Prospective Grant of an Exclusive Patent License: T Cell Receptor Fusion Proteins for the Treatment of Cancer, 43859-43860 [2024-10970]
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Federal Register / Vol. 89, No. 98 / Monday, May 20, 2024 / Notices
Time: 9:00 a.m. to 8:00 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: Elia E Ortenberg, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3108,
Bethesda, MD 20892, 301–827–7189,
femiaee@csr.nih.gov.
Name of Committee: Molecular, Cellular
and Developmental Neuroscience Integrated
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Date: June 13–14, 2024.
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Agenda: To review and evaluate grant
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Place: Hilton Washington/Rockville, 1750
Rockville Pike, Rockville, MD 20852 (InPerson Meeting).
Contact Person: Prithi Rajan, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD
20892, (301) 435–1042, prithi.rajan@nih.gov.
Name of Committee: Biology of
Development and Aging Integrated Review
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Pharmacology C Study Section.
Date: June 13–14, 2024.
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Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Jeffrey Smiley, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6194,
MSC 7804, Bethesda, MD 20892, (301) 272–
4596, smileyja@csr.nih.gov.
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Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Xinrui Li, Ph.D., Scientific
Review Officer, Center for Scientific Review,
National Institutes of Health, 6701 Rockledge
Drive, Bethesda, MD 20892, (301) 594–2084,
xinrui.li@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Special
Topics: Noninvasive Neuromodulation and
Neuroimaging Technologies.
Date: June 13–14, 2024.
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Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (In-Person and Virtual
Meeting).
Contact Person: Pablo M. Blazquez Gamez,
Ph.D., Scientific Review Officer, Center for
VerDate Sep<11>2014
19:14 May 17, 2024
Jkt 262001
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD
20892, (301) 435–1042,
pablo.blazquezgamez@nih.gov.
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Behavioral Processes Integrated Review
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and Ethology Study Section.
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Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Sara Louise Hargrave,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institute of
Health, 6701 Rockledge Drive, Room 3170,
Bethesda, MD 20892, (301) 443–7193,
hargravesl@mail.nih.gov.
Name of Committee: Oncology 2—
Translational Clinical Integrated Review
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Study Section.
Date: June 13–14, 2024.
Time: 9:30 a.m. to 6:30 p.m.
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Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Shahana Majid, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD
20892, (301) 867–5309, shahana.majid@
nih.gov.
Name of Committee: Infectious Diseases
and Immunology A Integrated Review Group;
Cellular and Molecular Immunology—A
Study Section.
Date: June 13–14, 2024.
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Agenda: To review and evaluate grant
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Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Velasco Cimica, Ph.D.,
Scientific Review Officer, Center for
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Bethesda, MD 20892, 301–594–1760,
velasco.cimica@nih.gov.
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22–070—HEAL Initiative: Development and
Validation of Non-Rodent Mammalian
Models of Pain.
Date: June 13, 2024.
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Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
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Contact Person: Jennifer Kielczewski,
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(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
PO 00000
Frm 00060
Fmt 4703
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43859
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: May 15, 2024.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2024–10987 Filed 5–17–24; 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: T Cell Receptor Fusion
Proteins for the Treatment of 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 INTcRON LLC
(‘‘INTcRON’’) located in Memphis,
Tennessee.
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 June 4, 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: Andrew Burke, Ph.D.,
Senior Technology Transfer Manager,
NCI Technology Transfer Center,
Telephone: (240) 276–5484; Email:
andy.burke@nih.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
Intellectual Property
1. United States Provisional Patent
Application No. 62/369,883 filed
August 2, 2016, entitled ‘‘Anti-KRAS
G12D T Cell Receptors’’ [HHS Reference
No. E–175–2016–0–US–01];
2. PCT Patent Application No. PCT/
US2017/044615 filed July 31, 2017,
entitled ‘‘Anti-KRAS G12D T Cell
Receptors’’ [HHS Reference No. E–175–
2016–0–PCT–02];
3. Australian Patent No. 2017306038
issued October 5, 2023, entitled ‘‘AntiKRAS G12D T Cell Receptors’’ [HHS
Reference No. E–175–2016–0–AU–03];
4. Canadian Patent Application No.
3,032,870 effective filing date of July 31,
E:\FR\FM\20MYN1.SGM
20MYN1
lotter on DSK11XQN23PROD with NOTICES1
43860
Federal Register / Vol. 89, No. 98 / Monday, May 20, 2024 / Notices
2017, entitled ‘‘Anti-KRAS G12D T Cell
Receptors’’ [HHS Reference No. E–175–
2016–0–CA–04];
