Prospective Grant of Exclusive Patent License: T-Cells Transduced with HLA A11 Restricted CT-RCC HERV-E Reactive T-Cell Receptors for the Treatment of Renal Cell Carcinoma, 56622-56623 [2017-25743]
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Federal Register / Vol. 82, No. 228 / Wednesday, November 29, 2017 / Notices
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concatenated L2 peptides for the
prevention of Human Papillomavirus
(HPV) infection and associated diseases.
Specifically excluded from the field of
use are L2 based virus-like particles
(VLPs), L1/L2 chimeric peptides, and
L1/L2 chimeric peptide/protein based
VLPs.’’
The subject technologies are
papillomavirus L2 capsid protein based
vaccines against HPV. The L2 protein is
the minor papillomavirus capsid protein
for papillomaviruses. It is known that
antibodies to this protein can neutralize
homologous infection. Furthermore, L2
proteins can induce cross-neutralizing
antibodies. Specifically, epitopes at the
N-terminus of L2 shared by cutaneous
and mucosal types of papillomavirus
types and by types that infect divergent
species are broadly cross-neutralizing.
These epitopes at the N-terminus of L2
can be used to elicit cross-neutralizing
antibodies against different types of
HPV.
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.
In response to this Notice, the public
may file comments or objections.
Comments and objections, other than
those in the form of a license
application, will not be treated
confidentially, and may be made
publicly available.
License applications submitted in
response to this Notice will be
presumed to contain business
confidential information and any release
of information in these license
applications will be made only as
required and upon a request under the
Freedom of Information Act, 5 U.S.C.
552.
Dated: November 14, 2017.
Richard U. Rodriguez,
Associate Director, Technology Transfer
Center, National Cancer Institute.
[FR Doc. 2017–25744 Filed 11–28–17; 8:45 am]
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National Cancer Institute; Notice of
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The meetings will be closed to the
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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
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Bethesda, MD 20892–9750, 240–276–6611,
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and Cellular Analysis Technologies.
Date: February 8, 2018.
Time: 10:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant
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Place: National Cancer Institute, Shady
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7W030, Rockville, MD 20850 (Telephone
Conference Call).
Contact Person: Nadeem Khan, Ph.D.,
Scientific Review Officer, Research
Technology and Contract Review Branch,
Division of Extramural Activities, National
Cancer Institute, NIH, 9609 Medical Center
Drive, Room 7W260, Bethesda, MD 20892–
9750, 240–276–5856, nadeem.khan@nih.gov.
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VI Review.
Date: February 8–9, 2018.
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Scientific Review Officer, Research Program
Review Branch, Division of Extramural
PO 00000
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Activities, National Cancer Institute, NIH,
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Bethesda, MD 20892–9750, 240–276–5007,
tandlea@mail.nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel;
Quantitative Imaging.
Date: February 14, 2018.
Time: 10:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Cancer Institute, Shady
Grove, 9609 Medical Center Drive, Room
4W030, Rockville, MD 20850 (Telephone
Conference Call).
Contact Person: Eduardo E. Chufan, Ph.D.,
Scientific Review Officer, Research
Technology and Contract Review Branch,
Division of Extramural Activities, National
Cancer Institute, NIH, 9609 Medical Center
Drive, Room 7W254, Bethesda, MD 20892–
9750, 240–276–7975, chufanee@mail.nih.gov.
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Treatment Research; 93.396, Cancer Biology
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Cancer Control, National Institutes of Health,
HHS)
Dated: November 22, 2017.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2017–25732 Filed 11–28–17; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive Patent
License: T-Cells Transduced with HLA
A11 Restricted CT–RCC HERV–E
Reactive T-Cell Receptors for the
Treatment of Renal Cell Carcinoma
National Institutes of Health.
Notice.
