[Federal Register Volume 84, Number 188 (Friday, September 27, 2019)]
[Notices]
[Page 51170]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-20994]


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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: Chris Kornak at 240-627-3705 or 
[email protected]. Licensing information may be obtained by 
communicating with 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unpublished information related to the invention.

SUPPLEMENTARY INFORMATION: Technology description follows:

Improvement of Broadly HIV-Neutralizing Antibodies; Anti-HIV-1 Antibody 
VRC01.23 for Prevention or Treatment of HIV Infection

    Description of Technology:
    Scientists at NIAID have developed broadly neutralizing antibodies 
(bNAbs) with enhanced neutralizing activity against HIV-1. 
Specifically, previously unknown gp120 interactions with a newly 
elucidated quaternary receptor (CD4)-binding site in the HIV-1 envelope 
have been discovered by engrafting the extended heavy-chain framework 
region 3 (FR3) loop of VRC03 onto several potent bNAbs (including 
VRC01, VRC07 and N6). The new antibodies show improved binding with CD4 
by interacting with both binding sites and as a result show improved 
neutralization of various HIV-1 strains. Furthermore, they show reduced 
autoreactivity and, as a result, have prolonged in vivo half-life.
    One of several antibodies that were developed using this technology 
is VRC01.23. It combines the VRC03 framework 3 alteration, with a G54W 
mutation in the heavy chain, and a 3 amino acid deletion in the light 
chain. The modifications improved the potency while reducing the 
autoreactivity. In particular, VRC01.23 is capable of neutralizing 96% 
of HIV-1 viruses tested at geometric mean IC50 =0.042 ug/ml, which is 
~10-fold more potent than VRC01.
    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:

 Improving human monoclonal antibodies for HIV treatment or 
prevention
 New candidates for use as a therapeutic or as a prophylactic

    Competitive Advantages:

 Interaction with multiple HIV binding sites
 Reduced autoreactivity when using the VRC03 framework 3 region 
mutation
 Improved neutralization breadth and potency over existing 
antibodies
 Extended in vivo half-life

    Development Stage:

 Pre-clinical

    Inventors: Paolo Lusso, Qingbo Liu, Peter Kwong, Young Do Kwon, and 
John Mascola, all of NIAID.
    Publications: Liu, Qingbo, et al. ``Improvement of antibody 
functionality by structure-guided paratope engraftment.'' Nature 
communications 10.1 (2019): 721.
    Intellectual Property: HHS Reference No. E-034-2018-0-PCT-01--PCT 
Application No. PCT/US2019/019021 filed on 21 February 2019.
    Licensing Contact: To license this technology, please contact Chris 
Kornak at 240-627-3705 or [email protected], and reference E-034-
2018.
    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 this technology. For collaboration 
opportunities, please contact Chris Kornak at 240-627-3705 or 
[email protected].

    Dated: September 18, 2019.
Wade W. Green,
Acting Deputy Director, Technology Transfer and Intellectual Property 
Office, National Institute of Allergy and Infectious Diseases.
[FR Doc. 2019-20994 Filed 9-26-19; 8:45 am]
 BILLING CODE 4140-01-P