81 FR 75421 - Government-Owned Inventions; Availability for Licensing
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 81, Issue 210 (October 31, 2016)
National Institutes of Health
Federal Register Volume 81, Issue 210 (October 31, 2016)
| Page Range | 75421-75423 | |
| FR Document | 2016-26129 |
[Federal Register Volume 81, Number 210 (Monday, October 31, 2016)] [Notices] [Pages 75421-75423] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-26129] ----------------------------------------------------------------------- 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. [[Page 75422]] 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 [email protected]. A signed Confidential Disclosure Agreement may be required to receive copies of the patent applications. SUPPLEMENTARY INFORMATION: Technology description follows. Title of Invention Small Molecule Inhibitors of Drug Resistant Forms of HIV-1 Integrase Description of Technology Integrase strand transfer inhibitors (``INSTIs'') are currently in use as a component of prophylactic antiretroviral therapy for preventing HIV-1 infection from progressing to AIDS. Three INSTIs are approved by the FDA for inclusion in antiretroviral regiments: Raltegravir (RAL), elvitegravir (EVG) and dolutegravir (DTG). Clinicians have already identified several HIV-1 integrase mutations that confer resistance to RAL and EVG, and additional mutations that confer resistance to all three INSTIs has been identified in the laboratory. Researchers at the National Cancer Institute discovered small- molecule compounds containing 1-hydroxy-2-oxo-1,8-naphthyridine moieties whose activity against HIV-1 integrase mutants confer resistance to currently approved INSTIs. These new compounds exhibit potent and selective activity against comprehensive and varied panels of INSTI-resistant mutants of HIV-1 integrase. Preliminary rodent efficacy, metabolic, and pharmacokinetic studies have been completed by the NCI researchers. The National Cancer Institute (NCI) seeks partners to in-license or co-develop this class of compounds for therapeutic use. Parties interested in licensing the technology should submit an Application for Licensing, and seek detailed information from the Licensing and Patenting Manager indicated below. Co-development partners would apply under a Cooperative Research and Development (CRADA) to conduct pre-clinical studies that include lead optimization, in vitro and in vivo evaluation and preclinical development of a novel series of INSTIs for the treatment of infection by HIV-1 strains with resistance to currently available integrase inhibitors, including raltegravir and elvitegravir. Under the CRADA, further in vitro and in vivo ADME, as well as activity studies, will be conducted by the partner on current and optimized lead compounds using rodent and non-rodent models. Efficacy studies in non-human primates of select compounds are needed and will be part of the CRADA program. The CRADA scope will also include all aspects of toxicity studies, and synthesis scale up under GMP of optimized lead compounds to support submission of a successful IND application. Interested potential CRADA collaborators can receive detailed information by contacting the Licensing and Patenting Manager (see below). Interested parties will receive detailed information on the current status of the project after signing a confidentiality disclosure agreement (CDA) with NCI. Interested candidate partners must submit a statement of interest and capability to the NCI point of contact for consideration by 5:00 p.m. Eastern Standard Time, December 30, 2016. Guidelines for the preparation of a full CRADA proposal will be communicated to all respondents with whom initial confidential discussions have been established. Licensing of background technology related to this CRADA opportunity, specifically HHS Reference No.: E- 093-2013/0,1,2, entitled ``Compounds for Inhibiting Drug-Resistant Strains of HIV-1 Integrase'', is also available to potential collaborators. All proposals received by the above date will be considered. NCI reserves the right to consider additional proposals or none at all if no partner is selected from the initial response. Further information about the NCI Technology Transfer Center can be found on its Web site