83_FR_50862 83 FR 50667 - Government-Owned Inventions; Availability for Licensing

83 FR 50667 - Government-Owned Inventions; Availability for Licensing

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 83, Issue 195 (October 9, 2018)

Page Range50667-50668
FR Document2018-21762

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 195 (Tuesday, October 9, 2018) 
[Federal Register Volume 83, Number 195 (Tuesday, October 9, 2018)]
[Notices]
[Pages 50667-50668]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-21762]


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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to receive copies of unpublished patent applications.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.

HIV-1 Env Fusion Peptide Immunogens and Their Use

    Description of Technology: Millions of people are infected with 
HIV-1 worldwide, and 2.5 to 3 million new infections have been 
estimated to occur yearly. Although effective antiretroviral therapies 
are available, millions succumb to AIDS every year, especially in Sub-
Saharan Africa, underscoring the need to develop measures to prevent 
the spread of this disease.
    HIV-1 is an enveloped virus, which hides from humoral recognition 
behind a wide array of protective mechanisms. During infection, the 
major envelope protein of HIV-1 is cleaved by host cell proteases into 
two smaller versions (gp120 and gp41). Together gp120 and gp41 make up 
the HIV-1 Env spike, which is a target for neutralizing antibodies. It 
is believed that immunization with an effective immunogen based on the 
HIV-1 Env glycoprotein can elicit a neutralizing response, which may be 
protective against HIV-1 infection.
    Researchers at the Vaccine Research Center (VRC) of the National 
Institute of Allergy and Infectious Diseases used knowledge from the 
crystal structure of an HIV-1 neutralizing antibody, VRC34.01, in 
complex with its epitope on the HIV-1 Env trimer, to develop novel 
immunogens. HIV-1 uses a fusion peptide, located at the N-terminus of 
the gp41 subunit, to fuse with a target cell to infect the cell. The 
crystal structure revealed the epitope recognized by VRC34.01 to be 
composed primarily of the exposed 8 residues of the fusion peptide at 
the N-terminus of the gp41 subunit. Researchers designed fusion peptide 
immunogens that were comprised of the exposed residues of the fusion 
peptide coupled to highly immunogenic carrier proteins to focus the 
immune response to this conserved site of vulnerability. The fusion 
peptide can be displayed on scaffold proteins and--when coupled to HIV-
1 Env trimer boosts--has the potential to elicit antibodies capable of 
neutralizing diverse HIV-1 strains in mice, guinea pigs and rhesus 
macaques, and might therefore serve as the basis for an effective HIV 
vaccine.
    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:

HIV-1 vaccine

    Competitive Advantages:

Potential to be a broadly neutralizing HIV-1 vaccine

    Development Stage: In vivo testing (rodents and non-human 
primates).
    Inventors: Peter Kwong (NIAID), John Mascola (NIAID), Kai Xu 
(NIAID), Rui Kong (NIAID), Tongqing Zhou (NIAID), Li Ou (NIAID), Cheng 
Cheng (NIAID), Wing-Pui Kong (NIAID), Gwo-Yu Chuang (NIAID), Kevin Liu 
(NIAID), Michael Gordon Joyce (NIAID), Yongping Yang (NIAID), Baoshan 
Zhang (NIAID)
    Publications:

(a) Kong, Rui, et al. ``Fusion peptide of HIV-1 as a site of 
vulnerability to

[[Page 50668]]

neutralizing antibody.'' Science 352.6287 (2016): 828-833.
(b) Xu, Kai, et al. ``Epitope-based vaccine design yields fusion 
peptide-directed antibodies that neutralize diverse strains of HIV-1.'' 
Nature Medicine 24, 857-867 (2018).

