83_FR_47812 83 FR 47629 - Government-Owned Inventions; Availability for Licensing

83 FR 47629 - Government-Owned Inventions; Availability for Licensing

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 83, Issue 183 (September 20, 2018)

Page Range47629-47630
FR Document2018-20484

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.

Federal Register, Volume 83 Issue 183 (Thursday, September 20, 2018)
[Federal Register Volume 83, Number 183 (Thursday, September 20, 2018)]
[Notices]
[Pages 47629-47630]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-20484]


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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.

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

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to receive copies of unpublished patent applications.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



                                                                       Federal Register / Vol. 83, No. 183 / Thursday, September 20, 2018 / Notices                                            47629

                                              order to facilitate their entry into the                government-issued photo ID, driver’s license,            The VRC01-class of potent, broadly
                                              building. Contact Ann Ferrero using the                 or passport) and to state the purpose of their        neutralizing antibodies (bnAbs) targets
                                              information mentioned above by                          visit.                                                the conserved CD4-binding site (CD4bs)
                                                                                                        Information is also available on the
                                              Thursday, October 18, 2018, 12:00 p.m.                  Institute’s/Center’s home page: NCRA: http://
                                                                                                                                                            of HIV-1 Env which has been a major
                                              ET. All attendees are required to present               deainfo.nci.nih.gov/advisory/ncra/ncra.htm,           target of HIV-vaccine design. The
                                              government-issued identification prior                  where an agenda and any additional                    current best priming immunogen to
                                              to entry. The meeting will also be                      information for the meeting will be posted            engage the VRC01-class germline
                                              accessible via webcast. Instructions on                 when available.                                       precursors is the eOD-GT8 60mer,
                                              how to access the meeting via webcast                   (Catalogue of Federal Domestic Assistance             which elicits VRC01-class precursors in
                                              will be provided upon registration.                     Program Nos. 93.392, Cancer Construction;             multiple transgenic mouse models.
                                                                                                      93.393, Cancer Cause and Prevention                   However, a large proportion of the
                                              Amy P. McNulty,                                         Research; 93.394, Cancer Detection and                antibodies elicited by eOD-GT8 60mer
                                              Acting Director, Division of the Executive              Diagnosis Research; 93.395, Cancer
                                                                                                      Treatment Research; 93.396, Cancer Biology
                                                                                                                                                            are non-CD4bs or ‘‘off-target’’
                                              Secretariat.
                                                                                                      Research; 93.397, Cancer Centers Support;             antibodies, undermining its
                                              [FR Doc. 2018–20428 Filed 9–19–18; 8:45 am]
                                                                                                      93.398, Cancer Research Manpower; 93.399,             effectiveness in eliciting the VRC01-
                                              BILLING CODE 4165–15–P
                                                                                                      Cancer Control, National Institutes of Health,        class bnAb precursors.
                                                                                                      HHS)                                                     Researchers at the Vaccine Research
                                                                                                        Dated: September 14, 2018.                          Center (VRC) of the National Institute of
                                              DEPARTMENT OF HEALTH AND                                                                                      Allergy and Infectious Diseases
                                              HUMAN SERVICES                                          Melanie J. Pantoja,
                                                                                                                                                            introduced multiple N-linked
                                                                                                      Program Analyst, Office of Federal Advisory
                                              National Institutes of Health                           Committee Policy.
                                                                                                                                                            glycosylation sites to mask non-CD4bs
                                                                                                                                                            regions of eOD-GT8 60mer to focus the
                                                                                                      [FR Doc. 2018–20418 Filed 9–19–18; 8:45 am]
                                              National Cancer Institute; Notice of                                                                          antibody immune response to the
                                                                                                      BILLING CODE 4140–01–P
                                              Meeting                                                                                                       CD4bs.
                                                                                                                                                               Several glycan-masked mutants
                                                 Pursuant to section 10(d) of the                                                                           showed significantly decreased
                                              Federal Advisory Committee Act, as                      DEPARTMENT OF HEALTH AND
                                                                                                                                                            antibody binding to non-CD4bs ‘‘off-
                                              amended, notice is hereby given of a                    HUMAN SERVICES
                                                                                                                                                            target’’ epitopes while maintaining
                                              meeting of the National Cancer Institute                                                                      strong binding to CD4bs-specific bnAbs.
                                              Council of Research Advocates.                          National Institutes of Health
                                                                                                                                                            Furthermore, in vivo studies showed
                                                 The meeting will be open to the                      Government-Owned Inventions;                          that immunization with the best glycan-