http://techtransfer.cancer.gov. Potential Commercial ApplicationsHIV therapeutic for drug-resistant compounds of HIV-1 integrase Value Proposition Currently, the only INSTI effective against drug resistant mutants of HIV-1 integrase Development Stage Pre-clinical (in vivo validation) Inventor(s) Terrence Burke, Stephen Hughes, Yves Pommier, Xue Zhao, Mathieu Metifiot, Stephen Smith, Barry Johnson, Christophe Marchand (all from NCI) Intellectual Property HHS Reference No.: E-093-2013/0,1,2; all entitled ``Compounds For Inhibiting Drug-Resistant Strains Of HIV-1 Integrase'' US Provisional App. No.: 61/952,928 filed May 16, 2013 US Provisional App. No.: 61/899,061 filed November 1, 2013 International App. No.: PCT/US2014/037905 filed May 13, 2014 Brazilian App. No.: BR1120150287603 filed May 13, 2014 Canadian App. No.: CA2912064 filed May 13, 2014 Chinese App. No.: 2014-80039611.5 filed May 13, 2014 European App. No.: 14728395.6 filed May 13, 2014 Indian App. No.: 3937/KOLNP/2015 filed May 13, 2014 Japanese App. No.: JP100078282 filed May 13, 2014 US Non-Provisional App. No.: 14/891,309 filed May 13, 2014 South African App. No.: ZA2015/08408 filed May 13, 2014 Publications Zhao, X.Z. et al., ``HIV-1 Integrase Strand Transfer Inhibitors with Reduced Susceptibility to Drug Resistant Mutant Integrases'', ACS Chem Biol., Apr 15, 2016, 11(4):1074-81. M[eacute]tifiot, M. et al., ``Selectivity for strand-transfer over 3'-processing and susceptibility to clinical resistance of HIV-1 integrase inhibitors are driven by key enzyme-DNA interactions in the active site'', Nucleic Acids Res., Aug 19, 2016, 44(14):6896- 906. Zhao, X. Z. et al., ``4-Amino-1-hydroxy-2-oxo-1,8-naphthyridine- containing compounds having high potency against raltegravir- resistant integrase mutants of HIV-1'', J. Med. Chem., 57, 5190-5202 (2014), Doi: 10.1021/jm501059k Zhao, X. Z. et al., ``Bicyclic 1-hydroxy-2-oxo-1,2-dihydropyridine- 3-carboxamide-containing HIV-1 integrase inhibitors having high antiviral potency against cells harboring raltegravir-resistant integrase mutants'', J. Med. Chem., 57, 1573-1582 (2014), Doi: 10.1021/jm401902n Contact Information Requests for copies of the patent application and inquiries about licensing, research collaborations, and co-development opportunities for this invention should be sent to Lauren Nguyen-Antczak, Ph.D., J.D., Senior Licensing & Patenting Manager, NCI Technology Transfer Center, 8490 Progress Drive, Suite 400, Frederick, MD 21701, Tel: (301) 624-8752, email: [email protected]. [[Page 75423]] Dated: October 25, 2016. John D. Hewes, Technology Transfer Specialist, Technology Transfer Center, National Cancer Institute. [FR Doc. 2016-26129 Filed 10-28-16; 8:45 am] BILLING CODE 4140-01-P
![Federal Register / Vol. 81, No. 210 / Monday, October 31, 2016 / Notices 75421
Dated: October 26, 2016. Contact Person: Richard Ingraham, Ph.D., Time: 1:00 p.m. to 4:00 p.m.
Leslie Kux, Scientific Review Officer, Center for Agenda: To review and evaluate grant
Associate Commissioner for Policy. Scientific Review, National Institutes of applications.
Health, 6701 Rockledge Drive, Room 4116, Place: National Institutes of Health, 6701
[FR Doc. 2016–26243 Filed 10–28–16; 8:45 am] MSC 7814, Bethesda, MD 20892, 301–496– Rockledge Drive, Bethesda, MD 20892
BILLING CODE 4164–01–P 8551, ingrahamrh@mail.nih.gov. (Telephone Conference Call).
Name of Committee: Center for Scientific Contact Person: Christine A Piggee, Ph.D.,
Review Special Emphasis Panel; Small Scientific Review Officer, Center for
DEPARTMENT OF HEALTH AND Business: Neuroscience Assay, Diagnostics Scientific Review, National Institutes of
HUMAN SERVICES and Animal Model Development. Health, 6701 Rockledge Drive, Room 4186,
Date: November 29, 2016. MSC 7850, Bethesda, MD 20892, 301–435–
National Institutes of Health Time: 8:00 a.m. to 5:00 p.m. 0657, christine.piggee@nih.gov.
Agenda: To review and evaluate grant Name of Committee: Center for Scientific
Center for Scientific Review; Notice of applications. Review Special Emphasis Panel; Member
Closed Meetings Place: The St. Regis Washington DC, 923 Conflict: Cognition and Perception.
16th Street NW., Washington, DC 20006. Date: November 30, 2016.
Pursuant to section 10(d) of the Contact Person: Susan Gillmor, Ph.D., Time: 1:00 p.m. to 3:00 p.m.
