Government-Owned Inventions; Availability for Licensing, 7820-7821 [2016-02970]

Download as PDF 7820 Federal Register / Vol. 81, No. 30 / Tuesday, February 16, 2016 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings mstockstill on DSK4VPTVN1PROD with NOTICES Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), 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 applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: AIDS and Related Research Integrated Review Group, AIDS Discovery and Development of Therapeutics Study Section. Date: March 8, 2016. Time: 8:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda, MD 20814. Contact Person: Shiv A Prasad, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5220, MSC 7852, Bethesda, MD 20892, 301–443– 5779, prasads@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel, Infectious Diseases and Microbiology. Date: March 8, 2016. Time: 9:30 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Guangyong Ji, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3211, MSC 7808, Bethesda, MD 20892, 301–435– 1146, jig@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel, AREA application in Infectious Diseases and Microbiology. Date: March 8, 2016. Time: 9:30 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Virtual Meeting). Contact Person: Liangbiao Zheng, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3202, MSC 7808, Bethesda, MD 20892, 301–996– 5819, zhengli@csr.nih.gov. VerDate Sep<11>2014 22:15 Feb 12, 2016 Jkt 238001 (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393–93.396, 93.837–93.844, 93.846–93.878, 93.892, 93.893, National Institutes of Health, HHS) Dated: February 9, 2016. Sylvia Neal, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2016–02974 Filed 2–12–16; 8:45 am] BILLING CODE 4140–01–P 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 and/or co-development in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 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 and/or co-development. SUMMARY: Invention Development and Marketing Unit, Technology Transfer Center, National Cancer Institute, 9609 Medical Center Drive, Mail Stop 9702, Rockville, MD 20850–9702. ADDRESSES: FOR FURTHER INFORMATION CONTACT: Information on licensing and codevelopment research collaborations, and copies of the U.S. patent applications listed below may be obtained by contacting: Attn. Invention Development and Marketing Unit, Technology Transfer Center, National Cancer Institute, 9609 Medical Center Drive, Mail Stop 9702, Rockville, MD, 20850–9702, Tel. 240–276–5515 or email ncitechtransfer@mail.nih.gov. A signed Confidential Disclosure Agreement may be required to receive copies of the patent applications. SUPPLEMENTARY INFORMATION: Technology description follows. AAV-based Vectors for the Therapeutic Management of Menkes Disease and Related Copper Transport Disorders Frm 00079 Fmt 4703 The only currently available treatment for Menkes disease, subcutaneous copper histidinate injections, is successful only in patients with ATP7A gene mutations that do not completely corrupt ATP7A copper transport function (estimated 20–25% of affected patients) and when started at a very early age (first month of life). The combination of viral gene therapy with copper injections provides working copies of the ATP7A copper transporter into the brain, together with a source of the substrate (copper) needed for proper brain growth and clinical neurodevelopment. Codon-optimized nucleic acids encoding a reduced-size ATP7A protein and compositions of AAV vectors were discovered by NICHD researchers along with methods of administering this therapy. Human P-type ATPase coppertransporting ATPase 1 (ATP7A) transports copper from enterocytes (where it is taken up from dietary copper) into the blood. ATP7A also mediates passage of copper across the blood-cerebrospinal fluid (CSF) barrier and the blood-brain barrier. In Menkes disease and occipital horn syndrome (OHS), copper accumulates in intestinal cells and less copper is absorbed into the blood, resulting in restricted copper supply to other tissues, particularly the brain. Death in infancy or early childhood is a common consequence. Therapeutic delivery of the copper transport protein via an AAV vector, combined with subcutaneous copper histidinate treatment will relieve the copper deficiency to the brain and permit normal neurological development and function. Potential Commercial Applications • Treatment of Menkes Disease, Occipital Horn Syndrome, and of ATP7A-related distal motor neuropathy Value Proposition • Provides working copies of the ATP7A copper transporter into the brain, together with a source of the substrate (copper) needed for proper brain growth and clinical neurodevelopment. Development Stage Pre-clinical (in vivo validation) Inventor(s) Stephen G. Kaler, M.D. (NICHD) Title of Invention PO 00000 Description of Technology Sfmt 4703 Intellectual Property HHS Reference No. E–062–2015/0 U.S. Provisional Application No. 62/ 244,594 filed 21 October 2015 E:\FR\FM\16FEN1.SGM 16FEN1 Federal Register / Vol. 81, No. 30 / Tuesday, February 16, 2016 / Notices Licensing Opportunity: Researchers at the NICHD seek licensing and/or codevelopment