Prospective Grant of an Exclusive Patent License: Development and Commercialization of Cell Therapies for Cancer, 2537-2539 [2019-01431]
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Federal Register / Vol. 84, No. 26 / Thursday, February 7, 2019 / Notices
Addiction Research Programs, National
Institutes of Health, HHS)
Dated: February 1, 2019.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–01412 Filed 2–6–19; 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: 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 Ziopharm
Oncology, Inc. (‘‘Ziopharm’’),
headquartered in Boston, MA.
SUMMARY:
Only written comments and/or
applications for a license which are
received by the National Cancer
Institute’s Technology Transfer Center
on or before February 22, 2019 will be
considered.
DATES:
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.
ADDRESSES:
SUPPLEMENTARY INFORMATION:
Intellectual Property
Group A
E–028–2015: Anti-Mutated KRAS T Cell
Receptors
1. US 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);
VerDate Sep<11>2014
17:23 Feb 06, 2019
Jkt 247001
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);
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. US 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. US 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);
PO 00000
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Fmt 4703
Sfmt 4703
2537
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. US 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. US Provisional Patent Application
62/560,930, filed September 20, 2017
(E–181–2017–0–US–01);
2. International Patent Application
PCT/US2018/051641, filed September
19, 2018 (E–181–2017–0–PCT–02);
3. Argentine Patent Application
P180102695, filed September 20, 2018
(E–181–2017–0–AR–03);
4. Taiwan Patent Application
107133221, filed September 20, 2018
(E–181–2017–0–TW–05); and
5. United States Utility Patent
Application 16/135,231, filed
September 19, 2018 (E–181–2017–0–
US–06).
E–239–2017: HLA Class I-Restricted T
Cell Receptors Against Mutated RAS
1. US Provisional Patent Application
62/594,244, filed December 4, 2017 (E–
239–2017–0–US–01); and
2. International Patent Application
PCT/US2018/063581, filed December 3,
2018 (E–239–2017–0–PCT–02).
E–166–2018: HLA–A3-Restricted T Cell
Receptors Against Mutated RAS
1. US Provisional Patent Application
62/749,750, filed October 24, 2018 (E–
166–2018–0–US–01).
E:\FR\FM\07FEN1.SGM
07FEN1
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Federal Register / Vol. 84, No. 26 / Thursday, February 7, 2019 / Notices
Group B
E–237–2017–0: T Cell Receptors
Recognizing Mutated P53
1. US Provisional Patent Application
62/565,383, filed September 29, 2017
(E–237–2017–0–US–01); and
2. International Patent Application
PCT/US2018/051285, filed September
17, 2018 (E–237–2017–2–PCT–01).
Group C
E–098–2018: T Cell Receptors Which
Recognize Mutated EGFR
1. US Provisional Patent Application
62/665,234, filed May 01, 2018 (E–098–
2018–0–US–01).
Group D
E–237–2017–1: Methods of Isolating T
Cells Having Antigenic Specificity for a
P53 Cancer-Specific Mutation
1. US Provisional Patent Application
62/565,464, filed September 29, 2017
(E–237–2017–1–US–01); and
2. International Patent Application
PCT/US2018/051280, filed September
17, 2018 (E–237–2017–1–PCT–02).
Group E
E–182–2017: Methods for Selectively
Expanding Cells Expressing a TCR with
a Murine Constant Region
1. US Provisional Patent Application
62/568,339, filed October 5, 2017 (E–
182–2017–0–US–01); and
2. International Patent Application
PCT/US2018/052432, filed September
24, 2018 (E–182–2017–0–PCT–02).
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 transposon-mediated
gene transfer 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, a) retrovirally-engineered
peripheral blood T cell therapy products
for the treatment of human cancers, and
b) CRISPR-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
VerDate Sep<11>2014
17:23 Feb 06, 2019
Jkt 247001
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 transposon-mediated
gene transfer to express T cell receptors
reactive to mutated P53, as claimed in
the Licensed Patent Rights, for the
treatment of human cancers.
