Prospective Grant of an Exclusive Patent License: Development and Commercialization of Thermally Responsive T Cell Therapies for the Treatment of HPV-Positive Cancer(s), 1107-1108 [2024-00209]
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Federal Register / Vol. 89, No. 6 / Tuesday, January 9, 2024 / Notices
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Dated: January 4, 2024.
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[FR Doc. 2024–00248 Filed 1–8–24; 8:45 am]
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[FR Doc. 2024–00201 Filed 1–8–24; 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: Development and
Commercialization of Thermally
Responsive T Cell Therapies for the
Treatment of HPV-Positive Cancer(s)
AGENCY:
National Institutes of Health,
HHS.
Jkt 262001
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ACTION:
1107
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 Port
Therapeutics, Inc. (‘‘Port’’). Port
incorporated in Delaware and is
presently headquartered in Los Angeles,
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 January 24, 2024 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,
Telephone: (240) 276–5484; Email:
andy.burke@nih.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
Intellectual Property
1. United States Provisional Patent
Application No. 62/004,335 filed May 29,
2014, entitled ‘‘Anti-Human Papillomavirus
16 E7 T Cell Receptors’’ [HHS Reference No.
E–176–2014–0–US–01];
2. PCT Patent Application No. PCT/
US2015/033129 filed May 29, 2015, entitled
‘‘Anti-Human Papillomavirus 16 E7 T Cell
Receptors’’ [HHS Reference No. E–176–2014–
0–PCT–02];
3. Australian Patent No. 2015266818
issued January 16, 2020, entitled ‘‘AntiHuman Papillomavirus 16 E7 T Cell
Receptors’’ [HHS Reference No. E–176–2014–
0–AU–03];
4. Brazilian Patent Application No.
BR112016027805–4 effective filing date of
May 29, 2015, entitled ‘‘Anti-Human
Papillomavirus 16 E7 T Cell Receptors’’ [HHS
Reference No. E–176–2014–0–BR–04];
5. Canadian Patent Application No.
2,950,192 effective filing date of May 29,
2015, entitled ‘‘Anti-Human Papillomavirus
16 E7 T Cell Receptors’’ [HHS Reference No.
E–176–2014–0–CA–05];
6. Chinese Patent No. ZL201580031789.X
issued May 4, 2021, entitled ‘‘Anti-Human
Papillomavirus 16 E7 T Cell Receptors’’ [HHS
Reference No. E–176–2014–0–CN–06];
7. European Patent No. 3149031 issued
December 18, 2019, entitled ‘‘Anti-Human
Papillomavirus 16 E7 T Cell Receptors’’ [HHS
Reference No. E–176–2014–0–EP–07];
a. Validated in: AL, AT, BE, BG, CH, CY,
CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU,
IE, IS, IT, LT, LU, LV, MK, MT, NL, NO, PL,
PT, RO, SE, SI, SK, SM and TR.
8. Israeli Patent No. 248797 issued
September 1, 2021, entitled ‘‘Anti-Human
E:\FR\FM\09JAN1.SGM
09JAN1
khammond on DSKJM1Z7X2PROD with NOTICES
1108
Federal Register / Vol. 89, No. 6 / Tuesday, January 9, 2024 / Notices
Papillomavirus 16 E7 T Cell Receptors’’ [HHS
Reference No. E–176–2014–0–IL–08];
9. Japanese Patent No. 6742991 issued
August 19, 2020, entitled ‘‘Anti-Human
Papillomavirus 16 E7 T Cell Receptors’’ [HHS
Reference No. E–176–2014–0–JP–09];
10. Korean Patent No. 10–2445667 issued
September 16, 2022, entitled ‘‘Anti-Human
Papillomavirus 16 E7 T Cell Receptors’’ [HHS
Reference No. E–176–2014–0–KR–10];
11. Mexican Patent No. 375379 issued
September 25, 2020, entitled ‘‘Anti-Human
Papillomavirus 16 E7 T Cell Receptors’’ [HHS
Reference No. E–176–2014–0–MX–11];
12. Saudi Arabian Patent No. 7456 issued
January 5, 2021, entitled ‘‘Anti-Human
Papillomavirus 16 E7 T Cell Receptors’’ [HHS
Reference No. E–176–2014–0–SA–12];
13. United States Patent No. 10,174,098
issued January 8, 2019, entitled ‘‘AntiHuman Papillomavirus 16 E7 T Cell
Receptors’’ [HHS Reference No. E–176–2014–
0–US–13];
14. Hong Kong Patent No. HK1236203
issued January 8, 2021, entitled ‘‘AntiHuman Papillomavirus 16 E7 T Cell
Receptors’’ [HHS Reference No. E–176–2014–
0–HK–14];
15. United States Patent No. 10,870,687
issued December 22, 2020, entitled ‘‘AntiHuman Papillomavirus 16 E7 T Cell
Receptors’’ [HHS Reference No. E–176–2014–
0–US–15];