Federal Advisory Committee Act, as Scientific Review Officer, National Institutes Agenda: To review and evaluate grant
amended (5 U.S.C. App.), notice is of Health, Center for Scientific Review, 6701 applications.
hereby given of the following meetings. Rockledge Drive, Bethesda, MD 20892, 301– Place: National Institutes of Health, 6701
The meetings will be closed to the 435–1730, susan.gillmor@nih.gov. Rockledge Drive, Bethesda, MD 20892
public in accordance with the Name of Committee: Center for Scientific (Virtual Meeting).
provisions set forth in sections Review Special Emphasis Panel; Small Contact Person: Wind Cowles, Ph.D.,
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Business: Nephrology. Scientific Review Officer, Center for
Date: November 29–30, 2016. Scientific Review, National Institutes of
as amended. The grant applications and
Time: 9:00 a.m. to 6:00 p.m. Health, 6701 Rockledge Drive, Room 3172,
the discussions could disclose Agenda: To review and evaluate grant Bethesda, MD 20892, cowleshw@csr.nih.gov.
confidential trade secrets or commercial applications. (Catalogue of Federal Domestic Assistance
property such as patentable material, Place: National Institutes of Health, 6701 Program Nos. 93.306, Comparative Medicine;
and personal information concerning Rockledge Drive, Bethesda, MD 20892 93.333, Clinical Research, 93.306, 93.333,
individuals associated with the grant (Virtual Meeting). 93.337, 93.393–93.396, 93.837–93.844,
applications, the disclosure of which Contact Person: Atul Sahai, Ph.D., 93.846–93.878, 93.892, 93.893, National
would constitute a clearly unwarranted Scientific Review Officer, Center for Institutes of Health, HHS)
invasion of personal privacy. Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 2188, Dated: October 25, 2016.
Name of Committee: Center for Scientific MSC 7818, Bethesda, MD 20892, 301–435– Natasha M. Copeland,
Review Special Emphasis Panel; Small 1198, sahaia@csr.nih.gov. Program Analyst, Office of Federal Advisory
Business: Cell and Molecular Biology. Name of Committee: Center for Scientific Committee Policy.
Date: November 16–17, 2016.
Review Special Emphasis Panel; Biological [FR Doc. 2016–26128 Filed 10–28–16; 8:45 am]
Time: 8:00 a.m. to 5:00 p.m.
Chemistry and Macromolecular Biophysics.
Agenda: To review and evaluate grant BILLING CODE 4140–01–P
Date: November 29, 2016.
applications.
Time: 1:30 p.m. to 5:00 p.m.
Place: Embassy Suites at the Chevy Chase
Pavilion, 4300 Military Road NW., Agenda: To review and evaluate grant
applications. DEPARTMENT OF HEALTH AND
Washington, DC 20015. HUMAN SERVICES
Contact Person: Amy Kathleen Wernimont, Place: National Institutes of Health, 6701
Ph.D., Scientific Review Officer, Center for Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call). National Institutes of Health
Scientific Review, 6701 Rockledge Drivem
Bethesda, MD 20892, 301–827–6427, Contact Person: William A Greenberg,
Ph.D., Scientific Review Officer, Center for Government-Owned Inventions;
amy.wernimont@nih.gov.
Scientific Review, National Institutes of Availability for Licensing
Name of Committee: Center for Scientific
Health, 6701 Rockledge Drive, Room 4168,
Review Special Emphasis Panel; PAR Panel: AGENCY: National Institutes of Health,
MSC 7806, Bethesda, MD 20892, (301) 435–
Studies of HIV/AIDS and Aging. HHS.
1726, greenbergwa@csr.nih.gov.
Date: November 21, 2016.
Time: 10:00 a.m. to 5:00 p.m. Name of Committee: Center for Scientific ACTION: Notice.
Agenda: To review and evaluate grant Review Special Emphasis Panel; Small
applications. Business: Psycho/Neuropathology, Lifespan SUMMARY: The invention listed below is
Place: National Institutes of Health, 6701 Development, and STEM Education. owned by an agency of the U.S.
Rockledge Drive, Bethesda, MD 20892 Date: November 29, 2016. Government and is available for
(Virtual Meeting). Time: 12:00 p.m. to 6:00 p.m. licensing and/or co-development in the
Contact Person: Robert Freund, Ph.D., Agenda: To review and evaluate grant
U.S. in accordance with 35 U.S.C. 209
Scientific Review Officer, Center for applications.
