2023-21050. Prospective Grant of an Exclusive Patent License: Development and Commercialization of Engineered T Cell Therapies for the Treatment of Cancer

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 Moonlight Bio, Inc. (“Moonlight”), headquartered in Seattle, WA.

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 October 12, 2023 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. 63/492,256 filed March 27, 2023, entitled “T Cell Receptors Targeting Y220C or R175H Mutation in P53” [HHS Reference No. E–054–2023–0–US–01].

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 autologous T cell therapy products genetically engineered to express a P53 R175H-reactive TCR claimed in the Licensed Patent Rights for the treatment of cancer in humans.”

The E–054–2023 patent family is primarily directed to isolated T cell receptors (TCRs) reactive to certain mutated forms of tumor protein 53 (TP53 or P53), within the context of several human leukocyte antigens. P53 is the archetypal tumor suppressor gene and the most frequently mutated gene in cancer. Contemporary estimates suggest that >50% of all tumors carry mutations in P53. Because of its prevalence in cancer and its restricted expression to precancerous and cancerous cells, this antigen may be targeted on mutant P53-expressing tumors with minimal normal tissue toxicity.

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: September 21, 2023.

Richard U. Rodriguez,

Associate Director, Technology Transfer Center, National Cancer Institute.