[Federal Register Volume 88, Number 35 (Wednesday, February 22, 2023)]
[Notices]
[Pages 10906-10907]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-03595]


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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. Maryann Puglielli at (240)-627-
3723, 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-

[[Page 10907]]

2644. A signed Confidential Disclosure Agreement will be required to 
receive copies of unpublished information related to the invention.

SUPPLEMENTARY INFORMATION: Technology description follows:

Replicating RNA Vaccine for Crimean-Congo Hemorrhagic Fever Virus

    Description of Technology:
    Crimean-Congo hemorrhagic fever (CCHF) is a deadly hemorrhagic 
fever having a high mortality rate. The disease results from infection 
of an individual by Crimean-Congo hemorrhagic fever virus (CCHFV), 
which is a tick-borne bunyavirus endemic in Southern and Eastern 
Europe, Africa, the Middle East, and Asia. Geographically, case 
distribution is consistent with the range of Hyalomma genus ticks, the 
main reservoir of CCHFV, and is likely to expand due to climate change. 
Humans may be infected from tick bites, through contact with infected 
animals or animal tissue. Nosocomial human-to-human transmission has 
also been described primarily for healthcare workers. Initial symptoms 
of CCHF include acute onset of a non-specific febrile illness 
consisting of sudden fever, myalgia, diarrhea, nausea, and vomiting. 
The hemorrhagic phase is characterized by large areas of severe 
bruising and uncontrolled bleeding throughout the body; among 
hospitalized patients, case fatality rates have ranged from 9-50%. 
Currently, there is no approved specific antiviral or vaccine for CCHFV 
infection.
    Scientists at NIAID in collaboration with HDT Bio have developed a 
replicating RNA (repRNA) vaccine based on Venezuelan Equine 
Encephalitis Virus replicon RNA expressing either the nucleoprotein 
(repNP) or the glycoprotein precursor (repGPC) from CCHFV alone or in 
combination. In mice, the repNP vaccine primarily elicited a robust but 
non-neutralizing antibody response while repGPC elicited primarily 
cellular immunity against epitopes in the CCHFV NSm and Gc proteins. 
Vaccination with repNP or repNP + repGPC resulted in protection against 
challenge with a heterologous strain of CCHFV in mice.
    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 CCHFV infections in normal or 
high-risk populations.
     Therapeutic treatment, alone or in combination, in 
patients with CCHFV infection.
     Assay development for surveillance, diagnostic, and 
prevention measures.
    Competitive Advantages:
     Uses a cell-free system to express antigens thereby 
increasing safety of the vaccine.
     RepRNA as a platform can drive high-level protein 
expression and mimics viral replication in a single round of 
replication resulting in a more robust immune response in comparison to 
DNA and mRNA platforms.
    Development Stage: Pre-clinical.
    Inventors: Heinz Feldmann (NIAID); David Hawman, (NIAID); and Jesse 
Erasmus (HDT Bio).
    Publications: Leventhal, S. et al., ``Replicating RNA Vaccination 
Elicits an Unexpected Immune Response that Efficiently Protects Mice 
Against Lethal Crimean-Congo Hemorrhagic Fever Virus Challenge'', 
EBioMedicine 82:104188 (2022).
    Intellectual Property: U.S. provisional patent application 63/
365,015 filed May 19, 2022.
    Licensing Contact: To license this technology, please contact Dr. 
Maryann Puglielli at (240)-627-3723, or [email protected], and 
reference E-103-2022.
    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. Maryann Puglielli at (240)-627-3723, 
or [email protected].

    Dated: February 8, 2023.
Surekha Vathyam,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2023-03595 Filed 2-21-23; 8:45 am]
BILLING CODE 4140-01-P