Prospective Grant of an Exclusive Patent License: Anti-KK-LC-1 T Cell Receptors, 81089-81090 [2024-23029]
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81089
Federal Register / Vol. 89, No. 194 / Monday, October 7, 2024 / Notices
Comments regarding this
information collection are best assured
of having their full effect if received
within 60 days of the date of this
publication.
FOR FURTHER INFORMATION CONTACT: To
obtain a copy of the data collection
plans and instruments, submit
comments in writing, or request more
information on the proposed project,
contact Candace Maynard, Branch
Chief, Cancer Information Service
Branch, CISB/OCPL, 9609 Medical
Center Drive, Rockville, MD 20850, or
call non-toll-free number 240–276–6657
or email your request, including your
address to: deatonc@mail.nih.gov.
Formal requests for additional plans and
instruments must be requested in
writing.
SUPPLEMENTARY INFORMATION: Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 requires written
comments and/or suggestions from the
public, and affected agencies are invited
to address one or more of the following
points: (1) Whether the proposed
collection of information is necessary
DATES:
Institute (NCI) currently collects (1)
customer service and demographic
information from clients of the Cancer
Information Service (CIS) to properly
plan, implement, and evaluate cancer
education efforts, including assessing
the extent by which the CIS reaches and
impacts underserved populations; (2)
smoking/tobacco use behavior of
individuals seeking NCI’s smoking
cessation assistance through the CIS to
provide smoking cessation services
tailored to the individual client’s needs
and track their smoking behavior at
follow up. This is a request for OMB to
approve a revised submission for an
additional three years to provide
ongoing customer service collection of
demographic information and collection
of brief customer satisfaction questions
from NCI Cancer Information Service
Clients for the purpose of program
planning and evaluation.
OMB approval is requested for 3
years. Respondents’ only cost is their
time. The total estimated annualized
burden hours are 6,343.
for the proper performance of the
function of the agency, including
whether the information will have
practical utility; (2) The accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used; (3)
Ways to enhance the quality, utility, and
clarity of the information to be
collected; and (4) Ways to minimize the
burden of the collection of information
on those who are to respond, including
the use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology.
Proposed Collection Title: Collection
of Customer Service, Demographic, and
Smoking/Tobacco use Information from
the National Cancer Institute’s (NCI)
Cancer Information Service (CIS), 0925–
0208, Expiration Date 03/31/2025,
REVISION, National Cancer Institute
(NCI), National Institutes of Health
(NIH).
Need and Use of Information
Collection: The National Cancer
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Average time
per response
(in hours)
Total annual
burden hours
Category of respondent
Demographic & Customer Satisfaction Questions
(Appendix 1A or 1AB).
Demographic & Customer Satisfaction Questions
(Appendix 1B).
Smoking Cessation ‘‘Intake’’ Questions (Appendix 1C).
Smoking Call Backs (Appendix 1D) .....................
VA Call Backs (Appendix 1E) ...............................
Cancer Info Call Backs (Appendix 1F) .................
Email Intake Form (Appendix 2) ...........................
Individuals .....................
15,754
1
3/60
788
Individuals .....................
17,589
1
2/60
586
Individuals .....................
8,839
1
6/60
884
.....................
.....................
.....................
.....................
8,840
26,055
1,841
9,740
1
1
1
1
4/60
4/60
4/60
10/60
589
1,737
123
1,623
Demographic & Customer Satisfaction Questions
(Appendix 9).
Individuals .....................
400
1
2/60
13
Totals .............................................................
.......................................
........................
113,191
........................
6,343
Individuals
Individuals
Individuals
Individuals
Dated: October 2, 2024.
Diane Kreinbrink,
Project Clearance Liaison, National Cancer
Institute, National Institutes of Health.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2024–23127 Filed 10–4–24; 8:45 am]
Prospective Grant of an Exclusive
Patent License: Anti-KK–LC–1 T Cell
Receptors
BILLING CODE 4140–01–P
National Institutes of Health
AGENCY:
National Institutes of Health,
HHS.
lotter on DSK11XQN23PROD with NOTICES1
Number of
responses per
respondent
Form name
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
SUMMARY:
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Patents and Patent Applications listed
in the Supplementary Information
section of this notice to T-Cure
Biosciences, Inc. (‘‘T-Cure’’) located in
Calabasas, California.
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 22, 2024 will be
considered.
DATES:
Requests for copies of the
patent application, inquiries, and
comments relating to the contemplated
an Exclusive Patent License should be
directed to: Suna Gulay French, Ph.D.,
Technology Transfer Manager, NCI
ADDRESSES:
E:\FR\FM\07OCN1.SGM
07OCN1
81090
Federal Register / Vol. 89, No. 194 / Monday, October 7, 2024 / Notices
lotter on DSK11XQN23PROD with NOTICES1
Technology Transfer Center, 9609
Medical Center Drive, RM 3W–204,
MSC 9702, Bethesda, MD 20892–9702
(for business mail), Rockville, MD
20850–9702; Telephone: (240)–276–
5530; Email: suna.gulay@nih.gov.
