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Continuing Preclinical Development of PPCM Vaginal Contraceptive MPT to IND

Award Number: R44HD092206
ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 05/05/2017
PERIOD OF PERFORMANCE END DATE: 04/30/2022

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Continuing Preclinical Development of PPCM Vaginal Contraceptive MPT to IND - Women in all economic, social, and cultural circumstances suffer from high rates of unplanned pregnancy, along with a high prevalence and incidence of sexually transmitted diseases. Trends in the United States and lesser developed economies are going in the wrong direction. The availability of a single multipurpose prevention product (MPT) that prevents both unplanned pregnancy and one or more of the most prevalent sexually transmitted diseases is a priority for both NICHD and NIAID. The development of Yaso-GEL, a vaginal gel formulation, will provide one of the first MPT products offering both pregnancy and STI protection, one that is easy to obtain and to use, that does not require medical services. In addition, Yaso-GEL is applied vaginally pre-coitally, has pre-fertilization contraceptive action, is non-hormonal and non-systemic. These characteristics avoid many safety concerns of current contraceptive users. The primary purpose of this Phase 2B grant is to complete CMC and toxicology studies required by FDA to submit an IND for Yaso-GEL. Secondarily, based on in vitro data, we wish to study the prophylactic potential of Yaso-GEL against two common sexually transmitted infections in cutting edge murine models. We are developing a new drug, polyphenylene carboxymethylene (PPCM) in a vaginal contraceptive gel (Yaso-GEL) as a multipurpose prevention technology (MPT) under R44HD092206. In preclinical testing, PPCM inhibits a broad spectrum of sexually transmitted infections (STIs) including Neisseria gonorrhoeae (Ng), Chlamydia trachomatis (Ct), Herpes simplex virus (HSV) and human immunodeficiency virus (HIV), in addition to having contraceptive activity. Under this grant, we will complete the work needed to open our IND. This includes: a) scale up Yaso- GEL under cGMP, fill applicators for clinical trials and establish a 3-year stability study; b) complete a toxicology study in rats as a second species; c) complete the last genotoxicity study; d) validate the bioassay in human cervicovaginal secretions and plasma; e) design Phase I and Phase 2 clinical trials for safety and contraceptive efficacy, utilizing a new ex vivo assay of contraceptive activity to establish optimal dose response; f) submit the IND. Secondarily, Yaso-GEL will be evaluated in murine models for prevention of infection with Neisseria gonorrhoeae (Ng) and Chlamydia trachomatis (Ct). If effective, future clinical trials may be conducted to evaluate prevention of these important STI pathogens in humans.


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 = $0 )
2023	2020	YASO THERAPEUTICS INCORPORATED	7460 WARREN PKWY STE 100	FRISCO	TX	75034	DENTON	USA	Child Health and Human Development Extramural Research	000	4	5/15/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $984,778 )
2020	2020	YASO THERAPEUTICS INCORPORATED	15333 N PIMA RD STE 305 OFC 345	SCOTTSDALE	AZ	85260	MARICOPA	USA	Child Health and Human Development Extramural Research	000	4	4/28/2020	NON-COMPETING CONTINUATION	$984,778
														Subtotal = $984,778

Issue Date FY: 2019 ( Subtotal = $999,102 )
2019	2019	YASO THERAPEUTICS INCORPORATED	20860 N TATUM BLVD STE 300 OFFICE 320	PHOENIX	AZ	85050	MARICOPA	USA	Child Health and Human Development Extramural Research	000	3	3/8/2019	COMPETING CONTINUATION	$999,102
2019	2019	YASO THERAPEUTICS INCORPORATED	15333 N PIMA RD STE 305 OFC 345	SCOTTSDALE	AZ	85260	MARICOPA	USA	Child Health and Human Development Extramural Research	002	3	8/8/2019	COMPETING CONTINUATION	$96,747
2019	2018	YASO THERAPEUTICS INCORPORATED	15333 N PIMA RD STE 305 OFC 345	SCOTTSDALE	AZ	85260	MARICOPA	USA	Child Health and Human Development Extramural Research	001	2	8/8/2019	NON-COMPETING CONTINUATION	-$96,747
														Subtotal = $999,102

Issue Date FY: 2018 ( Subtotal = $982,217 )
2018	2018	YASO THERAPEUTICS INCORPORATED	20860 N TATUM BLVD STE 300 OFFICE 320	PHOENIX	AZ	85050	MARICOPA	USA	Child Health and Human Development Extramural Research	000	2	4/27/2018	NON-COMPETING CONTINUATION	$982,217
														Subtotal = $982,217

Issue Date FY: 2017 ( Subtotal = $985,250 )
2017	2017	YASO THERAPEUTICS INCORPORATED	20860 N TATUM BLVD STE 300 OFFICE 320	PHOENIX	AZ	85050	MARICOPA	USA	Child Health and Human Development Extramural Research	000	1	5/5/2017	NEW	$985,250
														Subtotal = $985,250

Grand Total All Awards = $3,951,347

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Continuing Preclinical Development of PPCM Vaginal Contraceptive MPT to IND

Award Number: R44HD092206

ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 05/05/2017

PERIOD OF PERFORMANCE END DATE: 04/30/2022

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