Prospective Grant of an Exclusive Patent License: Development and Commercialization of Cell Therapies for Cancer, 49109-49111 [2018-21096]
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49109
Federal Register / Vol. 83, No. 189 / Friday, September 28, 2018 / Notices
a specific new protein produced by a
new plant variety.
Description of Respondents: The
respondents to this collection of
information are developers of new plant
varieties intended for food use.
In the Federal Register of May 25,
2018 (83 FR 24315), we published a 60day notice requesting public comment
on the proposed collection of
information. One comment was received
but did not respond to any of the four
information collection topics solicited
and is therefore not addressed.
We therefore estimate the burden for
the information collection as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Category
Total
annual
responses
Average
burden per
response
Total hours
First four data components ......................
Two other data components ....................
3666
3666
6
6
1
1
6
6
4
16
24
96
Total ..................................................
........................
........................
........................
........................
........................
120
1 There
amozie on DSK3GDR082PROD with NOTICES1
Number of
responses per
respondent
Number of
respondents
Form FDA No.
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate. The
estimated number of annual responses
and average burden per response are
based on our experience with early food
safety evaluations. Completing an early
food safety evaluation for a new protein
from a new plant variety is a one-time
burden (one evaluation per new
protein). Many developers of novel
plants may choose not to submit an
evaluation because the field testing of a
plant containing a new protein is
conducted in such a way (e.g., on such
a small scale, or in such isolated
conditions, etc.) that cross-pollination
with traditional crops or commingling
of plant material is not likely to be an
issue. Also, other developers may have
previously communicated with us about
the food safety of a new plant protein,
for example, when the same protein was
expressed in a different crop.
We estimate the annual number of
NPCs submitted by developers will be
six or fewer. The early food safety
evaluation for new proteins includes six
main data components. Four of these
data components are easily and quickly
obtainable, having to do with the
identity and source of the protein. We
estimate that completing these data
components will take about 4 hours per
NPC. We estimate the reporting burden
for the first four data components to be
24 hours (4 hours × 6 responses).
Two data components ask for original
data to be generated. One data
component consists of a bioinformatics
analysis which can be performed using
publicly available databases. The other
data component involves ‘‘wet’’ lab
work to assess the new protein’s
stability and the resistance of the
protein to enzymatic degradation using
appropriate in vitro assays (protein
digestibility study). The paperwork
burden of these two data components
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19:22 Sep 27, 2018
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consists of the time it takes the company
to assemble the information on these
two data components and include it in
an NPC. We estimate that completing
these data components will take about
16 hours per NPC. We estimate the
reporting burden for the two other data
components to be 96 hours (16 hours ×
6 responses). Thus, we estimate the total
annual hour burden for this collection
of information to be 120 hours.
Dated: September 25, 2018.
Leslie Kux,
Associate Commissioner for Policy.
Requests for copies of the
patent applications, inquiries, and
comments relating to the contemplated
Exclusive Patent License should be
directed to: Andrew Burke, 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.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
[FR Doc. 2018–21148 Filed 9–27–18; 8:45 am]
Intellectual Property
BILLING CODE 4164–01–P
Group A
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive
Patent License: Development and
Commercialization of Cell Therapies
for Cancer
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 Tailored
Therapeutics, LLC. (‘‘Tailored’’), located
in Potomac, MD.
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 October 15, 2018 will be
considered.
