HHS References 2021 Cuban Patent Application In Licensing Notification: “HLA Class I-Restricted T Cell Receptors Against RAS with G12D Mutation”
/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 Replay Holdings LLC (“Replay”) located in San Diego, California.
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 January 17, 2023 will be considered.
ADDRESSES: Requests for copies of the patent application, inquiries, and comments relating to the contemplated an Exclusive Patent License should be directed to: Suna Gulay French, Technology Transfer Manager, Telephone: (240) 276-7424; Email: suna.gulay@nih.gov.
SUPPLEMENTARY INFORMATION: Intellectual Property Group A
142. Cuban Patent Application No. 2022-0044 effective filing date of February 12, 2021, entitled “HLA Class I-Restricted T Cell Receptors Against RAS with G12D Mutation” [HHS Ref. No. E-031-2020-0-CU-22];
(and U.S. and foreign patent applications claiming priority to the aforementioned applications)
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 allogeneic Natural Killer (NK) cell therapy products engineered to express a therapeutic T cell receptor claimed in the Licensed Patent Rights for the treatment or prevention of cancer in humans. Specifically excluded from this field of use are Natural Killer T (NKT) cell therapy products engineered via viral and non-viral means for the treatment of human cancers, wherein the NKT cell therapy product contains at least 50% NKT cells.”
Intellectual Property Group A is primarily directed to isolated T cell receptors (TCRs) reactive to mutated Kirsten rat sarcoma viral oncogene homolog (KRAS), within the context of several human leukocyte antigens (HLAs). Mutated KRAS, which plays a well-defined driver role in oncogenesis, is expressed by a variety of human cancers, including pancreatic, lung, endometrial, ovarian and prostate. Due to its restricted expression in precancerous and cancerous cells, this antigen may be targeted on mutant KRAS-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 in 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: December 23, 2022.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer Institute.
[FR Doc. 2022-28404 Filed 12-29-22; 8:45 am]
BILLING CODE 4140-01-P
