# Fast dissolving antibody tablets for preventing vaginal HSV transmission

> **NIH NIH R43** · MUCOMMUNE, LLC · 2022 · $306,500

## Abstract

Project Summary
Despite immense efforts in educational and behavioral interventions to promote safer sexual practices,
sexually transmitted infections (STIs) such as genital herpes remain highly prevalent, with an estimated
12% of people age 14-49 infected with HSV-2 in the United States. Unfortunately, there are no effective
vaccines or microbicides for the majority of STIs, including HSV. An on-demand, fast-acting, safe, effective,
and discreet vaginal microbicide would provide a powerful prevention tool to address gaps not addressed by
behavioral and current pharmacologic interventions. Human monoclonal antibodies (mAb) delivered locally
to mucosal surfaces offer exceptional promise, combining a long history of safety, anti-viral effectiveness, and
unparalleled target specificity. Mucommune has been pioneering mAb technologies designed for mucosal
applications, including muco-trapping mAbs that neutralizes and physically traps individual pathogens in
mucus, based on carefully-tuned affinity between IgG-Fc and mucins. These “muco-trapping” mAbs can fully
trap HSV particles in human cervicovaginal mucus (CVM) across the menstrual cycle and in CVM from
women with diverse vaginal microflora, with ~10-fold greater potency than protection by neutralization alone.
More importantly, trapping viruses in mucus with vaginally-dosed mAbs directly blocked transmission in a
mouse vaginal Herpes model, in the absence of other immune protective functions. In this Phase I SBIR, we
will build upon our work to formulate our pathogen-trapping mAb into fast dissolving Ab tablets (FDATs),
which will rapidly disintegrate and disburse upon contact with CVM, providing rapid and potent
immunoprotection. In Aim 1, we will incorporate muco-trapping mAbs against HSV into various FDAT
formulations containing different types/ratios of excipients, binders and disintegrants. We will characterize the
physical properties of the FDATs, measure the dissolution rates of FDATs in synthetic mucus and mixtures of
fresh human CVM/semen, as well as verify the binding affinity of the mAb pre- post- FDAT formulation and
dissolution. In Aim 2, we will evaluate our lead FDAT formulations from Aim 1 in a sheep vagina model to verify
FDAT disintegration times, mAb pharmacokinetics and biodistribution, pharmacodynamics, and safety.
Successful completion of these studies will enable us to identify a suitable FDAT formulation to advance into
IND-enabling preclinical and clinical development, and provide the essential data for a Phase II proposal
supporting development of shelf-stable FDAT that includes mAb cocktail consisting of both anti-HSV mAb and
our lead contraceptive mAb (MM008), providing effective multipurpose protection against both vaginal Herpes
transmission and pregnancy.

## Key facts

- **NIH application ID:** 10547476
- **Project number:** 1R43AI172654-01
- **Recipient organization:** MUCOMMUNE, LLC
- **Principal Investigator:** Keiichiro Kushiro
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $306,500
- **Award type:** 1
- **Project period:** 2022-09-01 → 2024-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10547476

## Citation

> US National Institutes of Health, RePORTER application 10547476, Fast dissolving antibody tablets for preventing vaginal HSV transmission (1R43AI172654-01). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10547476. Licensed CC0.

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