Project Grant R43HD109101
- This Project Grant award, provided by the National Institute of Child Health and Human Development (NICHD), is funding a Phase 1 clinical trial to evaluate the safety and pharmacokinetics of a novel contraceptive and microbicidal vaginal gel developed by Yaso Therapeutics Incorporated. The $545,966 award supports the first-in-human clinical assessment of the "YASO-GEL" product, which contains the active ingredient polyphenylene carboxymethylene sodium salt (PPCM). In addition to...
- This $474,946 Project Grant awarded on February 1, 2025 by the National Institute of Child Health and Human Development (NICHD) under the Child Health and Human Development Extramural Research program (CFDA 93.865) aims to develop a novel, multipurpose device for female-initiated, non-hormonal contraception. The key products to be delivered under this grant include: Design and prototyping of a dual-compartment vaginal device that enables women to administer a bioresponsive polymer fiber mat...
- The National Institute of Child Health and Human Development (NICHD), under the Child Health and Human Development Extramural Research Federal Grant Program (CFDA 93.865), awarded a $518,754 project grant to Magee-Womens Research Institute and Foundation. The goal of this project is to develop a bioadhesive vaginal film that can provide sustained release of contraceptive and antiviral monoclonal antibodies for 3-7 days. The film is intended to offer women a discreet, low-cost, and convenient...
- This $1,130,880 Project Grant award from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) under the Child Health and Human Development Extramural Research program (CFDA 93.865) supports the development of a fast-dissolving, non-hormonal contraceptive tablet (product code MM008) by Mucommune LLC, a biopharmaceutical company in Durham, North Carolina. The grant aims to formulate Mucommune's proprietary anti-sperm monoclonal antibodies into a...
- This Project Grant award of $380,692 from the National Institute of Child Health and Human Development (NICHD), under the Child Health and Human Development Extramural Research Federal Grant Program (CFDA 93.865), is for the development of an ultrapotent anti-sperm antibody construct for a non-hormonal contraceptive. The project aims to create a novel intravaginal ring product that releases an anti-sperm antibody to agglutinate and trap sperm, thereby preventing pregnancy. The award supports the...
- The U.S. National Institute of Child Health and Human Development (NICHD) awarded a $399,999 Project Grant to Sacyl Pharmaceuticals, Inc. under the Child Health and Human Development Extramural Research program (CFDA 93.865) to advance the development of a novel on-demand, non-hormonal male contraceptive towards Investigational New Drug (IND) enablement. The project aims to develop small molecule inhibitors of soluble adenylyl cyclase (ADCY10; SAC) in sperm, which has been genetically and...
- The National Institute of Child Health and Human Development (NICHD), through the Child Health and Human Development Extramural Research program (CFDA 93.865), awarded a $328,496 Project Grant to Pelva Health Corporation to develop a non-pharmaceutical hydrogel film and applicator delivery system to mitigate pain experienced during sexual intercourse by women with gynecological conditions such as vulvodynia and vestibulodynia. The goal is to create a force dissipating hydrogel film that can...
- This Project Grant award from the National Institute of Child Health and Human Development (NICHD), under the Child Health and Human Development Extramural Research Federal Grant Program (CFDA 93.865), provides $1,295,474 to Yale University to conduct a prospective two-year study on the use of the etonogestrel (ENG) contraceptive implant when inserted at an alternative subdermal scapular site. The study aims to collect long-term pharmacokinetic and pharmacodynamic data on the ENG implant...
- The National Institute of Child Health and Human Development (NICHD) awarded a $383,114 Small Business Innovation Research (SBIR) Phase I project grant (CFDA 93.865 - Child Health and Human Development Extramural Research) to Venova Technologies Inc., a women-led and minority-led medical device startup company. The grant funds the development of a novel, non-hormonal, long-acting female contraceptive device designed to address the critical unmet need for birth control options without hormonal...
- This $747,000 Project Grant award from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) under the Child Health and Human Development Extramural Research program (CFDA 93.865) will fund research to determine the effects of pre-exposure prophylactic (PrEP) drugs on female genital HIV infection and women's reproductive health. The research will focus on understanding how PrEP impacts the female reproductive tract microenvironment and any potential...
