Government-Owned Inventions; Availability for Licensing, 42686-42687 [2017-19088]

Download as PDF 42686 Federal Register / Vol. 82, No. 174 / Monday, September 11, 2017 / Notices statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before September 19, 2017. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by September 20, 2017. Persons attending FDA’s advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Serina HunterThomas at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at: https://www.fda.gov/ AdvisoryCommittees/ AboutAdvisoryCommittees/ ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: September 5, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017–19129 Filed 9–8–17; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2017–N–0809] asabaliauskas on DSKBBXCHB2PROD with NOTICES Issuance of Priority Review Voucher; Rare Pediatric Disease Product AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), SUMMARY: VerDate Sep<11>2014 16:34 Sep 08, 2017 Jkt 241001 as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that KYMRIAH (tisagenlecleucel), manufactured by Novartis Pharmaceuticals Corporation, meets the criteria for a priority review voucher. FOR FURTHER INFORMATION CONTACT: Gretchen Opper, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993–0002, 240– 402–7911. FDA is announcing the issuance of a priority review voucher to the sponsor of an approved rare pediatric disease product application. Under section 529 of the FD&C Act (21 U.S.C. 360ff), which was added by FDASIA, FDA will award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA has determined that KYMRIAH (tisagenlecleucel), manufactured by Novartis Pharmaceuticals Corporation, meets the criteria for a priority review voucher. KYMRIAH (tisagenlecleucel) is indicated for the treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse. For further information about the Rare Pediatric Disease Priority Review Voucher Program and for a link to the full text of section 529 of the FD&C Act, go tohttps://www.fda.gov/ForIndustry/ DevelopingProductsfor RareDiseasesConditions/ RarePediatricDiseasePriorityVoucher Program/default.htm. For further information about KYMRIAH (tisagenlecleucel), go to the Center for Biologics Evaluation and Research cellular and gene therapy products Web site at https://www.fda.gov/Biologics BloodVaccines/CellularGeneTherapy Products/ApprovedProducts/ default.htm. SUPPLEMENTARY INFORMATION: Dated: September 5, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017–19130 Filed 9–8–17; 8:45 am] BILLING CODE 4164–01–P PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing AGENCY: National Institutes of Health, HHS. ACTION: Notice. 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: Dr. Vince Contreras, 240–669–2823; Vince.Contreras@nih.gov. Licensing information and copies of the patent applications 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. SUMMARY: Broadly Neutralizing Antibodies Against HIV–1 Directed to the CD4 Binding Site of HIV Envelope Protein Description of Technology Inhibiting the ability of HIV–1, the virus that causes AIDS, to infect cells is one approach to both prevention and treatment of HIV. Scientists at the NIAID Vaccine Research Center have isolated and characterized neutralizing antibodies (VRC01, 02, 03, and 07) that bind to the CD4 binding site of HIV–1 envelope glycoprotein gp120. These human monoclonal antibodies can potentially be used as a therapeutic to: (1) Treat an HIV infection, (2) decrease and prevent HIV-transmission from mother to infant, and (3) be effectively combined with anti-retroviral drug therapy. Additionally, the antibodies can be used for detection of HIV–1 infection in biological samples, including body fluids; and tissues from biopsies, autopsies, and pathology specimens. VRC01 has been tested in several phase I clinical trials for safety and pharmacokinetics in infants, adults, and E:\FR\FM\11SEN1.SGM 11SEN1 Federal Register / Vol. 82, No. 174 / Monday, September 11, 2017 / Notices HIV-positive adults. VRC01 is currently being evaluated in a phase II clinical trial for prevention of HIV–1 acquisition. 