[Federal Register Volume 86, Number 64 (Tuesday, April 6, 2021)]
[Notices]
[Pages 17846-17847]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-06997]


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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 F. Petrik, Ph.D., 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unpublished patent applications.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:

Newcastle Disease Virus-Like Particle Displaying Prefusion Stabilized 
SARS-CoV-2 Spike and Its Use

    Description of Technology:
    SARS-CoV-2 has resulted in a global pandemic, sparking urgent 
vaccine development efforts. The trimeric SARS-CoV-2 spike stabilized 
in its prefusion conformation by the addition of 2 proline mutations 
(``SARS-CoV-2 S2P'') is the antigenic basis of SARS-CoV-2 vaccines that 
are currently authorized for use in the United States.
    Researchers at the Vaccine Research Center (VRC) of the National 
Institute of Allergy and Infectious Diseases (NIAID) sought to optimize 
the presentation of SARS-CoV-2 S2P to the immune system with the goal 
of eliciting a strong and durable immune response. The researchers 
designed fusion proteins made of SARS-CoV-2 S2P and Newcastle Disease 
fusion transmembrane domain and cytosolic tail which form virus like 
particles (VLPs) displaying the SARS-CoV-2 S2P on the particle surface.
    SARS-CoV-2 S2P displaying Newcastle Disease virus-like particles 
(``S2P-NDVLP'') elicited a robust immune response two weeks after a 
single immunization. The S2P-NDVLP also elicited an improved 
immunogenicity despite delivering a lower number of SARS-CoV-2 S2P 
antigens than the soluble SARS-CoV-2 S2P to which they were compared. 
This improved immunogenicity is likely due to several characteristics 
of S2P-NDVLPs such as the mass and large size of the VLP particle that 
can result in a strong immune response and increase uptake of the S2P 
by dendritic cells Displaying multiple SARS-CoV-2 S2P on a single 
particle could allow multiple B-cell receptors on individual B cells to 
bind that single particle, thereby cross-linking the B-cell receptors 
and activating those B cells. Lastly, the lipid membrane of the S2P-
NDVLP could allow the immunogen to more closely mimic the real virus 
and boost immune response.
    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:

 A single dose SARS-CoV-2 vaccine

    Competitive Advantages:

     S2P-NDVLP with potential to elicit higher levels of 
neutralizing antibodies than current vaccines with a single dose

    Development Stage: Preclinical Research.
    Inventors: Peter D. Kwong (NIAID); Yongping Yang (NIAID); Wei Shi 
(NIAID); John R. Mascola (NIAID); Olubukola Abiona (NIAID); Kizzmekia 
Corbett (NIAID); Barney Graham (NIAID).
    Publications: Yang, Y et al., (2021). Newcastle Disease Virus-Like 
Particles Displaying Prefusion-Stabilized SARS-

[[Page 17847]]

COV-2 Spikes Elicit Potent Neutralizing Responses. Vaccines, 9(2), 73.
    Intellectual Property: HHS Reference Number E-068-2021 includes 
U.S. Provisional Patent Application Number 63/140,250, filed 01/21/
2021.
    Licensing Contact: To license this technology, please contact Amy 
F. Petrik, Ph.D., 240-627-3721; [email protected].

    Dated: March 24, 2021.
Surekha Vathyam,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2021-06997 Filed 4-5-21; 8:45 am]
BILLING CODE 4140-01-P