[Federal Register Volume 86, Number 174 (Monday, September 13, 2021)]
[Notices]
[Pages 50898-50899]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-19604]


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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.

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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: <a href="/cdn-cgi/l/email-protection#66151308074801130a071f26080f0e48010910"><span class="__cf_email__" data-cfemail="1a696f747b347d6f767b635a747372347d756c">[email protected]</span></a>.

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);

[[Page 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 EGFR-expressing 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


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