF TEXAS HWY STE 260	AUSTIN	TX	78731	TRAVIS	USA	Aging Research	002	3	5/9/2022	NON-COMPETING CONTINUATION	$0
2022	2020	CASSAVA SCIENCES, INC.	7801 N CAPITAL OF TEXAS HWY STE 260	AUSTIN	TX	78731	TRAVIS	USA	Aging Research	001	3	11/1/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $450,142 )
2020	2020	CASSAVA SCIENCES, INC.	7801 N CAPITAL OF TEXAS HWY STE 260	AUSTIN	TX	78731	TRAVIS	USA	Aging Research	000	3	1/23/2020	NON-COMPETING CONTINUATION	$450,142
														Subtotal = $450,142

Issue Date FY: 2019 ( Subtotal = $1,109,748 )
2019	2019	PAIN THERAPEUTICS, INC.	7801 N CAPITAL OF TEXAS HWY STE 260	AUSTIN	TX	78731	TRAVIS	USA	Aging Research	000	2	1/14/2019	EXTENSION WITH OR WITHOUT FUNDS	$1,109,748
2019	2019	CASSAVA SCIENCES, INC.	7801 N CAPITAL OF TEXAS HWY STE 260	AUSTIN	TX	78731	TRAVIS	USA	Aging Research	001	2	8/29/2019	EXTENSION WITH OR WITHOUT FUNDS	$0
														Subtotal = $1,109,748

Grand Total All Awards = $1,559,890

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Development of PTI-125-DX, a blood-based diagnostic for Alzheimer's disease

Award Number: R44AG057329

ORGANIZATION: NATIONAL INSTITUTE ON AGING

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/30/2018

PERIOD OF PERFORMANCE END DATE: 12/31/2021

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