SUPPLEMENTARY INFORMATION:
Intellectual Property
1. United States Provisional Patent
Application No. 62/327,529, filed April
26, 2016 and entitled ‘‘Anti-KK–LC–1 T
Cell Receptors’’ [HHS Reference No. E–
153–2016–0–US–01];
2. PCT Patent Application No. PCT/
US2017/027865, filed April 17, 2017
and entitled ‘‘Anti-KK–LC–1 T Cell
Receptors’’ [HHS Reference No. E–153–
2016–0–PCT–02];
3. Australian Patent No. 2017258745,
issued July 14, 2022 and entitled ‘‘AntiKK–LC–1 T Cell Receptors’’ [HHS
Reference No. E–153–2016–0–AU–03];
4. Canadian Patent Application No.
3021898, filed April 17, 2017 and
entitled ‘‘Anti-KK–LC–1 T Cell
Receptors’’ [HHS Reference No. E–153–
2016–0–CA–04];
5. European Patent No. 3448882,
issued November 24, 2021 and entitled
‘‘Anti-KK–LC–1 T Cell Receptors’’ [HHS
Reference No. E–153–2016–0–EP–05];
a. Validated in the following
jurisdictions: CH, DE, BE, DK, ES, FI,
FR, GB, IE, IT, NL, NO and SE.
6. U.S. Patent No. 11,352,410, issued
June 7, 2022 and entitled ‘‘Anti-KK–LC–
1 T Cell Receptors’’ [HHS Reference No.
E–153–2016–0–US–06].
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
field of use may be limited to the
following:
‘‘1. Development, manufacture, and
commercialization of autologous T cell
therapy products, including T cells with
stem-like properties, engineered via
retrovirus-mediated gene transfer to
express T cell receptors reactive to KitaKyushu Lung Cancer Antigen 1 (KK–
LC–1), as claimed in the Licensed Patent
Rights; such products to be developed
for treatment of patients carrying HLA–
A*01:01 histocompatibility haplotype,
and diagnosed with a cancer expressing
KK–LC–1 protein (‘‘KK–LC–1 Targeting
TCR–T Products’’).
2. Development, manufacture, and
commercialization of a combination
therapy for the treatment of KK–LC–1
expressing human cancers, independent
of their HLA phenotype, wherein the
treatment comprises:
a. Modification of the patient’s tumor
using Licensee’s proprietary technology
VerDate Sep<11>2014
17:11 Oct 04, 2024
Jkt 262001
to express the HLA–A*01:01 restriction
element, and
b. Treatment with the KK–LC–1
Targeting TCR–T Products.
For the avoidance of doubt,
specifically excluded from these Fields
of Use are Natural Killer cell therapy
products engineered via viral vectors
(including lentivirus or retrovirus) to
express the TCR(s) claimed in the
Licensed Patent Rights.’’
This technology discloses isolated T
cell receptors (TCR) reactive to the KitaKyushu lung cancer antigen 1 (KK–LC–
1) within the context of human
leukocyte antigen (HLA) A*01:01. KK–
LC–1 is expressed by various epithelial
cancers including carcinomas of the
bladder, cervix, stomach, breast, lung,
and pancreas. Due to its minimal
expression in normal tissues, this
antigen may be targeted on KK–LC–1expressing tumors with minimal normal
tissue toxicity.
This notice is made in accordance
with 35 U.S.C. 209 and 37 CFR part 404.
The prospective exclusive license will
be royalty bearing, and the prospective
exclusive license may be granted unless
within fifteen (15) days from the date of
this published notice, the National
Cancer Institute receives written
evidence and argument that establishes
that the grant of the license would not
be consistent with the requirements of
35 U.S.C. 209 and 37 CFR part 404.
In response to this Notice, the public
may file comments or objections.
Comments and objections, other than
those in the form of a license
application, will not be treated
confidentially, and may be made
publicly available.
License applications submitted in
response to this Notice will be
presumed to contain business
confidential information and any release
of information in these license
applications will be made only as
required and upon a request under the
Freedom of Information Act, 5 U.S.C.
552.
Dated: October 1, 2024.
Richard U. Rodriguez,
Associate Director, Technology Transfer
Center, National Cancer Institute.
[FR Doc. 2024–23029 Filed 10–4–24; 8:45 am]
BILLING CODE 4140–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 1009 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
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Biological Chemistry
and Macromolecular Biophysics Integrated
Review Group; Drug Discovery and
Molecular Pharmacology B Study Section.
Date: October 31-November 1, 2024.
Time: 8:00 a.m. to 7:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Razvan Cornea, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 904L,
Bethesda, MD 20892, (301) 480–1955,
cornearl@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Imaging and
Bioengineering Technology for Visual
Systems (IBV).
Date: November 4–5, 2024.
Time: 8:00 a.m. to 7:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: The Watergate, 2650 Virginia
Avenue NW, Washington, DC 20037.
Contact Person: Susan Gillmor, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD
20892, (240) 762–3076, susan.gillmor@
nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel;
Fellowships: Learning, Memory, Language,
Communication and Related Neuroscience.
Date: November 4–5, 2024.