    Intellectual Property: HHS Reference Number E-279-2016 includes 
U.S. Provisional Patent Application Number 62/403,266 filed 10/03/2016 
and PCT Application Number PCT/US2017/054959 filed 10/03/2017 
(pending).
    Licensing Contact: Barry Buchbinder, Ph.D., 240-627-3678; 
[email protected]

    Dated: September 25, 2018.
Suzanne M. Frisbie,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2018-21762 Filed 10-5-18; 8:45 am]
 BILLING CODE 4140-01-P

Federal Register / Vol. 83, No. 195 / Tuesday, October 9, 2018 / Notices 50667 obtained by communicating with the commercialize for development of a HIV–1 is an enveloped virus, which indicated licensing contact at the vaccine for respiratory or other hides from humoral recognition behind Technology Transfer and Intellectual infections. For collaboration a wide array of protective mechanisms. Property Office, National Institute of opportunities, please contact Peter During infection, the major envelope Allergy and Infectious Diseases, 5601 Soukas, J.D., 301–594–8730; protein of HIV–1 is cleaved by host cell Fishers Lane, Rockville, MD 20852; tel. peter.soukas@nih.gov. proteases into two smaller versions 301–496–2644. A signed Confidential Dated: September 25, 2018. (gp120 and gp41). Together gp120 and Disclosure Agreement will be required Suzanne M. Frisbie, gp41 make up the HIV–1 Env spike, to receive copies of unpublished patent which is a target for neutralizing Deputy Director, Technology Transfer and applications. Intellectual Property Office, National Institute antibodies. It is believed that SUPPLEMENTARY INFORMATION: of Allergy and Infectious Diseases. immunization with an effective Technology description follows. [FR Doc. 2018–21764 Filed 10–5–18; 8:45 am] immunogen based on the HIV–1 Env glycoprotein can elicit a neutralizing Hybridoma Cell Lines Producing BILLING CODE 4140–01–P response, which may be protective Antibodies to RSV NS1 against HIV–1 infection. Description of Technology: This DEPARTMENT OF HEALTH AND Researchers at the Vaccine Research technology provides a new set of HUMAN SERVICES Center (VRC) of the National Institute of hybridoma cell lines each expressing a Allergy and Infectious Diseases used single monoclonal antibody against National Institutes of Health knowledge from the crystal structure of human respiratory syncytial virus (RSV) an HIV–1 neutralizing antibody, nonstructural protein 1 (NS1). These Government-Owned Inventions; VRC34.01, in complex with its epitope antibodies have variously been shown Availability for Licensing on the HIV–1 Env trimer, to develop to detect NS1 protein in an enzyme- novel immunogens. HIV–1 uses a fusion AGENCY: National Institutes of Health, peptide, located at the N-terminus of the linked immunosorbent assay (ELISA), HHS. gp41 subunit, to fuse with a target cell Western blot assay, immunofluorescence microscopy of ACTION: Notice. to infect the cell. The crystal structure paraformaldehyde-fixed cells, and flow revealed the epitope recognized by SUMMARY: The invention listed below is VRC34.01 to be composed primarily of cytometry. The various antibodies can vary in their efficiency in each of these owned by an agency of the U.S. the exposed 8 residues of the fusion assays. This technology provides a Government and is available for peptide at the N-terminus of the gp41 unique set of qualified monoclonal licensing to achieve expeditious subunit. Researchers designed fusion antibodies against RSV NS1 protein commercialization of results of peptide immunogens that were which currently do not exist. These federally-funded research and