SUMMARY:
PO 00000
Frm 00062
Fmt 4703
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E–028–2015: Anti-Mutated KRAS T Cell
Receptors
1. U.S. Provisional Patent Application
62/084,654, filed November 26, 2014
(E–028–2015–0–US–01);
2. International Patent Application
PCT/US2015/062269, filed November
24, 2015 (E–028–2015–1–PCT–01);
3. Australian Patent Application
2015353720, filed May 18, 2017 (E–028–
2015–1–AU–02);
4. Canadian Patent Application
2968399, filed May 18, 2017 (E–028–
2015–1–CA–03);
5. Chinese Patent Application
201580070673.7, filed June 23, 2017 (E–
028–2015–1–CN–04);
6. European Patent Application
15807756.0 filed June 23, 2017 (E–028–
2015–1–EP–05);
7. Israeli Patent Application 252258,
filed May 14, 2017 (E–028–2015–1–IL–
06);
8. Japanese Patent Application
527874/2017, filed May 24, 2017 (E–
028–2015–1–JP–07);
9. Korean Patent Application 2017–
7017289, filed June 23, 2017 (E–028–
2015–1–KR–08);
10. Mexican Patent Application MX/
a/2017/006865, filed May 25, 2017 (E–
028–2015–1–MX–09);
E:\FR\FM\28SEN1.SGM
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Federal Register / Vol. 83, No. 189 / Friday, September 28, 2018 / Notices
11. New Zealand Patent Application
732045, filed May 18, 2017 (E–028–
2015–1–NZ–10);
12. Saudi Arabian Patent Application
517381608, filed May 25, 2017 (E–028–
2015–1–SA–11);
13. Singapore Patent Application
11201704155U, filed May 23, 2017 (E–
028–2015–1–SG–12);
14. United States Utility Patent
Application 15/528,813, filed May 23,
2017 (E–028–2015–1–US–13); and
15. Hong Kong Patent Application
18103250.9, filed March 7, 2018 (E–
028–2015–1–HK–14).
E–180–2015: Anti-Mutated KRAS T Cell
Receptors
1. U.S. Provisional Patent Application
62/171,321, filed June 5, 2015 (E–180–
2015–0–US–01).
amozie on DSK3GDR082PROD with NOTICES1
E–265–2015: T Cell Receptors
Recognizing HLA–CW8 Restricted
Mutated KRAS
1. U.S. Provisional Patent Application
62/218,688, filed September 15, 2015
(E–265–2015–0–US–01);
2. International Patent Application
PCT/US2016/050875, filed September 9,
2016 (E–265–2015–0–PCT–02);
3. Australian Patent Application
2016323017, filed March 6, 2018 (E–
265–2015–0–AU–03);
4. Canadian Patent Application
2998869, filed March 15, 2018 (E–265–
2015–0–CA–04);
5. Chinese Patent Application
201680058891.3, filed April 3, 2018 (E–
265–2015–0–CN–05);
6. European Patent Application
16770408.9 filed March 7, 2018 (E–265–
2015–0–EP–06);
7. Israeli Patent Application 257840,
filed March 4, 2018 (E–265–2018–0–IL–
07);
8. Japanese Patent Application
513423/2018, filed March 13, 2018 (E–
265–2015–0–JP–08);
9. Korean Patent Application 2018–
7010326, filed April 12, 2018 (E–265–
2015–0–KR–09);
10. Mexican Patent Application MX/
a/2018/003062, filed March 12, 2018 (E–
265–2015–0–MX–10);
11. New Zealand Patent Application
740714, filed March 14, 2018 (E–265–
2015–0–NZ–11);
12. Saudi Arabian Patent Application
518391109, filed March 13, 2018 (E–
265–2015–0–SA–12);
13. Singapore Patent Application
11201802069U, filed March 13, 2018
(E–265–2015–0–SG–13); and
14. United States Utility Patent
Application 15/758,954, filed March 9,
2018 (E–265–2015–0–US–14).
VerDate Sep<11>2014
19:22 Sep 27, 2018
Jkt 244001
E–175–2016: Anti-KRAS G12D T Cell
Receptors
1. U.S. Provisional Patent Application
62/369,883, filed August 2, 2016 (E–
175–2016–0–US–01); and
2. International Patent Application
PCT/US2017/044615, filed July 31, 2017
(E–175–2016–0–PCT–02).
E–181–2017: HLA Class II-Restricted T
Cell Receptors Against Mutated RAS
1. U.S. Provisional Patent Application
62/560,930, filed September 20, 2017
(E–181–2017–0–US–01).
E–239–2017: HLA Class I-Restricted T
Cell Receptors Against Mutated RAS
1. U.S. Provisional Patent Application
62/594,244, filed December 4, 2017 (E–
239–2017–0–US–01).
Group B
E–237–2017–0: T Cell Receptors
Recognizing Mutated P53
1. U.S. Provisional Patent Application
62/565,383, filed September 29, 2017
(E–237–2017–0–US–01).
