82_FR_60649 82 FR 60406 - Prospective Grant of an Exclusive Patent License: The Development of an Anti-CD30 Chimeric Antigen Receptor (CAR) for the Treatment of Human Cancer

82 FR 60406 - Prospective Grant of an Exclusive Patent License: The Development of an Anti-CD30 Chimeric Antigen Receptor (CAR) for the Treatment of Human Cancer

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 82, Issue 243 (December 20, 2017)

Page Range60406-60407
FR Document2017-27416

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 Kite Pharma, Inc. (``Kite'') located in Santa Monica, CA.

Federal Register, Volume 82 Issue 243 (Wednesday, December 20, 2017) 
[Federal Register Volume 82, Number 243 (Wednesday, December 20, 2017)]
[Notices]
[Pages 60406-60407]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-27416]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive Patent License: The Development 
of an Anti-CD30 Chimeric Antigen Receptor (CAR) for the Treatment of 
Human Cancer

AGENCY: National Institutes of Health

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 Kite Pharma, 
Inc. (``Kite'') located in Santa Monica, CA.

DATES: Only written comments and/or complete applications for a license 
which are received by the National Cancer Institute's Technology 
Transfer Center on or before January 4, 2018 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
and comments relating to the contemplated Exclusive Patent License 
should be directed to: David A. Lambertson, Ph.D., Senior Technology 
Transfer Manager, NCI Technology Transfer Center, 9609 Medical Center 
Drive, RM 1E530, MSC 9702, Bethesda, MD 20892-9702 (for business mail), 
Rockville, MD 20850-9702; Telephone: (240)-276-5530; Facsimile: (240)-
276-5504; Email: [email protected].

SUPPLEMENTARY INFORMATION: 

Intellectual Property

    United States Provisional Patent Application No. 62/241,896, filed 
15 October 2015 and entitled ``Anti-CD30 Chimeric Antigen Receptors'' 
[HHS Reference No. E-016-2018/0-US-01]; PCT Patent Application PCT/
US2016/056262, filed 10 October 2016 and entitled ``Anti-CD30 Chimeric 
Antigen Receptors'' [HHS Reference No. E-016-2018/0-PCT-02]; 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:

    ``The development of a CD30 chimeric antigen receptor (CAR)-
based

[[Page 60407]]

immunotherapy using autologous (meaning one individual is both the 
donor and the recipient) T cells transfected with a retroviral 
vector (including lentiviral vectors), wherein the vector expresses 
a CAR having:
    (1) a single antigen specificity; and
    (2) comprising at least:
    (a) the complementary determining region (CDR) sequences of the 
anti-CD30 antibody known as 5F11; and
    (b) a T cell signaling domain;

for the prophylaxis and treatment of CD30-expressing human 
cancers.''

    This technology discloses the development of chimeric antigen 
receptors that recognize the CD30 protein (also known as tumor necrosis 
factor receptor superfamily member 8 (TNFRSF8)). CD30 is expressed on 
the cell surface of several rare forms of cancer, including Hodgkin 
lymphoma (HL), Non-Hodgkin's Lymphoma (NHL), diffuse large B cell 
lymphoma (DLBCL), peripheral T cell lymphoma not otherwise specified 
(PTCL-NOS), anaplastic large cell lymphoma (ALCL), and 
angioimmunoblastic T cell lymphoma (AITL). The development of a new 
therapeutic targeting CD30 will benefit public health by offering up a 
treatment for these rare cancers in instances when conventional first 
line therapies are ineffective.
    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 
completed 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 8, 2017.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2017-27416 Filed 12-19-17; 8:45 am]
 BILLING CODE 4140-01-P

