# Antibody-based Contraceptive MPTs:  Preclinical and Clinical Research

> **NIH NIH P50** · BOSTON UNIVERSITY MEDICAL CAMPUS · 2020 · $1,867,062

## Abstract

CRC OVERVIEW: ABSTRACT
We propose to establish a Contraceptive Research Center (CRC) to develop a new contraception method based
on the topical use of a potent antisperm monoclonal antibody (mAb). We propose to manufacture a first
generation HCA contraceptive product comprised of HCA human mAb, produced to GMP standards in an
innovative cost-effective mAb platform (Nicotiana), and formulated into a film that dissolves on contact with the
vaginal mucosa to deliver short-term (on-demand) contraception. The HCA film will be tested in vitro for efficacy
and safety, IND-enabling studies will be performed, and after filing an IND application with the FDA the HCA film
will be tested for safety and efficacy in two Phase 1 clinical trials. A prototype HCA-intravaginal ring (IVR) will
also be developed with the goal to provide long-term (>30 day) contraceptive protection. The HCA-IVR will
undergo testing in vitro and in a nonhuman primate (NHP) model for preliminary assessment of PK/PD, antibody
distribution and safety. The program will also produce and test HCA multivalent variants with potential enhanced
sperm trapping capabilities for use in second generation HCA contraception products. In the future HCA could
be used alone in films or IVRs for contraception, or in combination with mAbs or other microbicidal compounds
directed against STI pathogens, to enhance the acceptability, efficacy and marketability of Multipurpose
Prevention Technology (MPT) products.

## Key facts

- **NIH application ID:** 9933964
- **Project number:** 5P50HD096957-03
- **Recipient organization:** BOSTON UNIVERSITY MEDICAL CAMPUS
- **Principal Investigator:** Deborah J Anderson
- **Activity code:** P50 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $1,867,062
- **Award type:** 5
- **Project period:** 2018-09-14 → 2022-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9933964

## Citation

> US National Institutes of Health, RePORTER application 9933964, Antibody-based Contraceptive MPTs:  Preclinical and Clinical Research (5P50HD096957-03). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/9933964. Licensed CC0.

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