Prospective Grant of an Exclusive Patent License: Genetically-Modified Lymphocytes for Cancer Therapy, 45503-45505 [2019-18648]
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Federal Register / Vol. 84, No. 168 / Thursday, August 29, 2019 / Notices
HRSA specifically requests comments
on (1) the necessity and utility of the
proposed information collection for the
proper performance of the agency’s
functions; (2) the accuracy of the
estimated burden; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4) the
use of automated collection techniques
or other forms of information
technology to minimize the information
collection burden.
Maria G. Button,
Director, Division of the Executive Secretariat.
[FR Doc. 2019–18646 Filed 8–28–19; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the President’s Council on
Sports, Fitness, and Nutrition
Office of Disease Prevention
and Health Promotion, Office of the
Assistant Secretary for Health, Office of
the Secretary, Department of Health and
Human Services.
ACTION: Notice of meeting.
AGENCY:
As stipulated by the Federal
Advisory Committee Act, the U.S.
Department of Health and Human
Services (HHS) is hereby giving notice
that the President’s Council on Sports,
Fitness, and Nutrition (PCSFN) will
hold its annual meeting. The meeting
will be open to the public.
DATES: The meeting will be held on
September 19, 2019, from 1:00 p.m. to
4:30 p.m.
ADDRESSES: The Hubert H. Humphrey
Building, the Great Hall, 200
Independence Ave. SW, Washington,
DC 20201.
FOR FURTHER INFORMATION CONTACT:
Jennifer Anne Bishop, Designated
Federal Officer for the PCSFN, 1101
Wootton Parkway, Suite 420, Rockville,
MD 20852, (240) 453–8826. Information
about PCSFN, including details about
the upcoming meeting, can be obtained
at www.fitness.gov.
SUPPLEMENTARY INFORMATION: The
primary functions of the PCSFN
include: (1) Advising the President,
through the Secretary, concerning
progress made in carrying out the
provisions of Executive Order 13265, as
amended by Executive Order 13824, and
recommending to the President, through
the Secretary, actions to accelerate such
progress; and (2) recommending to the
Secretary actions to expand
opportunities at the national, state, and
local levels for participation in sports
and engagement in physical fitness and
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SUMMARY:
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activity, taking into account the
Department of Health and Human
Services’ Physical Activity Guidelines
for Americans, including consideration
for youth with disabilities.
Recommendations may address, but are
not necessarily limited to: Increasing
awareness of the benefits of
participation in sports and regular
physical activity and good nutrition;
promoting private and public sector
strategies to increase participation in
sports; identifying metrics to gauge
youth sports participation and physical
activity; and discussing a national and
local strategy to recruit volunteers who
will support youth participation in
sports and regular physical activity.
The Council shall meet, at a
minimum, once per fiscal year. At the
September 2019 meeting, the Council
will (1) discuss activities related to a
HHS National Youth Sports Strategy;
and (2) discuss actions to expand
opportunities at the national, state, and
local levels for participation in sports
and engagement in physical fitness. The
meeting agenda is in development and
will be posted at www.fitness.gov when
it is finalized. The meeting on
September 19, 2019, is open to the
public and the media. HHS will also
stream the meeting online via HHS.gov/
live. Every effort will be made to
provide reasonable accommodations for
individuals with disabilities and/or
special needs who wish to attend the
meeting. Individuals who require
accommodations should call (240) 276–
9567 to submit a request, no later than
5:00 p.m. (Eastern Time) on Monday,
September 9, 2019. Members of the
public who wish to attend the meeting
in-person must pre-register by emailing
rsvp.fitness@hhs.gov or by calling (240)
276–9567. Registration for in-person
public attendance must be completed
before 5:00 p.m. (Eastern Time) on
Wednesday, September 11, 2019.
Foreign nationals who wish to attend inperson should register no later than
Tuesday, September 3, 2019 to ensure
sufficient time for federal building
security approval.
Dated: August 16, 2019.
Don Wright,
Deputy Assistant Secretary for Health, Office
of Disease Prevention and Health Promotion.
[FR Doc. 2019–18726 Filed 8–28–19; 8:45 am]
BILLING CODE 4150–32–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Dental &
Craniofacial Research; Amended
Notice of Meeting
Notice is hereby given of a change in
the meeting of the NIDCR Special Grants
Review Committee, which was
published in the Federal Register on
February 15, 2019, 84 FR 4495, page
02428.
The meeting is being amended to
change location from Westgate Hotel to
Embassy Suites DC Convention Center.
The meeting is closed to the public.