16. European Patent Application No.
19217074.4 filed December 17, 2019, entitled
‘‘Anti-Human Papillomavirus 16 E7 T Cell
Receptors’’ [HHS Reference No. E–176–2014–
0–EP–16];
17. Australian Patent No. 2019283892
issued May 13, 2021, entitled ‘‘Anti-Human
Papillomavirus 16 E7 T Cell Receptors’’ [HHS
Reference No. E–176–2014–0–AU–17];
18. Japanese Patent No. 6997267 issued
December 20, 2021, entitled ‘‘Anti-Human
Papillomavirus 16 E7 T Cell Receptors’’ [HHS
Reference No. E–176–2014–0–JP–53];
19. Saudi Arabian Patent Application No.
520412601 filed August 10, 2020, entitled
‘‘Anti-Human Papillomavirus 16 E7 T Cell
Receptors’’ [HHS Reference No. E–176–2014–
0–SA–54];
20. Hong Kong Patent Application No.
42020020661.3 filed November 24, 2020,
entitled ‘‘Anti-Human Papillomavirus 16 E7
T Cell Receptors’’ [HHS Reference No. E–
176–2014–0–HK–55];
21. Mexican Patent Application No. MX/a/
2020/010035 filed September 24, 2020,
entitled ‘‘Anti-Human Papillomavirus 16 E7
T Cell Receptors’’ [HHS Reference No. E–
176–2014–0–MX–56];
22. United States Patent No. 11,434,272
issued September 6, 2020, entitled ‘‘AntiHuman Papillomavirus 16 E7 T Cell
Receptors’’ [HHS Reference No. E–176–2014–
0–US–57];
23. Australian Patent No. 2021202227
issued February 23, 2023, entitled ‘‘AntiHuman Papillomavirus 16 E7 T Cell
Receptors’’ [HHS Reference No. E–176–2014–
0–AU–58];
24. Chinese Patent Application No.
20210399056.9 filed April 14, 2021, entitled
‘‘Anti-Human Papillomavirus 16 E7 T Cell
Receptors’’ [HHS Reference No. E–176–2014–
0–CN–59];
VerDate Sep<11>2014
16:38 Jan 08, 2024
Jkt 262001
25. Israeli Patent No. 282518 issued July 2,
2022, entitled ‘‘Anti-Human Papillomavirus
16 E7 T Cell Receptors’’ [HHS Reference No.
E–176–2014–0–IL–60];
26. Hong Kong Patent Application No.
42022046605.6 filed January 19, 2022,
entitled ‘‘Anti-Human Papillomavirus 16 E7
T Cell Receptors’’ [HHS Reference No. E–
176–2014–0–HK–62];
27. Japanese Patent No. 7291196 issued
June 6, 2023, entitled ‘‘Anti-Human
Papillomavirus 16 E7 T Cell Receptors’’ [HHS
Reference No. E–176–2014–0–JP–63];
28. Israeli Patent Application No. 290655
filed February 16, 2022, entitled ‘‘AntiHuman Papillomavirus 16 E7 T Cell
Receptors’’ [HHS Reference No. E–176–2014–
0–IL–64];
