[Federal Register Volume 86, Number 59 (Tuesday, March 30, 2021)]
[Notices]
[Pages 16602-16603]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-06476]


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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

[[Page 16603]]

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: Elizabeth Pitts, Ph.D., 240-669-5299; 
[email protected]. Licensing information and copies of the patent 
applications 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unpublished information related to the invention.

SUPPLEMENTARY INFORMATION: Technology description follows.

Protein Nanoparticle-Based Vaccine for Influenza Virus

Description of Technology

    There is a great need for a broadly protective, ``universal'' 
influenza virus vaccine. Most influenza vaccines target the head of the 
influenza surface glycoprotein hemagglutinin (HA). However, this region 
of the HA protein undergoes fast antigenic drift. The current strategy 
to address this issue is to reformulate influenza vaccines annually 
against dominant circulating strains, but this leads to variable 
protective efficacy against annual epidemic strains and will not 
provide protection against novel influenza viruses with pandemic 
potential. A ``universal'' influenza vaccine could improve seasonal 
vaccination and provide pandemic preparedness.
    Broadly neutralizing antibodies with heterosubtypic binding have 
been discovered. However, commercial development of vaccines that 
produce broadly neutralizing antibodies has so far been unsuccessful. 
Researchers at NIAID used structure-guided techniques to identify and 
develop nanoparticles that express a conserved peptide from the HA 
stem, a preferred antigen for influenza vaccine development as it 
evolves slower than the HA head. The nanoparticles of this invention 
elicit antibodies to the HA stem, confer protection in mouse challenge 
models, are cross-reactive to heterosubtypic HA subtypes, and are heat 
stable. Additionally, the protein platform of the nanoparticles can be 
expressed for group 1 and group 2 influenza HA (H1 to H16), which 
allows mixing of antigens. This vaccine technology has great potential 
to provide protection against both annual influenza outbreaks and 
pandemic-potential influenza viruses.
    This technology is available for licensing for commercial 
development in accordance with 35 U.S.C. 209 and 37 CFR part 404.

Potential Commercial Applications

     Vaccines against influenza virus.
     Universal influenza virus vaccine.

Competitive Advantages

     Broad/universal protection against both seasonal and 
pandemic-potential influenza viruses.
     Nanoparticles allow mixing of antigens.
     Incorporates epitopes from group 1 and groups 2 influenza 
viruses.
     Stability of particle and immunogenicity after high 
temperature exposure.

Development Stage

     In vivo data assessment (animal).
    Inventors: Audray K. Harris (NIAID) and Dustin McCraw (NIAID).
    Intellectual Property: HHS Reference No. E-005-2017--U.S. 
Provisional Application No. 62/540,474, filed August 2, 2017; PCT 
Application No. PCT/US2018/045032, filed August 2, 2018; United States 
Application No. 16/635,240, filed January 30, 2020 (pending); European 
Application No. 18756111.3, filed August 2, 2018 (pending); Chinese 
Application No. 201880063622.5, filed August 2, 2018 (pending); and 
Indian Application No. 202017008138, August 2, 2018 (pending).
    Licensing Contact: To license this technology, please contact 
Elizabeth Pitts, Ph.D., 240-669-5299; [email protected].

    Dated: March 18, 2021.
Surekha Vathyam,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2021-06476 Filed 3-29-21; 8:45 am]
BILLING CODE 4140-01-P