Dated: August 23, 2019.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–18644 Filed 8–28–19; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive
Patent License: Genetically-Modified
Lymphocytes for Cancer Therapy
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 Patent License to
practice the inventions embodied in the
Patents and Patent Applications listed
in the Supplementary Information
section of this Notice to Intima
Bioscience, Inc. (‘‘Intima’’),
headquartered in New York, NY.
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 September 13, 2019 will be
considered.
ADDRESSES: Requests for copies of the
patent applications, inquiries, and
comments relating to the contemplated
Exclusive Patent License should be
directed to: Andrew Burke, Ph.D.,
Senior Technology Transfer 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) 276–5484;
Facsimile: (240) 276–5504; Email:
andy.burke@nih.gov.
SUMMARY:
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Federal Register / Vol. 84, No. 168 / Thursday, August 29, 2019 / Notices
SUPPLEMENTARY INFORMATION:
Intellectual Property
Group A
Intracellular Genomic Transplant and
Methods of Therapy
1. International Patent Application
PCT/US2016/044856, filed July 29, 2016
(E–171–2018–6–PCT–01).
Group B
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Modified Cells and Methods of Therapy
1. International Patent Application
PCT/US2016/044858, filed July 29, 2016
(E–171–2018–7–PCT–01);
2. Canadian Patent Application
2993431, priority to July 31, 2015 (E–
171–2018–7–CA–02);
3. European Patent Application
16833645.1, priority to July 31, 2015 (E–
171–2018–7–EP–03);
4. Israeli Patent Application 257105,
priority to July 31, 2015 (E–171–2018–
7–IL–04);
5. Chinese Patent Application
201680059180.8, priority to July 31,
2015 (E–171–2018–7–CN–05);
6. United Kingdom Patent
Application 1803280.5, priority to July
31, 2015 (E–171–2018–7–GB–06);
7. Japanese Patent Application 2018–
525531, priority to July 31, 2015 (E–
171–2018–7–JP–07);
8. Hong Kong Patent Application
18115478.9, priority to July 31, 2015 (E–
171–2018–7–HK–08);
9. United States Patent 10,166,255,
issued January 1, 2019 (E–171–2018–8–
US–01);
10. United States Patent Application
16/180,867, filed July 29, 2016 (E–171–
2018–8–US–02);
11. United States Patent Application
16/182,146, filed November 3, 2018 (E–
171–2018–8–US–03);
12. United States Patent Application
16/182,189, filed November 6, 2018 (E–
171–2018–8–US–04);
13. United States Patent Application
15/224,159, filed July 29, 2016 (E–171–
2018–9–US–01);
14. United States Patent Application
15/250,514, filed August 29, 2016 (E–
171–2018–9–US–02);
15. United States Patent Application
15/256,086, filed September 2, 2016 (E–
171–2018–9–US–03); and
16. United States Patent Application
16/513,933, filed July 17, 2019 (E–171–
2018–9–US–04).
Group C
Viral Methods of T Cell Therapy
1. International Patent Application
PCT/US2017/058615, filed October 26,
2017 (E–173–2018–2–PCT–01);
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2. United States Patent Application
16/389,586, filed April 19, 2019 (E–173–
2018–2–US–02);
3. Australian Patent Application
2017347854, priority to October 26,
2016 (E–173–2018–2–AU–03);
4. Canadian Patent Application
3,041,835, priority to October 26, 2016
(E–173–2018–2–CA–04);
5. European Patent Application
17865054.5, priority to October 26, 2016
(E–173–2018–2–EP–05);
6. Japanese Patent Application 2019–
522944, priority to October 26, 2016 (E–
173–2018–2–JP–06);
7. Chinese Patent Application
[awaiting application number], priority
to October 26, 2016 (E–173–2018–2–
CN–07); and
8. United Kingdom Patent
Application 1906850.1, priority to
October 26, 2016 (E–173–2018–2–GB–
08).
Group D
CAS9 Modified TIL for Treatment of
Gastrointestinal Cancer
1. International Patent Application
PCT/US2017/057228, filed October 18,
2017 (E–174–2018–2–PCT–01);
2. United States Patent Application
15/947,688, filed April 6, 2018 (E–174–
2018–2–US–02);
3. United Kingdom Patent
Application 1906855.0, priority to
October 18, 2016 (E–174–2018–2–GB–
03).
