Broadly Neutralizing Human Anti-HIV Monoclonal Antibody 10E8 and Related Antibodies Capable of Neutralizing Most HIV-1 Strains

The uses for human anti-HIV monoclonal antibody 10E8 and its variants include passive immunization, therapeutic vaccination, and the development of vaccine immunogens. 10E8 is one of the most potent HIV-neutralizing antibodies isolated and it neutralizes up to 98% of diverse HIV-1 strains. 10E8 is specific to the membrane-proximal external region (MPER) of the HIV envelope protein gp41 and 10E8 is orthogonal to other anti-HIV antibodies. In combination with other antibodies 10E8 may provide an antibody response that neutralizes nearly all strains of HIV-1. Additionally, 10E8 effectively induces antibody-dependent cellular cytotoxicity (ADCC) indicating its potential use for therapeutic vaccine strategies. Further, 10E8 is a tool for immunogen design and validation of immunogen structure.

NIAID is currently developing certain embodiments of 10E8 for clinical use. Therefore, for some fields of use, NIH will evaluate a license applicant's capabilities and experience in advancing similar technologies through the regulatory process. This technology is not eligible for the NIH's start-up license program.