Prospective Grant of Start-up Exclusive License: Development of Virus Like Particles for the Treatment of Breast Cancer, Lung Cancer, Melanoma, Pancreatic Cancer, and Hepatocellular Cancer, 31250-31251 [2016-11661]
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Federal Register / Vol. 81, No. 96 / Wednesday, May 18, 2016 / Notices
sradovich on DSK3TPTVN1PROD with NOTICES
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 2204,
MSC 7890, Bethesda, MD 20892, (301) 435–
1045, corsaroc@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Electrical
Signaling, Ion Transport and Arrhythmias
Special Panel.
Date: June 16, 2016.
Time: 11:00 a.m. to 1:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bethesda North Marriott Hotel &
Conference Center, 5701 Marinelli Road,
Bethesda, MD 20852.
Contact Person: Abdelouahab Aitouche,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4222,
MSC 7814, Bethesda, MD 20892, 301–435–
2365, aitouchea@csr.nih.gov.
Name of Committee: Center for Scientific
Review, Special Emphasis Panel; SBIB
Clinical Pediatric and Fetal Applications.
Date: June 16, 2016.
Time: 11:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892.
Contact Person: John Firrell, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5118,
MSC 7854, Bethesda, MD 20892, 301–435–
2598, firrellj@csr.nih.gov.
Name of Committee: Center for Scientific
Review, Special Emphasis Panel, Member
Conflict: Neural Trauma and Neurovascular
Pathology.
Date: June 17, 2016.
Time: 1:30 p.m. to 5:00 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: Alexei Kondratyev, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5200,
MSC 7846, Bethesda, MD 20892, 301–435–
1785, kondratyevad@csr.nih.gov.
(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: May 12, 2016.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–11662 Filed 5–17–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Start-up
Exclusive License: Development of
Virus Like Particles for the Treatment
of Breast Cancer, Lung Cancer,
Melanoma, Pancreatic Cancer, and
Hepatocellular Cancer
National Institutes Of Health,
Public Health Service, HHS.
AGENCY:
ACTION:
Notice.
This notice, in accordance
with 35 U.S.C. 209(c)(1) and 37 CFR
part 404.7, that the National Cancer
Institute, National Institutes of Health,
Department of Health and Human
Services, is contemplating the grant of a
Start-Up Exclusive Patent License to
practice the inventions embodied in the
following patent applications to
Chimeron Bio Corporation, a company
incorporated under the laws of
Delaware and having an office in
Philadelphia, PA.
Intellectual Property: U.S. Provisional
Patent Application No.: 61/615,687
Entitled ‘‘Delivery of Packaged RNA in
Mammalian Cells’’ HHS Ref. No.: E–
264–2011/0–US–01 Filed March 26,
2012; International Patent Application
No.: PCT/US2013/031876 Entitled
‘‘Delivery of Packaged RNA in
Mammalian Cells’’ HHS Ref. No.: E–
264–2011/0–PCT–02 Filed March 15,
2013; Australian Patent Application
No.: 2013–240248 Entitled ‘‘Delivery of
Packaged RNA in Mammalian Cells’’
HHS Ref. No.: E–264–2011/0–AU–03
Filed October 17, 2014; European Patent
Application No.: 13712661.1 Entitled
‘‘Delivery of Packaged RNA in
Mammalian Cells’’ HHS Ref. No.: E–
264–2011/0–EP–04 Filed October 24,
2014; Japanese Patent Application No.:
2015–503322 entitled ‘‘Delivery of
Packaged RNA in Mammalian Cells’’
HHS Ref. No.: E–264–2011/0–JP–05
Filed September 25, 2014; U.S. Patent
Application No.: 14/388,441 Entitled
Delivery of Packaged RNA in
Mammalian Cells’’ HHS Ref. No.: E–
264–2011/0–US–06 Filed September 26,
2014; U.S. Provisional Patent
Application No.: 61/916,394 Entitled
‘‘Cancer Immunotherapy: Delivery
HLA–11 using VLP-Replicon’’ HHS Ref.
No.: E–050–2014/0–US–01 Filed
December 16, 2013; International Patent
Application No.: PCT/US2014/070552
Entitled ‘‘Cancer Immunotherapy:
Delivery HLA–11 using VLP-Replicon’’
HHS Ref. No.: E–050–2014/0–PCT–02
Filed December 16, 2014;
SUMMARY:
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The patent rights to these inventions
have been assigned to the Government
of the United States of America.
