Government-Owned Inventions; Availability for Licensing, 16757 [2022-06174]

Download as PDF Federal Register / Vol. 87, No. 57 / Thursday, March 24, 2022 / Notices certification to ORI at the conclusion of the Supervision Period that his participation was not proposed on a research project for which an application for PHS support was submitted and that he has not participated in any capacity in PHSsupported research. (5) During the Exclusion and Supervision Periods, Respondent will exclude himself voluntarily from serving in any advisory or consultant capacity to PHS including, but not limited to, service on any PHS advisory committee, board, and/or peer review committee. Dated: March 21, 2022. Wanda K. Jones, Acting Director, Office of Research Integrity, Office of the Assistant Secretary for Health. [FR Doc. 2022–06246 Filed 3–23–22; 8:45 am] BILLING CODE 4150–31–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing AGENCY: National Institutes of Health, HHS. ACTION: Notice. 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. SUMMARY: khammond on DSKJM1Z7X2PROD with NOTICES FOR FURTHER INFORMATION CONTACT: Peter Tung at 240–669–5483 or peter.tung@nih.gov. 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 A signed Confidential Disclosure Agreement will be required to receive copies of unpublished patent applications.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: VerDate Sep<11>2014 17:39 Mar 23, 2022 Jkt 256001 16757 Novel Compositions of Matter Comprising Stabilized Coronavirus Antigens and Their Use • Computational method of designing vaccine antigens. Description of Technology • 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 SARSCoV–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 peter.tung@nih.gov. 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; peter.tung@nih.gov. 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 °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 singlecomponent 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. PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 Development Stage 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Center for Scientific Review Special Emphasis Panel; Antimicrobial Resistant Infections. Date: April 19, 2022. E:\FR\FM\24MRN1.SGM 24MRN1

Agencies

[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]


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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.

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

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


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