50898 Federal Register / Vol. 86, No. 174 / Monday, September 13, 2021 / Notices 

Jane M. Lambert, 

Project Clearance Liaison, National Institute 

of Environmental Health Sciences, National 

Institutes of Health. 

[FR Doc. 2021–19693 Filed 9–10–21; 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: Development and 

Commercialization of Cell Therapies 

for 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 Athenex, Inc. 

(‘‘Athenex’’) headquartered in Buffalo, 

NY. 

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 September 28, 2021 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, Ph.D., 

Technology Transfer Manager, NCI 

Technology Transfer Center, Telephone: 

(240)–276–5530; Email: suna.gulay@

nih.gov. 

SUPPLEMENTARY INFORMATION: 

Intellectual Property 

GROUP A: 

E–237–2017–0/2: T Cell Receptors 

Recognizing Mutated P53 

1. US Provisional Patent Application 

62/565,383, filed September 29, 2017 

(E–237–2017–0–US–01); 

2. International Patent Application 

PCT/US2018/051285, filed September 

17, 2018 (E–237–2017–2–PCT–01); 

3. Australian Patent Application 

2018342246, filed September 17, 2018 

(E–237–2017–2–AU–02); 

4. Brazilian Patent Application 

BR112020006012–7, filed September 17, 

2018 (E–237–2017–2–BR–03); 

5. Canadian Patent Application 

3977024, filed September 17, 2018 (E– 

237–2017–2–CA–04); 

6. Chinese Patent Application 

201880074539.8, filed September 17, 

2018 (E–237–2017–2–CN–05); 

7. Costa Rica Patent Application 

2020–0170, filed September 17, 2018 

(E–237–2017–2–CR–06); 

8. Eurasian Patent Application 

202090757, filed September 17, 2018 

(E–237–2017–2–EA–07); 

9. European Patent Application 

18780006.5, filed September 17, 2018 

(E–237–2017–2–EP–08); 

10. Israeli Patent Application 273515, 

filed September 17, 2018 (E–237–2017– 

2–IL–09); 

11. India Patent Application 

202047013911, filed September 17, 2018 

(E–237–2017–2–IN–10); 

12. Japanese Patent Application 2020– 

517556, filed September 17, 2018 (E– 

237–2017–2–JP–11); 

13. Korean Patent Application 2020– 

7012344, filed September 17, 2018 (E– 

237–2017–2–KR–12); 

14. Mexico Patent Application MX/a/ 

2020/003504, filed September 17, 2018 

(E–237–2017–2–MX–13); 

15. New Zealand Patent Application 

763023, filed September 17, 2018 (E– 

237–2017–2–NZ–14); 

16. Singapore Patent Application 

11202002636P, filed September 17, 

2018 (E–237–2017–2–SG–15); 

17. United States Utility Patent 

Application 16/651,242, filed 

September 17, 2018 (E–237–2017–2– 

US–16); and 

18. Hong Kong Patent Application 

62020021272.3, filed November 30, 

2020 (E–237–2017–2–HK–17). 

E–135–2019: T Cell Receptors 

Recognizing R175H or Y220C Mutation 

in P53 

1. US Provisional Patent Application 

62/867,619, filed June 27, 2019 (E–135– 

2019–0–US–01); 

2. International Patent Application 

PCT/US2020/039785, filed June 26, 

2020 (E–135–2019–0–PCT–02); and 

3. Taiwanese Patent Application 

109121744, filed June 26, 2020 (E–135– 

2019–0–TW–03). 

E–173–2020: T Cell Receptors 

Recognizing R273C or Y220C Mutation 

in P53 

1. US Provisional Patent Application 

63/074,747, filed September 4, 2020 (E– 

173–2020–0–US–01). 

E–098–2018: T Cell Receptors Which 

Recognize Mutated EGFR 

1. US Provisional Patent Application 

62/665,234, filed May 1, 2018 (E–098– 

2018–0–US–01); 

2. International Patent Application 

PCT/US2019/030108, filed May 1, 2019 

(E–098–2018–0–PCT–02); 

3. Australian Patent Application 

2019263233, filed May 1, 2019 (E–098– 

2018–0–AU–03); 

4. Canadian Patent Application 

3,099,106, filed May 1, 2019 (E–098– 

2018–0–CA–04); 

5. European Patent Application 

19723615.1, filed May 1, 2019 (E–098– 

2018–0–EP–05); and 

6. United States Utility Patent 

Application 17/051,860, filed May 1, 

2019 (E–098–2018–0–US–06). 

E–165–2020: HLA Class II-Restricted 

DRB T Cell Receptors Against RAS With 

G12D Mutation 

1. US Provisional Application 63/ 

050,9131, filed July 13, 2020 (E–165– 

2020–0–US–01); and 

2. International Patent Application 

PCT/US2021/041375, filed July 13, 2021 

(E–165–2020–0–PCT–02). 