Group C
E–237–2017–1: Methods of Isolating T
Cells Having Antigenic Specificity for a
P53 Cancer-Specific Mutation
1. U.S. Provisional Patent Application
62/565,464, filed September 29, 2017
(E–237–2017–1–US–01).
The patent rights in these inventions
have been assigned and/or exclusively
licensed to the government of the
United States of America.
The prospective exclusive license
territory may be worldwide, and the
fields of use may be limited to the
following:
Fields of Use Applying to Intellectual
Property Group A
‘‘Development, manufacture and
commercialization of autologous,
peripheral blood T cell therapy products
engineered by CRISPR to express T cell
receptors reactive to mutated KRAS, as
claimed in the Licensed Patent Rights,
for the treatment of human cancers.
Specifically excluded from this field of
use are retrovirally-engineered
peripheral blood T cell therapy products
for the treatment of human cancers.
Development, manufacture and
commercialization of companion
diagnostics approved or cleared by the
FDA or equivalent foreign regulatory
agency for Licensee-proprietary T cell
therapy products.’’
Fields of Use Applying to Intellectual
Property Group B
‘‘Development, manufacture and
commercialization of autologous,
PO 00000
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peripheral blood T cell therapy products
engineered by CRISPR to express T cell
receptors reactive to mutated p53, as
claimed in the Licensed Patent Rights,
for the treatment of cancer in humans.
Development, manufacture and
commercialization of companion
diagnostics approved or cleared by the
FDA or equivalent foreign regulatory
agency for Licensee-proprietary T cell
therapy products.’’
Fields of Use Applying to Intellectual
Property Group C
‘‘Development, manufacture and
commercialization of autologous, tumor
infiltrating lymphocyte-based adoptive
T cell therapy products reactive to
mutated p53, isolated as claimed in the
Licensed Patent Rights, for the treatment
of human cancers. Specifically excluded
from this field of use are genetically
engineered TIL cell therapy products for
the treatment of human cancers.
Development, manufacture and
commercialization of companion
diagnostics approved or cleared by the
FDA or equivalent foreign regulatory
agency for Licensee-proprietary T cell
therapy products.’’
Intellectual Property Group A is
primarily directed to isolated T cell
receptors (TCRs) reactive to mutated
Kirsten rat sarcoma viral oncogene
homolog (KRAS), within the context of
several human leukocyte antigens
(HLAs). Mutated KRAS, which plays a
well-defined driver role in oncogenesis,
is expressed by a variety of human
cancers, including: Pancreatic, lung,
endometrial, ovarian and prostate. Due
to its restricted expression in
precancerous and cancerous cells, this
antigen may be targeted on mutant
KRAS-expressing tumors with minimal
normal tissue toxicity.
Intellectual Property Group B is
primarily directed to isolated TCRs
reactive to mutated tumor protein 53
(TP53 or P53), within the context of
several HLAs. P53 is the archetypal
tumor suppressor gene and the most
frequently mutated gene in cancer.
Contemporary estimates suggest that
>50% of all tumors carry mutations in
P53. Because of its prevalence in cancer
and its restricted expression to
precancerous and cancerous cells, this
antigen may be targeted on mutant P53expressing tumors with minimal normal
tissue toxicity.
Intellectual Property Group C is
primarily directed to methods of
isolating T cells which are reactive to
mutated P53 antigens. Briefly, pools of
25-mer peptides covering known P53
‘‘hotspot’’ mutations have been
generated. These peptides may be
pulsed into autologous antigen
E:\FR\FM\28SEN1.SGM
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Federal Register / Vol. 83, No. 189 / Friday, September 28, 2018 / Notices
presenting cells which are subsequently
co-cultured with the patient’s isolated T
cells. Reactive T cells may be purified
and expanded in vitro to generate an
autologous cell therapy product. The
expanded cells may be administered to
the patient and mediate tumor
regression.
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 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: September 18, 2018.
Richard U. Rodriguez,
Associate Director, Technology Transfer
Center, National Cancer Institute.
[FR Doc. 2018–21096 Filed 9–27–18; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
amozie on DSK3GDR082PROD with NOTICES1
National Institute of Neurological
Disorders and Stroke; Notice of Closed
Meetings
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
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
VerDate Sep<11>2014
19:22 Sep 27, 2018
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49111
would constitute a clearly unwarranted
invasion of personal privacy.
