Government-Owned Inventions; Availability for Licensing, 15599-15600 [2024-04423]

Download as PDF Federal Register / Vol. 89, No. 43 / Monday, March 4, 2024 / Notices from Type 1 Diabetes Clinical Studies (R01— Clinical Trial Not Allowed). Date: March 29, 2024. Time: 10:30 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, NIDDK, Democracy II, Suite 7000A, 6707 Democracy Boulevard, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Ann A. Jerkins, Ph.D., Scientific Review Officer, Review Branch, DEA, NIDDK, National Institutes of Health, Room 7119, 6707 Democracy Boulevard, Bethesda, MD 20892–2542, 301–594–2242, jerkinsa@niddk.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.847, Diabetes, Endocrinology and Metabolic Research; 93.848, Digestive Diseases and Nutrition Research; 93.849, Kidney Diseases, Urology and Hematology Research, National Institutes of Health, HHS) Dated: February 27, 2024. Miguelina Perez, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2024–04444 Filed 3–1–24; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES 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. FOR FURTHER INFORMATION CONTACT: Brian Bailey, Ph.D., at 240–669–5128 or 301–201–9217, or by email at bbailey@ mail.nih.gov. Licensing information may be obtained by communicating with 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 A signed Confidential Disclosure Agreement will be required to receive copies of unpublished information related to the invention. SUPPLEMENTARY INFORMATION: Technology description follows: khammond on DSKJM1Z7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:45 Mar 01, 2024 Jkt 262001 SARS–CoV–2 Pseudotyping Plasmids for Cutting-Edge Studies DEPARTMENT OF HEALTH AND HUMAN SERVICES Description of Technology NIAID scientists have developed plasmids that allow for production of pseudoviruses expressing SARS–CoV–2 spike protein. As SARS–CoV–2 is a lethal airborne virus, it must be handled in high-containment Biosafety Level 3 (BSL–3) laboratories that require strict airflow, ventilation and decontamination procedures. The pseudotyping plasmids of this invention provide a secure platform for exploring SARS–CoV–2 dynamics without the need for high-risk handling of live virus and ensure a controlled environment for scientists to study SARS–CoV–2 more expeditiously in standard Biosafety Level 2 (BSL–2) laboratories. The plasmids can be used for diverse SARS– CoV–2 research applications, including the study of newly emerging or potential future variants of interest. 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. National Institutes of Health Potential Commercial Applications • Research material that can be used in the development of neutralization assays National Institutes of Health 15599 Competitive Advantages • Expedite SARS–CoV–2 related experiments by enabling them to be conducted in laboratories with a lower Biosafety Level (BSL–2) than that required for handling SARS–CoV–2 (BSL–3) Development Stage • Research material. Inventors Dr. Barney Graham, Dr. Lingshu Wang, Dr. John Mascola, Dr. Kizzmekia Corbett, all of NIAID. Intellectual Property HHS Reference No. E–223–2020–0. Licensing Contact To license this technology, please contact Brian Bailey, Ph.D.; 240–669– 5128 or 301–201–9217; bbailey@ mail.nih.gov, and reference E–223– 2020. Dated: February 14, 2024. Surekha Vathyam, Deputy Director, Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases. [FR Doc. 2024–04425 Filed 3–1–24; 8:45 am] BILLING CODE 4140–01–P PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 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. FOR FURTHER INFORMATION CONTACT: Brian Bailey, Ph.D., at 240–669–5128 or 301–201–9217, or by email at bbailey@ mail.nih.gov. Licensing information may be obtained by communicating with 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 information related to the invention. SUPPLEMENTARY INFORMATION: Technology description follows: SUMMARY: SARS–CoV–2 Spike Fused to Hepatitis B Surface Antigen Description of Technology: The emergence of the SARS–CoV–2 virus and its immune-escaping variants have led to global COVID–19 pandemic/ endemic, underscoring the urgent need for effective vaccines with strong and durable immune responses. Researchers at the Vaccine Research Center (VRC) of the National Institute of Allergy and Infectious Diseases (NIAID) used a novel approach to SARS–CoV–2 vaccine development by leveraging hepatitis B surface antigen (HBsAg), which has a proven track record of safety and efficacy in hepatitis B vaccines. They designed fusion protein constructs comprised of HBsAg linked by a series of glycine-serine residues to the prefusion stabilized spike protein of SARS–CoV–2. These constructs can selfassemble into nanoparticles in mammalian cells and bind monoclonal antibodies (mAbs) that are specific to different domains of the SARS–CoV–2 spike. The nanoparticles elicit potent and durable immune responses including neutralizing antibody E:\FR\FM\04MRN1.SGM 04MRN1 khammond on DSKJM1Z7X2PROD with NOTICES 15600 Federal Register / Vol. 89, No. 43 / Monday, March 4, 2024 / Notices response. In vitro and in vivo experiments demonstrate that this nanoparticle platform has the potential for use as a robust SARS–CoV–2 vaccine. 