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 • Monoclonal antibodies to treat and/or diagnose HIV and/or AIDS • Immunoassays and kits Competitive Advantages • Monoclonal neutralizing antibodies prevent viral entry into cells • Monoclonal neutralizing antibodies can be used for vaccine design and to develop diagnostics for HIV–1 Development Stage • • • • In vitro data available In vivo data available (animal) In vivo data available (human) Clinical Phase I Inventors: John Mascola, Mark Connors, Peter Kwong, Gary Nabel, Mario Roederer, Xueling Wu (all from NIAID). Publications asabaliauskas on DSKBBXCHB2PROD with NOTICES Nabel G et al. (2015) Broadly Neutralizing Human Immunodeficiency Virus Type 1 Antibody Gene Transfer Protects Nonhuman Primates from Mucosal Simian-Human Immunodeficiency Virus Infection. J Virol. 89(16):8334–45. [PMID26041300]. Nabel G et al. (2014) Enhanced potency of a broadly neutralizing HIV–1 antibody in vitro improves protection against lentiviral infection in vivo. J Virol. 88(21):12669–82. [PMID:25142607]. Wu X et al. (2010) Immunotypes of a quaternary site of HIV–1 vulnerability and their recognition by antibodies. J Virol. 2011: 85(9):4578–85. [PMID:21325411]. Zhou T et al. (2010) Structural basis for broad and potent neutralization of HIV–1 by antibody VRC01. Science. 329(5993):811–7. [PMID: 20616231]. Intellectual Property: HHS Reference No: E–300–2009 and E–051–2012. The E–300–2009 family includes U.S. Patent Application. 13/498,286, filed March 23, 2012 (Issued); Australia Patent Application 2010298025, filed September 24, 2010 (Issued); China Patent Application 201080053616.5 filed September 24, 2010 (Issued); E.U. Patent Application 10760878.8 filed VerDate Sep<11>2014 16:34 Sep 08, 2017 Jkt 241001 September 24, 2010 (Pending); India Patent Application 588/KOLNP/2012 filed March 13, 2012 (Pending); South Africa Patent Application 212/02116 filed September 24, 2017 (Pending); Canada Patent Application. 2274636 filed September 24, 2017 (Pending). The E–051–2012 family includes U.S. Patent Application 14–363,740, filed June 6, 2014 (Issued); Australia Patent Application. 2012347453, filed December 10,2010 (Issued); China Patent Application 201280069415.3, filed December 10, 2012 (Pending); E.U. Patent Application 1285597.6, filed December 10, 2012 (Pending); Indian Patent Application 4661/DELNP/2014, filed December 10, 2012 (Pending); South Africa Patent Application 2014/ 04077, filed December 10, 2012 (Pending). Licensing Contact: Dr. Vince Contreras, 240–669–2823; Vince.Contreras@nih.gov. Collaborative Research Opportunity: The National Institute of Allergy and Infectious Diseases is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate or commercialize Monoclonal antibodies to treat and/or diagnose HIV and/or AIDS. For collaboration opportunities, please contact Dr. Vince Contreras, 240– 669–2823; Vince.Contreras@nih.gov. Dated: September 1, 2017. Suzanne Frisbie, Deputy Director, Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases. [FR Doc. 2017–19088 Filed 9–8–17; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant Frm 00048 Fmt 4703 Sfmt 4703 applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Child Health and Human Development Initial Review Group Reproduction, Andrology, and Gynecology Subcommittee. Date: October 20, 2017. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda, MD 20814. Contact Person: Dennis E. Leszczynski, Ph.D., Scientific Review Administrator Division of Scientific Review National Institute of Child Health and Human Development, NIH, 6710B Bethesda Drive, Bethesda, MD 20892, (301) 435–2717, leszczyd@mail.nih.gov. Name of Committee: National Institute of Child Health and Human Development Special Emphasis Panel; Point of Care Technologies for the Evaluation and Management of Obstetrics, Neonatal, and Pediatric Critical Care Patients, and for Patients With Disorders of Reproductive Tract and Infertility. Date: November 6, 2017. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda, MD 20814. Contact Person: Sathasiva B. Kandasamy, Ph.D., Scientific Review Administrator Division of Scientific Review National Institute of Child Health and Human Development, 6710B Bethesda Drive, Bethesda, MD 20892, (301) 435–6680, skandasa@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.864, Population Research; 93.865, Research for Mothers and Children; 93.929, Center for Medical Rehabilitation Research; 93.209, Contraception and Infertility Loan Repayment Program, National Institutes of Health, HHS) Dated: September 5, 2017. Michelle Trout, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2017–19089 Filed 9–8–17; 8:45 am] Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed Meetings PO 00000 42687 BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Nursing Research Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and E:\FR\FM\11SEN1.SGM 11SEN1