comprised of the exposed residues of antibodies and cell lines may be of development. Foreign patent the fusion peptide coupled to highly interest to any persons investigating applications are filed on selected immunogenic carrier proteins to focus RSV infection processes, particularly as inventions to extend market coverage the immune response to this conserved it relates to the activity of NS1 in such for companies and may also be available site of vulnerability. The fusion peptide an infection process. for licensing. can be displayed on scaffold proteins This technology is available for FOR FURTHER INFORMATION CONTACT: and—when coupled to HIV–1 Env licensing for commercial development Barry Buchbinder, Ph.D., 240–627– trimer boosts—has the potential to elicit in accordance with 35 U.S.C. 209 and 37 3678; barry.buchbinder@nih.gov. antibodies capable of neutralizing CFR part 404, as well as for further Licensing information and copies of the diverse HIV–1 strains in mice, guinea development and evaluation under a U.S. patent application listed below pigs and rhesus macaques, and might research collaboration. may be obtained by communicating therefore serve as the basis for an Potential Commercial Applications: with the indicated licensing contact at effective HIV vaccine. • Viral diagnostics the Technology Transfer and This technology is available for • Vaccine research Intellectual Property Office, National licensing for commercial development Competitive Advantages: Institute of Allergy and Infectious in accordance with 35 U.S.C. 209 and 37 • Ease of manufacture Diseases, 5601 Fishers Lane, Rockville, CFR part 404. • Unique research tool MD, 20852; tel. 301–496–2644. A signed Potential Commercial Applications: Development Stage: Confidential Disclosure Agreement will HIV–1 vaccine • In vitro data assessment be required to receive copies of Competitive Advantages: Inventors: Thomas McCarty (NIAID), unpublished patent applications. Potential to be a broadly neutralizing Joseph Marcotrigiano (NIAID), Peter SUPPLEMENTARY INFORMATION: HIV–1 vaccine Collins (NIAID). Technology description follows. Development Stage: In vivo testing Publications: None. (rodents and non-human primates). HIV–1 Env Fusion Peptide Immunogens Inventors: Peter Kwong (NIAID), John Intellectual Property: HHS Reference and Their Use Mascola (NIAID), Kai Xu (NIAID), Rui No. E–018–2018/0—U.S. Provisional Application No. 62/661,320, filed April Description of Technology: Millions of Kong (NIAID), Tongqing Zhou (NIAID), 23, 2018 (pending). people are infected with HIV–1 Li Ou (NIAID), Cheng Cheng (NIAID), Licensing Contact: Peter Soukas, J.D., worldwide, and 2.5 to 3 million new Wing-Pui Kong (NIAID), Gwo-Yu amozie on DSK3GDR082PROD with NOTICES1 301–594–8730; peter.soukas@nih.gov. infections have been estimated to occur Chuang (NIAID), Kevin Liu (NIAID), Collaborative Research Opportunity: yearly. Although effective antiretroviral Michael Gordon Joyce (NIAID), The National Institute of Allergy and therapies are available, millions Yongping Yang (NIAID), Baoshan Zhang Infectious Diseases is seeking statements succumb to AIDS every year, especially (NIAID) of capability or interest from parties in Sub-Saharan Africa, underscoring the Publications: interested in collaborative research to need to develop measures to prevent the (a) Kong, Rui, et al. ‘‘Fusion peptide of further develop, evaluate or spread of this disease. HIV–1 as a site of vulnerability to VerDate Sep<11>2014 19:13 Oct 05, 2018 Jkt 247001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 E:\FR\FM\09OCN1.SGM 09OCN1