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 and universal vaccines against coronavirus • Vaccine development against other viral pathogens such as HIV and flu Competitive Advantages: • Higher potency, potentially longer protection compared to other SARS– CoV–2 vaccine formulations. • Potent immune response via genetic delivery, including DNA and RNA immunization. • Improved immunogenicity compared to other nanoparticle or viruslike-particle (VLP)-based vaccines for SARS–CoV–2 spike protein. Development Stage: • Pre-Clinical. Inventors: Drs. John Mascola, Cuiping Liu, Wei Shi, Amarendra Pegu, Lingshu Wang, Wing-Pui Kong, all of NIAID. Publication: Liu, C., Wang, L., Merriam, J.S. et al. Self-assembling SARS–CoV–2 spike-HBsAg nanoparticles elicit potent and durable neutralizing antibody responses via genetic delivery. npj Vaccines 8, 111 (2023). https://doi.org/10.1038/s41541023-00707-w. Intellectual Property: HHS Reference No. E–171–2021–0–EIR–00 U.S. Patent Application No. 63/278,956 filed on November 12, 2021; HHS Reference No. E–171–2021–0–EIR–00 U.S. Patent Application No WO 2023/086961; PCT/ US2022/079750, filed on November 11, 2022. Licensing Contact: To license this technology, please contact Brian Bailey, Ph.D.; 240–669–5128 or 301–201–9217; bbailey@mail.nih.gov, and reference E– 171–2021. 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 this technology. Areas of specific interest include (a) testing developability of the antibodies elicited by SARS–CoV–2 spike-HBsAg nanoparticles (e.g., biophysical characteristics, cross-reactivity, pharmacokinetics, toxicity), (b) preclinical model assessment, and (c) human clinical trials. For collaboration opportunities, please contact Brian VerDate Sep<11>2014 17:45 Mar 01, 2024 Jkt 262001 Bailey, Ph.D.; 240–669–5128 or 301– 201–9217, bbailey@mail.nih.gov. Dated: February 15, 2024. Surekha Vathyam, Deputy Director, Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases. [FR Doc. 2024–04423 Filed 3–1–24; 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 Meetings Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings. The meetings 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; Fellowships: Physiology and Pathobiology of Cardiovascular and Respiratory Systems: Cardiovascular. Date: March 21–22, 2024. Time: 10:00 a.m. to 8:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Michael L. Bloom, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6187, MSC 7804, Bethesda, MD 20892, 301–451– 0132, bloomm2@mail.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Topics in Microbial and Host Interactions. Date: March 21, 2024. Time: 10:00 a.m. to 3:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Jui Pandhare, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (301) 594–7735, pandharej2@ csr.nih.gov. PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 Name of Committee: Center for Scientific Review Special Emphasis Panel; Atherosclerosis and Vascular Inflammation. Date: March 21, 2024. Time: 11:00 a.m. to 3:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Natalia Komissarova, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5207, MSC 7846, Bethesda, MD 20892, 301–435– 1206, komissar@mail.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Population and Public Health Approaches in HIV/AIDS. Date: March 22, 2024. Time: 10:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Elia E. Ortenberg, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3108, Bethesda, MD 20892, 301–827–7189, femiaee@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Molecular Genetics and Genomics. Date: March 22, 2024. Time: 1:00 p.m. to 7:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Brian Paul Chadwick, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (301) 594–3586, chadwickbp@ csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Cell, Structure and Function-1. Date: March 22, 2024. Time: 1:00 p.m. to 6:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Anne Marie Strohecker, Ph.D., Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (301) 867–5309, stroheckeram@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; RFA–RM– 23–013: Partnerships with Common Fund Data Ecosystem Resources. Date: March 26, 2024. Time: 9:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). E:\FR\FM\04MRN1.SGM 04MRN1