5. Chinese Patent Application No.
201780059356.4 effective filing date of
July 31, 2017, entitled ‘‘Anti-KRAS
G12D T Cell Receptors’’ [HHS Reference
No. E–175–2016–0–CN–05];
6. European Patent No. 3494133
issued July 6, 2022, entitled ‘‘AntiKRAS G12D T Cell Receptors’’ [HHS
Reference No. E–175–2016–0–EP–06];
a. Validated in the following
jurisdictions: AL, AT, BE, BG, CH, CY,
CZ, DE, DK, EE, ES, FI, FR, GB, GR, HU,
HR, IE, IS, IT, LT, LU, LV, MC, MK, MT,
NL, NO, PL, PT, RO, RS, SE, SI, SK, SM
and TR.
7. Japanese Patent Application No.
2019–505220 effective filing date of July
31, 2017, entitled ‘‘Anti-KRAS G12D T
Cell Receptors’’ [HHS Reference No. E–
175–2016–0–JP–07];
8. United States Patent No. 10,611,816
issued April 7, 2020, entitled ‘‘AntiKRAS G12D T Cell Receptors’’ [HHS
Reference No. E–175–2016–0–US–08];
9. Israeli Patent No. 264425 issued
August 2, 2023, entitled ‘‘Anti-KRAS
G12D T Cell Receptors’’ [HHS Reference
No. E–175–2016–0–IL–09];
10. South Korean Patent No. 10–
2527052 issued April 25, 2023, entitled
‘‘Anti-KRAS G12D T Cell Receptors’’
[HHS Reference No. E–175–2016–0–KR–
10];
11. Singapore Patent Application No.
11201900654Q effective filing date of
July 31, 2017, entitled ‘‘Anti-KRAS
G12D T Cell Receptors’’ [HHS Reference
No. E–175–2016–0–SG–11];
12. Hong Kong Patent No.
HK40009637 issued July 7, 2023,
entitled ‘‘Anti-KRAS G12D T Cell
Receptors’’ [HHS Reference No. E–175–
2016–0–HK–12];
13. Hong Kong Patent Application No.
19132196.7 effective filing date of July
31, 2017, entitled ‘‘Anti-KRAS G12D T
Cell Receptors’’ [HHS Reference No. E–
175–2016–0–HK–13];
14. Singapore Patent Application No.
10201913959W filed December 31,
2019, entitled ‘‘Anti-KRAS G12D T Cell
Receptors’’ [HHS Reference No. E–175–
2016–0–SG–14];
15. United States Patent No.
11,208,456 issued December 28, 2021,
entitled ‘‘Anti-KRAS G12D T Cell
Receptors’’ [HHS Reference No. E–175–
2016–0–US–15];
16. United States Patent No.
11,897,933 issued February 13, 2024,
entitled ‘‘Anti-KRAS G12D T Cell
Receptors’’ [HHS Reference No. E–175–
2016–0–US–16];
17. United States Patent No.
11,840,561 issued December 12, 2023,
entitled ‘‘Anti-KRAS G12D T Cell
VerDate Sep<11>2014
19:14 May 17, 2024
Jkt 262001
Receptors’’ [HHS Reference No. E–175–
2016–0–US–17];
18. Japanese Patent No. 7413338
issued January 4, 2024, entitled ‘‘AntiKRAS G12D T Cell Receptors’’ [HHS
Reference No. E–175–2016–0–JP–18];
19. European Patent Application No.
22182473.3 filed July 1, 2022, entitled
‘‘Anti-KRAS G12D T Cell Receptors’’
[HHS Reference No. E–175–2016–0–EP–
19];
20. Israeli Patent Application No.
301894 filed April 3, 2023, entitled
‘‘Anti-KRAS G12D T Cell Receptors’’
[HHS Reference No. E–175–2016–0–IL–
01];
21. Hong Kong Patent Application No.
42023078137.9 filed August 28, 2023,
entitled ‘‘Anti-KRAS G12D T Cell
Receptors’’ [HHS Reference No. E–175–
2016–0–HK–01];
22. Australian Patent Application No.
2023233125 filed September 21, 2023,
entitled ‘‘Anti-KRAS G12D T Cell
Receptors’’ [HHS Reference No. E–175–
2016–0–AU–01];