Agencies

[Federal Register Volume 82, Number 174 (Monday, September 11, 2017)]
[Notices]
[Pages 42686-42687]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-19088]


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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: Dr. Vince Contreras, 240-669-2823; 
Vince.Contreras@nih.gov. Licensing information and copies of the patent 
applications 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.

Broadly Neutralizing Antibodies Against HIV-1 Directed to the CD4 
Binding Site of HIV Envelope Protein

Description of Technology

    Inhibiting the ability of HIV-1, the virus that causes AIDS, to 
infect cells is one approach to both prevention and treatment of HIV. 
Scientists at the NIAID Vaccine Research Center have isolated and 
characterized neutralizing antibodies (VRC01, 02, 03, and 07) that bind 
to the CD4 binding site of HIV-1 envelope glycoprotein gp120. These 
human monoclonal antibodies can potentially be used as a therapeutic 
to: (1) Treat an HIV infection, (2) decrease and prevent HIV-
transmission from mother to infant, and (3) be effectively combined 
with anti-retroviral drug therapy. Additionally, the antibodies can be 
used for detection of HIV-1 infection in biological samples, including 
body fluids; and tissues from biopsies, autopsies, and pathology 
specimens.
    VRC01 has been tested in several phase I clinical trials for safety 
and pharmacokinetics in infants, adults, and

[[Page 42687]]

HIV-positive adults. VRC01 is currently being evaluated in a phase II 
clinical trial for prevention of HIV-1 acquisition.
    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

 Monoclonal antibodies to treat and/or diagnose HIV and/or AIDS
 Immunoassays and kits

Competitive Advantages

 Monoclonal neutralizing antibodies prevent viral entry into 
cells
 Monoclonal neutralizing antibodies can be used for vaccine 
design and to develop diagnostics for HIV-1

Development Stage

 In vitro data available
 In vivo data available (animal)
 In vivo data available (human)
 Clinical Phase I

    Inventors: John Mascola, Mark Connors, Peter Kwong, Gary Nabel, 
Mario Roederer, Xueling Wu (all from NIAID).

Publications

Nabel G et al. (2015) Broadly Neutralizing Human Immunodeficiency Virus 
Type 1 Antibody Gene Transfer Protects Nonhuman Primates from Mucosal 
Simian-Human Immunodeficiency Virus Infection. J Virol. 89(16):8334-45. 
[PMID26041300].
Nabel G et al. (2014) Enhanced potency of a broadly neutralizing HIV-1 
antibody in vitro improves protection against lentiviral infection in 
vivo. J Virol. 88(21):12669-82. [PMID:25142607].
Wu X et al. (2010) Immunotypes of a quaternary site of HIV-1 
vulnerability and their recognition by antibodies. J Virol. 2011: 
85(9):4578-85. [PMID:21325411].
Zhou T et al. (2010) Structural basis for broad and potent 
neutralization of HIV-1 by antibody VRC01. Science. 329(5993):811-7. 
[PMID: 20616231].

    Intellectual Property: HHS Reference No: E-300-2009 and E-051-2012. 
The E-300-2009 family includes U.S. Patent Application. 13/498,286, 
filed March 23, 2012 (Issued); Australia Patent Application 2010298025, 
filed September 24, 2010 (Issued); China Patent Application 
201080053616.5 filed September 24, 2010 (Issued); E.U. Patent 
Application 10760878.8 filed September 24, 2010 (Pending); India Patent 
Application 588/KOLNP/2012 filed March 13, 2012 (Pending); South Africa 
Patent Application 212/02116 filed September 24, 2017 (Pending); Canada 
Patent Application. 2274636 filed September 24, 2017 (Pending).
    The E-051-2012 family includes U.S. Patent Application 14-363,740, 
filed June 6, 2014 (Issued); Australia Patent Application. 2012347453, 
filed December 10,2010 (Issued); China Patent Application 
201280069415.3, filed December 10, 2012 (Pending); E.U. Patent 
Application 1285597.6, filed December 10, 2012 (Pending); Indian Patent 
Application 4661/DELNP/2014, filed December 10, 2012 (Pending); South 
Africa Patent Application 2014/04077, filed December 10, 2012 
(Pending).
    Licensing Contact: Dr. Vince Contreras, 240-669-2823; 
Vince.Contreras@nih.gov.
    Collaborative Research Opportunity: The National Institute of 
Allergy and Infectious Diseases is seeking statements of capability or 
interest from parties interested in collaborative research to further 
develop, evaluate or commercialize Monoclonal antibodies to treat and/
or diagnose HIV and/or AIDS.
    For collaboration opportunities, please contact Dr. Vince 
Contreras, 240-669-2823; Vince.Contreras@nih.gov.

    Dated: September 1, 2017.
Suzanne Frisbie,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2017-19088 Filed 9-8-17; 8:45 am]
 BILLING CODE 4140-01-P
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