Evidence map›Paper›PMID 40157609›Full record

ArticleJournal of controlled release : official journal of the Controlled Release Society2025

Vaginally-delivered fast-dissolving antibody tablets (FDAT) for on-demand non-hormonal contraception and multi-purpose protection.

Keiichiro Kushiro, Scott Hammers, Yong Zhu, Haley B Flowers, Lauren Dawson, Alysha Panjwani, Alison Schaefer, David Quan, Katherine Gibb, Morgan McSweeney and 4 more

Abstract read
In one paragraph

Article in Journal of controlled release : official journal of the Controlled Release Society, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Keiichiro KushiroMucommune, LLC, Morrisville, NC 27560, USA. Electronic address: kushiro@mucommune.com.
Scott HammersMucommune, LLC, Morrisville, NC 27560, USA.
Yong ZhuDepartment of Obstetrics and Gynecology, University of Texas Medical Branch, Galveston, TX 77555, USA.
Haley B FlowersDepartment of Obstetrics and Gynecology, University of Texas Medical Branch, Galveston, TX 77555, USA.
Lauren DawsonDepartment of Obstetrics and Gynecology, University of Texas Medical Branch, Galveston, TX 77555, USA.
Alysha PanjwaniDepartment of Obstetrics and Gynecology, University of Texas Medical Branch, Galveston, TX 77555, USA.
Alison SchaeferDivision of Pharmacoengineering and Molecular Pharmaceutics, Eshelman School of Pharmacy, University of North Carolina-Chapel Hill, Chapel Hill, NC 27599, USA; Department of Microbiology & Immunology, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, USA.
David QuanMucommune, LLC, Morrisville, NC 27560, USA.
Katherine GibbMucommune, LLC, Morrisville, NC 27560, USA.
Morgan McSweeneyMucommune, LLC, Morrisville, NC 27560, USA.
Richard ConeMucommune, LLC, Morrisville, NC 27560, USA.
Thomas MoenchMucommune, LLC, Morrisville, NC 27560, USA.
Kathleen L VincentDepartment of Obstetrics and Gynecology, University of Texas Medical Branch, Galveston, TX 77555, USA.
Samuel K LaiDivision of Pharmacoengineering and Molecular Pharmaceutics, Eshelman School of Pharmacy, University of North Carolina-Chapel Hill, Chapel Hill, NC 27599, USA; Department of Microbiology & Immunology, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, USA. Electronic address: lai@unc.edu.

Funding

Next Generation Multipurpose Prevention Technology: An Intravaginal Ring for HIV Prevention and Nonhormonal ContraceptionR01HD101344 · NICHD · OAK CREST INSTITUTE OF SCIENCE · PI BAUM, MARC MICHAEL, LAI, SAMUEL · 2020 to 2024
$3.7M
IND‐enabling development of MM‐008 IVR, an antibody-based nonhormonal contraceptive intravaginal ringR44HD107824 · NICHD · MUCOMMUNE, LLC · PI CONE, RICHARD · 2022 to 2023
$2.1M
Engineering bispecific antibodies for non-hormonal contraceptionR01HD101562 · NICHD · UNIV OF NORTH CAROLINA CHAPEL HILL · PI LAI, SAMUEL · 2020 to 2023
$2.1M
In vivo dose finding for an antibody based nonhormonal contraceptive intravaginal ringR44HD100231 · NICHD · MUCOMMUNE, LLC · PI CONE, RICHARD · 2020 to 2021
$1.7M
Nonhormonal contraceptive intravaginal ring based on high valency anti-sperm antibody constructsR33HD099747 · NICHD · MUCOMMUNE, LLC · PI MOENCH, THOMAS RAY · 2021 to 2023
$1.6M
Fast dissolving antibody tablets for preventing vaginal HSV transmissionR43AI172654 · NIAID · MUCOMMUNE, LLC · PI KUSHIRO, KEIICHIRO · 2022 to 2022
$307k
Non-hormonal contraception based on vaginal delivery of multimeric sperm-binding antibodiesR43HD097941 · NICHD · MUCOMMUNE, LLC · PI CONE, RICHARD · 2019 to 2019
$225k
NIAID NIH HHS R43 AI172654NICHD NIH HHS R01 HD101344NICHD NIH HHS R01 HD101562NICHD NIH HHS R33 HD099747NICHD NIH HHS R43 HD097941NICHD NIH HHS R44 HD100231NICHD NIH HHS R44 HD107824
6 · The paper itself

Abstract

There are limited options available for safe and effective non-hormonal contraceptives or methods that block sexually transmitted diseases such as herpes simplex virus (HSV). Direct vaginal delivery of monoclonal antibodies (mAb) represents a promising approach toward both goals, but clinical translation has been limited by the lack of convenient dosage forms that can quickly and stably deliver mAbs without mess. Here, we report the development of fast-dissolving antibody tablets (FDAT) that allow for the complete release of fully functional mAbs within seconds in vaginal fluid simulants, and within two minutes in fresh human cervicovaginal mucus ex vivo. As proof-of-concept, we developed two FDAT formulations: one for HSV8, a potent neutralizing mAb against both HSV Type 1 and 2, and a second for MM008, a unique 10-Fab anti-sperm mAb that induces sperm agglutination and inhibits progressive sperm motility with picomolar potency. In sheep studies, vaginally inserted HSV8-FDAT achieved uniform distribution in different parts of the vagina within minutes, while fully maintaining HSV8 neutralization activity. Similarly, MM008-FDAT completely eliminated all progressively motile sperm within 2 min of human semen instillation. Finally, the FDATs were stable for at least 3 months of storage at room temperature within desiccated water-impermeant foil pouches, and repeated daily application of FDATs for 7 days was safe and well tolerated in sheep. These results underscore the potentials of the FDAT platform for delivery of biologic interventions to reinforce female reproductive health.

Indexed as

Antibodies, MonoclonalAntibodies, NeutralizingAntibodies, ViralAdministration, IntravaginalAnimalsContraceptionFemaleHerpes GenitalisHumansMaleSheepSperm MotilityTabletsVaginaAntibodies, MonoclonalAntibodies, NeutralizingAntibodies, ViralTabletsAnti-sperm antibodyFemale reproductive healthHSV antibodyVaginal tablet

Identifiers

PMID40157609
PMCPMC12065660

What Socratic holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.