Prospective Grant of an Exclusive Patent License: Anti-KK-LC-1 T Cell Receptors for the Treatment of Cancer, 99888 [2024-29076]
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99888
Federal Register / Vol. 89, No. 238 / Wednesday, December 11, 2024 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive
Patent License: Anti–KK–LC–1 T Cell
Receptors for the Treatment of Cancer
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The National Cancer Institute
(NCI), 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 StraightLine Bio, Inc.
located in Princeton, New Jersey.
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 December 26, 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
Technology Transfer Center at
Telephone; (240)–276–5530, Email:
suna.gulay@nih.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
lotter on DSK11XQN23PROD with NOTICES1
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.
VerDate Sep<11>2014
18:17 Dec 10, 2024
Jkt 265001
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:
Development, manufacture and
commercialization of autologous T cell
therapy products that are genetically
engineered via retroviral-mediated gene
transfer or CRISPR-based gene transfer
or transposon-mediated gene transfer to
express a T cell receptor (TCR) targeting
human Kita-Kyushu Lung Cancer
Antigen 1 (KK–LC–1) restricted to HLA–
A*01, as claimed in the Licensed Patent
Rights, for the treatment of KK–LC–1
positive cancers and premalignant
conditions in humans.
For the avoidance of doubt,
specifically excluded from the Field of
Use are:
1. Development, manufacture, and
commercialization of Natural Killer cell
therapy products engineered via viral
vectors (including lentivirus or
retrovirus) to express the TCR(s)
claimed in the Licensed Patent Rights;
and
2. Development, manufacture and
commercialization of a combination
therapy for the treatment of KK–LC–1
positive human cancers that do not have
the HLA–A*01 genotype, wherein the
treatment comprises as a step:
Modification of the patient’s tumor to
express the HLA–A*01 restriction
element.
This technology discloses isolated T
cell receptors (TCR) reactive to the 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.
PO 00000
Frm 00062
Fmt 4703
Sfmt 4703
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.
Date: December 6, 2024.
Richard U. Rodriguez,
Associate Director, Technology Transfer
Center, National Cancer Institute.
[FR Doc. 2024–29076 Filed 12–10–24; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
Pursuant to section 1009 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
Allergy and Infectious Diseases Special
Emphasis Panel; NIAID Resource Related
Research Projects (R24 Clinical Trial Not
Allowed).
Date: January 30, 2025.
Time: 10:30 a.m. to 12:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3G56,
Rockville, MD 20892 (Video Assisted).
Contact Person: Maryam Rohani, Ph.D.,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
National Institute of Allergy and Infectious
Diseases, National Institutes of Health, 5601
Fishers Lane, Room 3G56, Rockville, MD
20892, (301) 761–6656, maryam.rohani@
nih.gov.
E:\FR\FM\11DEN1.SGM
11DEN1
]]>Agencies
[Federal Register Volume 89, Number 238 (Wednesday, December 11, 2024)]
[Notices]
[Page 99888]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-29076]
[[Page 99888]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive Patent License: Anti-KK-LC-1 T
Cell Receptors for the Treatment of Cancer
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The National Cancer Institute (NCI), 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 StraightLine
Bio, Inc. located in Princeton, New Jersey.
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 December 26, 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 Technology Transfer Center at 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:
Development, manufacture and commercialization of autologous T cell
therapy products that are genetically engineered via retroviral-
mediated gene transfer or CRISPR-based gene transfer or transposon-
mediated gene transfer to express a T cell receptor (TCR) targeting
human Kita-Kyushu Lung Cancer Antigen 1 (KK-LC-1) restricted to HLA-
A*01, as claimed in the Licensed Patent Rights, for the treatment of
KK-LC-1 positive cancers and premalignant conditions in humans.
For the avoidance of doubt, specifically excluded from the Field of
Use are:
1. Development, manufacture, and commercialization of Natural
Killer cell therapy products engineered via viral vectors (including
lentivirus or retrovirus) to express the TCR(s) claimed in the Licensed
Patent Rights; and
2. Development, manufacture and commercialization of a combination
therapy for the treatment of KK-LC-1 positive human cancers that do not
have the HLA-A*01 genotype, wherein the treatment comprises as a step:
Modification of the patient's tumor to express the HLA-A*01 restriction
element.
This technology discloses isolated T cell receptors (TCR) reactive
to the 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.
Date: December 6, 2024.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer
Institute.
[FR Doc. 2024-29076 Filed 12-10-24; 8:45 am]
BILLING CODE 4140-01-P
