[Federal Register Volume 87, Number 57 (Thursday, March 24, 2022)]
[Notices]
[Page 16757]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-06174]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government-Owned Inventions; Availability for Licensing

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

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: Peter Tung at 240-669-5483 or 
[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unpublished patent applications.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:

Novel Compositions of Matter Comprising Stabilized Coronavirus Antigens 
and Their Use

Description of Technology

    Using a computational design methodology, SARS-CoV-2 spike proteins 
containing engineered amino acid changes to the receptor binding domain 
(RBD) were designed. These engineered spike proteins improved the 
immune response upon immunization of animals. An engineered RBD was 
also expressed at greater yield, had increased temperature stability, 
and improved the immune response upon immunization of animals. 
Specifically, the disclosed RBD designs can be produced approximately 7 
times more efficiently than the native sequence, facilitating vaccine 
manufacturing on a global scale. The disclosed designs also have up to 
10 [deg]C higher thermal stability than the native sequence, suggesting 
enhanced stability during storage and when in the body. Finally, 
immunization of animals with the disclosed antigens produces up to 10-
fold higher levels of blocking antibodies than the native sequence and 
30-fold higher levels of pseudoviral neutralizing antibodies. An 
additional RBD protein has been engineered to eliminate the need for 
glycosylation, facilitating production and single-component 
nanoparticle display of the antigen. The engineered receptor binding 
domain (RBD) and spike protein antigens produce significant 
improvements in pre-clinical animal models and may be used to develop 
improved coronavirus vaccines.
    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

     Novel SARS-CoV-2 vaccine.
     Improved SARS-CoV-2 diagnostics using stabilized antigens.
     Method of designing vaccine candidates or stabilized 
antigens by computational. optimization of amino acid identity, 
followed by additional sequence comparison and selection (Stabilizer 
for Protein Expression and Epitope Design (SPEEDesign)).

Competitive Advantages

     Novel SARS-CoV-2 spike vaccine with improved breadth and 
duration of protection.
     Novel RBD monomer and nanoparticle designs that are more 
immunogenic and stable than the naturally occurring RBD sequence.
     Computational method of designing vaccine antigens.

Development Stage

     Pre-clinical testing of the novel immunogens in non-human 
primates.
    Inventors: Dr. Niraj Tolia and Dr. Thayne Dickey, both of NIAID.
    Publications: ``Design of the SARS-CoV-2 RBD vaccine antigen 
improves neutralizing antibody response'', https://doi.org/10.1101/2021.05.09.443238.
    Intellectual Property: HHS Reference No. E-045-2021-0-US-01--U.S. 
Provisional Application No. 63/200,194, filed February 18, 2021; PCT/
US2022/070744, filed February 1, 2022
    Licensing Contact: To license this technology, please contact Peter 
Tung at 240-669-5483 or [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 the invention. For collaboration 
opportunities, please contact Peter Tung at 240-669-5483; 
[email protected].

    Dated: March 17, 2022.
Surekha Vathyam,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2022-06174 Filed 3-23-22; 8:45 am]
BILLING CODE 4140-01-P