                                              public, with attendance limited to space                Availability for Licensing                            masked eOD-GT8 mutants resulted in
                                              available. Individuals who plan to                                                                            significant increases in the elicitation of
                                              attend and need special assistance, such                AGENCY:    National Institutes of Health,             CD4bs-specific serum antibodies,
                                              as sign language interpretation or other                HHS.                                                  CD4bs-specific B cells in the spleen, and
                                              reasonable accommodations, should                       ACTION:   Notice.                                     VRC01-class precursors, compared to
                                              notify the Contact Person listed below                                                                        immunization with the parental eOD-
                                              in advance of the meeting. The open                     SUMMARY:   The invention listed below is
                                                                                                      owned by an agency of the U.S.                        GT8 immunogen. In conclusion,
                                              session will be videocast and can be                                                                          because of their improved antigenic and
                                              accessed from the NIH Videocasting and                  Government and is available for
                                                                                                      licensing to achieve expeditious                      immunogenic profiles, glycan-masked
                                              Podcasting website (http://                                                                                   eOD-GT8 60mer mutants may serve as
                                              videocast.nih.gov).                                     commercialization of results of
                                                                                                      federally-funded research and                         improved priming immunogens to elicit
                                                Name of Committee: National Cancer
                                                                                                      development. Foreign patent                           VRC01-class bnAbs in humans.
                                              Institute Council of Research Advocates.                                                                         Potential Commercial Applications:
                                                                                                      applications are filed on selected
                                                Date: October 19, 2018.                                                                                        • HIV-1 vaccine—the priming
                                                Time: 9:00 a.m. to 4:30 p.m.                          inventions to extend market coverage
                                                                                                                                                            component in a prime-boost approach.
                                                Agenda: Welcome and Chairman’s                        for companies and may also be available                  Competitive Advantages:
                                              Remarks, NCI Updates, Legislative Update,               for licensing.                                           • Reduced off-target immunogenicity.
                                              Budget Update, and Director’s Update.                   FOR FURTHER INFORMATION CONTACT:                         • Improved efficacy in eliciting
                                                Place: National Institutes of Health, 35A             Barry Buchbinder, Ph.D., 240–627–                     precursors for broadly neutralizing
                                              Convent Drive, Building 35A, 640, Bethesda,             3678; barry.buchbinder@nih.gov.
                                              MD 20892.                                                                                                     CD4bs antibodies.
                                                 Contact Person: Amy Williams, NCI Office
                                                                                                      Licensing information and copies of the                  • Facilitates the development of
                                              of Advocacy Relations, National Cancer                  U.S. patent application listed below                  VRC01-class bnAbs in humans.
                                              Institute, NIH, 31 Center Drive, Building 31,           may be obtained by communicating                         Development Stage: In vivo testing
                                              Room 10A28, Bethesda, MD 20892, 240–781–                with the indicated licensing contact at               (rodents).
                                              3360 williaam@mail.nih.gov.                             the Technology Transfer and                              Inventors: John R. Mascola (NIAID),
                                                 Any interested person may file written               Intellectual Property Office, National                Hongying Duan (NIAID), Xuejun Chen
                                              comments with the committee by forwarding               Institute of Allergy and Infectious                   (NIAID), Cheng Cheng (NIAID) and
                                              the statement to the Contact Person listed on           Diseases, 5601 Fishers Lane, Rockville,               Jeffrey C. Boyington (NIAID).
                                              this notice. The statement should include the           MD 20852; tel. 301–496–2644. A signed                    Publications: Duan, H. et al., Glycan
                                              name, address, telephone number and when                Confidential Disclosure Agreement will                Masking Focuses Immune Responses to
                                              applicable, the business or professional                be required to receive copies of                      the HIV-1 CD4-Binding Site and
amozie on DSK3GDR082PROD with NOTICES1




                                              affiliation of the interested person.                                                                         Enhances Elicitation of VRC01-Class
                                                                                                      unpublished patent applications.
                                                 In the interest of security, NIH has
                                              instituted stringent procedures for entrance            SUPPLEMENTARY INFORMATION:                            Precursor Antibodies. Immunity 49, 301
                                              onto the NIH campus. All visitor vehicles,                 Technology description follows.                    (2018).
                                              including taxicabs, hotel, and airport shuttles                                                                  Intellectual Property: HHS Reference
                                                                                                      Glycan-Masked Engineered Outer                        Number E–083–2017 includes U.S.
                                              will be inspected before being allowed on
                                              campus. Visitors will be asked to show one
                                                                                                      Domains of HIV-1 GP120 and Their Use                  Provisional Patent Application Number
                                              form of identification (for example, a                    Description of Technology:                          62/476,397 filed 03/24/2017 and PCT