4. Australian Patent Application
2017346885, priority to October 18,
2016 (E–174–2018–2–AU–04);
5. Canadian Patent Application
3,041,068, priority to October 18, 2016
(E–174–2018–2–CA–05);
6. Chinese Patent Application,
2017800784716, priority to October 18,
2016 (E–174–2018–2–CN–06);
7. Japanese Patent Application, 2019–
520738, priority to October 18, 2016 (E–
174–2018–2–JP–08); and
8. European Patent Application,
17861792.4, priority to October 18, 2016
(E–174–2018–2–EP–09).
The patent rights in these inventions
are co-owned by (a) the United States of
America, as represented by the
Secretary, Department of Health and
Human Services, (b) Regents of the
University of Minnesota, and (c) Intima
Bioscience, Inc.
The prospective exclusive license
territory may be worldwide, and the
fields of use may be limited to the
following:
‘‘Autologous T cell therapy products
genetically engineered by CRISPR to
specifically reduce expression or
activity of a checkpoint gene (e.g. CISH,
PD–1 or CTLA–4) for the treatment of
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gastrointestinal (GI) epithelial cancer,
lung cancer, breast cancer and/or B cell
lymphoma (BCL) in humans.
Autologous T cell therapy products
(excluding tumor infiltrating
lymphocytes) genetically engineered by
CRISPR or adeno-associated viral
vectors to express exogenous, tumorreactive T cell receptors for the
treatment of gastrointestinal (GI)
epithelial cancer, lung cancer, breast
cancer and/or B cell lymphoma (BCL) in
humans.
Allogeneic T cell therapy products
genetically engineered by CRISPR/CAS9
to specifically reduce expression or
activity of a checkpoint gene for the
treatment of gastrointestinal (GI)
epithelial cancer, lung cancer, breast
cancer and/or B cell lymphoma (BCL) in
humans.
Allogeneic T cell therapy products
genetically engineered by CRISPR/CAS9
or adeno-associated viral vectors to
express exogenous, tumor-reactive T
cell receptors for the treatment of
gastrointestinal (GI) epithelial cancer,
lung cancer, breast cancer and/or B cell
lymphoma (BCL) in humans.’’
Intellectual Property Group A is
primarily directed to methods and
compositions relating to the generation
of T cells engineered to contain multiple
genomic disruptions and methods of
treating cancer using the same.
Intellectual Property Group B is
primarily directed to methods and
compositions relating to the generation
of T cells genetically engineered to
express an exogenous T cell receptor
and a genomic disruption in a
checkpoint gene and methods of treating
cancer using the same.
Intellectual Property Group C is
primarily directed to methods and
compositions relating to the generation
of T cells genetically engineered by
CRISPR and adeno-associated viral
vectors to coordinately introduce a
genomic disruption in a checkpoint
gene and an exogenous T cell receptor,
and methods of treating cancer using the
same.
Intellectual Property Group D is
primarily directed to methods and
compositions relating to the generation
of tumor infiltrating lymphocytes
comprising a genomic disruption in the
checkpoint gene CISH and methods of
treating cancer using the same.
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 which
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Federal Register / Vol. 84, No. 168 / Thursday, August 29, 2019 / Notices
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 from 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: August 22, 2019.
Richard U. Rodriguez,
Associate Director, Technology Transfer
Center, National Cancer Institute.
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Arthritis and
Musculoskeletal and Skin Diseases;
Notice of Closed Meeting
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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 of
Arthritis and Musculoskeletal and Skin
Diseases Special Emphasis Panel; Member
Conflict: Arthritis and Musculoskeletal and
Skin Diseases Clinical Trials Review
Committee.
Date: October 29, 2019.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Arthritis and
Musculoskeletal and Skin Diseases,
Democracy One, 6701 Democracy Blvd.,
Suite 800, Bethesda, MD 20892 (Telephone
Conference Call).
Contact Person: Kathy Salaita, SCD, Chief,
Scientific Review Branch, DHHS/NIH/
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(Catalogue of Federal Domestic Assistance
Program Nos. 93.846, Arthritis,
Musculoskeletal and Skin Diseases Research,
National Institutes of Health, HHS)
Dated: August 23, 2019.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–18642 Filed 8–28–19; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Contact Person: Kenneth M Izumi, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3204,
MSC 7808, Bethesda, MD 20892, 301–496–
6980, izumikm@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: August 23, 2019.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–18643 Filed 8–28–19; 8:45 am]
BILLING CODE 4140–01–P
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
[FR Doc. 2019–18648 Filed 8–28–19; 8:45 am]
VerDate Sep<11>2014
NIAMS, One Democracy Plaza, Suite 800,
6701 Democracy Blvd., MSC 4872, Bethesda,
MD 20892, 301–594–5033, Kathy.Salaita@
nih.gov.
