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Federal Register / Vol. 86, No. 174 / Monday, September 13, 2021 / Notices
lotter on DSK11XQN23PROD with NOTICES1

5. Chinese Patent Application 201880063656.4, filed September 17, 2018 E23720171CN05;
6. European Patent Application 18782605.2, filed September 17, 2018
E23720171EP06;
7. Israeli Patent Application 273516, filed September 17, 2018 E2372017
1IL07;
8. Japanese Patent Application 2020
517553, filed September 17, 2018 E
23720171JP08;
9. Korean Patent Application 2020
7012343, filed September 17, 2018 E
23720171KR09;
10. Singapore Patent Application 11202002635R, filed September 17, 2018 E23720171SG10;
11. United States Utility Patent Application 16/650,696, filed September 17, 2018 E23720171
US11; and 12. Hong Kong Patent Application 62020021274.9, filed November 30, 2020 E23720171HK12.
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 fields of use may be limited to the following:
Fields of Use Applying to Intellectual Property Group A
Development, manufacture, and commercialization of allogeneic Natural Killer T NKT cell therapy products engineered via viral and non-viral means, including CRISPR modification, to express T
cell receptors reactive to mutated P53, KRAS, and EGFR within the context of multiple HLAs, as claimed in the Licensed Patent Rights, for the treatment of human cancers.
For the purposes of this license, NKT cells are a subset of peripheral blood lymphocytes specifically and intentionally isolated based on unique characteristics of NKT cells resulting in a manufactured clinical product containing at least 50% NKT cells.
Fields of Use Applying to Intellectual Property Group B
Development, manufacture, and commercialization of allogeneic Natural Killer T NKT cell therapy products engineered via viral and non-viral means, including CRISPR modification, to express T
cell receptors reactive to mutated P53, isolated as claimed in the Licensed Patent Rights, for the treatment of human cancers.
For the purposes of this license, NKT cells are a subset of peripheral blood lymphocytes specifically and intentionally isolated based on unique characteristics of NKT cells resulting in a manufactured clinical product containing at least 50% NKT cells.

Intellectual Property Group A
description is as follows:
E23720170, E1352019 and E173
2020 patent rights are primarily directed to
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isolated TCRs reactive to mutated tumor protein 53 TP53 or P53, within the context of several HLAs. 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.
E1652020, E1722020, E1892020 and E1902020 patent rights are primarily directed to isolated 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.
E0982018 patent rights are primarily directed to isolated TCRs reactive to mutated epidermal growth factor receptor EGFR, within the context of HLA DPA102:01
DPB101:01. EGFR is a transmembrane protein involved in cell growth and proliferation signaling. Mutations in the gene encoding EGFR can lead to its overexpression, causing several types of cancer e.g., non-small cell lung cancer NSCLC. Because of its prevalence in certain cancers and its restricted expression to precancerous and cancerous tissues, this antigen may be targeted on mutant EGFRexpressing tumors with minimal normal tissue toxicity.

Intellectual Property Group B
description is as follows:
E23720171 patent rights are primarily directed to methods of rapidly isolating T
cells which are reactive to mutated P53
antigens. Briefly, pools of 25-mer peptides covering all known P53 hotspot mutations have been generated. These peptides may be pulsed into antigen presenting cells which are subsequently co-cultured with isolated T
cells. Reactive T cells are then purified and may be used as source material for the further isolation of mutant P53-targeting TCRs.

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
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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: September 7, 2021.
Richard U. Rodriguez, Associate Director, Technology Transfer Center, National Cancer Institute.
FR Doc. 202119604 Filed 91021; 8:45 am BILLING CODE 414001P

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