[Federal Register Volume 90, Number 126 (Thursday, July 3, 2025)]
[Notices]
[Page 29573]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-12455]


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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 at 240-669-5128, or 
[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unpublished information related to the invention.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:

Anti-Nucleoprotein Crimean-Congo Hemorrhagic Fever Virus Monoclonal 
Antibodies for Assay Creation

Description of Technology

    Crimean-Congo hemorrhagic fever (CCHF) is the most widespread form 
of viral hemorrhagic fever, found in Eastern and Southern Europe, the 
Mediterranean, northwestern China, central Asia, Africa, the Middle 
East, and the Indian subcontinent. Typically beginning with non-
specific fever, myalgia, nausea, diarrhea, and general malaise, 
symptoms of infection with the tick-borne CCHF virus (CCHFV) can 
rapidly progress to hemorrhagic manifestations, with case fatality 
rates as high as 30-40% in some regions. Critically, there are no 
approved vaccines for CCHF, and prevention is limited to control of 
exposure to infected ticks and livestock.
    Researchers at the Vaccine Research Center (VRC) of the National 
Institute of Allergy and Infectious Disease (NIAID) have recently 
demonstrated robust immunogenicity and significant protection in a 
Rhesus macaque model of CCHF following vaccination with a novel repRNA 
vaccine. Single memory B cells from peripheral blood mononuclear cells 
(PBMCs) were isolated from the vaccinated macaques to derive monoclonal 
antibodies that target the nucleocapsid protein (NP) of CCHFV, which 
plays a critical role in the replication and pathogenesis of the virus. 
This technology comprises mAbs with strong potential for the 
development of diagnostic tools, in vitro assays, research reagents, 
and other analytical methods for CCHFV NP recognition.
    This technology is available for licensing for commercial 
development in accordance with 35 U.S.C. 209 and 37 CFR part 404.
    Potential Commercial Applications:
     Development of diagnostic assays for rapid, accurate CCHFV 
detection in clinical and non-clinical settings.
    Competitive Advantages:
     There are no readily available antibodies that bind to the 
NP protein of CCHFV.
    Development Stage: Preclinical.
    Relevant Publications: Hawman DW, et al. A replicating RNA vaccine 
confers protection in a rhesus macaque model of Crimean-Congo 
hemorrhagic fever. NPJ Vaccines 2024;9:86. https://doi.org/10.1038/s41541-024-00887-z.
    Inventors: Daniel Douek, David Hawman, Leonid Serebryannyy, Noemia 
Santana Lima, Chaim Schramm, Sarah Smith (Kerscher), Amy Henry, Alicen 
Spaulding (all of NIAID)
    Intellectual Property: HHS Reference No. E-129-2025.
    Licensing Contact: To license this technology, please contact Brian 
Bailey at 240-669-5128, or [email protected], and reference E-129-
2025.

    Dated: June 30, 2025.
Surekha Vathyam,
Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2025-12455 Filed 7-2-25; 8:45 am]
BILLING CODE 4140-01-P