Notice2024-02491
Prospective Grant of an Exclusive Patent License: Vaccine Augmented Adoptive Cell Therapy for the Treatment of Cancer
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
February 7, 2024
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 Marble Therapeutics, Inc. ("Marble"), headquartered in Boston, MA.
Full Text
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<title>Federal Register, Volume 89 Issue 26 (Wednesday, February 7, 2024)</title>
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[Federal Register Volume 89, Number 26 (Wednesday, February 7, 2024)]
[Notices]
[Pages 8438-8439]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-02491]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive Patent License: Vaccine
Augmented Adoptive Cell Therapy for the Treatment of Cancer
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 Marble
Therapeutics, Inc. (``Marble''), headquartered in Boston, MA.
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 February 22, 2024 will be considered.
ADDRESSES: Requests for copies of the patent applications, inquiries,
and comments relating to the contemplated
[[Page 8439]]
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#97f6f9f3eeb9f5e2e5fcf2d7f9feffb9f0f8e1"><span class="__cf_email__" data-cfemail="375659534e195542455c5277595e5f19505841">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
Intellectual Property
1. United States Provisional Patent Application No. 63/295,762
filed December 31, 2021, entitled ``T Cell Therapy with Vaccination as
a Combination Immunotherapy Against Cancer'' [HHS Reference No. E-046-
2022-0-US-01]; and
2. International Patent Application No. PCT/US2022/082579 filed
December 29, 2022, entitled ``T Cell Therapy with Vaccination as a
Combination Immunotherapy Against Cancer'' [HHS Reference No. E-046-
2022-0-PCT-02].
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 combination
immunotherapies for the treatment of cancer in humans, comprising at
least the following elements:
1. An autologous T cell product, where the T cells are tumor
infiltrating lymphocytes (TIL) or chimeric antigen receptor-
expressing T cells (CAR-T); and
2. A neoantigen cancer vaccine.''
The E-046-2022 patent family is primarily directed to a combination
immunotherapy comprising a population of antigen-specific immune cells
(e.g., T cells) and a vaccine targeting the same antigen(s). In
oncology, many investigational adoptive cell therapies rely on antigen-
specific T cells isolated from the patient in need of treatment.
However, these cells often exist in a terminally differentiated and
exhausted state and are unable to mount a robust immune response
following reinfusion. Recent evidence suggests that administration of a
vaccine in parallel with the T cell product can ameliorate this
performance defect when the vaccine targets antigen(s) recognized by
the T cells. It is hoped that this two-part approach will enhance
treatment efficacy. The exclusive field of use which may be granted to
Marble applies to only certain autologous T cell products and
vaccination strategies and does not include, for example, at least two
broad classes of cell therapies: allogeneic T cell-based products and
TCR-engineered T cell products (TCR-T). Accordingly, the proposed scope
of rights which may be conveyed under the license covers a portion of
the possible applications of E-046-2022.
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: February 2, 2024.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer
Institute.
[FR Doc. 2024-02491 Filed 2-6-24; 8:45 am]
BILLING CODE 4140-01-P
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