[Federal Register Volume 83, Number 47 (Friday, March 9, 2018)]
[Notices]
[Pages 10499-10500]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-04701]


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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: Jenish Patel, Ph.D., 240-669-2894; 
[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to receive copies of unpublished patent applications.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.

Protein Nanoparticles for Antigen Display in Vaccines

Description of Technology

    The technology relates to a protein-based nanoparticle platform 
that allows presentation of immunogenic molecules such as influenza 
virus antigens. This protein platform is made up of hepatitis B capsid/
core proteins. The core proteins contain immunogenic loop c/e1, where 
other antigens can be inserted and the chimeric protein retains the 
ability to form capsid-like particles. The technology describes the 
insertion of one or more copies of influenza epitopes derived from the 
globular head or the

[[Page 10500]]

stem region of hemagglutinin protein into or around the c/e1 loop of 
the core protein. The nanoparticles formed by the use of Hepatitis B 
virus core proteins can be disassembled and re-assembled, allowing 
mixing of antigens. Furthermore, the nanoparticles can be expressed in 
prokaryotic and eukaryotic expression systems. Thus, the platform 
provides a means for an optimal display of influenza epitopes for the 
induction of immune response including broadly neutralizing antibodies 
against the virus and therefore has the potential to be developed into 
an efficient universal vaccine against influenza virus infection.
    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 against viruses; vaccines against influenza virus; 
universal influenza virus vaccine

Competitive Advantages

     The nanoparticles may be disassembled and re-assembled 
allowing mixing of antigens
     Expression in prokaryotic and eukaryotic systems
     Avoids production and usage of live viruses for vaccine 
generation
     Effective immune response due to the use of authentic 
viral antigens
     Stability of particle and immunogenicity after high 
temperature exposure
     Incorporation of epitopes from group 1 and group 2 
influenza viruses
     Broadly neutralizing antibodies against influenza virus

Development Stage

 Pre-clinical; in vivo data available (animal)
    Inventors: Audray K. Harris, Ph.D., (NIAID) and Dustin McCraw, 
Ph.D., (NIAID).
    Publications: Gallagher JR, et al., Characterization of the 
disassembly and reassembly of the HBV glycoprotein surface antigen, a 
pliable nanoparticle vaccine platform. Virology, 2017, Feb; 502:176-187 
[PMID 28061386].
    Intellectual Property: HHS Reference No. E-005-2017/0--U.S. Patent 
Application No. 62/540,474 filed August 2, 2017.
    Licensing Contact: Jenish Patel, Ph.D., 240-669-2894; 
[email protected].
    Collaborative Research Opportunity: The National Institute of 
Allergy and Infectious Diseases is also seeking statements of 
capability or interest from parties interested in collaborative 
research. NIAID would like a prospective collaborator to have one or 
more of the following capabilities: (1) Capacity to produce recombinant 
protein for animal vaccine studies; (2) perform and evaluate 
immunogenicity (antibody response) of influenza vaccine antigens in 
animal (e.g. mouse models); (3) perform and evaluate challenge and 
protection studies of vaccines and influenza viruses. (e.g. mouse 
models); and (4) if results are promising from animal studies, capacity 
to generate clinical grade materials and perform clinical studies. 
NIAID will consider executing a Confidentiality Agreement with a 
prospective collaborator to facilitate receipt of a Capability 
Statement if requested. For collaboration opportunities, please contact 
Jenish Patel, Ph.D., 240-669-2894; [email protected].

    Dated: February 27, 2018.
Suzanne Frisbie,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2018-04701 Filed 3-8-18; 8:45 am]
 BILLING CODE 4140-01-P