[Federal Register Volume 89, Number 5 (Monday, January 8, 2024)]
[Notices]
[Pages 929-930]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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unpublished information related to the invention.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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