[Federal Register Volume 86, Number 98 (Monday, May 24, 2021)]
[Notices]
[Page 27853]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-10821]


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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unpublished patent applications.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:

Antibodies With Potent and Broad Neutralizing Activity Against 
Antigenically Diverse and Highly Transmissible SARS-CoV-2 Variants

    Emergence of highly transmissible SARS-CoV-2 variants of concern 
that are resistant to current therapeutic antibodies highlights the 
need for continuing discovery of broadly reactive antibodies.
    Scientists at the Vaccine Research Center of the National Institute 
of Allergy and Infectious Diseases discovered and characterized a group 
of human monoclonal antibodies that target unique epitopes on the 
receptor binding domain of SARS-CoV-2 spike protein. These antibodies 
ultra-potently neutralize >12 variants of SARS-CoV-2, including P1, 
B.1.429, B.1.1.7 and B.1.351, as shown in a pseudovirus neutralization 
assay. These antibodies target 3 distinct epitopes in the receptor 
binding domain of the spike protein and function by blocking ACE2 
binding. These antibodies are not impacted by spike mutations that 
knockout binding to other therapeutic antibodies, including E484K, 
N439K, Y453F, L452R and K417N. Several antibodies are able to 
simultaneously bind to the spike protein and are compatible for use in 
combination therapies. In in vitro assays, these combinations were 
shown to decrease the appearance of escape mutants suggesting the 
potential to mitigate resistance development when used as combination 
therapy.
    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

 Treatment of SARS-CoV-2 infection

Competitive Advantages

 Ultra-potent neutralization of currently identified SARS-CoV-2 
variants
 Combinations show the potential to mitigate resistance
 Mechanism of Action--These antibodies bind to block ACE2 
receptor binding to the SARS-CoV-2 spike protein
    Development Stage: Preclinical Research.
    Inventors: John Misasi (VRC, NIAID), Lingshu Wang (VRC, NIAID), 
John Mascola (VRC, NIAID), Daniel Douek (VRC, NIAID), Nancy Sullivan 
(VRC, NIAID), Amy Renseir Henry (VRC, NIAID), Tongqing Zhou (VRC, 
NIAID), Peter Kwong (VRC, NIAID), Wei Shi (VRC, NIAID), Yi Zhang (VRC, 
NIAID), Eu Sung Yang (VRC, NIAID), Mario Roederer (VRC, NIAID), 
Rosemarie Mason (VRC, NIAID), Amarendra Pegu (VRC, NIAD).
    Publications: Wang, L. et al., (2021). Antibodies with potent and 
broad neutralizing activity against antigenically diverse and highly 
transmissible SARS-CoV-2 variants. BioRxiv.
    Intellectual Property: HHS Reference Number E-037-2021 includes 
U.S. Provisional Patent Application Number 63/147,419 filed February 9, 
2021.
    Licensing Contact: To license this technology, please contact Amy 
F. Petrik, Ph.D., 240-627-3721; [email protected].

    Dated: April 27, 2021.
Surekha Vathyam,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2021-10821 Filed 5-21-21; 8:45 am]
BILLING CODE 4140-01-P