29. United States Patent Application No.
17/816,496 filed August 1, 2022, entitled
‘‘Anti-Human Papillomavirus 16 E7 T Cell
Receptors’’ [HHS Reference No. E–176–2014–
0–US–65];
30. Korean Patent Application No. 2022–
7032043 filed September 15, 2022, entitled
‘‘Anti-Human Papillomavirus 16 E7 T Cell
Receptors’’ [HHS Reference No. E–176–2014–
0–KR–66];
31. Australian Patent Application No.
2023200608 filed February 6, 2023, entitled
‘‘Anti-Human Papillomavirus 16 E7 T Cell
Receptors’’ [HHS Reference No. E–176–2014–
0–AU–01]; and
32. Japanese Patent Application No. 2023–
091878 filed June 2, 2023, entitled ‘‘AntiHuman Papillomavirus 16 E7 T Cell
Receptors’’ [HHS Reference No. E–176–2014–
0–JP–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:
‘‘Thermally controlled autologous T
cell therapy products for the treatment
of HPV-positive cancer in humans.’’
The E–176–2014 patent family is
primarily directed to an isolated TCR
reactive to HPV 16 E7 antigen in the
context of HLA–A*02:01 (the ‘‘E7
TCR’’). HPV describes a group of human
viruses known to cause malignancy. Of
the group, HPV–16 is the most prevalent
strain. Approximately 90% of adults are
estimated to have been exposed at some
point in their lifetime. HPV drives
transformation of infected cells through
the expression of certain oncoproteins,
chiefly E5, E6 and E7. The latter two are
constitutively expressed in malignant
cells and are necessary to maintain a
transformed state, rendering them
attractive therapeutic targets.
The E7 TCR may be useful in the
development of certain diagnostics and/
or therapeutics for the treatment of
cancers which express both the HPV 16
E7 oncoprotein and HLA–A*02:01.
Potential therapeutic applications of the
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
E7 TCR may include, but are not limited
to, engineered autologous or allogeneic
immune cell therapies (e.g., T cell or
natural killer cell-based) and TCR fusion
proteins and conjugates (e.g., soluble
TCR bi-specifics or TCR-drug
conjugates). The exclusive field of use
which may be granted to Port applies to
‘‘thermally controlled’’ autologous T
cell products, which is a subset of
engineered immune cell therapies.
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 4, 2024.
Richard U. Rodriguez,
Associate Director, Technology Transfer
Center, National Cancer Institute.
[FR Doc. 2024–00209 Filed 1–8–24; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Office of the Director, National
Institutes of Health; Notice of Meeting
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the Council of Councils.
The meeting will be held as a virtual
meeting open to the public as indicated
below, with attendance limited to space
available. Individuals who plan to
attend as well as those who need special
assistance, such as sign language
interpretation or other reasonable
accommodations, must notify the
Contact Person listed below in advance
of the meeting. The open session will be
E:\FR\FM\09JAN1.SGM
09JAN1
]]>Agencies
[Federal Register Volume 89, Number 6 (Tuesday, January 9, 2024)]
[Notices]
[Pages 1107-1108]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-00209]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive Patent License: Development and
Commercialization of Thermally Responsive T Cell Therapies for the
Treatment of HPV-Positive Cancer(s)
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 Port
Therapeutics, Inc. (``Port''). Port incorporated in Delaware and is
presently headquartered in Los Angeles, 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 January 24, 2024 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, Telephone: (240) 276-5484;
Email: [email protected].