PREPARATION AND SUBMISSION OF AN IND FOR PPCM GEL CONTRACEPTIVE - PROJECT SUMMARY POLYPHENYLENE CARBOXYMETHYLENE SODIUM SALT (PPCM) IS BEING DEVELOPED BY YASO THERAPEUTICS AS A WOMAN-CONTROLLED, ON-DEMAND VAGINAL CONTRACEPTIVE GEL (PPCM-GEL) WITH A UNIQUE, NON-CYTOTOXIC MECHANISM THAT TRIGGERS PREMATURE ACROSOMAL LOSS OF SPERM, RENDERING THEM INCAPABLE OF FERTILIZATION. SINCE PPCM ALSO BINDS HIGHLY CONSERVED GLYCOSAMINOGLYCANS, THIS NOVEL GEL HAS ADDITIONAL POTENTIAL TO FUNCTION AS A MULTIPURPOSE PREVENTION TECHNOLOGY (MPT) THAT PROTECTS AGAINST IMPORTANT BACTERIAL AND VIRAL SEXUALLY TRANSMITTED INFECTIONS (STIS). UNDER THIS GRANT WE PROPOSE TO COMPLETE ONE LAST PACKAGING COMPATIBILITY AND STABILITY STUDY OF PPCM-GEL, COMPLETE WRITING THE IND PER ECTD AND FDA GUIDELINES, AND HAVE A REGULATORY CONSULTING FIRM ELECTRONICALLY SUBMIT THE IND TO FDA. WITH THE SUPPORT OF PRIOR NIAID AND NICHD GRANTS (R42AI069659, R43/44AI084225,5R44HD092206), WE HAVE ADVANCED PPCM THROUGH PRECLINICAL EVALUATION AND HAVE SUCCESSFULLY FORMULATED A MUCOADHESIVE, NON- IRRITATING VAGINAL GEL THAT IS READY FOR CLINICAL EVALUATION. THE MECHANISM OF ACTION ON SPERM HAS ENABLED US TO CONDUCT PRE-CLINICAL STUDIES USING A COMMERCIALLY AVAILABLE SPERM QUALITY BIOMARKER, HYALURONAN BINDING ASSAY (HBA) TO ASSESS POTENTIAL CONTRACEPTIVE ACTIVITY. IN PRE-CLINICAL TESTING, WE HAVE ALSO DEMONSTRATED POTENT ACTIVITY AGAINST NEISSERIA GONORRHOEAE, HERPES SIMPLEX VIRUS, AND HIV. PPCM-GEL IS FORMULATED FOR NON- SYSTEMIC TOPICAL USE, IS NON-HORMONAL, AND HAS POTENTIAL TO BE ONE OF THE FIRST SUCCESSFUL MPT PRODUCTS WITH CONTRACEPTIVE AND BROAD STI/HIV PREVENTION EFFICACIES. THE PREVALENCE OF UNPLANNED PREGNANCY AND STIS AMONG WOMEN IN ALL ECONOMIC, SOCIAL, AND CULTURAL CIRCUMSTANCES HAS REMAINED HIGH DESPITE EXISTING PREVENTION OPTIONS. THERE IS A LONG-STANDING PAUCITY OF AVAILABLE ON-DEMAND AND NONHORMONAL BROAD-SPECTRUM PREVENTION OPTIONS. AVAILABILITY OF A DUAL-PURPOSE PRODUCT FOR CONTRACEPTION AND STI/HIV PREVENTION WILL ARM PEOPLE WITH AN IMPORTANT OPTION FOR REPRODUCTIVE HEALTH.
Mod # | Description | ReasonForModification | Federal Obligation | Date |
|---|---|---|---|---|
| Not listed | $0 | 12/22/23 | ||
| Not listed | $0 | 10/11/22 | ||
| Not listed | $0 | 10/11/22 | ||
| Not listed | $0 | 10/11/22 | ||
| Not listed | $298.5k | 4/7/22 |