Prospective Grant of Exclusive Patent Commercialization License: N6, A Novel, Broad, Highly Potent HIV-Specific Antibody, 56623-56624 [2017-25745]
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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
Jkt 241001
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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pmangrum on DSK3GDR082PROD with NOTICES1
56624
Federal Register / Vol. 82, No. 228 / Wednesday, November 29, 2017 / Notices
Serial No. 201737032671, filed on 09/
14/2017.
All rights in these inventions have
been assigned to the Government of the
United States of America.
The prospective exclusive patent
commercialization license territory may
be worldwide and the field of use may
be limited to: ‘‘Administration to
humans of a GP120-binding protein or
proteins, containing the 6 CDRs of the
N6 antibody, all as described in the
Licensed Patent Rights. This field of use
does not include bi-specific/multispecific constructs utilizing the
Licensed Patent Rights.’’
The N6 antibody has evolved a
unique mode of binding that depends
less on a variable area of the HIV
envelope known as the V5 region and
focuses more on conserved regions,
which change relatively little among
HIV strains. This allows N6 to tolerate
changes in the HIV envelope, including
the attachment of sugars in the V5
region, a major mechanism by which
HIV develops resistance to other VRC01class antibodies. N6 was shown in preclinical studies to neutralize
approximately 98 percent of HIV
isolates tested. The studies also
demonstrate that N6 neutralizes
approximately 80 percent of HIV
isolates which were resistant to other
antibodies of the same class, and does
so very potently. Its breadth and
potency makes N6 a highly desirable
candidate for development in
therapeutic or prophylactic strategies.
An abstract of the subject invention was
published in the Federal Register on
March 13, 2017.
This notice is made in accordance
with 35 U.S.C. 209 and 37 CFR part 404.
The prospective exclusive patent
commercialization license will be
royalty bearing and may be granted
unless within fifteen (15) days from the
date of this published notice, the
National Institute of Allergy and
Infectious Diseases 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
timely filed in response to this notice
will be treated as objections to the grant
of the contemplated exclusive patent
commercialization license. Comments
and objections submitted in response to
this notice will not be made available
for public inspection and, to the extent
permitted by law, will not be released
VerDate Sep<11>2014
15:19 Nov 28, 2017
Jkt 241001
under the Freedom of Information Act,
5 U.S.C. 552.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Suzanne Frisbie,
Deputy Director, Technology Transfer and
Intellectual Property Office, National Institute
of Allergy and Infectious Diseases.
National Institutes of Health
[FR Doc. 2017–25745 Filed 11–28–17; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Aging; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, 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 on
Aging Special Emphasis Panel; AD
Sequencing II.
Date: December 1, 2017.
Time: 1:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute on Aging,
Gateway Building, Suite 2C212, 7201
Wisconsin Avenue, Bethesda, MD 20814
(Telephone Conference Call).
Contact Person: Bita Nakhai, Ph.D.,
Scientific Review Branch, National Institute
on Aging, Gateway Bldg., 2C212, 7201
Wisconsin Avenue, Bethesda, MD 20814,
301–402–7701, nakhaib@nia.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.866, Aging Research,
National Institutes of Health, HHS)
Dated: November 22, 2017.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2017–25734 Filed 11–28–17; 8:45 am]
BILLING CODE 4140–01–P
PO 00000
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National Center for Advancing
Translational Sciences; Notice of
Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of
meetings of the National Center for
Advancing Translational Sciences.
The meetings will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
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: Cures Acceleration
Network Review Board.
Date: January 11, 2018.
Time: 8:30 a.m. to 3:00 p.m.
Agenda: Report from the Institute Director.
Place: National Institutes of Health,
Building 31, Conference Room 10, 31 Center
Drive, Bethesda, MD 20892.
Contact Person: Anna L. Ramsey-Ewing,
Ph.D., Executive Secretary, National Center
for Advancing Translational Sciences, 1
Democracy Plaza, Room 1072, Bethesda, MD
20892, 301–435–0809, anna.ramseyewing@
nih.gov.
Name of Committee: National Center for
Advancing Translational Sciences Advisory
Council.
Date: January 11, 2018.
Open: 8:30 a.m. to 3:00 p.m.
Agenda: Report from the Institute Director
and other staff.
Place: National Institutes of Health,
Building 31, Conference Room 10, 31 Center
Drive, Bethesda, MD 20892.
Closed: 3:15 p.m. to 4:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Building 31, Conference Room 10, 31 Center
Drive, Bethesda, MD 20892.
Contact Person: Anna L. Ramsey-Ewing,
Ph.D., Executive Secretary, National Center
for Advancing Translational Sciences, 1
Democracy Plaza, Room 1072, Bethesda, MD
20892, 301–435–0809, anna.ramseyewing@
nih.gov.
E:\FR\FM\29NON1.SGM
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Agencies
[Federal Register Volume 82, Number 228 (Wednesday, November 29, 2017)]
[Notices]
[Pages 56623-56624]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-25745]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive Patent Commercialization License:
N6, A Novel, Broad, Highly Potent HIV-Specific Antibody
AGENCY: National Institutes of Health.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: 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
[[Page 56624]]
Serial No. 201737032671, filed on 09/14/2017.
All rights in these inventions have been assigned to the Government
of the United States of America.
The prospective exclusive patent commercialization license
territory may be worldwide and the field of use may be limited to:
``Administration to humans of a GP120-binding protein or proteins,
containing the 6 CDRs of the N6 antibody, all as described in the
Licensed Patent Rights. This field of use does not include bi-specific/
multi-specific constructs utilizing the Licensed Patent Rights.''
The N6 antibody has evolved a unique mode of binding that depends
less on a variable area of the HIV envelope known as the V5 region and
focuses more on conserved regions, which change relatively little among
HIV strains. This allows N6 to tolerate changes in the HIV envelope,
including the attachment of sugars in the V5 region, a major mechanism
by which HIV develops resistance to other VRC01-class antibodies. N6
was shown in pre-clinical studies to neutralize approximately 98
percent of HIV isolates tested. The studies also demonstrate that N6
neutralizes approximately 80 percent of HIV isolates which were
resistant to other antibodies of the same class, and does so very
potently. Its breadth and potency makes N6 a highly desirable candidate
for development in therapeutic or prophylactic strategies. An abstract
of the subject invention was published in the Federal Register on March
13, 2017.
This notice is made in accordance with 35 U.S.C. 209 and 37 CFR
part 404. The prospective exclusive patent commercialization license
will be royalty bearing and may be granted unless within fifteen (15)
days from the date of this published notice, the National Institute of
Allergy and Infectious Diseases 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 timely filed in response to this notice will be treated as
objections to the grant of the contemplated exclusive patent
commercialization license. Comments and objections submitted in
response 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.
Suzanne Frisbie,
Deputy Director, Technology Transfer and Intellectual Property Office,
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2017-25745 Filed 11-28-17; 8:45 am]
BILLING CODE 4140-01-P