SUPPLEMENTARY INFORMATION:
Intellectual Property
1. United States Provisional Patent Application No. 62/004,335
filed May 29, 2014, entitled ``Anti-Human Papillomavirus 16 E7 T
Cell Receptors'' [HHS Reference No. E-176-2014-0-US-01];
2. PCT Patent Application No. PCT/US2015/033129 filed May 29,
2015, entitled ``Anti-Human Papillomavirus 16 E7 T Cell Receptors''
[HHS Reference No. E-176-2014-0-PCT-02];
3. Australian Patent No. 2015266818 issued January 16, 2020,
entitled ``Anti-Human Papillomavirus 16 E7 T Cell Receptors'' [HHS
Reference No. E-176-2014-0-AU-03];
4. Brazilian Patent Application No. BR112016027805-4 effective
filing date of May 29, 2015, entitled ``Anti-Human Papillomavirus 16
E7 T Cell Receptors'' [HHS Reference No. E-176-2014-0-BR-04];
5. Canadian Patent Application No. 2,950,192 effective filing
date of May 29, 2015, entitled ``Anti-Human Papillomavirus 16 E7 T
Cell Receptors'' [HHS Reference No. E-176-2014-0-CA-05];
6. Chinese Patent No. ZL201580031789.X issued May 4, 2021,
entitled ``Anti-Human Papillomavirus 16 E7 T Cell Receptors'' [HHS
Reference No. E-176-2014-0-CN-06];
7. European Patent No. 3149031 issued December 18, 2019,
entitled ``Anti-Human Papillomavirus 16 E7 T Cell Receptors'' [HHS
Reference No. E-176-2014-0-EP-07];
a. Validated in: AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI,
FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, MK, MT, NL, NO, PL, PT,
RO, SE, SI, SK, SM and TR.
8. Israeli Patent No. 248797 issued September 1, 2021, entitled
``Anti-Human
[[Page 1108]]
Papillomavirus 16 E7 T Cell Receptors'' [HHS Reference No. E-176-
2014-0-IL-08];
9. Japanese Patent No. 6742991 issued August 19, 2020, entitled
``Anti-Human Papillomavirus 16 E7 T Cell Receptors'' [HHS Reference
No. E-176-2014-0-JP-09];
10. Korean Patent No. 10-2445667 issued September 16, 2022,
entitled ``Anti-Human Papillomavirus 16 E7 T Cell Receptors'' [HHS
Reference No. E-176-2014-0-KR-10];
11. Mexican Patent No. 375379 issued September 25, 2020,
entitled ``Anti-Human Papillomavirus 16 E7 T Cell Receptors'' [HHS
Reference No. E-176-2014-0-MX-11];
12. Saudi Arabian Patent No. 7456 issued January 5, 2021,
entitled ``Anti-Human Papillomavirus 16 E7 T Cell Receptors'' [HHS
Reference No. E-176-2014-0-SA-12];
13. United States Patent No. 10,174,098 issued January 8, 2019,
entitled ``Anti-Human Papillomavirus 16 E7 T Cell Receptors'' [HHS
Reference No. E-176-2014-0-US-13];
14. Hong Kong Patent No. HK1236203 issued January 8, 2021,
entitled ``Anti-Human Papillomavirus 16 E7 T Cell Receptors'' [HHS
Reference No. E-176-2014-0-HK-14];
15. United States Patent No. 10,870,687 issued December 22,
2020, entitled ``Anti-Human Papillomavirus 16 E7 T Cell Receptors''
[HHS Reference No. E-176-2014-0-US-15];
16. European Patent Application No. 19217074.4 filed December
17, 2019, entitled ``Anti-Human Papillomavirus 16 E7 T Cell
Receptors'' [HHS Reference No. E-176-2014-0-EP-16];
17. Australian Patent No. 2019283892 issued May 13, 2021,
entitled ``Anti-Human Papillomavirus 16 E7 T Cell Receptors'' [HHS
Reference No. E-176-2014-0-AU-17];
18. Japanese Patent No. 6997267 issued December 20, 2021,
entitled ``Anti-Human Papillomavirus 16 E7 T Cell Receptors'' [HHS
Reference No. E-176-2014-0-JP-53];
19. Saudi Arabian Patent Application No. 520412601 filed August
10, 2020, entitled ``Anti-Human Papillomavirus 16 E7 T Cell
Receptors'' [HHS Reference No. E-176-2014-0-SA-54];
20. Hong Kong Patent Application No. 42020020661.3 filed
November 24, 2020, entitled ``Anti-Human Papillomavirus 16 E7 T Cell
Receptors'' [HHS Reference No. E-176-2014-0-HK-55];
21. Mexican Patent Application No. MX/a/2020/010035 filed
