[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.

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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: 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will be required to receive copies of unpublished information related 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