23. Japanese Patent Application No.
2023–221526 filed December 27, 2023,
entitled ‘‘Anti-KRAS G12D T Cell
Receptors’’ [HHS Reference No. E–175–
2016–0–JP–01];
24. United States Patent Application
No. 18/423,020 filed January 25, 2024,
entitled ‘‘Anti-KRAS G12D T Cell
Receptors’’ [HHS Reference No. E–175–
2016–0–US–02]; and
25. Chinese Patent Application No.
202410214235.4 filed February 27,
2024, entitled ‘‘Anti-KRAS G12D T Cell
Receptors’’ [HHS Reference No. E–175–
2016–0–CN–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
field of use may be limited to the
following:
‘‘Development, manufacture and
commercialization of acellular fusion
protein therapy products for the
treatment of cancer in humans, wherein:
1. The fusion protein contains at least
the antigen binding domain of either T
cell receptor (TCR) ‘‘TRAV12–2/
TRBV10/2’’ or ‘‘TRAV4/TRBV5–6 (A, B
or C)’’, as disclosed and claimed in the
Licensed Patent Rights;
2. The cancer expresses mutant KRAS
G12D; and
3. The human(s) express(es) at least
HLA–C*08:02 or HLA–C*05:01.
For the avoidance of doubt,
specifically excluded from this Licensed
Field of Use are cell therapy products
(e.g., T cell or natural killer cell-based)
which have been genetically engineered
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
to express the TCR(s) claimed in the
Licensed Patent Rights.’’
The Intellectual Property is primarily
directed to isolated T cell receptors
(TCRs) reactive to mutated Kirsten rat
sarcoma viral oncogene homolog
(KRAS), within the context of human
leukocyte antigens (HLAs) C*08:02 or
C*05:01. 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.
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: May 15, 2024.
Richard U. Rodriguez,
Associate Director, Technology Transfer
Center, National Cancer Institute.
[FR Doc. 2024–10970 Filed 5–17–24; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of General Medical
Sciences; 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
E:\FR\FM\20MYN1.SGM
20MYN1
Agencies
[Federal Register Volume 89, Number 98 (Monday, May 20, 2024)]
[Notices]
[Pages 43859-43860]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-10970]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive Patent License: T Cell Receptor
Fusion Proteins for the Treatment of 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 INTcRON LLC
(``INTcRON'') located in Memphis, Tennessee.
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 June 4, 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: Andrew Burke, Ph.D., Senior Technology Transfer
Manager, NCI Technology Transfer Center, Telephone: (240) 276-5484;
Email: [email protected].
SUPPLEMENTARY INFORMATION:
Intellectual Property
1. United States Provisional Patent Application No. 62/369,883
filed August 2, 2016, entitled ``Anti-KRAS G12D T Cell Receptors'' [HHS
Reference No. E-175-2016-0-US-01];
2. PCT Patent Application No. PCT/US2017/044615 filed July 31,
2017, entitled ``Anti-KRAS G12D T Cell Receptors'' [HHS Reference No.
E-175-2016-0-PCT-02];
3. Australian Patent No. 2017306038 issued October 5, 2023,
entitled ``Anti-KRAS G12D T Cell Receptors'' [HHS Reference No. E-175-
2016-0-AU-03];
4. Canadian Patent Application No. 3,032,870 effective filing date
of July 31,
[[Page 43860]]
2017, entitled ``Anti-KRAS G12D T Cell Receptors'' [HHS Reference No.
E-175-2016-0-CA-04];
5. Chinese Patent Application No. 201780059356.4 effective filing
date of July 31, 2017, entitled ``Anti-KRAS G12D T Cell Receptors''
[HHS Reference No. E-175-2016-0-CN-05];
6. European Patent No. 3494133 issued July 6, 2022, entitled
``Anti-KRAS G12D T Cell Receptors'' [HHS Reference No. E-175-2016-0-EP-
06];
a. Validated in the following jurisdictions: AL, AT, BE, BG, CH,
CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HU, HR, IE, IS, IT, LT, LU, LV,
MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM and TR.