Neurosciences, National Institutes of Health,
HHS)
Name of Committee: Neurological Sciences
Training Initial Review Group; NST–2
Subcommittee.
Date: October 25, 2018.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: The Alexandrian, 480 King Street,
Alexandria, VA 22314.
Contact Person: Elizabeth A. Webber,
Ph.D., Scientific Review Officer, Scientific
Review Branch, Division of Extramural
Research, NINDS/NIH/DHHS, Neuroscience
Center, 6001 Executive Blvd., Suite 3208,
MSC 9529, Bethesda, MD 20892–9529, (301)
496–1917, webbere@mail.nih.gov.
Name of Committee: National Institute of
Neurological Disorders and Stroke Special
Emphasis Panel; NSD Member Conflict.
Date: October 29, 2018.
Time: 11:00 a.m. to 12:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852 (Telephone
Conference Call).
Contact Person: Birgit Neuhuber, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, NINDS/NIH/DHHS, Neuroscience
Center, 6001 Executive Blvd., Suite 3208,
MSC 9529, Bethesda, MD 20892–9529, (301)
496–3562, neuhuber@ninds.nih.gov.
Name of Committee: National Institute of
Neurological Disorders and Stroke Initial
Review Group; Neurological Sciences and
Disorders K.
Date: November 5, 2018.
Time: 8:30 a.m. to 4:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852 (Virtual
Meeting).
Contact Person: Shanta Rajaram, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, NINDS/NIH/DHHS, Neuroscience
Center, 6001 Executive Blvd., Suite 3208,
MSC 9529, Bethesda, MD 20892–9529, (301)
435–6033, rajarams@mail.nih.gov.
Name of Committee: National Institute of
Neurological Disorders and Stroke Special
Emphasis Panel; NIH StrokeNet Clinical Trial
Application Review.
Date: November 5, 2018.
Time: 8:30 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852.
Contact Person: Marilyn Moore-Hoon,
Ph.D., Scientific Review Officer, Scientific
Review Branch, NINDS/NIH/DHHS,
Neuroscience Center, 6001 Executive Blvd.,
Suite 3285, MSC 9529, Bethesda, MD 20892–
9529, (301) 827–9087, mooremar@
mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.853, Clinical Research
Related to Neurological Disorders; 93.854,
Biological Basis Research in the
Dated: September 24, 2018.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory
Committee Policy.
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[FR Doc. 2018–21173 Filed 9–27–18; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood
Institute; Notice of Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings of the NHLBI
Special Emphasis Panel.
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 Heart, Lung,
and Blood Institute Special Emphasis Panel;
T4 Implementation Research for Heart, Lung,
and Blood Diseases and Sleep Disorders.
Date: October 19, 2018.
Time: 8:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Courtyard by Marriott, 5520
Wisconsin Avenue, Chevy Chase, MD 20815.
Contact Person: Chang Sook Kim, Ph.D.,
Scientific Review Officer, Office of Scientific
Review/DERA, National Heart, Lung, and
Blood Institute, 6701 Rockledge Drive, Room
7188, Bethesda, MD 20892–7924, 301–827–
7940, carolko@mail.nih.gov.
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel;
NHLBI Single-Site Clinical Trials Review.
Date: October 23, 2018.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Courtyard by Marriott, 5520
Wisconsin Avenue, Chevy Chase, MD 20815.
Contact Person: Chang Sook Kim, Ph.D.,
Scientific Review Officer, Office of Scientific
Review/DERA, National Heart, Lung, and
Blood Institute, 6701 Rockledge Drive, Room
7188, Bethesda, MD 20892–7924, 301–827–
7940, carolko@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.233, National Center for
Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung
Diseases Research; 93.839, Blood Diseases
E:\FR\FM\28SEN1.SGM
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]]>Agencies
[Federal Register Volume 83, Number 189 (Friday, September 28, 2018)]
[Notices]
[Pages 49109-49111]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-21096]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive Patent License: Development and
Commercialization of Cell Therapies for Cancer
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 Tailored
Therapeutics, LLC. (``Tailored''), located in Potomac, MD.
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 October 15, 2018 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, 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].