The prospective exclusive start-up
licensed territory may be worldwide
and the field of use may be limited to:
‘‘Use of virus like particles comprising
MHCII and CD80 for the treatment of
breast cancer, lung cancer, melanoma,
pancreatic cancer, and hepatocellular
cancer.’’
Only written comments and/or
applications for a license which are
received by the NCI Technology
Transfer Center on or before June 2,
2016 will be considered.
DATES:
Requests for copies of the
patent application, inquiries, and
comments relating to the contemplated
exclusive license should be directed to:
Lauren Nguyen-Antczak, Ph.D., J.D., Sr.
Licensing and Patenting Manager,
Technology Transfer Center, National
Cancer Institute, 8490 Progress Drive,
Riverside 5, Suite 400, Frederick, MD
21701; Telephone: (301) 624–8752;
Email: lauren.nguyen-antczak@nih.gov.
ADDRESSES:
The
invention is directed to virus-like
particles (‘‘VLPs’’) that serve to induce
transgene expression of at least one
recombinant protein of interest in
specific, targeted cells. This technology
can be used to treat a variety of diseases,
depending on the cell type to be
targeted. Preferably, invention VLPs
may be used to treat tumor bearing
cancers, including breast cancer, lung
cancer, melanoma, pancreatic cancer,
and hepatocellular cancer.
The prospective Start-Up Exclusive
Patent License, which will be royalty
bearing, is being considered under the
small business initiative launched on 1
October 2011 and will comply with the
terms and conditions of 35 U.S.C. 209
and 37 CFR part 404.7. The prospective
Start-Up Exclusive Patent License may
be granted unless the NIH receives
written evidence and argument, within
fifteen (15) days from the date of this
published notice, 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 404.7.
Complete applications for a license in
the field of use filed in response to this
notice will be treated as objections to
the grant of the contemplated exclusive
start-up license. 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.
SUPPLEMENTARY INFORMATION:
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Federal Register / Vol. 81, No. 96 / Wednesday, May 18, 2016 / Notices
Dated: May 12, 2016.
Richard U. Rodriguez,
Associate Director, Technology Transfer
Center, National Cancer Institute.
Dated: May 12, 2016.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–11661 Filed 5–17–16; 8:45 am]
[FR Doc. 2016–11663 Filed 5–17–16; 8:45 am]
BILLING CODE 4140–01–P
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institutes of Health
National Institute of Dental &
Craniofacial Research; Notice of
Closed Meetings
Prospective Grant of an Exclusive
License: The Development of an AntiGPC3 Chimeric Antigen Receptor
(CAR) Based on YP7 for the Treatment
of Human Cancers
sradovich on DSK3TPTVN1PROD 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: National Institute of
Dental and Craniofacial Research Special
Emphasis Panel; NIDCR Data Analysis and
Statistical Methodology PARs.
Date: June 10, 2016.
Time: 11:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, One
Democracy Plaza, 6701 Democracy
Boulevard, Bethesda, MD 20892.
Contact Person: Victor Henriquez, Ph.D.,
Scientific Review Officer DEA/SRB/NIDCR,
6701 Democracy Blvd., Room 668, Bethesda,
MD 20892–4878, 301–451–2405, henriquv@
nidcr.nih.gov.
Name of Committee: NIDCR Special Grants
Review Committee.
Date: June 16–17, 2016.
Time: 8:00 a.m. to 12:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Wyndham San Antonio Riverwalk
111 East Pecan Street, San Antonio, TX
78205
Contact Person: Marilyn Moore-Hoon,
Ph.D., Scientific Review Officer, Scientific
Review Branch, National Institute of Dental
and Craniofacial Research, 6701 Democracy
Blvd., Rm. 676, Bethesda, MD 20892–4878,
301–594–4861, mooremar@nidcr.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.121, Oral Diseases and
Disorders Research, National Institutes of
Health, HHS)
VerDate Sep<11>2014
17:10 May 17, 2016
Jkt 238001
Public Health Service, National
Institutes of Health, HHS.
ACTION: Notice.
