[Federal Register Volume 83, Number 228 (Tuesday, November 27, 2018)]
[Notices]
[Page 60879]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-25787]


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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: Barry Buchbinder, Ph.D., 240-627-3678; 
[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to receive copies of unpublished patent applications.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 HIV-1 Envelope Proteins and Their Use

Description of Technology

    An effective human immunodeficiency virus type 1 (HIV-1) vaccine 
has long been sought to contend with the Acquired Immunodeficiency 
Syndrome (AIDS) pandemic.
    One approach researchers have taken to elicit broadly neutralizing 
antibodies against HIV-1 is to stabilize the structurally flexible HIV-
1 envelope (Env) trimer. Researchers stabilized the Env trimer in a 
conformation that displays predominantly broadly neutralizing epitopes 
and few non-neutralizing epitopes. Currently, BG505 DS-SOSIP is a 
leading vaccine candidate with the desired conformation and 
antigenicity.
    Ideally, to be useful as a vaccine, such a conformationally fixed 
Env immunogen should have high thermostability and should remain in the 
desired antigenic state, even in the presence of CD4, a glycoprotein 
found on the surface of immune cells.
    Researchers at the Vaccine Research Center (VRC) of the National 
Institute of Allergy and Infectious Diseases (NIAID) undertook efforts 
to improve the properties of BG505 DS-SOSIP for use as a vaccine. The 
VRC researchers introduced three additional mutations to further 
stabilize BG505 DS-SOSIP in the vaccine-preferred prefusion-closed 
conformation and refer to the engineered BG505 DS-SOSIP as BG505 DS-
SOSIP.3mut. Experiments showed that these modifications conferred 
improved thermostability that will allow easier transport and storage 
of BG505 DS-SOSIP.3mut compared to BG505 DS-SOSIP. In addition, BG505 
DS-SOSIP.3mut has lower antigenicity toward non/weak neutralizing 
antibodies compared to BG505 DS-SOSIP, which suggests that it could 
potentially elicit higher neutralization titer by targeting only 
broadly neutralizing antibodies. With improved antigenicity and 
stability, this version may have utility as an HIV-1 immunogen or in 
other antigen-specific contexts, such as for use with B-cell probes.
    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

     Vaccine--to elicit potent neutralizing antibodies against 
the HIV-1 Env glycoprotein.
     Probes--to identify broad and potent HIV-1-neutralizing 
antibodies.

Competitive Advantages

    Compared to previous engineered Env trimer versions:
     300-fold reduction in CD4-binding affinity.
     Reduced binding affinity to ineffective HIV-1 antibodies.
     Increase in melting temperature (10 degrees over BG505 
SOSIP).
    Development Stage: In vivo testing (rodents).
    Inventors: Peter Kwong (NIAID), John Mascola (NIAID), Gwo-Yu Chuang 
(NIAID), Cheng Cheng (NIAID), Hui Geng (NIAID), Yongping Yang (NIAID) 
and Jeffrey C. Boyington (NIAID).
    Intellectual Property: HHS Reference Number E-240-2017 includes 
U.S. Provisional Patent Application Number 62/579,973 filed 10/16/2017.
    Related Intellectual Property: HHS Reference Number E-187-2014 
includes U.S. Provisional Patent Application Number 62/046,059 filed 9/
4/2014, U.S. Provisional Patent Application Number 62/136,480 filed 3/
21/2015, PCT Application No. PCT/US2015/048729 filed 9/4/2015, US 
Patent Application 15/508,885 filed 3/3/2017, EP Patent Application 
Number 15766697.5 filed 3/29/2017.
    Licensing Contact: Barry Buchbinder, Ph.D., 240-627-3678; 
[email protected].

    Dated: November 14, 2018.
Suzanne M. Frisbie,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2018-25787 Filed 11-26-18; 8:45 am]
 BILLING CODE 4140-01-P