Notice2024-00087
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
January 8, 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 5 (Monday, January 8, 2024)</title>
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[Federal Register Volume 89, Number 5 (Monday, January 8, 2024)]
[Notices]
[Pages 929-930]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-00087]
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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: Dr. Terrence Joyce at (240) 987-2347,
or <a href="/cdn-cgi/l/email-protection#2276475050474c41470c484d5b4147626c6b6a0c454d54"><span class="__cf_email__" data-cfemail="2470415656414a47410a4e4b5d4741646a6d6c0a434b52">[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unpublished information related to the invention.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:
Vesicular Stomatitis Virus (VSV)-Based Vaccine Against Sudan Virus
Description of Technology:
There are five known Ebolavirus species: Ebola virus (Zaire
ebolavirus); Sudan virus (Sudan ebolavirus or SUDV); Ta[iuml] Forest
virus (Ta[iuml] Forest ebolavirus, formerly Cote d'Ivoire ebolavirus);
Bundibugyo virus (Bundibugyo ebolavirus); and Reston virus (Reston
ebolavirus). Last year an ebolavirus outbreak resulted in 164 cases and
55 deaths. While there is an
[[Page 930]]
FDA-approved Ebola virus vaccine authorized for use against Ebola virus
infections, ERVEBO, this vaccine is not effective against SUDV due to
the significant variation between Ebola virus and SUDV. ERVEBO is a
live recombinant viral vaccine consisting of a vesicular stomatitis
virus (VSV) backbone deleted for the VSV envelope glycoprotein and
substituted with the envelope glycoprotein of the Ebola virus (Kikwit
1995 strain).
This invention provides a VSV-based vaccine expressing the SUDV-
Gulu GP (VSV-SUDV). The VSV backbone of this vaccine appears to be very
similar to the VSV backbone used in the ERVEBO vaccine discussed above.
This could allow for a quicker and more efficient regulatory approval
pathway through the FDA. Efficacy studies in non-human primates
demonstrated that a single intramuscular vaccination protected animals
from a lethal challenge dose of SUDV even when vaccination occurred
only seven days prior to challenge. In addition, pre-exposure to the
VSV vector did not inhibit a robust response to the SUDV GP component
of the 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> Prophylactic usage against SUDV infections in normal or
high-risk populations.
<bullet> Therapeutic treatment, alone or in combination, in
patients with SUDV infection.
<bullet> Assay development for surveillance, diagnostic, and
prevention measures.
Competitive Advantages:
<bullet> Uses a VSV-based system to express antigens thereby
increasing safety of the vaccine.
<bullet> Efficacious after single low dose vaccination in NHPs.
<bullet> VSV-platform induces a strong & rapid immune response.
Development Stage: Pre-clinical.
Inventors: Andrea Marzi, Ph.D., and Heinz Feldmann, MD, Ph.D., both
of NIAID.
Publications: Marzi, A, et al., ``Species-specific immunogenicity
and protective efficacy of a vesicular stomatitis virus-based Sudan
virus vaccine: a challenge study in macaques,'' Lancet Microbe, 2023
Mar;4(3): e171-e178. doi: 10.1016/S2666-5247(23)00001-0. Epub 2023 Feb
2.
Intellectual Property: U.S. Provisional Application No. 63/419,637,
filed October 26, 2022, U.S. Provisional Application No. 63/517,246
filed August 02, 2023, and PCT application PCT/US2023/077444 filed on
October 20, 2023.
Licensing Contact: To license this technology, please contact Dr.
Terrence Joyce at (240) 987-2347, or <a href="/cdn-cgi/l/email-protection#f6a293848493989593d89c998f9593b6b8bfbed8919980"><span class="__cf_email__" data-cfemail="6c38091e1e09020f09420603150f092c222524420b031a">[email protected]</span></a>, and
reference E-002-2023.
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. For collaboration
opportunities, please contact Dr. Terrence Joyce at (240) 987-2347, or
<a href="/cdn-cgi/l/email-protection#f5a1908787909b9690db9f9a8c9690b5bbbcbddb929a83"><span class="__cf_email__" data-cfemail="bfebdacdcddad1dcda91d5d0c6dcdafff1f6f791d8d0c9">[email protected]</span></a>.
Dated: January 2, 2024.
Haiqing Li,
Acting Deputy Director, Technology Transfer and Intellectual Property
Office, National Institute of Allergy and Infectious Diseases.
[FR Doc. 2024-00087 Filed 1-5-24; 8:45 am]
BILLING CODE 4140-01-P
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