AGENCY:
ACTION:
The National Heart, Lung, and
Blood Institute (‘‘NHLBI’’), an institute
of the National Institutes of Health; an
agency within the Department of Health
and Human Services, is contemplating
the grant of an Exclusive Patent License
to commercialize the invention(s)
embodied in the intellectual property
estate stated in the Summary
Information section of this notice to
T-Cure Bioscience, Inc. located in
Thousand Oaks, California and
incorporated under the laws of
Delaware.
DATES: Only written comments and/or
applications for a license which are
received by the NHLBI Office of
Technology Transfer and Development
SUMMARY:
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pmangrum on DSK3GDR082PROD with NOTICES1
Federal Register / Vol. 82, No. 228 / Wednesday, November 29, 2017 / Notices
on or before December 14, 2017 will be
considered.
ADDRESSES: Requests for copies of the
patent application, inquiries, and
comments relating to the contemplated
exclusive license should be directed to:
Cristina Thalhammer-Reyero, Ph.D.,
MBA, Senior Licensing and Patenting
Manager, NHLBI Office of Technology
Transfer and Development, 31 Center
Drive Room 4A29, MSC2479, Bethesda,
MD 20892–2479; Telephone: +1–301–
435–4507; Fax: +1–301–594–3080;
Email: thalhamc@mail.nih.gov.
SUPPLEMENTARY INFORMATION: The
following represents the intellectual
property to be licensed under the
prospective agreement:
US Provisional Patent Application
No. 62/357,265, filed June 30, 2016; and
PCT Patent Application PCT/US2017/
040449, filed June 30, 2017, ‘‘HERV–E
Reactive T Cell Receptors and Methods
of Use’’, NIH Reference No. E–120–
2016/0,1.
With respect to persons who have an
obligation to assign their right, title and
interest to the Government of the United
States of America, the patent rights in
these inventions have been assigned to
the Government of the United States of
America.
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 and
commercialization of T cell receptor
based cancer immunotherapy for Renal
Cell Carcinoma’’.
The subject technology is based on an
allogeneic T cell clone isolated from a
clear cell renal cell carcinoma (ccRCC)
HLA–A11 patient who showed
prolonged tumor regression after an
allogeneic transplant. This clone was
found to have tumor specific
cytotoxicity, killing patient’s tumor cells
in vitro. The antigen recognized by this
clone is an HLA–A11 restricted peptide
(named CT–RCC–1) and it is encoded by
a novel human endogenous retrovirus-E
(named CT–RCC HERV–E) whose
expression was discovered to be
restricted to ccRCC, but not observed in
normal tissues or other tumor types.
More than 80% of ccRCC tumors
express CT–RCC HERV–E provirus,
which makes it an ideal target for T cell
based immunotherapy. The genes for a
T cell receptor (TCR) that specifically
recognizes an HLA–A11 restricted CT–
RCC–1 antigen were sequenced and
cloned. A retroviral vector encoding this
TCR as well as a truncated CD34 protein
lacking the intracellular domain, which
can be used to facilitate the isolation of
T-cells transduced with this TCR, was
VerDate Sep<11>2014
15:19 Nov 28, 2017
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created. The vector can be used to
transduce and expand normal T cells
from HLA–A11 patients with metastatic
ccRCC with the TCR. The transduced
cytotoxic T cells can then be
administered to subjects to treat or
inhibit metastatic kidney cancer. Kidney
cancer is responsible for approximately
12,000 deaths every year in the United
States alone. As with most cancer, when
detected at early stages, surgical
intervention is highly effective. Phase I/
II clinical trials are currently being
planned in patients with metastatic
ccRCC using normal patient’s T-cells
transduced with this vector.
This notice is made in accordance
with 35 U.S.C. 209 and 37 CFR part 404.
The prospective Exclusive Patent
License will be royalty bearing and may
be granted unless within fifteen (15)
days from the date of this published
notice, the NHLBI Office of Technology
Transfer and Development 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.
The public may file comments or
objections in response to this Notice.
Comments and objections, other than
those in the form of a license
application, will not be treated
confidentially, and may be made
publicly available.
