Prospective Grant of an Exclusive Patent License: Adoptive T Cell Therapy Products Produced Using a Pharmacological p38 Mitogen-Activated Protein Kinase (MAPK) Inhibitor, 20486 [2024-06128]

Download as PDF 20486 Federal Register / Vol. 89, No. 57 / Friday, March 22, 2024 / Notices 27, 2024, 10:30 a.m. to March 27, 2024, 12:30 p.m., National Institutes of Health, NIDDK, Democracy II, Suite 7000A, 6707 Democracy Boulevard, Bethesda, MD 20892 which was published in the Federal Register on March 14, 2024, 89 FR 18652. This meeting was amended to change the start date and end date from 03–27– 2024 to 04–02–2024. The meeting is closed to the public. Dated: March 18, 2024. Miguelina Perez, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2024–06127 Filed 3–21–24; 8:45 am] BILLING CODE 4140–01–P 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 MitogenActivated Protein Kinase (MAPK) Inhibitor AGENCY: National Institutes of Health, HHS. ACTION: Notice. 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. SUMMARY: 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: andy.burke@nih.gov. SUPPLEMENTARY INFORMATION: ddrumheller on DSK120RN23PROD with NOTICES1 ADDRESSES: 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 VerDate Sep<11>2014 19:15 Mar 21, 2024 Jkt 262001 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. PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Respiratory Sciences. Date: April 16, 2024. Time: 9:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892. Contact Person: Ghenima Dirami, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4122, MSC 7814, Bethesda, MD 20892, 240–498– 7546, diramig@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Vascular and Hematology Member Application Review. Date: April 17, 2024. Time: 11:00 a.m. to 3:00 p.m. E:\FR\FM\22MRN1.SGM 22MRN1

Agencies

[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.