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A Methamphetamine Conjugate Vaccine: From Manufacturing to IND

Award Number: U01DA035511
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: 09/01/2014
PERIOD OF PERFORMANCE END DATE: 05/31/2019

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A Methamphetamine Conjugate Vaccine: From Manufacturing to IND - DESCRIPTION (provided by applicant): Abuse of methamphetamine (METH) exacts significant medical and social costs in the US and worldwide; yet, there are no medications approved for the treatment of METH addiction. Immunization of addicted patients with a METH-conjugate vaccine (MCV) is a promising new strategy that could stimulate a patient's own immune system to generate long acting, protective anti-METH antibodies. These antibodies would block or slow the rate at which METH enters the brain, shield the user from METH's rewarding and toxic effects, and thereby reduce the medical consequences of relapse to METH use during rehabilitation therapy. The purpose of the proposed work is to scale-up the manufacturing process to produce an MCV, test the MCV in toxicology studies to show its safety, and complete plans for a first in human clinical trial. The candidate MCV was developed and optimized at the University of Arkansas for Medical Sciences (UAMS) where extensive preclinical animal testing demonstrated both safety and efficacy. Vaccines for treating nicotine and cocaine addiction have already been tested in humans, with positive outcomes for those patients making large quantities of anti-drug antibodies. This innovative new MCV, in combination with a state of the art adjuvant, is expected to stimulate significantly higher antibody titers with very high affinity for METH. The important characteristics of this MCV include a rigorously tested and optimized METH hapten chemical structure, refined chemistry for the conjugation of METH hapten to an immunostimulatory carrier protein, and a next generation adjuvant that rapidly generates high titers of anti- METH antibodies. Together, the hapten, carrier protein and adjuvant are essential parameters that determine the success of a vaccine; this MCV fulfills them all. The ultimate goal of this project is to submit a successful investigational new drug application (IND) to the FDA. To reach this goal, the team from InterveXion Therapeutics and UAMS, along with several highly qualified vendors, will accomplish four specific aims. First, the manufacturing platform will be scaled-up and data will be generated to show that the production system is reliable and the MCV is stable during storage. Once proven, a batch of MCV suitable for use in humans will be produced. Second, toxicology studies in rats will provide support for the expected safe administration of MCV with adjuvant to humans. Third, a protocol and all supporting documents for the first clinical trial wil be developed to show the safety and tolerability of the MCV in human subjects. Finally, the IND package will be written, assembled, and submitted to the FDA. At the conclusion of the proposed work, this team will be poised to initiate the first clinical trial for an active METH vaccine.


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: 2020 ( Subtotal = $4,827 )
2020	2016	INTERVEXION THERAPEUTICS, LLC.	4301 W MARKHAM #831	LITTLE ROCK	AR	72205	PULASKI	USA	Drug Use and Addiction Research Programs	000	3	5/20/2020	NON-COMPETING CONTINUATION	$4,827
														Subtotal = $4,827

Issue Date FY: 2019 ( Subtotal = -$649,050 )
2019	2016	INTERVEXION THERAPEUTICS, LLC.	4301 W MARKHAM #831	LITTLE ROCK	AR	72205	PULASKI	USA	Drug Use and Addiction Research Programs	000	3	9/27/2019	NON-COMPETING CONTINUATION	-$649,050
														Subtotal = -$649,050

Issue Date FY: 2018 ( Subtotal = $0 )
2018	2016	INTERVEXION THERAPEUTICS, LLC.	4301 W MARKHAM #831	LITTLE ROCK	AR	72205	PULASKI	USA	Drug Use and Addiction Research Programs	000	3	5/3/2018	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2016 ( Subtotal = $4,033,814 )
2016	2016	INTERVEXION THERAPEUTICS LLC	4301 WEST MARKHAM STREET	LITTLE ROCK	AR	72205	PULASKI	USA	Drug Use and Addiction Research Programs	000	3	5/13/2016	NON-COMPETING CONTINUATION	$4,033,814
														Subtotal = $4,033,814

Issue Date FY: 2015 ( Subtotal = $1,843,400 )
2015	2015	INTERVEXION THERAPEUTICS LLC	4301 WEST MARKHAM STREET	LITTLE ROCK	AR	72205	PULASKI	USA	Drug Use and Addiction Research Programs	000	2	5/13/2015	NON-COMPETING CONTINUATION	$1,843,400
														Subtotal = $1,843,400

Issue Date FY: 2014 ( Subtotal = $3,606,802 )
2014	2014	INTERVEXION THERAPEUTICS LLC	4301 WEST MARKHAM STREET	LITTLE ROCK	AR	72205	PULASKI	USA	Drug Use and Addiction Research Programs	000	1	8/22/2014	NEW	$3,606,802
														Subtotal = $3,606,802

Grand Total All Awards = $8,839,793

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A Methamphetamine Conjugate Vaccine: From Manufacturing to IND

Award Number: U01DA035511

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: 09/01/2014

PERIOD OF PERFORMANCE END DATE: 05/31/2019

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