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Development and Evaluation of Dual Compartment Combination Microbicides

Award Number: U19AI101961
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 06/22/2012
PERIOD OF PERFORMANCE END DATE: 05/31/2019

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Development and Evaluation of Dual Compartment Combination Microbicides - We propose to bring a well-established team of Investigators with diverse multidisciplinary backgrounds in virology, toxicology, clinical infectios disease, pharmacology, pharmaceutics, physiology, psychology/behavioral science, materials science, and biomedical engineering to develop a combination microbicide product formulated for delivery to both the vaginal and the colorectal compartments. The rationally designed products will include dual compartment gels (DuoGels) and Smart Suppositories that will function as delivery vehicles for two highly potent antiretroviral agents - tenofovir and IQP-0528. Our program will integrate in vitro and ex vivo evaluations of product efficacy, safety, pharmacokinetics and pharmacodynamics, as well as PK/PD/safety/efficacy evaluations in nonhuman primates and pre-Phase 1 safety and PK studies in humans. Our proposal also incorporates advancements in microbicide science, including the development of a novel in vitro method for determination of API dosing levels, behavioral studies extended to the rectal compartment and dual compartment products, and imaging and modeling that will enhance our ability to predict the interactions between formulated microbicide products, virus, biological matrices, and target fluids and tissue in the vagina and rectum. Our project will culminate in the creation of effective and acceptable, dual compartment use gels (DuoGels) and solid dosage vehicles (Smart Suppositories) for clinical development. We will create and apply advanced means to formulate and deliver these novel compounds (alone or in combinations) in coitally-dissociated ways. Pursuit of the two different delivery modalities (DuoGels versus Smart Suppositories) will account for both differences in microbicide functionality against HIV-1 and different product preferences amongst women. The time course of product development will include concomitant studies that define acceptability to women and men, so that cooptimization of biological functionality and behavioral acceptability is achieved. Through our industrial partnership with ImQuest Pharmaceuticals our methodology and products will have an immediate outlet to further clinical development.


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: 2018 ( Subtotal = $0 )
2018	2016	IMQUEST BIOSCIENCES, INC.	7340 EXECUTIVE WAY STE R	FREDERICK	MD	21704	FREDERICK	USA	Allergy and Infectious Diseases Research	000	5	5/2/2018	EXTENSION WITH OR WITHOUT FUNDS	$0
														Subtotal = $0

Issue Date FY: 2017 ( Subtotal = $0 )
2017	2016	IMQUEST BIOSCIENCES, INC.	7340 EXECUTIVE WAY STE R	FREDERICK	MD	21704	FREDERICK	USA	Allergy and Infectious Diseases Research	001	5	1/18/2017	EXTENSION WITH OR WITHOUT FUNDS	$1,354,934
2017	2015	IMQUEST BIOSCIENCES, INC.	7340 EXECUTIVE WAY STE R	FREDERICK	MD	21704	FREDERICK	USA	Allergy and Infectious Diseases Research	000	4	1/18/2017	NON-COMPETING CONTINUATION	-$1,354,934
														Subtotal = $0

Issue Date FY: 2016 ( Subtotal = $2,149,121 )
2016	2016	IMQUEST BIOSCIENCES INC	7340 EXECUTIVE WAY	FREDERICK	MD	21704	FREDERICK	USA	Allergy and Infectious Diseases Research	000	5	5/20/2016	EXTENSION WITH OR WITHOUT FUNDS	$2,149,121
														Subtotal = $2,149,121

Issue Date FY: 2015 ( Subtotal = $2,443,193 )
2015	2015	IMQUEST BIOSCIENCES INC	7340 EXECUTIVE WAY	FREDERICK	MD	21704	FREDERICK	USA	Allergy and Infectious Diseases Research	000	4	4/29/2015	NON-COMPETING CONTINUATION	$2,443,193
														Subtotal = $2,443,193

Issue Date FY: 2014 ( Subtotal = $2,876,353 )
2014	2014	IMQUEST BIOSCIENCES INC	7340 EXECUTIVE WAY	FREDERICK	MD	21704	FREDERICK	USA	Allergy and Infectious Diseases Research	000	3	6/5/2014	NON-COMPETING CONTINUATION	$2,876,353
														Subtotal = $2,876,353

Issue Date FY: 2013 ( Subtotal = $3,574,067 )
2013	2013	IMQUEST BIOSCIENCES INC	7340 EXECUTIVE WAY	FREDERICK	MD	21704	FREDERICK	USA	Allergy and Infectious Diseases Research	000	2	7/10/2013	NON-COMPETING CONTINUATION	$3,574,067
														Subtotal = $3,574,067

Issue Date FY: 2012 ( Subtotal = $3,224,012 )
2012	2012	IMQUEST BIOSCIENCES INC	7340 EXECUTIVE WAY	FREDERICK	MD	21704	FREDERICK	USA	Allergy and Infectious Diseases Research	000	1	6/20/2012	NEW	$3,224,012
														Subtotal = $3,224,012

Grand Total All Awards = $14,266,746

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Development and Evaluation of Dual Compartment Combination Microbicides

Award Number: U19AI101961

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 06/22/2012

PERIOD OF PERFORMANCE END DATE: 05/31/2019

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