Place: National Institutes of Health, 6701 and 37 CFR part 404 to achieve
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5216, Rockledge Drive, Bethesda, MD 20892 expeditious commercialization of
MSC 7852, Bethesda, MD 20892, 301–435– (Virtual Meeting). results of federally-funded research and
1050, freundr@csr.nih.gov. Contact Person: John H Newman, Ph.D., development. Foreign patent
Name of Committee: Center for Scientific Scientific Review Officer, Center for applications are filed on selected
Review Special Emphasis Panel; Scientific Review, National Institutes of inventions to extend market coverage
sradovich on DSK3GMQ082PROD with NOTICES
Musculoskeletal, Oral and Skin Sciences Health, 6701 Rockledge Drive, Room 3222, for companies and may also be available
Continuous Submission. MSC 7808, Bethesda, MD 20892, (301) 435– for licensing and/or co-development.
Date: November 21, 2016. 0628, newmanjh@csr.nih.gov.
ADDRESSES: Invention Development and
Time: 1:00 p.m. to 4:30 p.m. Name of Committee: Center for Scientific
Agenda: To review and evaluate grant Review Special Emphasis Panel; Member Marketing Unit, Technology Transfer
applications. Conflict: Molecular Cellular Developmental Center, National Cancer Institute, 9609
Place: National Institutes of Health, 6701 Neuroscience. Medical Center Drive, Mail Stop 9702,
Rockledge Drive, Bethesda, MD 20892. Date: November 30, 2016. Rockville, MD 20850–9702.
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![Federal Register / Vol. 81, No. 210 / Monday, October 31, 2016 / Notices 75423
Dated: October 25, 2016. Name of Committee: National Cancer DEPARTMENT OF HOMELAND
John D. Hewes, Advisory Board and NCI Board of Scientific SECURITY
Technology Transfer Specialist, Technology Advisors.
Transfer Center, National Cancer Institute. Open: December 6, 2016, 8:30 a.m. to 4:00 U.S. Customs and Border Protection
[FR Doc. 2016–26129 Filed 10–28–16; 8:45 am] p.m.
[Docket No. USCBP–2016–0066]
Agenda: Joint meeting of the National
BILLING CODE 4140–01–P
Cancer Advisory Board and NCI Board of Commercial Customs Operations
Scientific Advisors; NCI Board of Scientific Advisory Committee (COAC)
DEPARTMENT OF HEALTH AND Advisors Concepts Review, NCI acting
HUMAN SERVICES Director’s report and presentations. AGENCY: U.S. Customs and Border
Closed: December 6, 2016, 4:00 p.m. to Protection (CBP), Department of
National Institutes of Health 5:30 p.m. Homeland Security (DHS).
Agenda: Review of intramural program site ACTION: Committee Management; Notice
National Cancer Institute; Notice of visit outcomes and the discussion of of Federal Advisory Committee Meeting.
Meeting confidential personnel issues.
Open: December 7, 2016, 9:00 a.m. to 12:00 SUMMARY: The Commercial Customs
Pursuant to section 10(d) of the p.m. Operations Advisory Committee (COAC)
Federal Advisory Committee Act, as Agenda: Joint meeting of the National will meet in Washington, DC. The
amended (5 U.S.C. App. 2), notice is Cancer Advisory Board and NCI Board of meeting will be open to the public.
hereby given of the joint meeting of the Scientific Advisors and presentations. DATES: The Commercial Customs
National Cancer Advisory Board Place: National Cancer Institute—Shady Operations Advisory Committee (COAC)
(NCAB) and NCI Board of Scientific Grove, National Institutes of Health, 9609 will meet on Thursday, November 17,
Advisors (BSA). Medical Center Drive, Room TE406, 2016, from 12:30 p.m. to 4:30 p.m. EST.
The meeting will be open to the Bethesda, MD 20892. Please note that the meeting may close
public as indicated below, with Contact Person: Paulette S. Gray, Ph.D., early if the committee has completed its
attendance limited to space available. Director, Division of Extramural Activities, business.