45505
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, 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/or contract proposals 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 and/or contract proposals,
the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR Panel:
Research to Improve Native American
Health.
Date: September 25, 2019.
Time: 8:00 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: Lauren Fordyce, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3214,
Bethesda, MD 20892, 301–827–8269,
fordycelm@mail.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR Panel:
Improving Animal Models of Influenza
Infection that are Predictive of Human
Immunity and Vaccination.
Date: September 25, 2019.
Time: 11:00 a.m. to 6:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
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DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
[Docket No. USCG–2019–0704]
Cooperative Research and
Development Agreement: Cell Phone
Geolocation for USCG Search and
Rescue
Coast Guard, DHS.
Notice of intent; request for
public comments.
AGENCY:
ACTION:
The Coast Guard announces
its Cooperative Research and
Development Agreement (CRADA) with
Callyo 2009 Corporation, to investigate
the potential operational use of
leveraging smart phone technology,
specifically the phone’s location
services, to help locate mariners in
distress more efficiently. The CRADA
with Callyo 2009 Corporation is based
on market research and visits to vendors
with advertised expertise in this unique
application of technology in the
maritime environment for Search and
Rescue. While the Coast Guard is
currently partnering with Callyo 2009
Corporation, the agency is soliciting
public comment on the possible nature
of and participation of other parties in
the proposed CRADA. In addition, the
Coast Guard also invites other potential
non-Federal participants, who have the
interest and capability to bring similar
contributions to this type of research, to
consider submitting proposals for
consideration in similar CRADAs.
DATES: Comments must be submitted to
the online docket via https://
www.regulations.gov on or before
September 9, 2019.
Synopses of proposals regarding
future CRADAs must reach the Coast
Guard (see FOR FURTHER INFORMATION
SUMMARY:
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]]>Agencies
[Federal Register Volume 84, Number 168 (Thursday, August 29, 2019)]
[Notices]
[Pages 45503-45505]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-18648]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive Patent License: Genetically-
Modified Lymphocytes for Cancer Therapy
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 Patent License to practice the
inventions embodied in the Patents and Patent Applications listed in
the Supplementary Information section of this Notice to Intima
Bioscience, Inc. (``Intima''), headquartered in New York, NY.
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 September 13, 2019 will be considered.
ADDRESSES: Requests for copies of the patent applications, inquiries,
and comments relating to the contemplated Exclusive Patent License
should be directed to: Andrew Burke, Ph.D., Senior Technology Transfer
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) 276-5484; Facsimile: (240)
276-5504; Email: [email protected].
[[Page 45504]]
SUPPLEMENTARY INFORMATION:
Intellectual Property
Group A
Intracellular Genomic Transplant and Methods of Therapy
1. International Patent Application PCT/US2016/044856, filed July
29, 2016 (E-171-2018-6-PCT-01).
Group B
Modified Cells and Methods of Therapy
1. International Patent Application PCT/US2016/044858, filed July
29, 2016 (E-171-2018-7-PCT-01);
2. Canadian Patent Application 2993431, priority to July 31, 2015
(E-171-2018-7-CA-02);
3. European Patent Application 16833645.1, priority to July 31,
2015 (E-171-2018-7-EP-03);
4. Israeli Patent Application 257105, priority to July 31, 2015 (E-
171-2018-7-IL-04);
5. Chinese Patent Application 201680059180.8, priority to July 31,
2015 (E-171-2018-7-CN-05);
6. United Kingdom Patent Application 1803280.5, priority to July
31, 2015 (E-171-2018-7-GB-06);
7. Japanese Patent Application 2018-525531, priority to July 31,
2015 (E-171-2018-7-JP-07);
8. Hong Kong Patent Application 18115478.9, priority to July 31,
2015 (E-171-2018-7-HK-08);
9. United States Patent 10,166,255, issued January 1, 2019 (E-171-
2018-8-US-01);
10. United States Patent Application 16/180,867, filed July 29,
2016 (E-171-2018-8-US-02);
11. United States Patent Application 16/182,146, filed November 3,
2018 (E-171-2018-8-US-03);
12. United States Patent Application 16/182,189, filed November 6,
2018 (E-171-2018-8-US-04);
13. United States Patent Application 15/224,159, filed July 29,
2016 (E-171-2018-9-US-01);
14. United States Patent Application 15/250,514, filed August 29,
2016 (E-171-2018-9-US-02);
15. United States Patent Application 15/256,086, filed September 2,
2016 (E-171-2018-9-US-03); and
16. United States Patent Application 16/513,933, filed July 17,
2019 (E-171-2018-9-US-04).