research collaborations for the therapeutic management of Menkes Disease and related copper transport disorders. Contact Information Requests for copies of the patent application or inquiries about licensing, research collaborations, and codevelopment opportunities should be sent to John D. Hewes, Ph.D., email: john.hewes@nih.gov. Dated: February 8, 2016. John D. Hewes, Technology Transfer Specialist, Technology Transfer Center, National Cancer Institute. [FR Doc. 2016–02970 Filed 2–12–16; 8:45 am] BILLING CODE 4140–01–P 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 and/or co-development in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 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 and/or co-development. ADDRESSES: Information on licensing, co-development research collaborations, and/or copies of the U.S. patent applications listed below may be obtained by contacting: Attn. Invention Development and Marketing Unit, Technology Transfer Center, National Cancer Institute, 9609 Medical Center Drive, Mail Stop 9702, Rockville, MD, 20850–9702, Tel. 240–276–5515 or email ncitechtransfer@mail.nih.gov. A signed Confidential Disclosure Agreement may be required to receive copies of the patent applications. FOR FURTHER INFORMATION CONTACT: Requests for copies of the patent application or inquiries about licensing and/or co-development should be sent to John D. Hewes, Ph.D., email: john.hewes@nih.gov. SUPPLEMENTARY INFORMATION: Technology description follows. mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 22:15 Feb 12, 2016 Jkt 238001 Title of invention: Modified griffithsin tandemers for enhanced activity and reduced viral aggregation. Description of Technology: Griffithsin (GRFT) is a lectin with potent antiviral properties that is capable of preventing and treating infections caused by a number of enveloped viruses (including HIV, SARS, HCV, HSV, and Japanese encephalitis) and is currently in clinical development as an anti-HIV microbicide. In addition to its broad antiviral activity, GRFT is stable at high temperature and at a broad pH range, displays low toxicity and immunogenicity, and is amenable to large-scale manufacturing. Native GRFT is a domain-swapped homodimer that binds to viral envelope glycoproteins and has displayed mid-picomolar activity in cell-based anti-HIV assays. This invention is directed to synthetic proteins that comprise two (or more) obligate monomers (‘‘mGRFT’’) joined by an amino acid linker to form tandemers (‘‘mGRFT tandemers’’). Each obligate monomer is generated by the addition of Gly-Ser residues in the hinge region of wild-type GRFT. Two or more obligate monomers are joined by an amino acid linker to form the mGRFT tandamers. The properties of the mGRFT tandemers can be modulated by the length of the amino acid linker and the number of obligate monomers cojoined. mGRFT tandemers exhibit gore potent anti-viral properties when compared against native GRFT and are equipotent against viruses that are both sensitive and resistant to naive GRFT. As such, potential uses of the invention tandemers include topical and intravenous therapy to treat HIV infection, particularly to treat HIV infections that are resistant to native GRFT. Potential Commercial Applications • Broad-spectrum antiviral agent similar to wild type GRFT • Potential activity against SARS CoV, MERS, Ebola, HCV and influenza Value Proposition • Broad antiviral activity • Stable at high temperature and at a broad pH range • Displays low toxicity and immunogenicity. Development Stage: In vivo/Lead Validation. Inventor(s): Barry R. O’Keefe (NCI), A. Wlodawer (NCI), T. Moulaei (NCI). Publication(s) —Moulaei T. et al., Griffithsin tandemers: flexible and potent lectin inhibitors of the human immunodeficiency virus. Retrovirology. 2015 Jan 23;12:6. PO 00000 Frm 00080 Fmt 4703 Sfmt 4703 7821 —A. Chatterjee et al.,Griffithsin and Carrageenan Combination To Target Herpes Simplex Virus 2 and Human Papillomavirus, Antimicrob Agents Chemother. 2015 Dec; 59(12): 7290–7298. Intellectual Property HHS Reference No. E–034–2013/0– US–01. PCT Application No. PCT/US2014/ 040992 (HHS Reference No. E–034– 2013/0- US–01) filed June 5, 2013 entitled ‘‘Modified griffithsin tandemers for enhanced activity and reduced viral aggregation’’. Licensing and Collaborative/CoDevelopment Research Opportunity: Researchers at the NCI seek licensees and/or co-development partners for the commercialization of Griffithsin and Griffithsin tandemers, specifically, additional studies on stability, toxicity, immunogenicity, and large-scale production. Dated: February 1, 2016. John D. Hewes, Technology Transfer Specialist, Technology Transfer Center, National Cancer Institute. [FR Doc. 2016–02971 Filed 2–12–16; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), 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 the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Center for Scientific Review Special Emphasis Panel; Special Topic: Social Sciences and Population Studies. Date: February 23, 2016. Time: 12:00 p.m. to 12:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Suzanne Ryan, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of E:\FR\FM\16FEN1.SGM 16FEN1