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                                              47630                    Federal Register / Vol. 83, No. 183 / Thursday, September 20, 2018 / Notices

                                              Application Number PCT/US2018/                          672, Bethesda, MD 20892, zhanggu@                     DEPARTMENT OF HEALTH AND
                                              024330 filed 03/26/2018.                                mail.nih.gov.                                         HUMAN SERVICES
                                                Licensing Contact: Barry Buchbinder,                  (Catalogue of Federal Domestic Assistance
                                              Ph.D., 240–627–3678;                                    Program Nos. 93.121, Oral Diseases and                National Institutes of Health
                                              barry.buchbinder@nih.gov.                               Disorders Research, National Institutes of
                                                                                                      Health, HHS)                                          Center for Scientific Review; Amended
                                                 Dated: September 10, 2018.                                                                                 Notice of Meeting
                                                                                                        Dated: September 14, 2018.
                                              Suzanne M. Frisbie,
                                                                                                      Natasha M. Copeland,                                    Notice is hereby given of a change in
                                              Deputy Director, Technology Transfer and
                                              Intellectual Property Office, National Institute        Program Analyst, Office of Federal Advisory           the meeting of the Molecular Genetics B
                                              of Allergy and Infectious Diseases.                     Committee Policy.                                     Study Section, September 27, 2018,
                                              [FR Doc. 2018–20484 Filed 9–19–18; 8:45 am]             [FR Doc. 2018–20424 Filed 9–19–18; 8:45 am]           10:00 a.m. to September 28, 2018, 06:00
                                              BILLING CODE 4140–01–P                                  BILLING CODE 4140–01–P                                p.m., National Institutes of Health, 6701
                                                                                                                                                            Rockledge Drive, Bethesda, MD, 20892
                                                                                                                                                            which was published in the Federal
                                              DEPARTMENT OF HEALTH AND                                DEPARTMENT OF HEALTH AND                              Register on September 06, 2018,
                                              HUMAN SERVICES                                          HUMAN SERVICES                                        83FR173 pg. 45264.
                                                                                                      National Institutes of Health                           The meeting will be held on
                                              National Institutes of Health                                                                                 September 27, 2018, starting at 8:30 a.m.
                                                                                                      National Institute of Allergy and                     The meeting location remains the same.
                                              National Institute of Dental &
                                                                                                      Infectious Diseases; Notice of Closed                 The meeting is closed to the public.
                                              Craniofacial Research; Notice of
                                              Closed Meetings                                         Meeting                                                 Dated: September 14, 2018.
                                                                                                                                                            Melanie J. Pantoja,
                                                 Pursuant to section 10(d) of the                       Pursuant to section 10(d) of the                    Program Analyst, Office of Federal Advisory
                                              Federal Advisory Committee Act, as                      Federal Advisory Committee Act, as                    Committee Policy.
                                              amended, notice is hereby given of the                  amended, notice is hereby given of the                [FR Doc. 2018–20415 Filed 9–19–18; 8:45 am]
                                              following meetings.                                     following meeting.                                    BILLING CODE 4140–01–P
                                                 The meetings will be closed to the                     The meeting will be closed to the
                                              public in accordance with the                           public in accordance with the
                                              provisions set forth in section                         provisions set forth in sections                      DEPARTMENT OF HEALTH AND
                                              552b(c)(6), Title 5 U.S.C., as amended.                 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,            HUMAN SERVICES
                                              The grant applications and the                          as amended. The grant applications and
                                              discussions could disclose confidential                 the discussions could disclose                        National Institutes of Health
                                              trade secrets or commercial property                    confidential trade secrets or commercial
                                              such as patentable material, and                                                                              Center for Scientific Review; Notice of
                                                                                                      property such as patentable material,
                                              personal information concerning                                                                               Closed Meetings
                                                                                                      and personal information concerning
                                              individuals associated with the grant                   individuals associated with the grant
                                              applications, the disclosure of which                                                                           Pursuant to section 10(d) of the
                                                                                                      applications, the disclosure of which                 Federal Advisory Committee Act, as
                                              would constitute a clearly unwarranted                  would constitute a clearly unwarranted
                                              invasion of personal privacy.                                                                                 amended, notice is hereby given of the
                                                                                                      invasion of personal privacy.                         following meetings.
                                                Name of Committee: National Institute of                Name of Committee: National Institute of              The meetings will be closed to the
                                              Dental and Craniofacial Research Special                Allergy and Infectious Diseases Special
                                              Emphasis Panel; DPBRN ARC.
                                                                                                                                                            public in accordance with the
                                                                                                      Emphasis Panel Centers of Excellence for              provisions set forth in sections
                                                Date: November 14, 2018.                              Translational Research (CETR) (U19).
                                                Time: 8:00 a.m. to 5:00 p.m.                                                                                552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
                                                                                                        Date: October 11–12, 2018.
                                                Agenda: To review and evaluate grant                                                                        as amended. The grant applications and
                                                                                                        Time: 8:00 a.m. to 6:00 p.m.
                                              applications.                                             Agenda: To review and evaluate grant                the discussions could disclose
                                                Place: Hilton Garden Inn, 7301 Waverly                                                                      confidential trade secrets or commercial
                                                                                                      applications.
                                              Street, Bethesda, MD 20814.                                                                                   property such as patentable material,
                                                                                                        Place: Doubletree Hotel Bethesda,
                                                Contact Person: Guo He Zhang, MPH,                                                                          and personal information concerning
                                                                                                      (Formerly Holiday Inn Select), 8120
                                              Ph.D., Scientific Review Officer, Scientific                                                                  individuals associated with the grant
                                                                                                      Wisconsin Avenue, Bethesda, MD 20814.
                                              Review Branch, National Institute of Dental
                                              and Craniofacial Research, National Institutes
                                                                                                        Contact Person: Yong Gao, Ph.D., Scientific         applications, the disclosure of which
                                                                                                      Review Officer Scientific Review Program,             would constitute a clearly unwarranted
                                              of Health, 6701 Democracy Boulevard, Suite
                                                                                                      Division of Extramural Activities, Room               invasion of personal privacy.
                                              672, Bethesda, MD 20892, zhanggu@
                                                                                                      #3G13B, National Institutes of Health/NIAID,
                                              mail.nih.gov.                                                                                                   Name of Committee: Brain Disorders and
                                                                                                      5601 Fishers Lane, MSC 9823, Rockville, MD
                                                Name of Committee: National Institute of              20892–7616, (240) 669–5048, yong.gao@                 Clinical Neuroscience Integrated Review
                                              Dental and Craniofacial Research Special                nih.gov.                                              Group; Clinical Neuroscience and
                                              Emphasis Panel; DPBRN Coordinating                                                                            Neurodegeneration Study Section.
                                              Center.                                                 (Catalogue of Federal Domestic Assistance               Date: October 3–4, 2018.
                                                Date: November 14, 2018.                              Program Nos. 93.855, Allergy, Immunology,               Time: 8:00 a.m. to 5:00 p.m.
                                                Time: 10:00 a.m. to 5:00 p.m.                         and Transplantation Research; 93.856,                   Agenda: To review and evaluate grant
                                                Agenda: To review and evaluate grant                  Microbiology and Infectious Diseases                  applications.
amozie on DSK3GDR082PROD with NOTICES1




