[Federal Register Volume 89, Number 26 (Wednesday, February 7, 2024)]
[Notices]
[Pages 8438-8439]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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: [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]; 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