AGENCY:
This notice, in accordance
with 35 U.S.C. 209(c)(1) and 37 CFR
Part 404.7(a)(1)(i), that the National
Institutes of Health, Department of
Health and Human Services, is
contemplating the grant of an exclusive
license to practice the inventions
embodied in:
SUMMARY:
Intellectual Property
U.S. Provisional Patent Application
61/654,232 entitled ‘‘High-affinity
Monoclonal Antibodies To Glypican-3
And Use Thereof’’ [HHS Ref. E–136–
2012/0–US–01]; PCT Patent Application
PCT/US2013/043633 entitled ‘‘Highaffinity Monoclonal Antibodies To
Glypican-3 And Use Thereof’’ [HHS Ref.
E–136–2012/0–PCT–02]; Chinese Patent
Application 201380039993.7 entitled
‘‘High-affinity Monoclonal Antibodies
To Glypican-3 And Use Thereof’’ [HHS
Ref. E–136–2012/0–CN–03]; Japanese
Patent Application 2015–515243
entitled ‘‘High-affinity Monoclonal
Antibodies To Glypican-3 And Use
Thereof’’ [HHS Ref. E–136–2012/0–JP–
04]; South Korea Patent Application 10–
2014–7037046 entitled ‘‘High-affinity
Monoclonal Antibodies To Glypican-3
And Use Thereof’’ [HHS Ref. E–136–
2012/0–KR–05]; Singapore Patent
Application 11201407972R entitled
‘‘High-affinity Monoclonal Antibodies
To Glypican-3 And Use Thereof’’ [HHS
Ref. E–136–2012/0–SG–06]; United
States Patent Application 14/403,896
entitled ‘‘High-affinity Monoclonal
Antibodies To Glypican-3 And Use
Thereof’’ [HHS Ref. E–136–2012/0–US–
07];
and all continuing U.S. and foreign
patents/patent applications for the
technology family, to Lentigen
Technology, Inc.
The patent rights to these inventions
have been assigned to and/or
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31251
exclusively licensed to the Government
of the United States of America.
The prospective exclusive licensed
territory may be the United States,
Australia, Canada, the European Union,
Russia, China, Hong Kong, Japan,
Taiwan, South Korea and Singapore,
and the field of use may be limited to:
‘‘The development of a glypican-3
(GPC3) chimeric antigen receptor (CAR)based immunotherapy using autologous
(meaning one individual is both the
donor and the recipient) primary human
lymphocytes (T cells or NK cells)
transfected with a lentiviral or retroviral
vector, wherein the vector expresses a
CAR having (1) a single antigen
specificity and (2) comprising at least:
(a) The complementary determining
region (CDR) sequences of the anti-GPC3
antibody known as YP7; and (b) a T cell
signaling domain; for the prophylaxis
and treatment of GPC3-expressing
cancers.’’
DATES: Only written comments and/or
applications for a license which are
received by the NCI Technology
Transfer Center on or before June 2,
2016 will be considered.
ADDRESSEES: Requests for copies of the
patent application, inquiries, comments,
and other materials relating to the
contemplated exclusive license should
be directed to: David A. Lambertson,
Ph.D., Senior Licensing and Patenting
Manager, National Cancer Institute,
9609 Medical Center Drive, Rm 1–E530
MSC9702, Rockville, MD 20850–9702,
Email: david.lambertson@nih.gov.
SUPPLEMENTARY INFORMATION: This
invention concerns an anti-GPC3
(Glypican-3) chimeric antigen receptor
(CAR) and methods of using the CAR for
the treatment of GPC3-expressing
cancers. GPC3 is a cell surface antigen
that is preferentially expressed on
certain types of cancer cells, particularly
liver cancers such as hepatocellular
carcinoma (HCC). The anti-GPC3 CARs
of this technology contain (1) antigen
recognition sequences that bind
specifically to GPC3 and (2) signaling
domains that can activate the cytotoxic
functions of a T cell. The anti-GPC3
CAR can be transduced into T cells that
are harvested from a donor, followed by
(a) selection and expansion of the T
cells expressing the anti-GPC3 CAR, and
(b) reintroduction of the T cells into the
patient. Once the anti-GPC3 CARexpressing T cells are reintroduced into
the patient, the T cells can selectively
bind to GPC3-expressing cancer cells
through its antigen recognition
sequences, thereby activating the T cell
through its signaling domains to
selectively kill the cancer cells. Through
this mechanism of action, the selectivity
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]]>Agencies
[Federal Register Volume 81, Number 96 (Wednesday, May 18, 2016)]
[Notices]
[Pages 31250-31251]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-11661]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Start-up Exclusive License: Development of
Virus Like Particles for the Treatment of Breast Cancer, Lung Cancer,
Melanoma, Pancreatic Cancer, and Hepatocellular Cancer
AGENCY: National Institutes Of Health, Public Health Service, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR
part 404.7, that the National Cancer Institute, National Institutes of
Health, Department of Health and Human Services, is contemplating the
grant of a Start-Up Exclusive Patent License to practice the inventions
embodied in the following patent applications to Chimeron Bio
Corporation, a company incorporated under the laws of Delaware and
having an office in Philadelphia, PA.
