[Federal Register Volume 83, Number 73 (Monday, April 16, 2018)]
[Notices]
[Pages 16377-16378]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-07821]


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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unpublished patent applications.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.

Novel Multivalent Nanoparticle Vaccines

    Description of Technology: Current seasonal influenza vaccines are 
designed to elicit immunity to circulating strains of influenza each 
year. The targeted strains are selected based on predictions of which 
strains are likely to be predominant in the human population for a 
given year. This prediction must be made well ahead of the influenza 
season to allow time for vaccine production and can be inaccurate.
    Scientists at NIAID's Vaccine Research Center are developing an 
alternative approach for design and production of seasonal influenza 
vaccines. The design includes recombinant fusion proteins that self-

[[Page 16378]]

assemble into nanoparticles with influenza antigenic proteins displayed 
on the nanoparticle surface (Nature 499, 102-106 (2013)). Further 
engineering these recombinant fusion proteins, the scientists have 
developed nanoparticles that simultaneously display multiple strains of 
influenza viral protein antigens (the receptor-binding domain of 
hemagglutinin) on their surface. Due to the heterogeneity of the 
antigenic protein derived from multiple strains, these nanoparticles 
are referred to as mosaic nanoparticles.
    Upon immunization of mice with mosaic nanoparticles displaying 
antigens from eight different H1N1 strains, the elicited antibodies 
neutralized a panel of H1N1 strains from 1918 through 2009 including 
the strains that had not been displayed on the mosaic nanoparticle. 
However, mice immunized with a mixture of the eight types of 
nanoparticles, each displaying a single antigenic protein, did not 
elicit a similar breadth of neutralizing antibody response.
    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:
     Vaccine platform for seasonal influenza with broader 
protection coverage
    Competitive Advantages:
     Nucleic acid or recombinant protein-based vaccine
     Increased ease of production compared to current seasonal 
influenza vaccines
    Development Stage:
     In vivo (animal studies)
    Inventors: Barney S. Graham, Hadi Yassine, Masaru Kanekiyo (all 
from NIAID).
    Publications: Kanekiyo, M, et al. Manuscript under revision.
    Intellectual Property: HHS Reference Number E-060-2015 includes 
U.S. Patent Application No. 15/540,898 filed June 29, 2017 (Pending); 
Canada Patent Application No. 2,974,346 filed December 31, 2015 
(Pending); China Patent Application No. 201580076324.6 filed December 
31, 2015 (Pending); Europe Patent Application No. 15825772.5 filed July 
7, 2017 (Pending); India Patent Application No 201717026077 filed July 
21, 2017 (Pending); Australia Patent Application No. 2015373928 filed 
July 21, 2017; Brazil Patent Application No. BR112017014219-8 filed 
June 29, 2017; Israel Patent Application No. 253187 filed December 31, 
2015; Japan Patent Application No. 2017-534796 filed June 28, 2017; 
South Korean Patent Application No. 10-2017-7021112 filed July 27, 
2017; Singapore Patent Application No. 11201705264W filed June 23, 
2017.
    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. 2018-07821 Filed 4-13-18; 8:45 am]
 BILLING CODE 4140-01-P