7. Japanese Patent Application No. 2019-505220 effective filing
date of July 31, 2017, entitled ``Anti-KRAS G12D T Cell Receptors''
[HHS Reference No. E-175-2016-0-JP-07];
8. United States Patent No. 10,611,816 issued April 7, 2020,
entitled ``Anti-KRAS G12D T Cell Receptors'' [HHS Reference No. E-175-
2016-0-US-08];
9. Israeli Patent No. 264425 issued August 2, 2023, entitled
``Anti-KRAS G12D T Cell Receptors'' [HHS Reference No. E-175-2016-0-IL-
09];
10. South Korean Patent No. 10-2527052 issued April 25, 2023,
entitled ``Anti-KRAS G12D T Cell Receptors'' [HHS Reference No. E-175-
2016-0-KR-10];
11. Singapore Patent Application No. 11201900654Q effective filing
date of July 31, 2017, entitled ``Anti-KRAS G12D T Cell Receptors''
[HHS Reference No. E-175-2016-0-SG-11];
12. Hong Kong Patent No. HK40009637 issued July 7, 2023, entitled
``Anti-KRAS G12D T Cell Receptors'' [HHS Reference No. E-175-2016-0-HK-
12];
13. Hong Kong Patent Application No. 19132196.7 effective filing
date of July 31, 2017, entitled ``Anti-KRAS G12D T Cell Receptors''
[HHS Reference No. E-175-2016-0-HK-13];
14. Singapore Patent Application No. 10201913959W filed December
31, 2019, entitled ``Anti-KRAS G12D T Cell Receptors'' [HHS Reference
No. E-175-2016-0-SG-14];
15. United States Patent No. 11,208,456 issued December 28, 2021,
entitled ``Anti-KRAS G12D T Cell Receptors'' [HHS Reference No. E-175-
2016-0-US-15];
16. United States Patent No. 11,897,933 issued February 13, 2024,
entitled ``Anti-KRAS G12D T Cell Receptors'' [HHS Reference No. E-175-
2016-0-US-16];
17. United States Patent No. 11,840,561 issued December 12, 2023,
entitled ``Anti-KRAS G12D T Cell Receptors'' [HHS Reference No. E-175-
2016-0-US-17];
18. Japanese Patent No. 7413338 issued January 4, 2024, entitled
``Anti-KRAS G12D T Cell Receptors'' [HHS Reference No. E-175-2016-0-JP-
18];
19. European Patent Application No. 22182473.3 filed July 1, 2022,
entitled ``Anti-KRAS G12D T Cell Receptors'' [HHS Reference No. E-175-
2016-0-EP-19];
20. Israeli Patent Application No. 301894 filed April 3, 2023,
entitled ``Anti-KRAS G12D T Cell Receptors'' [HHS Reference No. E-175-
2016-0-IL-01];
21. Hong Kong Patent Application No. 42023078137.9 filed August 28,
2023, entitled ``Anti-KRAS G12D T Cell Receptors'' [HHS Reference No.
E-175-2016-0-HK-01];
22. Australian Patent Application No. 2023233125 filed September
21, 2023, entitled ``Anti-KRAS G12D T Cell Receptors'' [HHS Reference
No. E-175-2016-0-AU-01];
23. Japanese Patent Application No. 2023-221526 filed December 27,
2023, entitled ``Anti-KRAS G12D T Cell Receptors'' [HHS Reference No.
E-175-2016-0-JP-01];
24. United States Patent Application No. 18/423,020 filed January
25, 2024, entitled ``Anti-KRAS G12D T Cell Receptors'' [HHS Reference
No. E-175-2016-0-US-02]; and
25. Chinese Patent Application No. 202410214235.4 filed February
27, 2024, entitled ``Anti-KRAS G12D T Cell Receptors'' [HHS Reference
No. E-175-2016-0-CN-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 field of use may be limited to the following:
``Development, manufacture and commercialization of acellular
fusion protein therapy products for the treatment of cancer in humans,
wherein:
1. The fusion protein contains at least the antigen binding domain
of either T cell receptor (TCR) ``TRAV12-2/TRBV10/2'' or ``TRAV4/TRBV5-
6 (A, B or C)'', as disclosed and claimed in the Licensed Patent
Rights;
2. The cancer expresses mutant KRAS G12D; and
3. The human(s) express(es) at least HLA-C*08:02 or HLA-C*05:01.
For the avoidance of doubt, specifically excluded from this
Licensed Field of Use are cell therapy products (e.g., T cell or
natural killer cell-based) which have been genetically engineered to
express the TCR(s) claimed in the Licensed Patent Rights.''
The Intellectual Property is primarily directed to isolated T cell
receptors (TCRs) reactive to mutated Kirsten rat sarcoma viral oncogene
homolog (KRAS), within the context of human leukocyte antigens (HLAs)
C*08:02 or C*05:01. 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.
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: May 15, 2024.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer
Institute.
[FR Doc. 2024-10970 Filed 5-17-24; 8:45 am]
BILLING CODE 4140-01-P