Intellectual Property: U.S. Provisional Patent Application No.: 61/
615,687 Entitled ``Delivery of Packaged RNA in Mammalian Cells'' HHS
Ref. No.: E-264-2011/0-US-01 Filed March 26, 2012; International Patent
Application No.: PCT/US2013/031876 Entitled ``Delivery of Packaged RNA
in Mammalian Cells'' HHS Ref. No.: E-264-2011/0-PCT-02 Filed March 15,
2013; Australian Patent Application No.: 2013-240248 Entitled
``Delivery of Packaged RNA in Mammalian Cells'' HHS Ref. No.: E-264-
2011/0-AU-03 Filed October 17, 2014; European Patent Application No.:
13712661.1 Entitled ``Delivery of Packaged RNA in Mammalian Cells'' HHS
Ref. No.: E-264-2011/0-EP-04 Filed October 24, 2014; Japanese Patent
Application No.: 2015-503322 entitled ``Delivery of Packaged RNA in
Mammalian Cells'' HHS Ref. No.: E-264-2011/0-JP-05 Filed September 25,
2014; U.S. Patent Application No.: 14/388,441 Entitled Delivery of
Packaged RNA in Mammalian Cells'' HHS Ref. No.: E-264-2011/0-US-06
Filed September 26, 2014; U.S. Provisional Patent Application No.: 61/
916,394 Entitled ``Cancer Immunotherapy: Delivery HLA-11 using VLP-
Replicon'' HHS Ref. No.: E-050-2014/0-US-01 Filed December 16, 2013;
International Patent Application No.: PCT/US2014/070552 Entitled
``Cancer Immunotherapy: Delivery HLA-11 using VLP-Replicon'' HHS Ref.
No.: E-050-2014/0-PCT-02 Filed December 16, 2014;
The patent rights to these inventions have been assigned to the
Government of the United States of America.
The prospective exclusive start-up licensed territory may be
worldwide and the field of use may be limited to: ``Use of virus like
particles comprising MHCII and CD80 for the treatment of breast cancer,
lung cancer, melanoma, pancreatic cancer, and hepatocellular cancer.''
DATES: Only written comments and/or applications for a license which
are received by the NCI Technology Transfer Center on or before June 2,
2016 will be considered.
ADDRESSES: Requests for copies of the patent application, inquiries,
and comments relating to the contemplated exclusive license should be
directed to: Lauren Nguyen-Antczak, Ph.D., J.D., Sr. Licensing and
Patenting Manager, Technology Transfer Center, National Cancer
Institute, 8490 Progress Drive, Riverside 5, Suite 400, Frederick, MD
21701; Telephone: (301) 624-8752; Email: lauren.nguyen-antczak@nih.gov.
SUPPLEMENTARY INFORMATION: The invention is directed to virus-like
particles (``VLPs'') that serve to induce transgene expression of at
least one recombinant protein of interest in specific, targeted cells.
This technology can be used to treat a variety of diseases, depending
on the cell type to be targeted. Preferably, invention VLPs may be used
to treat tumor bearing cancers, including breast cancer, lung cancer,
melanoma, pancreatic cancer, and hepatocellular cancer.
The prospective Start-Up Exclusive Patent License, which will be
royalty bearing, is being considered under the small business
initiative launched on 1 October 2011 and will comply with the terms
and conditions of 35 U.S.C. 209 and 37 CFR part 404.7. The prospective
Start-Up Exclusive Patent License may be granted unless the NIH
receives written evidence and argument, within fifteen (15) days from
the date of this published notice, 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 404.7.
Complete applications for a license in the field of use filed in
response to this notice will be treated as objections to the grant of
the contemplated exclusive start-up license. 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.
[[Page 31251]]
Dated: May 12, 2016.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer
Institute.
[FR Doc. 2016-11661 Filed 5-17-16; 8:45 am]
BILLING CODE 4140-01-P