Individuals who plan to attend and National Cancer Institute—Shady Grove, Pre-Registration: Meeting participants
need special assistance, such as sign National Institutes of Health, 9609 Medical may attend either in person or via
language interpretation or other Center Drive, Room 7W444, Bethesda, MD webinar after pre-registering using a
reasonable accommodations, should 20892, 240–276–6340, grayp@mail.nih.gov. method indicated below:
notify the Contact Person listed below Any interested person may file written —For members of the public who plan
in advance of the meeting. The open comments with the committee by forwarding
to attend the meeting in person,
session will be videocast and can be the statement to the Contact Person listed on
please register by 5:00 p.m. EST by
accessed from the NIH Videocasting and this notice. The statement should include the
November 15, 2016 either online at
Podcasting Web site (http:// name, address, telephone number and when
https://apps.cbp.gov/te_reg/
videocast.nih.gov). applicable, the business or professional
index.asp?w=97 by email to
A portion of the National Cancer affiliation of the interested person.
tradeevents@dhs.gov; or by fax to
Advisory Board meeting will be closed In the interest of security, NIH has
(202) 325–4290. You must register
to the public in accordance with the instituted stringent procedures for entrance
onto the NCI—Shady Grove campus. All
prior to the meeting in order to attend
provisions set forth in section the meeting in person.
552b(c)(6), Title 5 U.S.C., as amended, visitors will be asked to show one form of
identification (for example, a government-
—For members of the public who plan
for the review, discussion, and to participate via webinar, please
issued photo ID, driver’s license, or passport)
evaluation of individual intramural register online at https://
and to state the purpose of their visit.
programs and projects conducted by the apps.cbp.gov/te_reg/index.asp?w=96
Information is also available on the
National Cancer Institute, including by 5:00 p.m. EST by November 15,
Institute’s/Center’s home page: NCAB: http://
consideration of personnel 2016. Please feel free to share this
deainfo.nci.nih.gov/advisory/ncab/ncab.htm,
qualifications and performance, and the information with other interested
BSA: http://deainfo.nci.nih.gov/advisory/
competence of individual investigators, bsa/bsa.htm, where an agenda and any members of your organization or
the disclosure of which would additional information for the meeting will association.
constitute a clearly unwarranted be posted when available. Members of the public who are pre-
invasion of personal privacy. registered and later need to cancel,
(Catalogue of Federal Domestic Assistance
Name of Committee: National Cancer Program Nos. 93.392, Cancer Construction; please do so in advance of the meeting
Advisory Board; Ad Hoc Subcommittee on 93.393, Cancer Cause and Prevention by accessing one (1) of the following
Global Cancer Research. links: https://apps.cbp.gov/te_reg/
Research; 93.394, Cancer Detection and
Open: December 5, 2016, 4:30 p.m. to 6:00 cancel.asp?w=97 to cancel an in person
p.m. Diagnosis Research; 93.395, Cancer
Treatment Research; 93.396, Cancer Biology registration, or https://apps.cbp.gov/te_
Agenda: Discussion on Global Cancer
Research. Research; 93.397, Cancer Centers Support; reg/cancel.asp?w=96 to cancel a
Place: Gaithersburg Marriott 93.398, Cancer Research Manpower; 93.399, webinar registration.
Washingtonian Center, 9751 Washington Cancer Control, National Institutes of Health, ADDRESSES: The meeting will be held at
Boulevard, Lakeside 1 Meeting Room, HHS) the Washington Marriott Wardman Park
Gaithersburg, MD 20878. Hotel, 2660 Woodley Road NW.,
sradovich on DSK3GMQ082PROD with NOTICES
Dated: October 25, 2016.
Contact Person: Dr. Edward Trimble, Washington, DC 20008. There will be
Executive Secretary, NCAB Ad Hoc Melanie J. Gray,
signage posted directing visitors to the
Subcommittee on Global Cancer Research, Program Analyst, Office of Federal Advisory
National Cancer Institute—Shady Grove, location of the meeting room.
Committee Policy.
National Institutes of Health, 9609 Medical For information on facilities or
[FR Doc. 2016–26130 Filed 10–28–16; 8:45 am] services for individuals with disabilities
Center Drive, Room 3W562, Bethesda, MD
20892, (240) 276–5796, trimblet@ BILLING CODE 4140–01–P or to request special assistance at the
mail.nih.gov. meeting, contact Ms. Karmeshia Tuck,
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Document Created: 2018-02-02 12:13:31
Document Modified: 2018-02-02 12:13:31
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| 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 [email protected] A signed Confidential Disclosure Agreement may be required to receive copies of the patent applications. | |
| FR Citation | 81 FR 75421 |
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