[Federal Register Volume 88, Number 16 (Wednesday, January 25, 2023)]
[Notices]
[Pages 4833-4834]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-01418]


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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unpublished patent applications.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.
    Description of Technology:
    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 have engineered a group of human 
monoclonal antibodies that target epitopes on the receptor binding 
domain of SARS-CoV-2 spike protein.

[[Page 4834]]

These engineered antibodies ultra-potently neutralize >12 variants of 
SARS-CoV-2, including the highly transmissible BA.4 and BA.5 
subvariants of Omicron, as shown in a pseudovirus neutralization assay. 
These engineered antibodies target 3 distinct epitopes in the receptor 
binding domain of the spike protein and function by blocking ACE2 
binding. These engineered antibodies are not impacted by spike 
mutations that knockout binding to other therapeutic antibodies, 
including E484K, N439K, Y453F, L452R and K417N. Several of the 
engineered 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. Additionally, these 
engineered antibodies are better suited for manufacturing than the 
parental antibodies.
    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 including Omicron subvariants
 Combinations show the potential to mitigate resistance
 Improved manufacturability relative to parental antibodies
 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), Nancy Sullivan (VRC, NIAID), Misook Choe 
(VRC, NIAID), Richard Alan Koup (VRC, NIAID), Man Chen, (VRC, NIAID), 
Tongqing Zhou (VRC, NIAID), Peter Kwong (VRC, NIAID), Wei Shi (VRC, 
NIAID), Yi Zhang (VRC, NIAID), Eun Sung Yang (VRC, NIAID).
    Publications: None.
    Intellectual Property: HHS Reference Number E-185-2022 includes 
U.S. Provisional Patent Application Number 63/404,473 filed September 
7, 2022.
    Licensing Contact: To license this technology, please contact Amy 
F. Petrik, Ph.D., 240-627-3721; [email protected].

    Dated: January 19, 2023.
Surekha Vathyam,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2023-01418 Filed 1-24-23; 8:45 am]
BILLING CODE 4140-01-P