Notice2026-18877
Prospective Grant of an Exclusive Patent License: Development and Commercialization of Engineered Cell Therapies for the Treatment of HPV 16 E6-Expressing Cancers
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
September 15, 2026
Issuing agencies
Health and Human Services DepartmentNational Institutes of Health
Abstract
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 MedGene Therapeutics, Inc. ("MedGene"), a company located in Silver Spring, Maryland, the United States of America.
Full Text
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<title>Federal Register, Volume 91 Issue 177 (Tuesday, September 15, 2026)</title>
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[Federal Register Volume 91, Number 177 (Tuesday, September 15, 2026)]
[Notices]
[Pages 58458-58459]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-18877]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive Patent License: Development and
Commercialization of Engineered Cell Therapies for the Treatment of HPV
16 E6-Expressing Cancers
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
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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 MedGene
Therapeutics, Inc. (``MedGene''), a company located in Silver Spring,
Maryland, the United States of America.
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 September 30, 2026 will be considered.
ADDRESSES: 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: <a href="/cdn-cgi/l/email-protection#503225223b353122103d31393c7e3e39387e373f26"><span class="__cf_email__" data-cfemail="a5c7d0d7cec0c4d7e5c8c4ccc98bcbcccd8bc2cad3">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
Intellectual Property
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Reference No. (with country code) Application No. File date Patent No. Issue date
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E-495-2013-0-US-01.................... 61/846,167.............. 7/15/2013 .............. ..............
E-495-2013-0-PCT-02................... PCT/US2014/046480....... 7/14/2014 .............. ..............
E-495-2013-0-JP-07.................... 2016-527006............. 1/15/2016 6628719 12/13/2019
E-495-2013-0-US-08.................... 14/905,108.............. 1/14/2016 9,822,162 11/21/2017
E-495-2013-0-US-09.................... 15/786,966.............. 10/18/2017 10,329,339 6/25/2019
E-495-2013-0-US-11.................... 16/408,939.............. 5/10/2019 10,913,785 2/9/2021
E-495-2013-0-JP-19.................... 2019-219105............. 12/3/2019 6959970 10/12/2021
E-495-2013-0-US-22.................... 17/142,486.............. 1/6/2021 11,697,676 7/11/2023
E-495-2013-0-JP-23.................... 2021-166407............. 10/8/2021 7223822 2/8/2023
E-495-2013-0-US-02.................... 18/323,493.............. 5/25/2023 12,187,779 1/7/2025
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[[Page 58459]]
The prospective exclusive license territory may be ``Japan,
Republic of Korea and the United States of America'', and the field of
use may be limited to the following:
``Ex vivo generated T cell therapy products comprising autologous
or allogeneic T cells genetically engineered to express exogenous T-
cell receptors reactive to the HPV-16 E6 oncoprotein for the treatment
of HPV-associated cervical cancer, head and neck cancer (including
oropharyngeal cancer), and anogenital cancer in humans.''
The E-495-2013 patent family is primarily directed to an isolated T
cell receptor (TCR) reactive to HPV 16 E6 antigen in the context of
HLA-A*02. Among other applications, the claimed TCR may be useful in
the development of engineered adoptive cell therapy products for the
treatment of HPV-16 E6-positive cancers in patients who also express
HLA-A*02.
Human papillomaviruses (HPV) are a diverse group of viral pathogens
which commonly infect humans. While most infections are rapidly cleared
by the host, certain HPV (e.g., HPV 16 and 18) may establish chronic
infections and are highly associated with the development of cancer. In
such cases, cancer formation is facilitated by the sustained activity
of certain oncoproteins, chiefly E5, E6 and E7.
E6 is a small (~150 amino acid) protein that promotes malignant
transformation primarily through its ability to bind the tumor
suppressor p53 in complex with the cellular ubiquitin ligase E6-AP
(UBE3A), thereby targeting p53 for proteasomal degradation. Together
with the E7 oncoprotein (which inactivates the tumor suppressor pRb),
E6 cooperatively drives carcinogenesis in infected cells, and its
continued expression is required for maintenance of the transformed
phenotype. By virtue of this essential role and its restricted
expression to diseased cells, E6 is a recognized therapeutic target.
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. Complete applications for a license that are timely filed
in response to this notice will be treated as objections to the grant
of the contemplated exclusive patent license. 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.
``This Notice is made in accordance with 35 U.S.C. 209(e) and 37
CFR 404 Authority to grant exclusive licenses.''
Dated: September 11, 2026.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer
Institute.
[FR Doc. 2026-18877 Filed 9-14-26; 8:45 am]
BILLING CODE 4140-01-P
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