[Federal Register Volume 86, Number 14 (Monday, January 25, 2021)]
[Notices]
[Pages 6891-6892]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-01490]


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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: Carol A. Salata at 240-627-3727; 
<a href="/cdn-cgi/l/email-protection#a3c0d0c2cfc2d7c2e3cdcac2cac78dcdcacb8dc4ccd5"><span class="__cf_email__" data-cfemail="ceadbdafa2afbaaf8ea0a7afa7aae0a0a7a6e0a9a1b8">[email protected]</span></a>. 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to receive copies of unpublished patent applications.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:

Prefusion-Stabilized Fusion (F) Glycoprotein Vaccine Immunogens for 
Human Metapneumovirus

    Description of Technology:
    Human metapneumovirus (hMPV) infections have been shown as a common 
cause of upper and lower respiratory diseases such as bronchiolitis and 
pneumonia in young children, the elderly, and other immunocompromised 
individuals. Studies show that infections by the non-segmented negative 
strand RNA virus begin with attachment and entry of viral glycoproteins 
that mediate fusion with host cellular membranes. Like for the human 
respiratory syncytial virus (hRSV), a viral entry is initiated by the 
fusion (F) protein. Given its role in hMPV entry, the F protein has 
thus been a target for eliciting neutralizing antibodies and 
development of novel protein-based therapeutic vaccines.
    Researchers at the Vaccine Research Center (VRC) of the National 
Institute of Allergy and Infectious Diseases (NIAID) developed improved 
recombinant human metapneumovirus (hMPV) F proteins stabilized in the 
prefusion conformation that can elicit potent neutralizing antibodies 
against infection. Double and triple stabilized candidates were 
designed with inter-and intraprotomer disulfide mutations that increase 
protein production and show improved antigenic recognition by 
prefusion-specific antibodies. These second-generation immunogens 
constitute an improvement over the first generation constructs and are 
characterized by additional stabilization that results in optimal 
neutralization responses.
    The second-generation stabilized prefusion hMPV F immunogens may be 
an ideal vaccine immunogen to elicit broad potent neutralizing 
antibodies against metapneumovirus infection, particularly in children 
and immunocompromised adults.
    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:
    <bullet> A promising vaccine immunogen to elicit broad potent 
neutralizing antibodies against metapneumovirus infection, particularly 
in children and immunocompromised adults.
    Competitive Advantages:
    <bullet> There are no approved vaccines or therapeutics against the 
second leading cause of pediatric viral lower respiratory tract 
infection in infants and young children.
    <bullet> Second-generation hMPV F immunogens induce higher titer 
neutralizing responses than first-generation versions in mice.
    Development Stage: Preclinical Research.
    Inventors: Peter D. Kwong (NIAID); Guillaume Stewart-Jones (NIAID); 
John R. Mascola (NIAID); Ursula J. Buchholz (NIAID); Peter L. Collins 
(NIAID); Jason Gorman (NIAID); Li Ou,(NIAID); Tongquing Zhou (NIAID); 
Baoshan Zhang (NIAID); Wing-Pui Kong (NIAID); Yaroslav Tsybovsky (NCI).
    Publications: Liu, P., et al (2013). A live attenuated human 
metapneumovirus vaccine strain provides complete protection against 
homologous viral infection and cross-protection against heterologous 
viral infection in BALB/c mice. Clinical and Vaccine Immunology, 20(8), 
1246-1254.
    Battles, M.B., et al, (2017). Structure and immunogenicity of pre-
fusion-stabilized human metapneumovirus F glycoprotein. Nature 
communications, 8(1), 1-11.
    Intellectual Property: HHS Reference Number E-131-2019 includes 
U.S. Provisional Patent Application Number 63/017,581, filed on 04/29/
2020.

[[Page 6892]]

    Licensing Contact: To license this technology, please contact Carol 
A. Salata at 240-627-3727; <a href="/cdn-cgi/l/email-protection#066575676a67726746686f676f6228686f6e28616970"><span class="__cf_email__" data-cfemail="c2a1b1a3aea3b6a382acaba3aba6ecacabaaeca5adb4">[email protected]</span></a>.

    Dated: January 8, 2021.
Surekha Vathyam,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2021-01490 Filed 1-22-21; 8:45 am]
BILLING CODE 4140-01-P


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