SUPPLEMENTARY INFORMATION:
Intellectual Property
Group A
E-028-2015: Anti-Mutated KRAS T Cell Receptors
1. U.S. Provisional Patent Application 62/084,654, filed November
26, 2014 (E-028-2015-0-US-01);
2. International Patent Application PCT/US2015/062269, filed
November 24, 2015 (E-028-2015-1-PCT-01);
3. Australian Patent Application 2015353720, filed May 18, 2017 (E-
028-2015-1-AU-02);
4. Canadian Patent Application 2968399, filed May 18, 2017 (E-028-
2015-1-CA-03);
5. Chinese Patent Application 201580070673.7, filed June 23, 2017
(E-028-2015-1-CN-04);
6. European Patent Application 15807756.0 filed June 23, 2017 (E-
028-2015-1-EP-05);
7. Israeli Patent Application 252258, filed May 14, 2017 (E-028-
2015-1-IL-06);
8. Japanese Patent Application 527874/2017, filed May 24, 2017 (E-
028-2015-1-JP-07);
9. Korean Patent Application 2017-7017289, filed June 23, 2017 (E-
028-2015-1-KR-08);
10. Mexican Patent Application MX/a/2017/006865, filed May 25, 2017
(E-028-2015-1-MX-09);
[[Page 49110]]
11. New Zealand Patent Application 732045, filed May 18, 2017 (E-
028-2015-1-NZ-10);
12. Saudi Arabian Patent Application 517381608, filed May 25, 2017
(E-028-2015-1-SA-11);
13. Singapore Patent Application 11201704155U, filed May 23, 2017
(E-028-2015-1-SG-12);
14. United States Utility Patent Application 15/528,813, filed May
23, 2017 (E-028-2015-1-US-13); and
15. Hong Kong Patent Application 18103250.9, filed March 7, 2018
(E-028-2015-1-HK-14).
E-180-2015: Anti-Mutated KRAS T Cell Receptors
1. U.S. Provisional Patent Application 62/171,321, filed June 5,
2015 (E-180-2015-0-US-01).
E-265-2015: T Cell Receptors Recognizing HLA-CW8 Restricted Mutated
KRAS
1. U.S. Provisional Patent Application 62/218,688, filed September
15, 2015 (E-265-2015-0-US-01);
2. International Patent Application PCT/US2016/050875, filed
September 9, 2016 (E-265-2015-0-PCT-02);
3. Australian Patent Application 2016323017, filed March 6, 2018
(E-265-2015-0-AU-03);
4. Canadian Patent Application 2998869, filed March 15, 2018 (E-
265-2015-0-CA-04);
5. Chinese Patent Application 201680058891.3, filed April 3, 2018
(E-265-2015-0-CN-05);
6. European Patent Application 16770408.9 filed March 7, 2018 (E-
265-2015-0-EP-06);
7. Israeli Patent Application 257840, filed March 4, 2018 (E-265-
2018-0-IL-07);
8. Japanese Patent Application 513423/2018, filed March 13, 2018
(E-265-2015-0-JP-08);
9. Korean Patent Application 2018-7010326, filed April 12, 2018 (E-
265-2015-0-KR-09);
10. Mexican Patent Application MX/a/2018/003062, filed March 12,
2018 (E-265-2015-0-MX-10);
11. New Zealand Patent Application 740714, filed March 14, 2018 (E-
265-2015-0-NZ-11);
12. Saudi Arabian Patent Application 518391109, filed March 13,
2018 (E-265-2015-0-SA-12);
13. Singapore Patent Application 11201802069U, filed March 13, 2018
(E-265-2015-0-SG-13); and
14. United States Utility Patent Application 15/758,954, filed
March 9, 2018 (E-265-2015-0-US-14).
E-175-2016: Anti-KRAS G12D T Cell Receptors
1. U.S. Provisional Patent Application 62/369,883, filed August 2,
2016 (E-175-2016-0-US-01); and
2. International Patent Application PCT/US2017/044615, filed July
31, 2017 (E-175-2016-0-PCT-02).
E-181-2017: HLA Class II-Restricted T Cell Receptors Against Mutated
RAS
1. U.S. Provisional Patent Application 62/560,930, filed September
20, 2017 (E-181-2017-0-US-01).