50668 Federal Register / Vol. 83, No. 195 / Tuesday, October 9, 2018 / Notices neutralizing antibody.’’ Science Recombinant RSV B1 Expressing eGFP • In vitro data assessment 352.6287 (2016): 828–833. as a Reporter Gene Inventors: Ursula Buchholz (NIAID), (b) Xu, Kai, et al. ‘‘Epitope-based Description of Technology: The Peter Collins (NIAID). vaccine design yields fusion inventors have created a reverse Publications: None. peptide-directed antibodies that genetics system for RSV strain B1 of Intellectual Property: HHS Reference neutralize diverse strains of HIV– antigenic subgroup B encoding a No. E–159–2018–0. 1.’’ Nature Medicine 24, 857–867 replication-competent recombinant RSV Licensing Contact: Peter Soukas, J.D., (2018). that contains a codon-optimized G ORF 301–594–8730; peter.soukas@nih.gov. and expresses enhanced green Collaborative Research Opportunity: Intellectual Property: HHS Reference fluorescence protein (GFP). There are The National Institute of Allergy and Number E–279–2016 includes U.S. two antigenic subgroups of RSV, Infectious Diseases is seeking statements Provisional Patent Application Number subgroups A and B, and most of the of capability or interest from parties 62/403,266 filed 10/03/2016 and PCT available information and reagents are interested in collaborative research to Application Number PCT/US2017/ for subgroup A. Immunity against either further develop, evaluate or 054959 filed 10/03/2017 (pending). subgroup has reduced effectiveness in commercialize for development of a Licensing Contact: Barry Buchbinder, restricting the heterologous subgroup, vaccine for respiratory or other Ph.D., 240–627–3678; suggesting that an effective RSV vaccine infections. For collaboration barry.buchbinder@nih.gov might need to contain both subgroups. opportunities, please contact Peter Dated: September 25, 2018. The sequence of the wild type G gene Soukas, J.D., 301–594–8730; was refractory to cloning into full-length peter.soukas@nih.gov. Suzanne M. Frisbie, Deputy Director, Technology Transfer and antigenomic cDNA in E. coli, and so the Dated: September 25, 2018. Intellectual Property Office, National Institute inventors made and successfully used a Suzanne M. Frisbie, of Allergy and Infectious Diseases. codon optimized version. In addition, Deputy Director, Technology Transfer and [FR Doc. 2018–21762 Filed 10–5–18; 8:45 am] the inventors inserted an eGFP gene into Intellectual Property Office, National Institute BILLING CODE 4140–01–P the first gene position (promoter of Allergy and Infectious Diseases. proximal). The resulting virus is [FR Doc. 2018–21767 Filed 10–5–18; 8:45 am] replication-competent and efficiently BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND expresses GFP in infected cells. This HUMAN SERVICES virus can be used as a tool to detect RSV-neutralizing antibodies to RSV DEPARTMENT OF HEALTH AND National Institutes of Health subgroup B in a plaque-reduction assay. HUMAN SERVICES It also can be used to evaluate RSV Government-Owned Inventions; infection in vitro and in vivo using GFP National Institutes of Health Availability for Licensing fluorescence to track infection. The antigenomic cDNA clone also provides Submission for OMB Review; 30-Day AGENCY: National Institutes of Health, the starting material for making live- Comment Request; Generic Clearance HHS. attenuated subgroup B-specific RSV To Conduct Voluntary Customer/ ACTION: Notice. vaccine candidates containing defined Partner Surveys (NLM) mutations. These defined mutations can AGENCY: National Institutes of Health, SUMMARY: The invention listed below is include ones that we previously HHS. owned by an agency of the U.S. developed for RSV subgroup A, and ACTION: Notice. Government and is available for include stabilized point mutations, licensing to achieve expeditious stabilized codon-deletions, and gene- SUMMARY: In compliance with the commercialization of results of deletions. Paperwork Reduction Act of 1995, the federally-funded research and The present invention provides a National Institutes of Health (NIH) has development. Foreign patent reverse genetics system encoding strain submitted to the Office of Management applications are filed on selected B1 of RSV subgroup B containing a and Budget (OMB) a request for review inventions to extend market coverage codon-optimized G ORF and encoding and approval of the information for companies and may also be available eGFP. This provides a tool for RSV collection listed below. for licensing. subgroup B serology assays, for tracking DATES: Comments regarding this RSV infection, and a starting point for information collection are best assured FOR FURTHER INFORMATION CONTACT: making attenuated subgroup B strains of having their full effect if received Peter Soukas, J.D., 301–594–8730; for vaccine purposes. peter.soukas@nih.gov. Licensing within 30-days of the date of this This technology is available for information and copies of the patent publication. licensing for commercial development applications listed below may be in accordance with 35 U.S.C. 209 and 37 ADDRESSES: Written comments and/or obtained by communicating with the CFR part 404, as well as for further suggestions regarding the item(s) indicated licensing contact at the development and evaluation under a contained in this notice, especially Technology Transfer and Intellectual research collaboration. regarding the estimated public burden Property Office, National Institute of Potential Commercial Applications: and associated response time, should be Allergy and Infectious Diseases, 5601 • Viral diagnostics directed to the: Office of Management amozie on DSK3GDR082PROD with NOTICES1 Fishers Lane, Rockville, MD, 20852; tel. • Vaccine research and Budget, Office of Regulatory Affairs, 301–496–2644. A signed Confidential • Serology assays OIRA_submission@omb.eop.gov or by Disclosure Agreement will be required • Vaccine manufacture fax to 202–395–6974, Attention: Desk to receive copies of unpublished patent Competitive Advantages: Officer for NIH. applications. • Ease of manufacture FOR FURTHER INFORMATION CONTACT: To SUPPLEMENTARY INFORMATION: • Unique research tool request more information on the Technology description follows. Development Stage: proposed project or to obtain a copy of VerDate Sep<11>2014 19:13 Oct 05, 2018 Jkt 247001 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 E:\FR\FM\09OCN1.SGM 09OCN1


Document Created: 2018-10-06 00:58:54
Document Modified: 2018-10-06 00:58:54
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 50667 
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