E–172–2020: HLA Class II-Restricted 

DRB T Cell Receptors Against RAS With 

G12V Mutation 

1. US Provisional Application 63/ 

052,502, filed July 16, 2020 (E–172– 

2020–0–US–01); and 

2. International Patent Application 

PCT/US2021/041737, filed July 15, 2021 

(E–172–2020–0–PCT–02). 

E–189–2020: HLA Class II-Restricted DQ 

T Cell Receptors Against RAS With 

G13D Mutation 

1. US Provisional Application 63/ 

086,674, filed October 2, 2020 (E–189– 

2020–0–US–01). 

E–190–2020: HLA Class I-Restricted T 

Cell Receptors Against RAS With G12V 

Mutation 

1. US Provisional Application 63/ 

060,340, filed August 3, 2020 (E–190– 

2020–0–US–01) and U.S., PCT and 

foreign patent applications claiming 

priority to the aforementioned 

application. 

GROUP B: 

E–237–2017–1: Methods of Isolating T 

Cells Having Antigenic Specificity for a 

P53 Cancer-Specific Mutation 

1. US Provisional Patent Application 

62/565,464, filed September 29, 2017 

(E–237–2017–1–US–01); 

2. International Patent Application 

PCT/US2018/051280, filed September 

17, 2018 (E–237–2017–1–PCT–02); 

3. Australian Patent Application 

2018342245, filed September 17, 2018 

(E–237–2017–1–AU–03); 

4. Canadian Patent Application 

3080274, filed September 17, 2018 (E– 

237–2017–1–CA–04); 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 86, No. 174 / Monday, September 13, 2021 / Notices 50899 

5. Chinese Patent Application 

201880063656.4, filed September 17, 

2018 (E–237–2017–1–CN–05); 

6. European Patent Application 

18782605.2, filed September 17, 2018 

(E–237–2017–1–EP–06); 

7. Israeli Patent Application 273516, 

filed September 17, 2018 (E–237–2017– 

1–IL–07); 

8. Japanese Patent Application 2020– 

517553, filed September 17, 2018 (E– 

237–2017–1–JP–08); 

9. Korean Patent Application 2020– 

7012343, filed September 17, 2018 (E– 

237–2017–1–KR–09); 

10. Singapore Patent Application 

11202002635R, filed September 17, 

2018 (E–237–2017–1–SG–10); 

11. United States Utility Patent 

Application 16/650,696, filed 

September 17, 2018 (E–237–2017–1– 

US–11); and 

12. Hong Kong Patent Application 

62020021274.9, filed November 30, 

2020 (E–237–2017–1–HK–12). 

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: 

E–237–2017–0, E–135–2019 and E–173– 

2020 patent rights are primarily directed to 

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. 

E–165–2020, E–172–2020, E–189–2020 and 

E–190–2020 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. 

E–098–2018 patent rights are primarily 

directed to isolated TCRs reactive to mutated 

epidermal growth factor receptor (EGFR), 

within the context of HLA DPA1*02:01 

DPB1*01:01. 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: 

E–237–2017–1 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 

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. 2021–19604 Filed 9–10–21; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF THE INTERIOR 

Bureau of Land Management 

[L14400000 PN0000 HQ350000 212; OMB 

Control Number 1004–0012] 

Agency Information Collection 

Activities; Application for Land for 

Recreation or Public Purposes 

AGENCY: Bureau of Land Management, 

Interior. 

ACTION: Notice of information collection; 

request for comment. 

SUMMARY: In accordance with the 

Paperwork Reduction Act of 1995 

(PRA), the Bureau of Land Management 

(BLM) proposes to renew an information 

collection. 

DATES: Interested persons are invited to 

submit comments on or before October 

13, 2021. 

ADDRESSES: Written comments and 

recommendations for this information 

collection request (ICR) should be sent 

within 30 days of publication of this 

notice to www.reginfo.gov/public/do/ 

PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under 30-day Review—Open 

for Public Comments’’ or by using the 

search function. 

FOR FURTHER INFORMATION CONTACT: To 

request additional information about 

this ICR, contact Susie Greenhalgh by 

email at lgreenhalgh@blm.gov, or by 

telephone at 202–302–4288. Individuals 

who are hearing or speech impaired 

may call the Federal Relay Service at 1– 

800–877–8339 for TTY assistance. You 

may also view the ICR at http://

www.reginfo.gov/public/do/PRAMain. 

SUPPLEMENTARY INFORMATION: In 

accordance with the PRA and 5 CFR 

1320.8(d)(1), we provide the general 

public and other Federal agencies with 

an opportunity to comment on new, 


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