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]
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Federal Register / Vol. 82, No. 135 / Monday, July 17, 2017 / Notices
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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]
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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.
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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.
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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]
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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:
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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
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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]
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