Group C
Viral Methods of T Cell Therapy
1. International Patent Application PCT/US2017/058615, filed
October 26, 2017 (E-173-2018-2-PCT-01);
2. United States Patent Application 16/389,586, filed April 19,
2019 (E-173-2018-2-US-02);
3. Australian Patent Application 2017347854, priority to October
26, 2016 (E-173-2018-2-AU-03);
4. Canadian Patent Application 3,041,835, priority to October 26,
2016 (E-173-2018-2-CA-04);
5. European Patent Application 17865054.5, priority to October 26,
2016 (E-173-2018-2-EP-05);
6. Japanese Patent Application 2019-522944, priority to October 26,
2016 (E-173-2018-2-JP-06);
7. Chinese Patent Application [awaiting application number],
priority to October 26, 2016 (E-173-2018-2-CN-07); and
8. United Kingdom Patent Application 1906850.1, priority to October
26, 2016 (E-173-2018-2-GB-08).
Group D
CAS9 Modified TIL for Treatment of Gastrointestinal Cancer
1. International Patent Application PCT/US2017/057228, filed
October 18, 2017 (E-174-2018-2-PCT-01);
2. United States Patent Application 15/947,688, filed April 6, 2018
(E-174-2018-2-US-02);
3. United Kingdom Patent Application 1906855.0, priority to October
18, 2016 (E-174-2018-2-GB-03).
4. Australian Patent Application 2017346885, priority to October
18, 2016 (E-174-2018-2-AU-04);
5. Canadian Patent Application 3,041,068, priority to October 18,
2016 (E-174-2018-2-CA-05);
6. Chinese Patent Application, 2017800784716, priority to October
18, 2016 (E-174-2018-2-CN-06);
7. Japanese Patent Application, 2019-520738, priority to October
18, 2016 (E-174-2018-2-JP-08); and
8. European Patent Application, 17861792.4, priority to October 18,
2016 (E-174-2018-2-EP-09).
The patent rights in these inventions are co-owned by (a) the
United States of America, as represented by the Secretary, Department
of Health and Human Services, (b) Regents of the University of
Minnesota, and (c) Intima Bioscience, Inc.
The prospective exclusive license territory may be worldwide, and
the fields of use may be limited to the following:
``Autologous T cell therapy products genetically engineered by
CRISPR to specifically reduce expression or activity of a checkpoint
gene (e.g. CISH, PD-1 or CTLA-4) for the treatment of gastrointestinal
(GI) epithelial cancer, lung cancer, breast cancer and/or B cell
lymphoma (BCL) in humans.
Autologous T cell therapy products (excluding tumor infiltrating
lymphocytes) genetically engineered by CRISPR or adeno-associated viral
vectors to express exogenous, tumor-reactive T cell receptors for the
treatment of gastrointestinal (GI) epithelial cancer, lung cancer,
breast cancer and/or B cell lymphoma (BCL) in humans.
Allogeneic T cell therapy products genetically engineered by
CRISPR/CAS9 to specifically reduce expression or activity of a
checkpoint gene for the treatment of gastrointestinal (GI) epithelial
cancer, lung cancer, breast cancer and/or B cell lymphoma (BCL) in
humans.
Allogeneic T cell therapy products genetically engineered by
CRISPR/CAS9 or adeno-associated viral vectors to express exogenous,
tumor-reactive T cell receptors for the treatment of gastrointestinal
(GI) epithelial cancer, lung cancer, breast cancer and/or B cell
lymphoma (BCL) in humans.''
Intellectual Property Group A is primarily directed to methods and
compositions relating to the generation of T cells engineered to
contain multiple genomic disruptions and methods of treating cancer
using the same.
Intellectual Property Group B is primarily directed to methods and
compositions relating to the generation of T cells genetically
engineered to express an exogenous T cell receptor and a genomic
disruption in a checkpoint gene and methods of treating cancer using
the same.
Intellectual Property Group C is primarily directed to methods and
compositions relating to the generation of T cells genetically
engineered by CRISPR and adeno-associated viral vectors to coordinately
introduce a genomic disruption in a checkpoint gene and an exogenous T
cell receptor, and methods of treating cancer using the same.
Intellectual Property Group D is primarily directed to methods and
compositions relating to the generation of tumor infiltrating
lymphocytes comprising a genomic disruption in the checkpoint gene CISH
and methods of treating cancer using the same.
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 which
[[Page 45505]]
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 from 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: August 22, 2019.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer
Institute.
[FR Doc. 2019-18648 Filed 8-28-19; 8:45 am]
BILLING CODE 4140-01-P
