Document ID: FDA-2016-N-0148-0001
Agency: fda
Document Type: Notice
Title: Government-Owned Inventions; Availability for Licensing; Influenza Virus Neuramindase
Posted Date: 2016-02-12T05:00Z

[Federal Register Volume 81, Number 29 (Friday, February 12, 2016)]
[Notices]
[Pages 7547-7548]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-02887]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0148]

Government-Owned Inventions; Availability for Licensing; 
Influenza Virus Neuramindase

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The invention listed in this document is owned by an Agency of 
the U.S. Government and is available for licensing in accordance with 
Federal regulations to achieve expeditious commercialization of results 
of Federally funded research and development.

FOR FURTHER INFORMATION CONTACT: 
    For licensing information and copies of the patent applications: 
Alice Welch, Technology Transfer Program Office, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4226, Silver 
Spring, MD 20993, 240-402-2561, FAX: 301-847-3539. A signed 
Confidential Disclosure Agreement will be required to receive copies of 
the patent applications.
    For parties interested in licensing or collaborative research 
activities: William Ronnenberg, Technology Transfer Program Office, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 
4214, Silver Spring, MD 20993, 240-402-4561, 
William.ronnenberg@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Technology description.
    Title of Abstract: Therapeutic and prophylactic anti-Influenza 
virus neuraminidase 1 (N1) antibody (CD6) with a novel epitope that 
spans neuramindase (NA) dimers.
    Description of Technology: Influenza virus neuramindase (NA) 
protein is a surface protein that plays an essential role in virus 
replication. Drugs and antibodies that block NA function can reduce 
both the symptoms and the length of illness; however, variants of 
influenza virus are resistant to NA inhibitors. The neuramindase 1 (N1) 
subtype of NA is important because it is found in the two pandemic H1N1 
influenza virus strains (1918 Spanish flu and 2009 swine flu) and the 
H5N1 avian influenza virus. Anti-neuramindase antibody CD6 is a novel 
antibody that spans a conserved 30 amino acid epitope across the 
lateral face of a neuramindase (NA) dimer.
    The subject technology may offer an alternative to therapeutic NA 
inhibitors

[[Page 7548]]

currently available. CD6 is a potent monoclonal antibody against N1 
subtypes of NA that inhibits the enzymatic activity of the NA protein, 
including NA variants resistant to NA inhibitors. In a murine model of 
infection, a single dose of antibody was protective against lethal 
challenge with H1N1 influenza virus. The CD6 antibody can potentially 
be used in combination with other antibodies in an antibody 
``cocktail'' or in conjunction with other therapeutic agents. 
Additionally, this unique anti-NA antibody may be useful in combination 
with known neutralizing anti-hemagglutinin (HA) antibodies.

Potential Commercial Applications

     Prophylactic and therapeutic against influenza virus 
infections;
     Diagnostic tests for influenza virus infections; and
     Reagent to measure the potency of H1N1 NA in influenza 
virus vaccines.

Competitive Advantages

     Monoclonal antibody demonstrated to be effective against 
circulating H1N1 influenza viruses;
     Monoclonal antibody binds a novel, conserved epitope 
spanning NA dimers; and
     Monoclonal antibody is well-suited for an antibody 
cocktail that includes anti-HA antibodies.
    Development Stage: Early state; In vitro data available; In vivo 
data available (animal).
    Inventors: Hongquan Wan (FDA); Maryna Eichelberger (FDA); Hua Yang 
(CDC); James Stevens (CDC); David Shore (CDC); and Rebecca Garten 
(CDC).
    Publication: Wan, H., H. Yang, D. A. Shore, R. J. Garten, L. 
Couzens, J. Gao, L. Jiang, P. J. Carney, J. Villanueva, J. Stevens, and 
M. C. Eichelberger. ``Structural Characterization of a Protective 
Epitope Spanning A(H1N1)pdm09 Influenza Virus Neuraminidase Monomers.'' 
6:6114, Nature Communications, 2015.
    Intellectual Property: HHS Reference No. E-005-2015/0--U.S. 
Provisional Patent Application No. 62/088,388 filed December 5, 2014.
    Licensing and Collaborative Research Opportunity: The invention is 
owned by an Agency of the U.S. Government and is available for 
licensing in accordance with 35 U.S.C. 209 and 37 CFR part 404.
    The Food and Drug Administration is seeking statements of 
capability or interest from parties interested in collaborative 
research to further develop, evaluate, or commercialize this 
technology. Parties interested in licensing or collaborative research 
activities for this technology should contact William Ronnenberg (see 
FOR FURTHER INFORMATION CONTACT).

    Dated: February 4, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-02887 Filed 2-11-16; 8:45 am]
 BILLING CODE 4164-01-P