[Federal Register Volume 83, Number 152 (Tuesday, August 7, 2018)]
[Notices]
[Pages 38716-38717]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-16835]


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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: Vince Contreras, Ph.D., 240-669-2823; 
<a href="/cdn-cgi/l/email-protection#2157484f42440f424e4f555344534052614f48490f464e57"><span class="__cf_email__" data-cfemail="5e2837303d3b703d31302a2c3b2c3f2d1e30373670393128">[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to receive copies of unpublished patent applications.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.

Substitutions-Modified Prefusion RSV F Proteins and Their Use

    Description of Technology: The respiratory syncytial virus (RSV) 
fusion (F) glycoprotein is the primary target of neutralizing 
antibodies. The F glycoprotein exists in at least two conformations, a 
meta-stable prefusion state, and an extremely stable postfusion state. 
Both states share several epitopes targeted by neutralizing antibodies, 
but it has been demonstrated that the prefusion conformation of F 
contains at least one epitope not present in the postfusion 
conformation. Natural infection results in neutralizing antibodies that 
are primarily directed against the prefusion conformation of F, not its 
postfusion conformation. The instability of the prefusion form of F has

[[Page 38717]]

hindered both its characterization and its use as a vaccine antigen.
    Researchers at the Vaccine Research Center (VRC) of the National 
Institute of Allergy and Infectious Diseases have overcome technical 
obstacles to produce a homogeneous, soluble RSV F glycoprotein vaccine 
which is stabilized in the prefusion conformation and has improved 
stability and immunogenicity compared to the native protein. 
Additionally, several modifications were introduced to remove the 
requirement for furin during production, resulting in an increase in 
expression levels of the immunogen. Stability of the immunogen was 
increased 20-fold as compared to DS-CAV1 (a prefusion-stabilized RSV F 
glycoprotein vaccine candidate that is currently being assessed in 
clinical trials) upon incubation at 60 [deg]C. In mice, these 
immunogens elicited neutralization titers that were 2 to 5-fold higher 
than DS-CAV1.
    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: RSV vaccine for human use.
    <bullet> Probe: B cell-sorting probe to isolate potent neutralizing 
monoclonal antibodies.
    <bullet> Diagnostics: To assess the titer of prefusion-specific 
antibodies in sera.
    Competitive Advantages:
    <bullet> Increased stability compared to the current leading RSV 
vaccine candidate (DS-Cav1).
    <bullet> Elicits increased neutralization titers in mice.
    Development Stage:
    <bullet> In vivo testing (mice).
    Inventors: Peter D. Kwong (NIAID), M. Gordon Joyce (NIAID), Baoshan 
Zhang (NIAID), Man Chen (NIAID), Barney S. Graham (NIAID), John R. 
Mascola (NIAID), Aliaksandr A. Druz (NIAID), Wing-Pui Kong (NIAID), 
Ivelin Georgiev (NIAID), Yaroslav Tsybovsky (Leidos Biomedical 
Research), Paul V. Thomas (NIAID), Marie L. Pancera (NIAID), Mallika 
Sastry (NIAID), Cinque Soto (NIAID), Guillaume B.E. Stewart-Jones 
(NIAID), Yongping Yang (NIAID), Li Ou (NIAID), Ulrich Baxa (NCI), Emily 
Rundlet (NIAID), Joseph Van Galen (NIAID).
    Publications: Joyce, M. Gordon, et al., Nature structural & 
molecular biology, 23.9 (2016): 811; PMID: 27478931.
    Intellectual Property: HHS Reference Number E-064-2016: U.S. Patent 
Application No. 62/314,946 filed 03/29/2016; PCT Application Number 
PCT/US2017/024714 filed 03/29/2017 (pending).
    Related Intellectual Property: HHS Reference Number E-081-2013.
    Licensing Contact: Vince Contreras, Ph.D., 240-669-2823; 
<a href="/cdn-cgi/l/email-protection#097f60676a6c276a66677d7b6c7b687a49676061276e667f"><span class="__cf_email__" data-cfemail="15637c7b76703b767a7b616770677466557b7c7d3b727a63">[email protected]</span></a>.

    Dated: July 20, 2018.
Suzanne M. Frisbie,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2018-16835 Filed 8-6-18; 8:45 am]
 BILLING CODE 4140-01-P


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