Agencies

[Federal Register Volume 81, Number 30 (Tuesday, February 16, 2016)]
[Notices]
[Pages 7820-7821]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-02970]


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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 and/or co-development in the 
U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 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 and/or co-development.

ADDRESSES: Invention Development and Marketing Unit, Technology 
Transfer Center, National Cancer Institute, 9609 Medical Center Drive, 
Mail Stop 9702, Rockville, MD 20850-9702.

FOR FURTHER INFORMATION CONTACT: Information on licensing and co-
development research collaborations, and copies of the U.S. patent 
applications listed below may be obtained by contacting: Attn. 
Invention Development and Marketing Unit, Technology Transfer Center, 
National Cancer Institute, 9609 Medical Center Drive, Mail Stop 9702, 
Rockville, MD, 20850-9702, Tel. 240-276-5515 or email 
ncitechtransfer@mail.nih.gov. A signed Confidential Disclosure 
Agreement may be required to receive copies of the patent applications.

SUPPLEMENTARY INFORMATION: Technology description follows.

Title of Invention

    AAV-based Vectors for the Therapeutic Management of Menkes Disease 
and Related Copper Transport Disorders

Description of Technology

    The only currently available treatment for Menkes disease, 
subcutaneous copper histidinate injections, is successful only in 
patients with ATP7A gene mutations that do not completely corrupt ATP7A 
copper transport function (estimated 20-25% of affected patients) and 
when started at a very early age (first month of life). The combination 
of viral gene therapy with copper injections provides working copies of 
the ATP7A copper transporter into the brain, together with a source of 
the substrate (copper) needed for proper brain growth and clinical 
neurodevelopment.
    Codon-optimized nucleic acids encoding a reduced-size ATP7A protein 
and compositions of AAV vectors were discovered by NICHD researchers 
along with methods of administering this therapy. Human P-type ATPase 
copper-transporting ATPase 1 (ATP7A) transports copper from enterocytes 
(where it is taken up from dietary copper) into the blood. ATP7A also 
mediates passage of copper across the blood-cerebrospinal fluid (CSF) 
barrier and the blood-brain barrier. In Menkes disease and occipital 
horn syndrome (OHS), copper accumulates in intestinal cells and less 
copper is absorbed into the blood, resulting in restricted copper 
supply to other tissues, particularly the brain. Death in infancy or 
early childhood is a common consequence. Therapeutic delivery of the 
copper transport protein via an AAV vector, combined with subcutaneous 
copper histidinate treatment will relieve the copper deficiency to the 
brain and permit normal neurological development and function.

Potential Commercial Applications

     Treatment of Menkes Disease, Occipital Horn Syndrome, and 
of ATP7A-related distal motor neuropathy

Value Proposition

     Provides working copies of the ATP7A copper transporter 
into the brain, together with a source of the substrate (copper) needed 
for proper brain growth and clinical neurodevelopment.

Development Stage

    Pre-clinical (in vivo validation)

Inventor(s)

    Stephen G. Kaler, M.D. (NICHD)

Intellectual Property

    HHS Reference No. E-062-2015/0
    U.S. Provisional Application No. 62/244,594 filed 21 October 2015

[[Page 7821]]

    Licensing Opportunity: Researchers at the NICHD seek licensing and/
or co-development research collaborations for the therapeutic 
management of Menkes Disease and related copper transport disorders.

Contact Information

    Requests for copies of the patent application or inquiries about 
licensing, research collaborations, and co-development opportunities 
should be sent to John D. Hewes, Ph.D., email: john.hewes@nih.gov.

    Dated: February 8, 2016.
John D. Hewes,
Technology Transfer Specialist, Technology Transfer Center, National 
Cancer Institute.
[FR Doc. 2016-02970 Filed 2-12-16; 8:45 am]
 BILLING CODE 4140-01-P

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