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.

Potential Commercial Applications:		Competitive Advantages:
Passive protection to prevent HIV infection Passive protection to prevent mother-to-infant HIV transmission Topical microbicide to prevent HIV infection Gene-based vectors for anti-gp41 antibody expression Therapeutic for the elimination of HIV infected cells that are actively producing virus		One of the most potent Human broadly-neutralizing anti HIV antibodies isolated to date Broad reactivity and high affinity to most HIV-1 strains Activity is highly complementary to existing broadly neutralizing antibodies, such as CD4 binding site antibodies Not auto-reactive

Development Stage:

• In vitro data available
• In vivo data available (animal)

Inventors:

John Mascola (NIAID)  ➽ more inventions...

Mark Connors (NIAID)  ➽ more inventions...

Leo Laub (NIAID)  ➽ more inventions...

Jinghe Huang (NIAID)  ➽ more inventions...

Peter Kwong (NIAID)  ➽ more inventions...

Gilad Ofek (NIAID)  ➽ more inventions...

Jiang Zhu (NIAID)  ➽ more inventions...

Gary Nabel (NIAID)  ➽ more inventions...

Rebecca Rudicell (NIAID)  ➽ more inventions...

Ivelin Georgiev (NIAID)  ➽ more inventions...

Yongping Yang (NIAID)  ➽ more inventions...


Intellectual Property:
US Pat: 9,783,595 issued 2017-10-10
US Pat: 9,475,862 issued 2016-10-25
US Pat: 10,047,148 issued 2018-08-14
US Application No. 61/698,480 filed on 2012-09-07
PCT Application No. PCT/US2012/063958 filed on 2012-11-07
US Application No. 14/356,557 filed on 2014-05-06
US Application No. 15/699,902 filed on 2017-09-08

Publications:
Huang J, et al. PMID 23151583

Collaboration Opportunity:
The National Institute of Allergy and Infectious Diseases is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate or commercialize 10E8-related vaccines or immunotherapies. For collaboration opportunities, please contact Bill Ronnenberg at +1 240-627-3726 or wronnenberg@niaid.nih.gov.


Licensing Contact:
Christopher Kornak, J.D.
Email: chris.kornak@nih.gov
Phone: 240-627-3705

OTT Reference No: E-253-2011-0
Updated: Jun 18, 2014