2024-06128. 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: [phone]; Email: [e-mail].

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.