[Federal Register Volume 82, Number 174 (Monday, September 11, 2017)]
[Notices]
[Pages 42686-42687]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-19088]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government-Owned Inventions; Availability for Licensing

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: The invention listed below is owned by an agency of the U.S. 
Government and is available for licensing to achieve expeditious 
commercialization of results of federally-funded research and 
development. Foreign patent applications are filed on selected 
inventions to extend market coverage for companies and may also be 
available for licensing.

FOR FURTHER INFORMATION CONTACT: Dr. Vince Contreras, 240-669-2823; 
[email protected]. Licensing information and copies of the patent 
applications listed below may be obtained by communicating with the 
indicated licensing contact at the Technology Transfer and Intellectual 
Property Office, National Institute of Allergy and Infectious Diseases, 
5601 Fishers Lane, Rockville, MD 20852; tel. 301-496-2644. A signed 
Confidential Disclosure Agreement will be required to receive copies of 
unpublished patent applications.

SUPPLEMENTARY INFORMATION: Technology description follows.

Broadly Neutralizing Antibodies Against HIV-1 Directed to the CD4 
Binding Site of HIV Envelope Protein

Description of Technology

    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

[[Page 42687]]

HIV-positive adults. VRC01 is currently being evaluated in a phase II 
clinical trial for prevention of HIV-1 acquisition.
    This technology is available for licensing for commercial 
development in accordance with 35 U.S.C. 209 and 37 CFR part 404, as 
well as for further development and evaluation under a research 
collaboration.

Potential Commercial Applications

 Monoclonal antibodies to treat and/or diagnose HIV and/or AIDS
 Immunoassays and kits

Competitive Advantages

 Monoclonal neutralizing antibodies prevent viral entry into 
cells
 Monoclonal neutralizing antibodies can be used for vaccine 
design and to develop diagnostics for HIV-1

Development Stage

 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).

Publications

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, 
filed March 23, 2012 (Issued); Australia Patent Application 2010298025, 
filed September 24, 2010 (Issued); China Patent Application 
201080053616.5 filed September 24, 2010 (Issued); E.U. Patent 
Application 10760878.8 filed September 24, 2010 (Pending); India Patent 
Application 588/KOLNP/2012 filed March 13, 2012 (Pending); South Africa 
Patent Application 212/02116 filed September 24, 2017 (Pending); Canada 
Patent Application. 2274636 filed September 24, 2017 (Pending).
    The E-051-2012 family includes U.S. Patent Application 14-363,740, 
filed June 6, 2014 (Issued); Australia Patent Application. 2012347453, 
filed December 10,2010 (Issued); China Patent Application 
201280069415.3, filed December 10, 2012 (Pending); E.U. Patent 
Application 1285597.6, filed December 10, 2012 (Pending); Indian Patent 
Application 4661/DELNP/2014, filed December 10, 2012 (Pending); South 
Africa Patent Application 2014/04077, filed December 10, 2012 
(Pending).
    Licensing Contact: Dr. Vince Contreras, 240-669-2823; 
[email protected].
    Collaborative Research 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 Monoclonal antibodies to treat and/
or diagnose HIV and/or AIDS.
    For collaboration opportunities, please contact Dr. Vince 
Contreras, 240-669-2823; [email protected].

    Dated: September 1, 2017.
Suzanne Frisbie,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2017-19088 Filed 9-8-17; 8:45 am]
 BILLING CODE 4140-01-P