Time: 8:00 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Canopy by Hilton, 940 Rose Avenue,
North Bethesda, MD 20852.
Contact Person: Alexei Kondratyev, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5200,
MSC 7846, Bethesda, MD 20892, 301–435–
1785 kondratyevad@csr.nih.gov.
E:\FR\FM\07OCN1.SGM
07OCN1
]]>Agencies
[Federal Register Volume 89, Number 194 (Monday, October 7, 2024)]
[Notices]
[Pages 81089-81090]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-23029]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive Patent License: Anti-KK-LC-1 T
Cell Receptors
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 T-Cure
Biosciences, Inc. (``T-Cure'') located in Calabasas, California.
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 22, 2024 will be considered.
ADDRESSES: Requests for copies of the patent application, inquiries,
and comments relating to the contemplated an Exclusive Patent License
should be directed to: Suna Gulay French, Ph.D., Technology Transfer
Manager, NCI
[[Page 81090]]
Technology Transfer Center, 9609 Medical Center Drive, RM 3W-204, MSC
9702, Bethesda, MD 20892-9702 (for business mail), Rockville, MD 20850-
9702; Telephone: (240)-276-5530; Email: [email protected].
SUPPLEMENTARY INFORMATION:
Intellectual Property
1. United States Provisional Patent Application No. 62/327,529,
filed April 26, 2016 and entitled ``Anti-KK-LC-1 T Cell Receptors''
[HHS Reference No. E-153-2016-0-US-01];
2. PCT Patent Application No. PCT/US2017/027865, filed April 17,
2017 and entitled ``Anti-KK-LC-1 T Cell Receptors'' [HHS Reference No.
E-153-2016-0-PCT-02];
3. Australian Patent No. 2017258745, issued July 14, 2022 and
entitled ``Anti-KK-LC-1 T Cell Receptors'' [HHS Reference No. E-153-
2016-0-AU-03];
4. Canadian Patent Application No. 3021898, filed April 17, 2017
and entitled ``Anti-KK-LC-1 T Cell Receptors'' [HHS Reference No. E-
153-2016-0-CA-04];
5. European Patent No. 3448882, issued November 24, 2021 and
entitled ``Anti-KK-LC-1 T Cell Receptors'' [HHS Reference No. E-153-
2016-0-EP-05];
a. Validated in the following jurisdictions: CH, DE, BE, DK, ES,
FI, FR, GB, IE, IT, NL, NO and SE.
6. U.S. Patent No. 11,352,410, issued June 7, 2022 and entitled
``Anti-KK-LC-1 T Cell Receptors'' [HHS Reference No. E-153-2016-0-US-
06].
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 field of use may be limited to the following:
``1. Development, manufacture, and commercialization of autologous
T cell therapy products, including T cells with stem-like properties,
engineered via retrovirus-mediated gene transfer to express T cell
receptors reactive to Kita-Kyushu Lung Cancer Antigen 1 (KK-LC-1), as
claimed in the Licensed Patent Rights; such products to be developed
for treatment of patients carrying HLA-A*01:01 histocompatibility
haplotype, and diagnosed with a cancer expressing KK-LC-1 protein
(``KK-LC-1 Targeting TCR-T Products'').
2. Development, manufacture, and commercialization of a combination
therapy for the treatment of KK-LC-1 expressing human cancers,
independent of their HLA phenotype, wherein the treatment comprises:
a. Modification of the patient's tumor using Licensee's proprietary
technology to express the HLA-A*01:01 restriction element, and
b. Treatment with the KK-LC-1 Targeting TCR-T Products.
For the avoidance of doubt, specifically excluded from these Fields
of Use are Natural Killer cell therapy products engineered via viral
vectors (including lentivirus or retrovirus) to express the TCR(s)
claimed in the Licensed Patent Rights.''
This technology discloses isolated T cell receptors (TCR) reactive
to the Kita-Kyushu lung cancer antigen 1 (KK-LC-1) within the context
of human leukocyte antigen (HLA) A*01:01. KK-LC-1 is expressed by
various epithelial cancers including carcinomas of the bladder, cervix,
stomach, breast, lung, and pancreas. Due to its minimal expression in
normal tissues, this antigen may be targeted on KK-LC-1-expressing
tumors with minimal normal tissue toxicity.
This notice is made in accordance with 35 U.S.C. 209 and 37 CFR
part 404. The prospective exclusive license will be royalty bearing,
and the prospective exclusive license may be granted unless within
fifteen (15) days from the date of this published notice, the National
Cancer Institute receives written evidence and argument that
establishes that the grant of the license would not be consistent with
the requirements of 35 U.S.C. 209 and 37 CFR part 404.
In response to this Notice, the public may file comments or
objections. Comments and objections, other than those in the form of a
license application, will not be treated confidentially, and may be
made publicly available.
License applications submitted in response to this Notice will be
presumed to contain business confidential information and any release
of information in these license applications will be made only as
required and upon a request under the Freedom of Information Act, 5
U.S.C. 552.
Dated: October 1, 2024.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer
Institute.
[FR Doc. 2024-23029 Filed 10-4-24; 8:45 am]
BILLING CODE 4140-01-P
