[Federal Register Volume 83, Number 183 (Thursday, September 20, 2018)]
[Notices]
[Pages 47629-47630]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-20484]


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

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: 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to receive copies of unpublished patent applications.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.

Glycan-Masked Engineered Outer Domains of HIV-1 GP120 and Their Use

    Description of Technology:
    The VRC01-class of potent, broadly neutralizing antibodies (bnAbs) 
targets the conserved CD4-binding site (CD4bs) of HIV-1 Env which has 
been a major target of HIV-vaccine design. The current best priming 
immunogen to engage the VRC01-class germline precursors is the eOD-GT8 
60mer, which elicits VRC01-class precursors in multiple transgenic 
mouse models. However, a large proportion of the antibodies elicited by 
eOD-GT8 60mer are non-CD4bs or ``off-target'' antibodies, undermining 
its effectiveness in eliciting the VRC01-class bnAb precursors.
    Researchers at the Vaccine Research Center (VRC) of the National 
Institute of Allergy and Infectious Diseases introduced multiple N-
linked glycosylation sites to mask non-CD4bs regions of eOD-GT8 60mer 
to focus the antibody immune response to the CD4bs.
    Several glycan-masked mutants showed significantly decreased 
antibody binding to non-CD4bs ``off-target'' epitopes while maintaining 
strong binding to CD4bs-specific bnAbs. Furthermore, in vivo studies 
showed that immunization with the best glycan-masked eOD-GT8 mutants 
resulted in significant increases in the elicitation of CD4bs-specific 
serum antibodies, CD4bs-specific B cells in the spleen, and VRC01-class 
precursors, compared to immunization with the parental eOD-GT8 
immunogen. In conclusion, because of their improved antigenic and 
immunogenic profiles, glycan-masked eOD-GT8 60mer mutants may serve as 
improved priming immunogens to elicit VRC01-class bnAbs in humans.
    Potential Commercial Applications:
     HIV-1 vaccine--the priming component in a prime-boost 
approach.
    Competitive Advantages:
     Reduced off-target immunogenicity.
     Improved efficacy in eliciting precursors for broadly 
neutralizing CD4bs antibodies.
     Facilitates the development of VRC01-class bnAbs in 
humans.
    Development Stage: In vivo testing (rodents).
    Inventors: John R. Mascola (NIAID), Hongying Duan (NIAID), Xuejun 
Chen (NIAID), Cheng Cheng (NIAID) and Jeffrey C. Boyington (NIAID).
    Publications: Duan, H. et al., Glycan Masking Focuses Immune 
Responses to the HIV-1 CD4-Binding Site and Enhances Elicitation of 
VRC01-Class Precursor Antibodies. Immunity 49, 301 (2018).
    Intellectual Property: HHS Reference Number E-083-2017 includes 
U.S. Provisional Patent Application Number 62/476,397 filed 03/24/2017 
and PCT

[[Page 47630]]

Application Number PCT/US2018/024330 filed 03/26/2018.
    Licensing Contact: Barry Buchbinder, Ph.D., 240-627-3678; 
[email protected].

    Dated: September 10, 2018.
Suzanne M. Frisbie,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2018-20484 Filed 9-19-18; 8:45 am]
 BILLING CODE 4140-01-P