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Preclinical development of a TriCoil-based nicotine vaccine

Award Number: UH3DA041162
ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/15/2015
PERIOD OF PERFORMANCE END DATE: 11/30/2020

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Preclinical development of a TriCoil-based nicotine vaccine - DESCRIPTION (provided by applicant): Tobacco addiction is the single largest cause of cancer and heart disease resulting in 6 million deaths a year world-wide. Vaccines that induce anti-nicotine antibodies and prevent nicotine from crossing the blood brain barrier are an important strategy for smoking cessation, although the concept is not yet proven in humans. Nicotine is non-immunogenic due to its small size and must be conjugated to a larger carrier protein. Thus, the challenge of inducing functional nicotine antibodies requires better methods for presenting nicotine antigens to the immune system. To accomplish this, we have invented a synthetic TriCoil carrier with a high density of nicotine haptens, which is a key determinant of immunogenicity, and a series of CD4 T cell epitopes for regulating B cell help. Proof-of-concept experiments demonstrated that the formulation of this vaccine with the clinical- stage adjuvant GLA-SE, induced a high affinity antibody response in mice that was 10-fold more effective than a conventional nicotine vaccine. We hypothesize that a TriCoil-based vaccine adjuvanted with GLA-SE will activate a larger repertoire of B and T cells in smokers and significantly increase functional anti-nicotine Ab concentrations. To advance this project to the clinic we will complete 2 go/no-go decision points. First, we will down-select a trivalent vaccine in mice with optimized B- and T cell epitopes, and then during year 2, test for efficacy using a "gold standard" behavioral model in rats. Achievement of this first goal will prompt a study in non-human primates that will establish vaccine superiority relative to a NIC7 mimetic vaccine, which is currently being tested in the clinic. Reaching this second goal during year 3 will trigger initiatin of cGMP manufacturing, GLP-tox safety testing, and submission of an IND during year 5. Successful completion of this project will result in a promising new vaccine for smoking cessation that has several distinct advantages including a structurally- defined hapten carrier, a more potent adjuvant, and a superior manufacturing process for scale-up and commercialization.


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: 2023 ( Subtotal = -$70,143 )
2023	2020	TRIA BIOSCIENCE CORP.	1616 EASTLAKE AVE E STE 260	SEATTLE	WA	98102	KING	USA	Drug Use and Addiction Research Programs	000	5	3/22/2023	NON-COMPETING CONTINUATION	-$70,143
														Subtotal = -$70,143

Issue Date FY: 2021 ( Subtotal = -$522,382 )
2021	2020	TRIA BIOSCIENCE CORP.	1616 EASTLAKE AVE E STE 260	SEATTLE	WA	98102	KING	USA	Drug Use and Addiction Research Programs	000	5	5/22/2021	NON-COMPETING CONTINUATION	-$522,382
														Subtotal = -$522,382

Issue Date FY: 2020 ( Subtotal = $1,364,701 )
2020	2020	TRIA BIOSCIENCE CORP.	1616 EASTLAKE AVE E STE 260	SEATTLE	WA	98102	KING	USA	Drug Use and Addiction Research Programs	000	5	12/5/2019	NON-COMPETING CONTINUATION	$1,228,231
2020	2020	TRIA BIOSCIENCE CORP.	1616 EASTLAKE AVE E STE 260	SEATTLE	WA	98102	KING	USA	Drug Use and Addiction Research Programs	001	5	2/11/2020	NON-COMPETING CONTINUATION	$136,470
														Subtotal = $1,364,701

Issue Date FY: 2019 ( Subtotal = $1,314,322 )
2019	2019	TRIA BIOSCIENCE CORP.	1616 EASTLAKE AVE E STE 260	SEATTLE	WA	98102	KING	USA	Drug Use and Addiction Research Programs	001	4	12/3/2018	NON-COMPETING CONTINUATION	$1,365,834
2019	2018	TRIA BIOSCIENCE CORP.	1616 EASTLAKE AVE E STE 260	SEATTLE	WA	98102	KING	USA	Drug Use and Addiction Research Programs	000	3	10/20/2018	EXTENSION WITH OR WITHOUT FUNDS	-$51,512
														Subtotal = $1,314,322

Issue Date FY: 2018 ( Subtotal = $1,501,576 )
2018	2018	TRIA BIOSCIENCE CORP.	1616 EASTLAKE AVE E STE 260	SEATTLE	WA	98102	KING	USA	Drug Use and Addiction Research Programs	000	3	11/6/2017	EXTENSION WITH OR WITHOUT FUNDS	$1,379,921
2018	2018	TRIA BIOSCIENCE CORP.	1616 EASTLAKE AVE E STE 260	SEATTLE	WA	98102	KING	USA	Drug Use and Addiction Research Programs	001	3	5/24/2018	EXTENSION WITH OR WITHOUT FUNDS	$121,655
2018	2018	TRIA BIOSCIENCE CORP.	1616 EASTLAKE AVE E STE 260	SEATTLE	WA	98102	KING	USA	Drug Use and Addiction Research Programs	002	3	8/29/2018	EXTENSION WITH OR WITHOUT FUNDS	$0
														Subtotal = $1,501,576

Grand Total All Awards = $3,588,074

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Preclinical development of a TriCoil-based nicotine vaccine

Award Number: UH3DA041162

ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 09/15/2015

PERIOD OF PERFORMANCE END DATE: 11/30/2020

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