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NIH grant 1R44HD121291-01: IND-enabling development of MM012, an antibody-based non-hormonal contraceptive intravaginal ring
Institute: {'code': 'HD', 'abbreviation': 'NICHD', 'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development', 'admin_org_id': '12500030', 'admin_funding_url': ''}. PI: Keiichiro Kushiro. Award: $1163587.
Start: 2026-09-25T00:00:00.
Summary
Nearly half of all pregnancies in the U.S. are unintended, and most occur in women who are not using
contraceptives. There are diverse reasons for not using contraceptives; one common reason is that many
women have a strong aversion to using exogenous hormones due to real and perceived side effects. It is likely
that contraceptive use and satisfaction would substantially increase if there were a non-hormonal, user-
controlled contraceptive method that does not require coitally-timed actions nor daily dosing. Such product
does not currently exist. We believe we can create such a contraceptive based on an intravaginal ring
(IVR) releasing an anti-sperm antibody (ASA) that agglutinates and traps sperm in mucus, thereby
preventing sperm from reaching the egg. We were part of a consortium that advanced the very first ASA
into exploratory clinical studies, where we showed a high dose of ASA (HC4 IgG) given immediately before
intercourse was highly effective at eliminating progressively motile sperm in the endocervical canal. To
further improve potency and create a product that offers sustained contraception, we have engineered a
next-generation ASA, LamH10, which targets the same well characterized and validated sperm epitope as the
HC4 IgG. Due to the incorporation of 10 Fab domains per molecule, LamH10 possess picomolar agglutinating
potencies under physiological conditions (e.g. at 37oC), exceeding the activity of the parent HC4 IgG by orders
of magnitude. LamH10 reduce progressively motile sperm by 99.9% in the sheep vagina in two minutes at a
dose of just 33 ug per sheep. We have also developed a proprietary capsule-IVR system that stably released
mAbs and provide virtually complete sperm agglutination in sheep at challenge for over 20 days (more than
adequate to cover the fertility window in most women). These advances put us in position to create a LamH10-
loaded IVR for sustained non-hormonal contracpetion; we term this product MM012. In this proposal, we are
seeking to complete the necessary preclinical activities to advance MM012 into the clinic, based on feedback
from the FDA on a pre-IND package submitted, which includes GLP toxicology study in sheep as well as
extractables and leachables testing. In Aim 1, we will manufacture MM012 tox lot materials following the same
processes to be used in producing MM012 clinical trial materials (including GMP production of LamH10, GMP
lyophilization to generate LamH10 drug substance, and GMP assembly of LamH10-loaded IVR (i.e. MM012).
We will then utilized the MM012 drug product to perform the FDA requested GLP studies in Aim 2. Successful
execution of these activities, combined with our other ongong efforts, will mark the successful completion of
critcal path IND-enabling activities and support initiating clinical development for MM012. If successful, MM012
may ultimately address a significant unmet need for millions of women in the contraceptive marketplace.document fetched 2026-10-04 02:43