Prospective Grant of Exclusive Patent License: Development, Commercial Application and Use of Fulvestrant in Combination Therapy for the Treatment of Cancers, 32712-32713 [2017-14860]

Download as PDF 32712 Federal Register / Vol. 82, No. 135 / Monday, July 17, 2017 / Notices asabaliauskas on DSKBBXCHB2PROD with NOTICES government and in accordance with federal travel regulations. Estimated Number and Frequency of Meetings. The Working Group will meet not less than twice a year. The meetings will be open to the public, except as determined otherwise by the Secretary, or another official to whom authority has been delegated, in accordance with the guidelines under Government in the Sunshine Act, 5 U.S.C. 552b(c). Nominations: Nominations, including self-nominations, of individuals who have the specified expertise and knowledge will be considered for appointment as public voting members of the Working Group. A nomination should include, at a minimum, the following for each nominee: (1) A letter of nomination that clearly states the name and affiliation of the nominee, the basis for the nomination, and a statement from the nominee that indicates that the individual is willing to serve as a member of the Working Group, if selected; (2) the nominator’s name, address, and daytime telephone number, and the address, telephone number, and email address of the individual being nominated; and (3) a current copy of the nominee’s curriculum vitae or resume, which should be limited to no more than 10 pages. Every effort will be made to ensure that the Working Group is a diverse group of individuals with representation from various geographic locations, racial and ethnic minorities, all genders, and persons living with disabilities. Individuals being considered for appointment as public voting members will be required to complete and submit a report of their financial holdings. An ethics review must be conducted to ensure that individuals appointed as public voting members of the Working Group are not involved in any activity that may pose a potential conflict of interest for the official duties that are to be performed. This is a federal ethics requirement that must be satisfied upon entering the position and annually throughout the established term of appointment on the Working Group. DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institutes of Health National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting Prospective Grant of Exclusive Patent License: Development, Commercial Application and Use of Fulvestrant in Combination Therapy for the Treatment of Cancers Dated: July 12, 2017. Donald Wright, Acting Assistant Secretary for Health. [FR Doc. 2017–14857 Filed 7–14–17; 8:45 am] 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: National Institute of Allergy and Infectious Diseases Special Emphasis Panel; NIAID Clinical Trial Planning Grant (R34). Date: July 31, 2017. Time: 2:00 p.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 5601 Fishers Lane, Rockville, MD 20892 (Telephone Conference Call). Contact Person: Jay R. Radke, Ph.D., AIDS Review Branch, Scientific Review Program, Division of Extramural Activities, Room #3G11B, National Institutes of Health, NIAID, 5601 Fishers Lane MSC–9823, Bethesda, MD 20892–9823, (240) 669–5046, jay.radke@ nih.gov. This notice is being published less than 15 days prior to the meeting due to the urgent need to meet timing limitations imposed by the intramural research review cycle. (Catalogue of Federal Domestic Assistance Program Nos. 93.855, Allergy, Immunology, and Transplantation Research; 93.856, Microbiology and Infectious Diseases Research, National Institutes of Health, HHS) Dated: July 10, 2017. Natasha M. Copeland, Program Analyst, Office of Federal Advisory Committee Policy. BILLING CODE 4140–01–P [FR Doc. 2017–14965 Filed 7–14–17; 8:45 am] BILLING CODE 4150–28–P VerDate Sep<11>2014 17:45 Jul 14, 2017 Jkt 241001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 AGENCY: National Institutes of Health, HHS. ACTION: Notice. The National Cancer Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Commercialization Patent License to practice the inventions embodied in the U.S. Patents and Patent Applications listed in the Supplementary Information section of this notice to NantBioScience, Inc., located in, California, USA. DATES: Only written comments and/or applications for a license which are received by the National Cancer Institute’s Technology Transfer Center on or before August 1, 2017 will be considered. ADDRESSES: Requests for copies of the patent application, inquiries, and comments relating to the contemplated Exclusive Commercialization Patent License should be directed to: Sabarni K. Chatterjee, Ph.D., M.B.A., Senior Licensing and Patenting Manager, NCI Technology Transfer Center, 9609 Medical Center Drive, RM 1E530 MSC 9702, Bethesda, MD 20892–9702 (for business mail), Rockville, MD 20850– 9702 Telephone: (240) 276–5530; Facsimile: (240) 276–5504 Email: sabarni.chatterjee@nih.gov. SUPPLEMENTARY INFORMATION: SUMMARY: Intellectual Property • United States Provisional Patent Application No. 62/290,117 filed February 02, 2016, and entitled ‘‘Fulvestrant Improves Immunemediated Cytotoxic Lysis of Cancer Cells.’’ [HHS Reference No. E–066– 2016/0–US–01]; • International PCT Application No. PCT/US2017/015829 filed January 31, 2017, entitled ‘‘Fulvestrant Improves Immune-mediated Cytotoxic Lysis of Cancer Cells.’’ [HHS Reference No. E– 066–2016/0–PCT–02]; and U.S. and foreign patent applications claiming priority to the aforementioned applications. The patent rights in these inventions have been assigned and/or exclusively licensed to the government of the United States of America. E:\FR\FM\17JYN1.SGM 17JYN1 asabaliauskas on DSKBBXCHB2PROD with NOTICES Federal Register / Vol. 82, No. 135 / Monday, July 17, 2017 / Notices The prospective exclusive license territory may be worldwide and the field of use may be limited to the use of Licensed Patent Rights for the following: ‘‘Development, commercial application and use of fulvestrant in estrogen receptor positive cancers, in combination with other products and therapies, excluding poxvirus-based vaccines.’’ For avoidance of doubt, the field of use specifically excludes the use of fulvestrant in combination with poxvirus-based vaccines. This technology discloses the use of fulvestrant, an estrogen receptor antagonist, as an immune modulating agent that enhances the effects of immunotherapy and/or chemotherapy in cancer cells. Fulvestrant treatment of mesenchymal-like lung carcinoma cells increases immune-mediated lysis by reversing epithelial mesenchymal transition (EMT), potentially repairing defective cell death mechanisms driven by EMT, and restoring immunemediated lysis to chemo-resistant cells. Overall, treatment of cancer cells with fulvestrant in combination with immunotherapy or chemotherapy agents results in increased cancer cell death. Although immunotherapy is leading the charge in cancer treatments, its efficacy is limited by patient resistance to immunotherapy and/or nonresponsiveness. Combination therapy with fulvestrant that enhances the therapeutic effects of immunotherapy and chemotherapy, is a promising strategy to improve the clinical outcome for patients with resistant or unresponsive tumors. This notice is made in accordance with 35 U.S.C. 209 and 37 CFR part 404. The prospective exclusive license will be royalty bearing, and the prospective exclusive license may be granted unless within fifteen (15) days from the date of this published notice, the National Cancer Institute receives written evidence and argument that establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR part 404. Complete applications for a license in the prospective field of use that are filed in response to this notice will be treated as objections to the grant of the contemplated Exclusive Commercialization Patent License Agreement. Comments and objections submitted to this notice will not be made available for public inspection and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552. VerDate Sep<11>2014 17:45 Jul 14, 2017 Jkt 241001 Dated: July 6, 2017. Richard U. Rodriguez, Associate Director, Technology Transfer Center, National Cancer Institute. [FR Doc. 2017–14860 Filed 7–14–17; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institute on Drug Abuse; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the National Institute on Drug Abuse Special Emphasis Panel, July 27, 2017, 09:00 a.m. to July 27, 2017, 05:00 p.m., National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852 which was published in the Federal Register on June 29, 2017, 82 125 FR 2017–13696. This meeting was amended to change the date from July 27, 2017 to July 25, 2017. The time of the meeting remains the same. The meeting is closed to the public. Dated: July 10, 2017. Natasha M. Copeland, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2017–14858 Filed 7–14–17; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing 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. Peter Tung; 240–669–5483; peter.tung@ 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 SUMMARY: PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 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. Compounds That Treat Malaria and Prevent Malaria Transmission National Institutes of Health AGENCY: 32713 Description of Technology Malaria is the single leading cause of death, especially among children, in the developing world. Malaria is caused by infection with parasites of the genus Plasmodium, transmitted by mosquitos. In addition to transmission, vital steps in the parasite lifecycle occur in the mosquito host. The invention offered for licensing relates to therapeutic compounds and related pharmaceutical compositions that can be used in the prevention and treatment of malaria infection. More specifically, the invention is drawn to compounds that may kill sexual and mosquito stage malaria parasites to block transmission. Specifically claimed is the antihistamine Ketotifen, which has demonstrated activity blocking parasite development in mosquitoes. Also claimed are treatments encompassing Ketotifen with other existing antimalarial drugs in a combination treatment aimed at multiple stages in the malaria life cycle. 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 • Prevention and treatment of malaria infections Competitive Advantages • Drugs that kill sexual and mosquito stages of the parasite are important for preventing and/or slowing the spread of malaria infection and ultimately for malaria eradication. • Primaquine, the only currently available drug shown to block transmission, is known to cause serious adverse side effects. Development Stage • Pre-Clinical (animal data available) Inventors: Xin-zhuan Su and Dipak Raj (NIAID). Publications: Eastman R.T. Pattaradilokrat S. Raj D.K. Dixit S. Deng B. Miura K. Yuan J. Tanaka T.Q. Johnson R.L. Jiang H. et al. 2013. A class E:\FR\FM\17JYN1.SGM 17JYN1

