Notice2024-04423
Government-Owned Inventions; Availability for Licensing
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
March 4, 2024
Issuing agencies
Health and Human Services DepartmentNational Institutes of Health
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 43 (Monday, March 4, 2024)</title>
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[Federal Register Volume 89, Number 43 (Monday, March 4, 2024)]
[Notices]
[Pages 15599-15600]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="/cdn-cgi/l/email-protection#523030333b3e372b123f333b3e7c3c3b3a7c353d24"><span class="__cf_email__" data-cfemail="9bf9f9faf2f7fee2dbf6faf2f7b5f5f2f3b5fcf4ed">[email protected]</span></a>. 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will be required to receive copies of unpublished information related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:
<bullet> Novel SARS-CoV-2 vaccine and universal vaccines against
coronavirus
<bullet> Vaccine development against other viral pathogens such as
HIV and flu
Competitive Advantages:
<bullet> Higher potency, potentially longer protection compared to
other SARS-CoV-2 vaccine formulations.
<bullet> Potent immune response via genetic delivery, including DNA
and RNA immunization.
<bullet> Improved immunogenicity compared to other nanoparticle or
virus-like-particle (VLP)-based vaccines for SARS-CoV-2 spike protein.
Development Stage:
<bullet> 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). <a href="https://doi.org/10.1038/s41541-023-00707-w">https://doi.org/10.1038/s41541-023-00707-w</a>.
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; <a href="/cdn-cgi/l/email-protection#f29090939b9e978bb29f939b9edc9c9b9adc959d84"><span class="__cf_email__" data-cfemail="caa8a8aba3a6afb38aa7aba3a6e4a4a3a2e4ada5bc">[email protected]</span></a>, 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, <a href="/cdn-cgi/l/email-protection#fd9f9f9c94919884bd909c9491d3939495d39a928b"><span class="__cf_email__" data-cfemail="adcfcfccc4c1c8d4edc0ccc4c183c3c4c583cac2db">[email protected]</span></a>.
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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