License applications submitted in
response to this Notice will be
presumed to contain business
confidential information and any release
of information in these license
applications will be made only as
required and upon a request under the
Freedom of Information Act, 5 U.S.C.
552.
Dated: November 16, 2017.
Cristina Thalhammer-Reyero,
Senior Licensing and Patenting Manager,
Office of Technology Transfer and
Development, National Heart, Lung, and
Blood Institute.
[FR Doc. 2017–25743 Filed 11–28–17; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive Patent
Commercialization License: N6, A
Novel, Broad, Highly Potent HIVSpecific Antibody
AGENCY:
ACTION:
PO 00000
National Institutes of Health.
Notice.
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56623
The National Institute of
Allergy and Infectious Diseases (NIAID),
an institute of the National Institutes of
Health, Department of Health and
Human Services, is contemplating the
grant of an exclusive patent
commercialization license to
GlaxoSmithKline Intellectual Property
Development Ltd (GSK) located at 980
Great West Road, Brentford, Middlesex,
TW8 9GS, United Kingdom, to practice
the inventions embodied in the patent
applications listed in the
SUPPLEMENTARY INFORMATION section of
this notice.
DATES: Only written comments and/or
applications for a license which are
received by the Technology Transfer
and Intellectual Property Office,
National Institute of Allergy and
Infectious Diseases on or before
December 14, 2017 will be considered.
ADDRESSES: Requests for copies of the
patent applications, inquiries, and
comments relating to the contemplated
exclusive patent commercialization
license should be directed to: Chris
Kornak, Lead Technology Transfer and
Patent Specialist, Technology Transfer
and Intellectual Property Office,
National Institute of Allergy and
Infectious Diseases, 5601 Fishers Lane,
Suite 6D, MSC 9804, Rockville, MD
20852–9804, phone number 301–496–
2644, or chris.kornak@nih.gov.
SUPPLEMENTARY INFORMATION: The
following represents the intellectual
property to be licensed under the
prospective agreement: HHS Reference
No. E–131–2015/0–US–01, United
States Provisonal Patent Application
Serial No. 62/136,228, filed on 03/20/
2015; HHS Reference No. E–131–2015/
1–US–01, United States Provisional
Patent Application Serial No. 62/
250,378 filed on 11/03/2015; HHS
Reference No. E–131–2015/2–PCT–01,
PCT Patent Application Serial No. PCT/
US2016/023145, filed on 03/18/2016;
HHS Reference No. E–131–2015/2–US–
07, United States Patent Application
Serial No. 15/559,791, filed on 09/19/
2017; HHS Reference No. E–131–2015/
2–EP–05, European Patent Application
Serial No. 16716979.6, filed on 10/19/
2017; HHS Reference No. E–131–2015/
2–CA–03, Canadian Patent Application
Serial No. 2,980,005, filed on 09/15/
2017; HHS Reference No. E–131–2015/
2–AU–02, Australian Patent Application
Serial No. 2016235541, filed on 09/08/
2017; HHS Reference No. E–131–2015/
2–CN–04, filing in process, HHS
Reference No. E–131–2015/2–ZA–08,
South African Patent Application Serial
No. 2017/06155, filed on 09/11/2017;
and HHS Reference No. E–131–2015/
2–IN–06, Indian Patent Application
SUMMARY:
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Agencies
[Federal Register Volume 82, Number 228 (Wednesday, November 29, 2017)]
[Notices]
[Pages 56622-56623]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-25743]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive Patent License: T-Cells Transduced
with HLA A11 Restricted CT-RCC HERV-E Reactive T-Cell Receptors for the
Treatment of Renal Cell Carcinoma
AGENCY: National Institutes of Health.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The National Heart, Lung, and Blood Institute (``NHLBI''), an
institute of the National Institutes of Health; an agency within the
Department of Health and Human Services, is contemplating the grant of
an Exclusive Patent License to commercialize the invention(s) embodied
in the intellectual property estate stated in the Summary Information
section of this notice to T-Cure Bioscience, Inc. located in Thousand
Oaks, California and incorporated under the laws of Delaware.