Agencies

[Federal Register Volume 82, Number 135 (Monday, July 17, 2017)]
[Notices]
[Pages 32712-32713]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-14860]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive Patent License: Development, 
Commercial Application and Use of Fulvestrant in Combination Therapy 
for the Treatment of Cancers

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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

SUMMARY: The National Cancer Institute, an institute of the National 
Institutes of Health, Department of Health and Human Services, is 
contemplating the grant of an Exclusive Commercialization Patent 
License to practice the inventions embodied in the U.S. Patents and 
Patent Applications listed in the Supplementary Information section of 
this notice to NantBioScience, Inc., located in, California, USA.

DATES: Only written comments and/or applications for a license which 
are received by the National Cancer Institute's Technology Transfer 
Center on or before August 1, 2017 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
and comments relating to the contemplated Exclusive Commercialization 
Patent License should be directed to: Sabarni K. Chatterjee, Ph.D., 
M.B.A., Senior Licensing and Patenting Manager, NCI Technology Transfer 
Center, 9609 Medical Center Drive, RM 1E530 MSC 9702, Bethesda, MD 
20892-9702 (for business mail), Rockville, MD 20850-9702 Telephone: 
(240) 276-5530; Facsimile: (240) 276-5504 Email: 
sabarni.chatterjee@nih.gov.

SUPPLEMENTARY INFORMATION:

Intellectual Property

     United States Provisional Patent Application No. 62/
290,117 filed February 02, 2016, and entitled ``Fulvestrant Improves 
Immune-mediated Cytotoxic Lysis of Cancer Cells.'' [HHS Reference No. 
E-066-2016/0-US-01];
     International PCT Application No. PCT/US2017/015829 filed 
January 31, 2017, entitled ``Fulvestrant Improves Immune-mediated 
Cytotoxic Lysis of Cancer Cells.'' [HHS Reference No. E-066-2016/0-PCT-
02]; and U.S. and foreign patent applications claiming priority to the 
aforementioned applications.
    The patent rights in these inventions have been assigned and/or 
exclusively licensed to the government of the United States of America.

[[Page 32713]]

    The prospective exclusive license territory may be worldwide and 
the field of use may be limited to the use of Licensed Patent Rights 
for the following: ``Development, commercial application and use of 
fulvestrant in estrogen receptor positive cancers, in combination with 
other products and therapies, excluding poxvirus-based vaccines.'' For 
avoidance of doubt, the field of use specifically excludes the use of 
fulvestrant in combination with poxvirus-based vaccines.
    This technology discloses the use of fulvestrant, an estrogen 
receptor antagonist, as an immune modulating agent that enhances the 
effects of immunotherapy and/or chemotherapy in cancer cells. 
Fulvestrant treatment of mesenchymal-like lung carcinoma cells 
increases immune-mediated lysis by reversing epithelial mesenchymal 
transition (EMT), potentially repairing defective cell death mechanisms 
driven by EMT, and restoring immune-mediated lysis to chemo-resistant 
cells. Overall, treatment of cancer cells with fulvestrant in 
combination with immunotherapy or chemotherapy agents results in 
increased cancer cell death. Although immunotherapy is leading the 
charge in cancer treatments, its efficacy is limited by patient 
resistance to immunotherapy and/or non-responsiveness. Combination 
therapy with fulvestrant that enhances the therapeutic effects of 
immunotherapy and chemotherapy, is a promising strategy to improve the 
clinical outcome for patients with resistant or unresponsive tumors.
    This notice is made in accordance with 35 U.S.C. 209 and 37 CFR 
part 404. The prospective exclusive license will be royalty bearing, 
and the prospective exclusive license may be granted unless within 
fifteen (15) days from the date of this published notice, the National 
Cancer Institute receives written evidence and argument that 
establishes that the grant of the license would not be consistent with 
the requirements of 35 U.S.C. 209 and 37 CFR part 404.
    Complete applications for a license in the prospective field of use 
that are filed in response to this notice will be treated as objections 
to the grant of the contemplated Exclusive Commercialization Patent 
License Agreement. Comments and objections submitted to this notice 
will not be made available for public inspection and, to the extent 
permitted by law, will not be released under the Freedom of Information 
Act, 5 U.S.C. 552.

    Dated: July 6, 2017.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2017-14860 Filed 7-14-17; 8:45 am]
 BILLING CODE 4140-01-P
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