Agencies

[Federal Register Volume 89, Number 43 (Monday, March 4, 2024)]
[Notices]
[Pages 15599-15600]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-04423]


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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: Brian Bailey, Ph.D., at 240-669-5128 
or 301-201-9217, or by email at [email protected]. Licensing 
information may be obtained by communicating with 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 information related 
to the invention.

SUPPLEMENTARY INFORMATION: Technology description follows:

SARS-CoV-2 Spike Fused to Hepatitis B Surface Antigen

    Description of Technology:
    The emergence of the SARS-CoV-2 virus and its immune-escaping 
variants have led to global COVID-19 pandemic/endemic, underscoring the 
urgent need for effective vaccines with strong and durable immune 
responses.
    Researchers at the Vaccine Research Center (VRC) of the National 
Institute of Allergy and Infectious Diseases (NIAID) used a novel 
approach to SARS-CoV-2 vaccine development by leveraging hepatitis B 
surface antigen (HBsAg), which has a proven track record of safety and 
efficacy in hepatitis B vaccines. They designed fusion protein 
constructs comprised of HBsAg linked by a series of glycine-serine 
residues to the prefusion stabilized spike protein of SARS-CoV-2. These 
constructs can self-assemble into nanoparticles in mammalian cells and 
bind monoclonal antibodies (mAbs) that are specific to different 
domains of the SARS-CoV-2 spike. The nanoparticles elicit potent and 
durable immune responses including neutralizing antibody

[[Page 15600]]

response. In vitro and in vivo experiments demonstrate that this 
nanoparticle platform has the potential for use as a robust SARS-CoV-2 
vaccine.
    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 and universal vaccines against 
coronavirus
     Vaccine development against other viral pathogens such as 
HIV and flu
    Competitive Advantages:
     Higher potency, potentially longer protection compared to 
other SARS-CoV-2 vaccine formulations.
     Potent immune response via genetic delivery, including DNA 
and RNA immunization.
     Improved immunogenicity compared to other nanoparticle or 
virus-like-particle (VLP)-based vaccines for SARS-CoV-2 spike protein.
    Development Stage:
     Pre-Clinical.
    Inventors: Drs. John Mascola, Cuiping Liu, Wei Shi, Amarendra Pegu, 
Lingshu Wang, Wing-Pui Kong, all of NIAID.
    Publication: Liu, C., Wang, L., Merriam, J.S. et al. Self-
assembling SARS-CoV-2 spike-HBsAg nanoparticles elicit potent and 
durable neutralizing antibody responses via genetic delivery. npj 
Vaccines 8, 111 (2023). https://doi.org/10.1038/s41541-023-00707-w.
    Intellectual Property: HHS Reference No. E-171-2021-0-EIR-00 U.S. 
Patent Application No. 63/278,956 filed on November 12, 2021; HHS 
Reference No. E-171-2021-0-EIR-00 U.S. Patent Application No WO 2023/
086961; PCT/US2022/079750, filed on November 11, 2022.
    Licensing Contact: To license this technology, please contact Brian 
Bailey, Ph.D.; 240-669-5128 or 301-201-9217; [email protected], and 
reference E-171-2021.
    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 this technology. Areas of specific 
interest include (a) testing developability of the antibodies elicited 
by SARS-CoV-2 spike-HBsAg nanoparticles (e.g., biophysical 
characteristics, cross-reactivity, pharmacokinetics, toxicity), (b) 
pre-clinical model assessment, and (c) human clinical trials. For 
collaboration opportunities, please contact Brian Bailey, Ph.D.; 240-
669-5128 or 301-201-9217, [email protected].

    Dated: February 15, 2024.
Surekha Vathyam,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2024-04423 Filed 3-1-24; 8:45 am]
BILLING CODE 4140-01-P

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