DATES: Only written comments and/or applications for a license which
are received by the NHLBI Office of Technology Transfer and Development
[[Page 56623]]
on or before December 14, 2017 will be considered.
ADDRESSES: Requests for copies of the patent application, inquiries,
and comments relating to the contemplated exclusive license should be
directed to: Cristina Thalhammer-Reyero, Ph.D., MBA, Senior Licensing
and Patenting Manager, NHLBI Office of Technology Transfer and
Development, 31 Center Drive Room 4A29, MSC2479, Bethesda, MD 20892-
2479; Telephone: +1-301-435-4507; Fax: +1-301-594-3080; Email:
thalhamc@mail.nih.gov.
SUPPLEMENTARY INFORMATION: The following represents the intellectual
property to be licensed under the prospective agreement:
US Provisional Patent Application No. 62/357,265, filed June 30,
2016; and PCT Patent Application PCT/US2017/040449, filed June 30,
2017, ``HERV-E Reactive T Cell Receptors and Methods of Use'', NIH
Reference No. E-120-2016/0,1.
With respect to persons who have an obligation to assign their
right, title and interest to the Government of the United States of
America, the patent rights in these inventions have been assigned to
the Government of the United States of America.
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 and commercialization of T cell
receptor based cancer immunotherapy for Renal Cell Carcinoma''.
The subject technology is based on an allogeneic T cell clone
isolated from a clear cell renal cell carcinoma (ccRCC) HLA-A11 patient
who showed prolonged tumor regression after an allogeneic transplant.
This clone was found to have tumor specific cytotoxicity, killing
patient's tumor cells in vitro. The antigen recognized by this clone is
an HLA-A11 restricted peptide (named CT-RCC-1) and it is encoded by a
novel human endogenous retrovirus-E (named CT-RCC HERV-E) whose
expression was discovered to be restricted to ccRCC, but not observed
in normal tissues or other tumor types. More than 80% of ccRCC tumors
express CT-RCC HERV-E provirus, which makes it an ideal target for T
cell based immunotherapy. The genes for a T cell receptor (TCR) that
specifically recognizes an HLA-A11 restricted CT-RCC-1 antigen were
sequenced and cloned. A retroviral vector encoding this TCR as well as
a truncated CD34 protein lacking the intracellular domain, which can be
used to facilitate the isolation of T-cells transduced with this TCR,
was created. The vector can be used to transduce and expand normal T
cells from HLA-A11 patients with metastatic ccRCC with the TCR. The
transduced cytotoxic T cells can then be administered to subjects to
treat or inhibit metastatic kidney cancer. Kidney cancer is responsible
for approximately 12,000 deaths every year in the United States alone.
As with most cancer, when detected at early stages, surgical
intervention is highly effective. Phase I/II clinical trials are
currently being planned in patients with metastatic ccRCC using normal
patient's T-cells transduced with this vector.
This notice is made in accordance with 35 U.S.C. 209 and 37 CFR
part 404. The prospective Exclusive Patent License will be royalty
bearing and may be granted unless within fifteen (15) days from the
date of this published notice, the NHLBI Office of Technology Transfer
and Development 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.
The public may file comments or objections in response to this
Notice. Comments and objections, other than those in the form of a
license application, will not be treated confidentially, and may be
made publicly available.
License applications submitted in response to this Notice will be
presumed to contain business confidential information and any release
of information in these license applications will be made only as
required and upon a request under the Freedom of Information Act, 5
U.S.C. 552.
Dated: November 16, 2017.
Cristina Thalhammer-Reyero,
Senior Licensing and Patenting Manager, Office of Technology Transfer
and Development, National Heart, Lung, and Blood Institute.
[FR Doc. 2017-25743 Filed 11-28-17; 8:45 am]
BILLING CODE 4140-01-P