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###### Department of Health and Human Services

###### National Institutes of Health

# 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:

                        Dr. Terrence Joyce at (240) 987-2347, or                         *Terrence.joyce@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 A signed Confidential Disclosure Agreement will be required to receive copies of unpublished information related to the invention.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:

## 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); Taï Forest virus (Taï 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                           ( print 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:*
    - Prophylactic usage against SUDV infections in normal or high-risk populations.
    - Therapeutic treatment, alone or in combination, in patients with SUDV infection.
    - Assay development for surveillance, diagnostic, and prevention measures.

*Competitive Advantages:*
    - Uses a VSV-based system to express antigens thereby increasing safety of the vaccine.
    - Efficacious after single low dose vaccination in NHPs.
    - 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                     *Terrence.joyce@NIH.gov,*                     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                     *Terrence.joyce@NIH.gov.*

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