                                              applications.                                           Research, National Institutes of Health, HHS)           Place: National Institutes of Health, 6701
                                                Place: Hilton Garden Inn Bethesda, 7301                 Dated: September 14, 2018.                          Rockledge Drive, Bethesda, MD 20892.
                                              Waverly Street, Bethesda, MD 20814.                     Natasha M. Copeland,                                    Contact Person: Alessandra C. Rovescalli,
                                                Contact Person: Guo He Zhang, MPH,                                                                          Ph.D., Scientific Review Officer, National
                                                                                                      Program Analyst, Office of Federal Advisory
                                              Ph.D., Scientific Review Officer, Scientific                                                                  Institutes of Health, Center for Scientific
                                                                                                      Committee Policy.
                                              Review Branch, National Institute of Dental                                                                   Review, 6701 Rockledge Drive, Rm 5205
                                              and Craniofacial Research, National Institutes          [FR Doc. 2018–20421 Filed 9–19–18; 8:45 am]           MSC7846, Bethesda, MD 20892, (301) 435–
                                              of Health, 6701 Democracy Boulevard, Suite              BILLING CODE 4140–01–P                                1021, rovescaa@mail.nih.gov.



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Document Created: 2018-09-20 02:08:54
Document Modified: 2018-09-20 02:08:54
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
ContactBarry 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.
FR Citation83 FR 47629 

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