Specifically excluded from this field of
use are CRISPR-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 C
‘‘Development, manufacture and
commercialization of autologous,
peripheral blood T cell therapy products
engineered by transposon-mediated
gene transfer to express T cell receptors
reactive to mutated EGFR, as claimed in
the Licensed Patent Rights, 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 D
‘‘Development, manufacture and
commercialization of autologous,
peripheral blood T cell therapy products
engineered by transposon-mediated
gene transfer to express T cell receptors
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 CRISPR-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 E
‘‘Development, manufacture and
commercialization of autologous,
peripheral blood T-cell therapy
products engineered by non-viral gene
PO 00000
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Fmt 4703
Sfmt 4703
transfer to express tumor-reactive T cell
receptors, as claimed in the Licensed
Patent Rights, 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 isolated TCRs
reactive to mutated epidermal growth
factor receptor (EGFR), within the
context of HLA DPA1*02:01 and HLA
DPB1*01:01. EGFR is a transmembrane
protein involved in cell growth and
proliferation signaling. Mutations in the
gene encoding EGFR can lead to its
overexpression, causing several types of
cancer (e.g., non-small cell lung cancer
(NSCLC)). Because of its prevalence in
certain cancers and its restricted
expression to precancerous and
cancerous tissues, this antigen may be
targeted on mutant EGFR-expressing
tumors with minimal normal tissue
toxicity.
Intellectual Property Group D 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
presenting cells which are subsequently
co-cultured with the patient’s isolated T
E:\FR\FM\07FEN1.SGM
07FEN1
Federal Register / Vol. 84, No. 26 / Thursday, February 7, 2019 / Notices
cells. Reactive T cells are then purified
and may be used as source material for
the further isolation of mutant P53targeting TCRs.
Intellectual Property Group E is
primarily directed to a method of
selectively sorting and expanding T
cells which have been engineered to
stably express a murine-human hybrid
TCR; a TCR wherein the human
constant region has been replaced with
the corresponding murine constant
region sequences. Unlike typical OKT3
antibody-mediated cell expansion
protocols, which operate in a nonspecific manner to stimulate all T cells
via the CD3 complex, the H57 antibody
utilized in the claimed method(s) binds
specifically to the mouse constant
region domain of the hybrid TCR,
leading to selective expansion of T cells
expressing the desired exogenous
receptor.
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: January 30, 2019.
Richard U. Rodriguez,
Associate Director, Technology Transfer
Center, National Cancer Institute.
[FR Doc. 2019–01431 Filed 2–6–19; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
VerDate Sep<11>2014
17:23 Feb 06, 2019
Jkt 247001
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: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Psychosocial Risks and Disease
Prevention.
Date: February 21, 2019.
Time: 10:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Weijia Ni, Ph.D., Chief/
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3100,
MSC 7808, Bethesda, MD 20892, 301–594–
3292, niw@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: February 2, 2019.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–01444 Filed 2–6–19; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; 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.
PO 00000
Frm 00053
Fmt 4703
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2539
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Mechanisms of Emotion, Stress and
Health.
Date: February 21, 2019.
Time: 12:00 p.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Serena Chu, Ph.D.,
Scientific Review Officer, BBBP IRG, Center
for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3178,
MSC 7848, Bethesda, MD 20892, 301–500–
5829, sechu@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: February 2, 2019.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–01459 Filed 2–6–19; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; 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 grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Cancer
Institute Special Emphasis Panel; Traceback
Testing: Increasing Identification and Genetic
Counseling of Mutation Carriers through
Family-based Outreach (U01).
Date: March 6, 2019.
Time: 1:00 p.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Cancer Institute, Shady
Grove, 9609 Medical Center Drive, Room
7W242 Rockville, MD 20850, (Telephone
Conference Call).
Contact Person: Zhiqiang Zou, MD, Ph.D.,
Scientific Review Officer, Special Review
Branch, Division of Extramural Activities,
E:\FR\FM\07FEN1.SGM
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]]>Agencies
[Federal Register Volume 84, Number 26 (Thursday, February 7, 2019)]
[Notices]
[Pages 2537-2539]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-01431]
-----------------------------------------------------------------------
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 Ziopharm
Oncology, Inc. (``Ziopharm''), headquartered in Boston, MA.
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 February 22, 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.
SUPPLEMENTARY INFORMATION:
Intellectual Property
Group A
E-028-2015: Anti-Mutated KRAS T Cell Receptors
1. US 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);
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. US 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. US 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. US 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. US Provisional Patent Application 62/560,930, filed September
20, 2017 (E-181-2017-0-US-01);
2. International Patent Application PCT/US2018/051641, filed
September 19, 2018 (E-181-2017-0-PCT-02);
3. Argentine Patent Application P180102695, filed September 20,
2018 (E-181-2017-0-AR-03);
4. Taiwan Patent Application 107133221, filed September 20, 2018
(E-181-2017-0-TW-05); and
5. United States Utility Patent Application 16/135,231, filed
September 19, 2018 (E-181-2017-0-US-06).
