[Federal Register Volume 86, Number 110 (Thursday, June 10, 2021)]
[Notices]
[Pages 30966-30967]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-12182]


-----------------------------------------------------------------------

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: Benjamin Hurley; tel. 240-669-5092; 
[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unpublished information related to the invention.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:
    Producing Modified Vaccinia Ankara (MVA) Virus with Continuous 
Mammalian Cell Lines: Viral Host-range Factors for Increasing MVA 
Vaccine Production Yield Description of Technology:
    Modified vaccinia Ankara (MVA) based vaccines are being deployed in 
numerous human clinical trials for indications such as measles, 
malaria, HIV-1 and MERS to name a few. As with many vaccines, scale-up 
and production are significant challenges with the MVA platform. Not 
only are current large-scale MVA vaccine production processes 
inefficient (such as the cumbersome use of chick embryo fibroblast 
(CEF) cells), but a major bottleneck lies in limited host cell 
propagation options and a lack of viable continuous cell lines suitable 
for MVA vaccine production.
    To address this need, scientists at NIAID have identified a number 
of key viral factors in MVA replication in mammalian cells and 
developed methods of modifying MVA viruses in a way that allows for the 
growth of MVA in cells that were previously considered unsuitable for 
such purpose. For example, NIAID scientists observed that the 
introduction of a serine protease inhibitor 1 (SPI-1) gene into the MVA 
genome led to more than a 2-log enhancement of virus spread in human 
diploid MRC-5 cells, whereas deletion of the gene diminished the spread 
of host-range extended viruses by similar extents. Additionally, MRC-5 
cells stably expressing SPI-1 also enhanced replication of 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:
     Vaccine Development: Recombinant MVA-based vaccine 
production in non-CEF cell lines.
     Therapeutic oncolytic virus: Recombinant MVA constructs 
encoding oncolytic tumor-suppressor proteins, pro-apoptotic proteins, 
cytokines, immunomodulatory proteins, cytotoxic peptides, suicide 
proteins, cytotoxins, pro-drugs, therapeutic RNAs, etc.
    Competitive Advantages:
     Recombinant MVA constructs for use in non-avian, continual 
cell line-mediated vaccine production.
     Efficient scale-up vaccine production as a result of 
higher viral yield, enhancing epidemic/pandemic preparedness.
    Inventors: Bernard Moss, Linda Wyatt, Ruikang Liu, Jorge Mendez-
Rios, 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.

    Intellectual Property: HHS Reference No. E-076-2019; International 
Application No. PCT/US20/33788.
    Licensing Contact: To license this technology, please contact 
Benjamin

[[Page 30967]]

Hurley at 240-669-5092 or [email protected], 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, 
[email protected].

    Dated: June 2, 2021.
Surekha Vathyam,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2021-12182 Filed 6-9-21; 8:45 am]
BILLING CODE 4140-01-P