[Federal Register Volume 83, Number 73 (Monday, April 16, 2018)]
[Notices]
[Pages 16376-16377]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-07822]


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unpublished patent applications.

SUPPLEMENTARY INFORMATION: Technology description follows.

Prefusion Coronavirus Spike Proteins and Their Use

Description of Technology

    Coronaviruses (CoVs) can cause severe respiratory disease with high 
fatality rates in humans. The 2002-2003 SARS-CoV epidemic resulted in 
8098 cases and 744 deaths, and MERS-CoV, which emerged in 2012, has 
resulted in 2144 cases and over 750 deaths as of March 2018. Currently, 
there are no effective prophylactic or therapeutic measures, and 
because other CoVs are poised to emerge as new human pathogens, there 
is a need to define a general CoV vaccine solution. Past efforts to 
develop CoV vaccines have used whole-inactivated virus, live-attenuated 
virus, recombinant protein subunit, or genetic approaches.
    CoV spike (S) proteins mediate cellular attachment and membrane 
fusion and are therefore the target of protective antibodies. Inventors 
at the Vaccine Research Center of the National Institute of Allergy and 
Infectious Diseases have developed a novel CoV S protein vaccine 
antigen. This

[[Page 16377]]

technology employs protein engineering to stabilize S in its prefusion 
conformation, preventing structural rearrangement, and exposing 
antigenically preferable surfaces. The technology has been applied to 
several CoV spikes, including those from human-relevant viruses, such 
as HKU1-CoV, SARS-CoV, and MERS-CoV. Particularly for MERS-COV, 
stabilized S proteins have been shown to elicit superior neutralizing 
antibody responses up to 10-fold higher in animal models and protect 
mice against lethal MERS-CoV infection. This technology is applicable 
for delivery via other platforms, such as mRNA.
    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: The stabilized prefusion 
coronavirus spike protein can be used as a vaccine antigen to elicit 
robust neutralizing antibody responses.
    Competitive Advantages:
     Improved immunogenicity compared to other coronavirus S 
vaccine formulations.
     Increased protein expression, stability, and 
manufacturability compared to wild-type CoV S.
    Development Stage:
     In vivo data available (animal).
    Inventors: Barney Graham (NIAID), Masaru Kanekiyo (NIAID), M. 
Gordon Joyce (NIAID), Kizzmekia Corbett (NIAID), Hadi Yassine (NIAID), 
Andrew Ward (Scripps), Robert Kirchdoefer (Scripps), Christopher 
Cottrell (Scripps), Jesper Pallesen (Scripps), Hannah Turner (Scripps), 
Nianshuang Wang (Dartmouth), Jason McLellan (Dartmouth),
    Intellectual Property: HHS Reference No. E-234-2016/0, U.S. 
Provisional Patent Application Number 62/412,703, filed October 25, 
2016, PCT Patent Application PCT/US2017/058370 filed October 25, 2017.
    Licensing Contact: Amy Petrik, Ph.D., 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 norovirus diagnostics or vaccines. 
For collaboration opportunities, please contact Amy Petrik, Ph.D., 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. 2018-07822 Filed 4-13-18; 8:45 am]
 BILLING CODE 4140-01-P