E-239-2017: HLA Class I-Restricted T Cell Receptors Against Mutated RAS
1. U.S. Provisional Patent Application 62/594,244, filed December
4, 2017 (E-239-2017-0-US-01).
Group B
E-237-2017-0: T Cell Receptors Recognizing Mutated P53
1. U.S. Provisional Patent Application 62/565,383, filed September
29, 2017 (E-237-2017-0-US-01).
Group C
E-237-2017-1: Methods of Isolating T Cells Having Antigenic Specificity
for a P53 Cancer-Specific Mutation
1. U.S. Provisional Patent Application 62/565,464, filed September
29, 2017 (E-237-2017-1-US-01).
The patent rights in these inventions have been assigned and/or
exclusively licensed to the government of the United States of America.
The prospective exclusive license territory may be worldwide, and
the fields of use may be limited to the following:
Fields of Use Applying to Intellectual Property Group A
``Development, manufacture and commercialization of autologous,
peripheral blood T cell therapy products engineered by CRISPR to
express T cell receptors reactive to mutated KRAS, as claimed in the
Licensed Patent Rights, for the treatment of human cancers.
Specifically excluded from this field of use are retrovirally-
engineered peripheral blood T cell therapy products for the treatment
of human cancers.
Development, manufacture and commercialization of companion
diagnostics approved or cleared by the FDA or equivalent foreign
regulatory agency for Licensee-proprietary T cell therapy products.''
Fields of Use Applying to Intellectual Property Group B
``Development, manufacture and commercialization of autologous,
peripheral blood T cell therapy products engineered by CRISPR to
express T cell receptors reactive to mutated p53, as claimed in the
Licensed Patent Rights, for the treatment of cancer in humans.
Development, manufacture and commercialization of companion
diagnostics approved or cleared by the FDA or equivalent foreign
regulatory agency for Licensee-proprietary T cell therapy products.''
Fields of Use Applying to Intellectual Property Group C
``Development, manufacture and commercialization of autologous,
tumor infiltrating lymphocyte-based adoptive T cell therapy products
reactive to mutated p53, isolated as claimed in the Licensed Patent
Rights, for the treatment of human cancers. Specifically excluded from
this field of use are genetically engineered TIL cell therapy products
for the treatment of human cancers.
Development, manufacture and commercialization of companion
diagnostics approved or cleared by the FDA or equivalent foreign
regulatory agency for Licensee-proprietary T cell therapy products.''
Intellectual Property Group A is primarily directed to isolated T
cell receptors (TCRs) reactive to mutated Kirsten rat sarcoma viral
oncogene homolog (KRAS), within the context of several human leukocyte
antigens (HLAs). Mutated KRAS, which plays a well-defined driver role
in oncogenesis, is expressed by a variety of human cancers, including:
Pancreatic, lung, endometrial, ovarian and prostate. Due to its
restricted expression in precancerous and cancerous cells, this antigen
may be targeted on mutant KRAS-expressing tumors with minimal normal
tissue toxicity.
Intellectual Property Group B is primarily directed to isolated
TCRs reactive to mutated tumor protein 53 (TP53 or P53), within the
context of several HLAs. P53 is the archetypal tumor suppressor gene
and the most frequently mutated gene in cancer. Contemporary estimates
suggest that >50% of all tumors carry mutations in P53. Because of its
prevalence in cancer and its restricted expression to precancerous and
cancerous cells, this antigen may be targeted on mutant P53-expressing
tumors with minimal normal tissue toxicity.
Intellectual Property Group C is primarily directed to methods of
isolating T cells which are reactive to mutated P53 antigens. Briefly,
pools of 25-mer peptides covering known P53 ``hotspot'' mutations have
been generated. These peptides may be pulsed into autologous antigen
[[Page 49111]]
presenting cells which are subsequently co-cultured with the patient's
isolated T cells. Reactive T cells may be purified and expanded in
vitro to generate an autologous cell therapy product. The expanded
cells may be administered to the patient and mediate tumor regression.
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 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: September 18, 2018.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer
Institute.
[FR Doc. 2018-21096 Filed 9-27-18; 8:45 am]
BILLING CODE 4140-01-P
