[Federal Register Volume 89, Number 57 (Friday, March 22, 2024)]
[Notices]
[Page 20486]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-06128]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive Patent License: Adoptive T Cell 
Therapy Products Produced Using a Pharmacological p38 Mitogen-Activated 
Protein Kinase (MAPK) Inhibitor

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 Poolbeg Pharma 
(UK) Limited, incorporated in the United Kingdom.

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 April 8, 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. 62/570,708 
filed October 11, 2017, entitled ``Methods of Producing T Cell 
Populations Using P38 MAPK Inhibitors'' [HHS Reference No. E-002-2018-
0-US-01];
    2. International Patent Application No. PCT/US2018/055206 filed 
October 10, 2018, entitled ``Methods of Producing T Cell Populations 
Using P38 MAPK Inhibitors'' [HHS Reference No. E-002-2018-0-PCT-02]; 
and
    3. United States Patent Application No. 16/754,926 filed April 9, 
2020, entitled ``Methods of Producing T Cell Populations Using P38 MAPK 
Inhibitors'' [HHS Reference No. E-002-2018-0-US-03].
    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 the United 
States of America, and the field of use may be limited to the 
following:
    ``The treatment of cancer in humans using adoptive T cell therapy 
products produced through the use of a pharmacological p38 MAPK 
inhibitor.''
    The E-002-2018 patent family is primarily directed to a method of 
producing populations of T cells for the treatment of cancer wherein 
the cells are cultured (e.g., expanded) in the presence of a p38 
mitogen-activated protein kinase (MAPK) inhibitor. 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, 
or enter such a state following manipulation ex vivo, and are unable to 
mount a robust immune response following reinfusion. Recent evidence 
suggests that inhibition of P38 MAPK signaling in T cells during ex 
vivo expansion can ameliorate this performance defect. It is hoped that 
this modified cell manufacturing approach will enhance treatment 
efficacy. The exclusive field of use which may be granted to Poolbeg 
applies to only certain T cell manufacturing methods which rely on 
pharmacologic P38 MAPK inhibitors. Accordingly, the proposed scope of 
rights which may be conveyed under the license covers a portion of the 
possible applications of E-002-2018.
    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: March 19, 2024.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2024-06128 Filed 3-21-24; 8:45 am]
BILLING CODE 4140-01-P