Collaborative Research and Licensing Opportunity: Broadly Neutralizing Antibodies against HIV-1 Directed to the CD4 Binding Site of HIV Envelope Protein
Scientists at the NIAID Vaccine Research Center have isolated and characterized neutralizing antibodies (VRC01, 02, 03, and 07) that bind to the CD4 binding site of HIV-1 envelope glycoprotein gp120. These human monoclonal antibodies can be used as a therapeutic to: (1) treat an HIV infection, (2) decrease and prevent HIV-transmission from mother to infant, and (3) be effectively combined with anti-retroviral drug therapy.
Inhibiting the ability of HIV-1, the virus that causes AIDS, to infect cells is one approach to both prevention and treatment of HIV. Scientists at the NIAID Vaccine Research Center have isolated and characterized neutralizing antibodies (VRC01, 02, 03, and 07) that bind to the CD4 binding site of HIV-1 envelope glycoprotein gp120. These human monoclonal antibodies can potentially be used as a therapeutic to: (1) treat an HIV infection, (2) decrease and prevent HIV-transmission from mother to infant, and (3) be effectively combined with anti-retroviral drug therapy. Additionally, the antibodies can be used for detection of HIV-1 infection in biological samples, including body fluids; and tissues from biopsies, autopsies, and pathology specimens.
VRC01 has been tested in several phase I clinical trials for safety and pharmacokinetics in infants, adults, and HIV-positive adults. VRC01 is currently being evaluated in a phase II clinical trial for prevention of HIV-1 acquisition.
Potential Commercial Applications:
- Monoclonal antibodies to treat and/or diagnose HIV and/or AIDS
- Immunoassays and kits
- Monoclonal neutralizing antibodies prevent viral entry into cells
- Monoclonal neutralizing antibodies can be used for vaccine design and to develop diagnostics for HIV-1
· In vitro data available
· In vivo data available (animal)
· In vivo data available (human)
· Clinical Phase I
Inventors: John Mascola, Mark Connors, Peter Kwong, Gary Nabel, Mario Roederer, Xueling Wu (all from NIAID).
Nabel G et al. (2015) Broadly Neutralizing Human Immunodeficiency Virus Type 1 Antibody Gene Transfer Protects Nonhuman Primates from Mucosal Simian-Human Immunodeficiency Virus Infection. J Virol. 89(16):8334-45. [PMID26041300].
Nabel G et al. (2014) Enhanced potency of a broadly neutralizing HIV-1 antibody in vitro improves protection against lentiviral infection in vivo. J Virol. 88(21):12669-82. [PMID:25142607].
Wu X et al. (2010) Immunotypes of a quaternary site of HIV-1 vulnerability and their recognition by antibodies. J Virol. 2011: 85(9):4578-85. [PMID:21325411].
Zhou T et al. (2010) Structural basis for broad and potent neutralization of HIV-1 by antibody VRC01. Science. 329(5993):811-7. [PMID: 20616231].
Intellectual Property: HHS Reference No: E-300-2009 and E-051-2012. The E-300-2009 family includes U.S. Patent Application 13/498,286 (Issued); Australia Patent Application 2010298025 (Issued); China Patent Application 201080053616.5 (Issued); E.U. Patent Application 10760878.8 (Pending); India Patent Application 588/KOLNP/2012 (Pending); South Africa Patent Application 212/02116 (Pending); Canada Patent Application (Pending).
The E-051-2012 family includes U.S. Patent Application 14-363,740 (Issued); Australia Patent Application. 2012347453 (Issued); China Patent Application 201280069415.3 (Pending); E.U. Patent Application 1285597.6 (Pending); Indian Patent Application 4661/DELNP/2014 (Pending); South Africa Patent Application 2014/04077 (Pending).
Licensing and Collaborative Research Opportunity:
The Technology Transfer and Intellectual Property Office (TTIPO) is seeking parties interested in licensing or collaborative research to further co-develop this technology. For opportunities, please contact Dr. Vince Contreras, 240-669-2823; Vince.Contreras@nih.gov.