Engineering monoclonal antibody-based contraception and multipurpose prevention technologies†

Area of Science:

• Reproductive Health
• Immunology
• Biotechnology

Background:

• High prevalence of sexually transmitted infections (STIs) and unplanned pregnancies represent significant global health challenges.
• Existing prevention methods have limitations, creating an unmet need for innovative female reproductive health solutions.

Purpose of the Study:

• To develop and test novel antibody-based multipurpose prevention technology (MPT) products.
• To create a vaginal film (MB66) containing monoclonal antibodies against HIV-1 and HSV-2.
• To engineer and evaluate an antisperm antibody for contraceptive efficacy.

Main Methods:

• Utilized a Nicotiana platform for manufacturing monoclonal antibodies against HIV-1 and HSV-2.
• Formulated antibodies into a vaginal film (MB66) for preclinical and Phase 1 clinical trials.
• Engineered an antisperm antibody (H6-3C4) recognizing CD52g on human sperm for contraceptive development.

Main Results:

• Preclinical and Phase 1 clinical testing of MB66 demonstrated safety and efficacy in women.
• The engineered antisperm antibody effectively agglutinates sperm at concentrations >10 μg/ml.
• The antisperm antibody maintains activity under various physiological conditions.

Conclusions:

• Antibody-based vaginal films show promise as safe and effective MPTs for preventing STIs and unplanned pregnancies.
• Further clinical trials are planned for the antisperm antibody to assess safety and proof-of-principle efficacy.
• Ongoing research focuses on cost reduction, enhanced antibody design, and improved delivery systems for extended protection.