[Federal Register Volume 83, Number 77 (Friday, April 20, 2018)]
[Notices]
[Pages 17559-17560]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-08244]


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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. 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unpublished patent applications.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.

Stabilized Influenza Hemagglutinin Stem Region Trimers and Uses Thereof

Description of Technology

    An effective universal influenza vaccine would eliminate the 
uncertain and costly process of seasonal influenza vaccine development 
each year. Researchers at the National Institute of Allergy and 
Infectious Diseases (NIAID) are developing immunogens which elicit 
neutralizing antibodies to the highly conserved stem region of the 
influenza viral protein hemagglutinin. By targeting this highly 
conserved region, which is nearly identical in various strains of 
influenza virus, these immunogens could train the immune system to 
defend against a wide variety of influenza strains including pandemic 
strains derived from animal reservoirs.
    This vaccine candidate employs a protein nanoparticle platform to 
display portions of the highly conserved stem region of the group 1 
hemagglutinin (HA) viral surface protein in its native, trimeric 
conformation. Animal studies have shown that the HA stem region trimers 
displayed on a nanoparticle are more immunogenic compared to HA stem 
region trimers alone. Immunization of mice and ferrets with an H1N1 
nanoparticle HA stem immunogen conferred protection from a lethal dose 
of H5N1 virus.
    NIAID is continuing development of these vaccine candidates through 
animal studies and moving toward clinical evaluation.
    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

 Universal influenza vaccine

Competitive Advantages

 Nucleic acid or recombinant protein-based vaccine
 Increased ease of production relative to current seasonal 
influenza vaccines

Development Stage

 Preclinical, animal data available

    Inventors: John R. Mascola, Jeffrey C. Boyington, Hadi M. Yassine, 
Peter D. Kwong, Barney S. Graham, Masaru Kanekiyo (all from NIAID).
    Publications: Yassine, H.M., et al. (2015) Hemagglutinin-stem 
nanoparticles generate heterosubtypic influenza protection. Nature 
Medicine 21: 1065-1070. [PMID: 26301691]
    Intellectual Property: HHS Reference Number E-066-2014 includes 
U.S. Patent Application No. 15/13,265 filed November 22, 2016 
(Pending); Canada Patent Application No. 2,950,085 filed May 27, 2015 
(Pending); China Patent Application No. 201580041202.3 filed January 
24, 2017 (Pending); Europe Patent Application No. 15727824.3 filed 
December 23, 2016 (Pending); India

[[Page 17560]]

Patent Application No. 201617042607 filed December 14, 2016 (Pending).
    Related Intellectual Property: HHS Reference Number E-293-2011.
    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: April 5, 2018.
Suzanne M. Frisbie,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2018-08244 Filed 4-19-18; 8:45 am]
 BILLING CODE 4140-01-P