# Project 1:  Industrialization of ZB-06

> **NIH NIH P50** · BOSTON UNIVERSITY MEDICAL CAMPUS · 2022 · $837,136

## Abstract

PROJECT 1 - ABSTRACT
 The purpose of the Industrialization Project, and of the entire P50 CRC program, is to develop an
antibody-based, woman-controlled contraceptive. This proposal is part of a long-term project to develop and
commercialize an antibody-based contraceptive (stand alone product), and a multipurpose prevention
technology (MPT) that includes a contraceptive monoclonal antibody (mAb) as well as mAbs against sexually
transmitted diseases. Two previous NICHD/NIAID grants supported manufacturing and clinical testing of
intravaginal films that were stages in the developmental pathway to an MPT. In the first grant we developed
MB66, a vaginal film that contained monoclonal antibodies (mAb) against HIV and HSV. The Phase 1 clinical
trial of MB66 showed that it was safe and well tolerated, and that vaginal samples collected up to 24 hours
after MB66 insertion significantly neutralized both HIV-1 and HSV-2 ex vivo. The second grant funded an
ongoing proof-of-concept trial of ZB-06, a film that contains HCA, a monoclonal antibody that targets CD52g,
a male reproductive tract glycoprotein. CD52g coats sperm, and when HCA binds to CD52g it results in
agglutination and mucus trapping of sperm. Preliminary results from the ongoing trial of the ZB-06 indicate
that it is effective at drastically decreasing the number of progressively motile sperm that reach the upper
cervix when administered ~30 minutes prior to intercourse (a post-coital test, PCT).
 The ongoing Phase 1 clinical trial of ZB-06 was carried out under an exploratory IND that allowed us
to test the the surrogate efficacy of ZB-06, but was not a standard safety Phase 1. Given the positive surrogate
efficacy results from the ongoing study, we now propose to carry out the Phase 1 safety trial required for
further development of ZB-06 and a dose ranging Phase 2 study. Project 1 will be responsible for the
manufacture of the HCA Drug Substance (DS) and ZB-06 Drug Product (DP), the IND enabling toxicology
studies of ZB-06, and regulatory and quality support for the manufacturing and clinical trial. While HCA DS
and ZB-06 DP were manufactured previously for the proof of concept Phase 1, the Drug Product manufacture
was done at lab scale. We will now develop a commercializable ZB-06 manufacturing process; the
manufacturing, release testing and stability programs will take advantage of (and be de-risked by) our
previous experience with MB66 and ZB-06, including FDA guidance. Similarly, our nonclinical toxicology
program is based on our previous experience with MB66 and ZB-06. Finally, the ZabBio team will provide
regulatory and quality oversight for this project as they have done for the two previous trials, and pursue
commercialization of an antibody-based contraceptive.

## Key facts

- **NIH application ID:** 10532092
- **Project number:** 2P50HD096957-05
- **Recipient organization:** BOSTON UNIVERSITY MEDICAL CAMPUS
- **Principal Investigator:** KEVIN WHALEY
- **Activity code:** P50 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $837,136
- **Award type:** 2
- **Project period:** 2018-09-14 → 2026-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10532092

## Citation

> US National Institutes of Health, RePORTER application 10532092, Project 1:  Industrialization of ZB-06 (2P50HD096957-05). Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/grant/nih/10532092. Licensed CC0.

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