[Federal Register Volume 85, Number 79 (Thursday, April 23, 2020)]
[Notices]
[Pages 22742-22743]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-08561]


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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: Amy F. Petrik, Ph.D., 240-627-3721; 
[email protected]. Licensing information and copies of the U.S. patent 
application listed below may be obtained by communicating with the 
indicated licensing contact at 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unpublished patent applications.

SUPPLEMENTARY INFORMATION: Technology description follows:

Recombinant Prefusion Measles and Mumps F and F-HN (H) Glycoproteins 
for Vaccine Development.

    Description of Technology: The Measles virus (MeV) and Mumps virus 
(MuV) are highly contagious paramyxoviruses that can be transmitted by 
respiratory droplets from or on direct contact with an infected person. 
The resulting diseases can lead to serious complications or death among 
children. The existing vaccines for MeV and MuV are live attenuated 
virus vaccines which are administered in two subcutaneous doses at 1 
year of age and as early as one month later. Two doses of a combination 
measles, mumps and rubella vaccine are 97% effective against measles 
and 88% against mumps. A single dose of a combination measles, mumps, 
and rubella vaccine is 93% effective against measles and 78% effective 
against mumps.
    Despite the effectiveness of the current licensed vaccines against 
MeV and MuV, incidences of both have increased in recent years. 
Contributing factors include reduced vaccination rates (especially in 
the U.S) due to vaccine hesitancy and circulation of divergent strains 
against which the licensed MMR vaccine offers limited protection.
    In the case of MuV, recent studies have shown that immunity wanes 
significantly after the second MMR vaccination which normally occurs in 
childhood. In response to recent recurring MuV disease outbreaks in the 
U.S and Europe, the Advisory Committee on Immunization Practices is 
advising a third MMR vaccination to boost protection. However, existing 
immunity neutralizes a third MMR vaccination limiting its 
effectiveness. Genotype G MuV is the main cause of recent outbreaks in 
the US and Europe, and a genotype-matched vaccine has been suggested as 
a solution for the recurring outbreaks.
    Researchers at the Vaccine Research Center (VRC) of the National 
Institute of Allergy and Infectious Diseases (NIAID) used structure-
guided design to create immunogen constructs aimed at stabilizing the 
measles and mumps F glycoproteins in their prefusion conformations. 
This was achieved by following the discovery that the pre-fusion 
stabilized F glycoproteins from other members of the paramyxoviridae 
family induced high titer neutralizing responses.
    The researchers developed recombinant immunogens based on: (a) The 
measles F glycoprotein trimer stabilized in its prefusion conformation 
(preF-MeV); (b) genotype G mumps F glycoprotein trimers stabilized in 
its prefusion conformation (preF-MuV); (c) a chimera in which a 
genotype G mumps F glycoprotein trimer stabilized in its prefusion 
conformation is fused with mumps HN protein (preF-HN); and (d) a 
chimera in which a genotype G mumps F glycoprotein trimer stabilized in 
its prefusion conformation is fused with measles H protein (preF-MuV/
MeV H).
    The prefusion stabilization of both the mumps and measles F 
glycoproteins relies on amino acid substitutions to allow the formation 
of intra-protomer disulfide bonds. Researchers found that the preF and 
preF-HN immunogens are stable for over a month at 37 [deg]C and 
hypothesize that lyophilized product would be stable at room 
temperature for months.
    When mice are immunized in a prime-boost-boost regimen with the MuV 
immunogen constructs, the group receiving the preF-HN immunogens 
elicited similar antibody titers against genotype G MuV and Jeryl Lynn 
strain of MuV (genotype A) indicating that the preF-HN immunogens offer 
broad protection against divergent strains of MuV. Interestingly, mice 
immunized in a prime-boost regimen with the pre-F MuV/MeV H chimeric 
immunogen elicited antibody titers to both MuV and MeV that are above 
the determined protective thresholds.
    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:
     The products can be used as measles or mumps vaccines.
    Competitive Advantages:
     Currently, there is no licensed recombinant measles or 
mumps vaccine for use as boosters as a third vaccination.
     The preF-HN immunogens offer broad protection against 
divergent strains of mumps.
     The stabilized prefusion F molecules may be deliverable as 
mRNA vaccines, increasing yields of expressed antigen and presentation 
of the optimal conformation of target proteins.

[[Page 22743]]

     PreF and preF-HN immunogens are stable for over a month at 
37 [deg]C, the lyophilized product may be stable at room temperature 
for months.
     Recombinant vaccine production is scalable, cost-effective 
vaccine production can be achieved.
    Development Stage: Preclinical Research.
    Inventors: Barney Graham, Ph.D. (NIAID); Guillaume Stewart-Jones, 
Ph.D. (NIAID).
    Intellectual Property: HHS Reference Number E-153-2019 includes 
U.S. Provisional Patent Application Number 62/946,902 filed 12/11/2019.
    Licensing Contact: To license this technology, please contact Amy 
F. Petrik, Ph.D., 240-627-3721; [email protected].

    Dated: April 12, 2020.
Wade W. Green,
Acting Deputy Director, Technology Transfer and Intellectual Property 
Office, National Institute of Allergy and Infectious Diseases.
[FR Doc. 2020-08561 Filed 4-22-20; 8:45 am]
 BILLING CODE 4140-01-P