Notice2023-03595
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
February 22, 2023
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
<html>
<head>
<title>Federal Register, Volume 88 Issue 35 (Wednesday, February 22, 2023)</title>
</head>
<body><pre>
[Federal Register Volume 88, Number 35 (Wednesday, February 22, 2023)]
[Notices]
[Pages 10906-10907]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-03595]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions; Availability for Licensing
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. Maryann Puglielli at (240)-627-
3723, or <a href="/cdn-cgi/l/email-protection#8fe2eefdf6eee1e1a1fffae8e3e6eae3e3e6cfe1e6e7a1e8e0f9"><span class="__cf_email__" data-cfemail="b8d5d9cac1d9d6d696c8cddfd4d1ddd4d4d1f8d6d1d096dfd7ce">[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-
[[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receive copies of unpublished information related to the invention.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:
<bullet> Prophylactic usage against CCHFV infections in normal or
high-risk populations.
<bullet> Therapeutic treatment, alone or in combination, in
patients with CCHFV infection.
<bullet> Assay development for surveillance, diagnostic, and
prevention measures.
Competitive Advantages:
<bullet> Uses a cell-free system to express antigens thereby
increasing safety of the vaccine.
<bullet> 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 <a href="/cdn-cgi/l/email-protection#d0bdb1a2a9b1bebefea0a5b7bcb9b5bcbcb990beb9b8feb7bfa6"><span class="__cf_email__" data-cfemail="c7aaa6b5bea6a9a9e9b7b2a0abaea2ababae87a9aeafe9a0a8b1">[email protected]</span></a>, 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 <a href="/cdn-cgi/l/email-protection#80ede1f2f9e1eeeeaef0f5e7ece9e5ecece9c0eee9e8aee7eff6"><span class="__cf_email__" data-cfemail="452824373c242b2b6b353022292c2029292c052b2c2d6b222a33">[email protected]</span></a>.
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
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on February 22, 2023.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.