[Federal Register Volume 89, Number 231 (Monday, December 2, 2024)]
[Notices]
[Pages 95224-95225]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-28081]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive Patent License: Vaccine
Augmented Tumor Infiltrating Lymphocytes 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 Iovance
Biotherapeutics, Inc. (``Iovance''), headquartered in San Carlos, CA.
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 17, 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. 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];
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];
3. Australian Patent Application No. 2022425620 filed June 25,
2024, entitled ``T Cell Therapy with Vaccination as a Combination
Immunotherapy Against Cancer'' [HHS Reference No. E-046-2022-0-AU-01];
4. Canadian Patent Application No. 3241588 filed June 18, 2024,
entitled ``T Cell Therapy with Vaccination as a Combination
Immunotherapy Against Cancer'' [HHS Reference No. E-046-2022-0-CA-01];
5. Chinese Patent Application No. 202280092973.5 filed August 30,
2024, entitled ``T Cell Therapy with Vaccination as a Combination
Immunotherapy Against Cancer'' [HHS Reference No. E-046-2022-0-CN-01];
6. European Patent Application No. 22854399.7 filed June 25, 2024,
entitled ``T Cell Therapy with Vaccination as a Combination
Immunotherapy Against Cancer'' [HHS Reference No. E-046-2022-0-EP-01];
7. Japanese Patent Application No. 2024-539628 filed June 28, 2024,
entitled ``T Cell Therapy with Vaccination as a Combination
Immunotherapy Against Cancer'' [HHS Reference No. E-046-2022-0-JP-01];
and
8. United States Patent Application No. 18/720,347 filed June 14,
2024, entitled ``T Cell Therapy with Vaccination as a Combination
Immunotherapy Against Cancer'' [HHS Reference No. E-046-2022-0-US-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 tumor infiltrating lymphocyte (TIL) T cell
product; 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 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. This two-part approach
may enhance treatment efficacy.
It is noted that the exclusive field of use which may be granted to
Iovance applies to only certain autologous T cell products and
vaccination strategies and does not include, for example, any non-TIL-
based applications. Accordingly, the scope of rights which may be
conveyed under the proposed license
[[Page 95225]]
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: November 25, 2024.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer
Institute.
[FR Doc. 2024-28081 Filed 11-29-24; 8:45 am]
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