[Federal Register Volume 83, Number 223 (Monday, November 19, 2018)]
[Notices]
[Page 58266]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-25189]


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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.

FOR FURTHER INFORMATION CONTACT: Dr. Vince Contreras, 240-669-2823; 
[email protected]. Licensing information and copies of the U.S. 
patent application 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to receive copies of unpublished patent applications.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.

Optimized Variants of the Broadly Neutralizing HIV-1 gp41 Antibody, 
10E8

Description of Technology

    Scientists at the National Institute of Allergy and Infectious 
Diseases (NIAID) recently discovered a human neutralizing antibody, 
10E8, that binds to the GP41 protein of HIV-1 and prevents infection by 
HIV-1. 10E8 potently neutralizes up to 98% of genetically diverse HIV-1 
strains.
    By engineering the 10E8 antibody, NIAID scientists have improved 
the properties of 10E8 that affect manufacturability, such as 
solubility, while preserving its neutralizing breadth and potency.
    10E8 variants are useful for passive protection from infection, as 
therapeutics, and as a tool for vaccine development.
    This technology is available for licensing for commercial 
development in accordance with 35 U.S.C. 209 and 37 CFR part 404.

Potential Commercial Applications

     Passive protection to prevent HIV infection
     Passive protection to prevent mother-to-infant HIV 
transmission
     Gene-based vectors for anti-gp41 antibody expression
     Therapeutics for elimination of HIV infected cells that 
are actively producing virus

Competitive Advantages

     Among the most potent and broadly neutralizing human 
antibodies isolated to date
     Broad reactivity and high affinity to most HIV-1 strains
     Improved manufacturability relative to the natural 10E8 
antibody

Development Stage

     In vivo data available (animal)
    Inventors: Peter D. Kwong (NIAID), Young Do Kwon (NIAID), Ivelin S. 
Georgiev (NIAID), Gilad A. Ofek (NIAID), Baoshan Zhang (NIAID), Krisha 
McKee (NIAID), John Mascola (NIAID), Gwo-Yu Chuang (NIAID), Sijy O'Dell 
(NIAID), Robert Bailer (NIAID), Mark Louder (NIAID), Mangaiarkarasi 
Asokan (NIAID), Richard Schwartz (NIAID), Jonathan Cooper (NIAID), 
Kevin Carlton (NIAID), Michael Bender (NIAID), Mark Connors (NIAID), 
Amarendra Pegu (NIAID), Lisa Kueltzo (NIAID), Tatyana Gindin (Columbia 
University), and Lawrence Shapiro (Columbia University).
    Publications: Kwon, Y.D. et al. (2016) Optimization of the 
Solubility of HIV-1-Neutralizing Antibody 10E8 through Somatic 
Variation and Structure-Based Design. J Virol. 90(13): 5899-914. [PMID: 
27053554]
    Intellectual Property: HHS Reference Number E-133-2015 includes 
Patent Cooperation Treaty Application Number PCT/US2016/060390 filed 
November 3, 2016; Canadian Patent Application Number 3003878 filed May 
1, 2018; China Patent Application Number TBD filed May 1, 2018; 
European Patent Application Number 16801639.2 filed June 1, 2018; India 
Patent Application Number 20187016184 filed 30 April 2018; U.S. Patent 
Application Number 15/772,443 filed 30 April 2018; South Africa Patent 
Application Number 2018/02875 filed 2 May 2018; Australia Patent 
Application Number 2016349392 filed 4 May 2018.
    Related Intellectual Property: HHS Reference Number E-253-2011.
    Licensing Contact: Dr. Vince Contreras, 240-669-2823; 
[email protected].

    Dated: November 7, 2018.
Suzanne M. Frisbie,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2018-25189 Filed 11-16-18; 8:45 am]
BILLING CODE 4140-01-P