E-239-2017: HLA Class I-Restricted T Cell Receptors Against Mutated RAS
1. US Provisional Patent Application 62/594,244, filed December 4,
2017 (E-239-2017-0-US-01); and
2. International Patent Application PCT/US2018/063581, filed
December 3, 2018 (E-239-2017-0-PCT-02).
E-166-2018: HLA-A3-Restricted T Cell Receptors Against Mutated RAS
1. US Provisional Patent Application 62/749,750, filed October 24,
2018 (E-166-2018-0-US-01).
[[Page 2538]]
Group B
E-237-2017-0: T Cell Receptors Recognizing Mutated P53
1. US Provisional Patent Application 62/565,383, filed September
29, 2017 (E-237-2017-0-US-01); and
2. International Patent Application PCT/US2018/051285, filed
September 17, 2018 (E-237-2017-2-PCT-01).
Group C
E-098-2018: T Cell Receptors Which Recognize Mutated EGFR
1. US Provisional Patent Application 62/665,234, filed May 01, 2018
(E-098-2018-0-US-01).
Group D
E-237-2017-1: Methods of Isolating T Cells Having Antigenic Specificity
for a P53 Cancer-Specific Mutation
1. US Provisional Patent Application 62/565,464, filed September
29, 2017 (E-237-2017-1-US-01); and
2. International Patent Application PCT/US2018/051280, filed
September 17, 2018 (E-237-2017-1-PCT-02).
Group E
E-182-2017: Methods for Selectively Expanding Cells Expressing a TCR
with a Murine Constant Region
1. US Provisional Patent Application 62/568,339, filed October 5,
2017 (E-182-2017-0-US-01); and
2. International Patent Application PCT/US2018/052432, filed
September 24, 2018 (E-182-2017-0-PCT-02).
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 transposon-
mediated gene transfer 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, a)
retrovirally-engineered peripheral blood T cell therapy products for
the treatment of human cancers, and b) CRISPR-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 transposon-
mediated gene transfer to express T cell receptors reactive to mutated
P53, as claimed in the Licensed Patent Rights, for the treatment of
human cancers. Specifically excluded from this field of use are CRISPR-
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 C
``Development, manufacture and commercialization of autologous,
peripheral blood T cell therapy products engineered by transposon-
mediated gene transfer to express T cell receptors reactive to mutated
EGFR, as claimed in the Licensed Patent Rights, 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 D
``Development, manufacture and commercialization of autologous,
peripheral blood T cell therapy products engineered by transposon-
mediated gene transfer to express T cell receptors 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 CRISPR-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 E
``Development, manufacture and commercialization of autologous,
peripheral blood T-cell therapy products engineered by non-viral gene
transfer to express tumor-reactive T cell receptors, as claimed in the
Licensed Patent Rights, 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 isolated
TCRs reactive to mutated epidermal growth factor receptor (EGFR),
within the context of HLA DPA1*02:01 and HLA DPB1*01:01. EGFR is a
transmembrane protein involved in cell growth and proliferation
signaling. Mutations in the gene encoding EGFR can lead to its
overexpression, causing several types of cancer (e.g., non-small cell
lung cancer (NSCLC)). Because of its prevalence in certain cancers and
its restricted expression to precancerous and cancerous tissues, this
antigen may be targeted on mutant EGFR-expressing tumors with minimal
normal tissue toxicity.
Intellectual Property Group D 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
presenting cells which are subsequently co-cultured with the patient's
isolated T
[[Page 2539]]
cells. Reactive T cells are then purified and may be used as source
material for the further isolation of mutant P53-targeting TCRs.
Intellectual Property Group E is primarily directed to a method of
selectively sorting and expanding T cells which have been engineered to
stably express a murine-human hybrid TCR; a TCR wherein the human
constant region has been replaced with the corresponding murine
constant region sequences. Unlike typical OKT3 antibody-mediated cell
expansion protocols, which operate in a non-specific manner to
stimulate all T cells via the CD3 complex, the H57 antibody utilized in
the claimed method(s) binds specifically to the mouse constant region
domain of the hybrid TCR, leading to selective expansion of T cells
expressing the desired exogenous receptor.
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: January 30, 2019.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer
Institute.
[FR Doc. 2019-01431 Filed 2-6-19; 8:45 am]
BILLING CODE 4140-01-P
