[Federal Register Volume 86, Number 110 (Thursday, June 10, 2021)]
[Notices]
[Pages 30967-30968]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-12179]


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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: Benjamin Hurley at 240-669-5092; 
<a href="/cdn-cgi/l/email-protection#3456515a5e55595d5a1a5c414658514d745a5d5c1a535b42"><span class="__cf_email__" data-cfemail="0260676c68636f6b6c2c6a77706e677b426c6b6a2c656d74">[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unpublished information related to the invention.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:

Producing Modified Vaccinia Ankara (MVA) Virus With Continuous Cell 
Lines: Modifications of Mammalian Host Cells for Increasing MVA Vaccine 
Production Yield

    Description of Technology: Modified vaccinia Ankara (MVA) is a 
well-known and important platform for vaccine development, and many 
MVA-based vaccine trials are currently underway to prevent a variety of 
microbial diseases. While MVA shows promise as a vaccine platform, 
wide-scale industry use of MVA may be currently held back due to MVA's 
severe host-restriction, and the fact that large bulks of culture cells 
are presently required to produce enough product for mass commercial 
use. At present, the range of commonly-used culture cells that can 
support high-titer production of MVA is limited to chick embryo 
fibroblast (CEF) cells. Unfortunately, the production of CEF cells in 
bulk involves many slow and inefficient manufacturing steps both 
upstream and downstream. Therefore, especially in the context of 
pandemic preparedness, continuous cell lines that allow for efficient, 
large-scale MVA propagation would be beneficial.
    There is a clear need for an expanded range of cell lines that are 
easily maintained in culture, and that allow for the production of high 
titers of infectious MVA virus. The present invention provides methods 
of modifying non-permissive cell lines in a way that allows for 
production of MVA.
    Scientists at NIAID have made a breakthrough discovery by 
identifying the mammalian Zinc finger antiviral protein (ZAP) as a 
restriction factor that inhibits MVA growth in mammalian cells. They 
have demonstrated that ZAP abrogation enhanced replication of the MVA 
in a range of mammalian cells that are normally non-permissive for MVA 
replication. In particular, CRISPR/Cas9 inactivation of ZAP was shown 
to produce stable cell lines capable of supporting MVA replication. 
Additionally, recombinant host cells engineered to produce vaccinia 
virus proteins C12L and C16L have been shown to overcome the host range 
inhibition of the MVA.
    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> Vaccine Development: Recombinant continuous cell lines 
useful for efficient, large-scale production of MVA.
    <bullet> May offer improved vaccine production scaling-response 
times, enhancing epidemic/pandemic preparedness.
    Competitive Advantages:
    <bullet> Overcomes inefficiencies associated with CEF production of 
MVA-based vaccines.
    Inventors: Bernard Moss, Linda Wyatt, Chen Peng, Gilad Sivan, Shira 
Glushakow-Smith, all of NIAID.
    Publications:

Liu R, Mendez-Rios JD, Peng C, et al. SPI-1 is a missing host-range 
factor required for replication of the attenuated modified vaccinia 
Ankara (MVA) vaccine vector in human cells.; PLoS Pathog. 2019.
Peng C, Moss B. Repair of a previously uncharacterized second host-
range gene contributes to full replication of modified vaccinia 
virus Ankara (MVA) in human cells. Proc Natl Acad Sci U S A. 2020.
Peng, C, Wyatt, L, Glushakow-Smith, SG, Lal-

[[Page 30968]]

Nag, M, Weisberg, AS, and Moss, B. Zinc-finger antiviral protein 
(ZAP) is a restriction factor for replication of modified vaccinia 
virus Ankara (MVA) in human cells. PLoS Pathog. 2020, accepted for 
publication.

    Intellectual Property: HHS Reference No. E-076-2019; International 
Application No. PCT/US20/33788.
    Licensing Contact: To license this technology, please contact 
Benjamin Hurley at 240-669-5092 or <a href="/cdn-cgi/l/email-protection#87e5e2e9ede6eaeee9a9eff2f5ebe2fec7e9eeefa9e0e8f1"><span class="__cf_email__" data-cfemail="ec8e8982868d818582c284999e808995ac828584c28b839a">[email protected]</span></a>, and 
reference E-076-2019.
    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 invention. For collaboration 
opportunities, please contact Benjamin Hurley; 240-669-5092, 
<a href="/cdn-cgi/l/email-protection#066463686c676b6f68286e73746a637f46686f6e28616970"><span class="__cf_email__" data-cfemail="4527202b2f24282c2b6b2d303729203c052b2c2d6b222a33">[email protected]</span></a>.

    Dated: June 2, 2021.
Surekha Vathyam,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2021-12179 Filed 6-9-21; 8:45 am]
BILLING CODE 4140-01-P


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