[Federal Register Volume 82, Number 205 (Wednesday, October 25, 2017)]
[Notices]
[Pages 49389-49390]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-23177]


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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. Amy Petrik, 240-627-3721; 
[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unpublished patent applications.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.

Neutralizing Antibodies to Influenza HA and Their Use and 
Identification

    Description of Technology: The effectiveness of current influenza 
vaccines varies by strain and season, in part because influenza viruses 
continuously evolve to evade human immune responses. While the majority 
of seasonal influenza infections cause relatively mild symptoms, each 
year influenza virus infections result in over 500,000 hospitalizations 
in the United States and Europe. Current standard of care for 
individuals hospitalized with uncomplicated influenza infection is 
administration of neuraminidase inhibitors. However, frequent use of 
such antiviral drugs increases the risk that the virus will develop 
drug resistance, especially in high-risk populations. Thus, alternative 
strategies are required to protect or treat vulnerable populations who 
have been hospitalized with severe influenza.
    Using a combination of recombinant proteins and sophisticated flow 
cytometry, scientists at NIAID isolated families of antibodies capable 
of

[[Page 49390]]

neutralizing diverse group 1 and group 2 influenza A viruses. 
Specifically, the families of antibodies identified precisely target 
parts of the hemagglutinin (HA) protein, present on the surface of the 
influenza virus, that are least variable from season to season (Joyce, 
M.G., et al. Cell (2016) 166 (3): 609-623). Therefore, it is 
hypothesized that passive administration of members of these families 
of antibodies to individuals would represent an alternative to the 
current standard of care for severe influenza virus infection. 
Additionally, these families of antibodies could be useful for 
development of a product aimed at conferring passive immunity in 
vulnerable populations during the time of an outbreak or emergence of a 
pandemic strain of influenza.
    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.
    NIAID is continuing development of these neutralizing antibodies to 
influenza toward a clinical product for treatment and/or prevention of 
influenza virus infection. Consequently, for some fields of use, NIAID 
will evaluate a license applicant's capabilities and experience in 
advancing similar technologies through the regulatory process.
    Potential Commercial Applications:
     Prevention of influenza A virus infection
     Therapeutic intervention to treat influenza infection
    Competitive Advantages:
     Ability to potently neutralize both group 1 and group 2 
influenza A strains
    Development Stage:
     Proof of concept in animal models
    Inventors: Adrian McDermott (NIAID), Peter Kwong (NIAID), John 
Mascola (NIAID), M. Gordon Joyce (NIAID), Robert Bailer (NIAID), Sarah 
Andrews (NIAID), Paul Thomas (NIAID), Gwo-Yu Chuang (NIAID), Adam 
Wheatley (NIAID), Yi Zhang (NIAID), James Whittle (NIAID).
    Publications: Joyce, M.G., et al. Cell (2016) 166 (3): 609-623
    Intellectual Property: HHS Reference No. E-061-2016--US Patent 
Application No. 62/330,837 filed May 2, 2016; Patent Cooperation Treaty 
Application No. PCT/US2017/030641 filed May 2, 2017.
    Licensing Contact: Dr. Amy Petrik, 240-627-3721; 
[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 influenza monoclonal antibody 
technologies. For collaboration opportunities, please contact Dr. Amy 
Petrik, 240-627-3721; [email protected].

    Dated: October 19, 2017.
Suzanne Frisbie,
Deputy Director,Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2017-23177 Filed 10-24-17; 8:45 am]
 BILLING CODE 4140-01-P