September 24, 2020, entitled ``Anti-Human Papillomavirus 16 E7 T
Cell Receptors'' [HHS Reference No. E-176-2014-0-MX-56];
22. United States Patent No. 11,434,272 issued September 6,
2020, entitled ``Anti-Human Papillomavirus 16 E7 T Cell Receptors''
[HHS Reference No. E-176-2014-0-US-57];
23. Australian Patent No. 2021202227 issued February 23, 2023,
entitled ``Anti-Human Papillomavirus 16 E7 T Cell Receptors'' [HHS
Reference No. E-176-2014-0-AU-58];
24. Chinese Patent Application No. 20210399056.9 filed April 14,
2021, entitled ``Anti-Human Papillomavirus 16 E7 T Cell Receptors''
[HHS Reference No. E-176-2014-0-CN-59];
25. Israeli Patent No. 282518 issued July 2, 2022, entitled
``Anti-Human Papillomavirus 16 E7 T Cell Receptors'' [HHS Reference
No. E-176-2014-0-IL-60];
26. Hong Kong Patent Application No. 42022046605.6 filed January
19, 2022, entitled ``Anti-Human Papillomavirus 16 E7 T Cell
Receptors'' [HHS Reference No. E-176-2014-0-HK-62];
27. Japanese Patent No. 7291196 issued June 6, 2023, entitled
``Anti-Human Papillomavirus 16 E7 T Cell Receptors'' [HHS Reference
No. E-176-2014-0-JP-63];
28. Israeli Patent Application No. 290655 filed February 16,
2022, entitled ``Anti-Human Papillomavirus 16 E7 T Cell Receptors''
[HHS Reference No. E-176-2014-0-IL-64];
29. United States Patent Application No. 17/816,496 filed August
1, 2022, entitled ``Anti-Human Papillomavirus 16 E7 T Cell
Receptors'' [HHS Reference No. E-176-2014-0-US-65];
30. Korean Patent Application No. 2022-7032043 filed September
15, 2022, entitled ``Anti-Human Papillomavirus 16 E7 T Cell
Receptors'' [HHS Reference No. E-176-2014-0-KR-66];
31. Australian Patent Application No. 2023200608 filed February
6, 2023, entitled ``Anti-Human Papillomavirus 16 E7 T Cell
Receptors'' [HHS Reference No. E-176-2014-0-AU-01]; and
32. Japanese Patent Application No. 2023-091878 filed June 2,
2023, entitled ``Anti-Human Papillomavirus 16 E7 T Cell Receptors''
[HHS Reference No. E-176-2014-0-JP-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:
``Thermally controlled autologous T cell therapy products for the
treatment of HPV-positive cancer in humans.''
The E-176-2014 patent family is primarily directed to an isolated
TCR reactive to HPV 16 E7 antigen in the context of HLA-A*02:01 (the
``E7 TCR''). HPV describes a group of human viruses known to cause
malignancy. Of the group, HPV-16 is the most prevalent strain.
Approximately 90% of adults are estimated to have been exposed at some
point in their lifetime. HPV drives transformation of infected cells
through the expression of certain oncoproteins, chiefly E5, E6 and E7.
The latter two are constitutively expressed in malignant cells and are
necessary to maintain a transformed state, rendering them attractive
therapeutic targets.
The E7 TCR may be useful in the development of certain diagnostics
and/or therapeutics for the treatment of cancers which express both the
HPV 16 E7 oncoprotein and HLA-A*02:01. Potential therapeutic
applications of the E7 TCR may include, but are not limited to,
engineered autologous or allogeneic immune cell therapies (e.g., T cell
or natural killer cell-based) and TCR fusion proteins and conjugates
(e.g., soluble TCR bi-specifics or TCR-drug conjugates). The exclusive
field of use which may be granted to Port applies to ``thermally
controlled'' autologous T cell products, which is a subset of
engineered immune cell therapies.
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 4, 2024.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer
Institute.
[FR Doc. 2024-00209 Filed 1-8-24; 8:45 am]
BILLING CODE 4140-01-P