60406 Federal Register / Vol. 82, No. 243 / Wednesday, December 20, 2017 / Notices • Any collection is targeted to the Average Expected Annual Number of DEPARTMENT OF HEALTH AND solicitation of opinions from activities: 7. HUMAN SERVICES respondents who have experience with Average number of Respondents per the program or may have experience National Institutes of Health Activity: 350. with the program in the near future; • Personally identifiable information Annual responses: 4,158. Prospective Grant of an Exclusive (PII) is collected only to the extent Frequency of Response: Once per Patent License: The Development of an necessary and is not retained; request. Anti-CD30 Chimeric Antigen Receptor • Information gathered will be used (CAR) for the Treatment of Human Average minutes per response: 5. Cancer only internally for general service improvement and program management Burden hours: 1,041. AGENCY: National Institutes of Health purposes and is not intended for release Request for Comments: Comments ACTION: Notice. outside of the agency; submitted in response to this notice will • Information gathered will not be be summarized and/or included in the SUMMARY: The National Cancer Institute, used for the purpose of substantially request for OMB approval. Comments an institute of the National Institutes of informing influential policy decisions; are invited on: (a) Whether the Health, Department of Health and and collection of information is necessary Human Services, is contemplating the • Information gathered will yield for the proper performance of the grant of an Exclusive Patent License to qualitative information; the collections functions of the agency, including practice the inventions embodied in the will not be designed or expected to whether the information shall have Patents and Patent Applications listed yield statistically reliable results or used in the SUPPLEMENTARY INFORMATION practical utility; (b) the accuracy of the as though the results are generalizable to section of this notice to Kite Pharma, agency’s estimate of the burden of the the population of study. Inc. (‘‘Kite’’) located in Santa Monica, Feedback collected under this generic collection of information; (c) ways to enhance the quality, utility, and clarity CA. clearance provides useful information, of the information to be collected; (d) DATES: Only written comments and/or but it does not yield data that can be ways to minimize the burden of the complete applications for a license generalized to the overall population. collection of information on which are received by the National This type of generic clearance for respondents, including through the use Cancer Institute’s Technology Transfer qualitative information will not be used of automated collection techniques or Center on or before January 4, 2018 will for quantitative information collections other forms of information technology; be considered. that are designed to yield reliably actionable results, such as monitoring and (e) estimates of capital or start-up ADDRESSES: Requests for copies of the trends over time or documenting costs and costs of operation, patent application, inquiries, and program performance. Such data uses maintenance, and purchase of services comments relating to the contemplated require more rigorous designs that to provide information. Burden means Exclusive Patent License should be address: The target population to which the total time, effort, or financial directed to: David A. Lambertson, Ph.D., generalizations will be made, the resources expended by persons to Senior Technology Transfer Manager, sampling frame, the sample design generate, maintain, retain, disclose or NCI Technology Transfer Center, 9609 (including stratification and clustering), provide information to or for a Federal Medical Center Drive, RM 1E530, MSC the precision requirements or power agency. This includes the time needed 9702, Bethesda, MD 20892–9702 (for calculations that justify the proposed to review instructions; to develop, business mail), Rockville, MD 20850– sample size, the expected response rate, acquire, install and utilize technology 9702; Telephone: (240)–276–5530; methods for assessing potential non- and systems for the purpose of Facsimile: (240)–276–5504; Email: response bias, the protocols for data collecting, validating and verifying david.lambertson@nih.gov. collection, and any testing procedures information, processing and SUPPLEMENTARY INFORMATION: that were or will be undertaken prior to maintaining information, and disclosing Intellectual Property fielding the study. Depending on the and providing information; to train degree of influence the results are likely personnel and to be able to respond to United States Provisional Patent to have, such collections may still be a collection of information, to search Application No. 62/241,896, filed 15 eligible for submission for other generic data sources, to complete and review October 2015 and entitled ‘‘Anti-CD30 mechanisms that are designed to yield the collection of information; and to Chimeric Antigen Receptors’’ [HHS quantitative results. transmit or otherwise disclose the Reference No. E–016–2018/0–US–01]; As a general matter, information information. PCT Patent Application PCT/US2016/ collections will not result in any new 056262, filed 10 October 2016 and All written comments will be entitled ‘‘Anti-CD30 Chimeric Antigen system of records containing privacy available for public inspection information and will not ask questions Receptors’’ [HHS Reference No. E–016– Regulations.gov. 2018/0–PCT–02]; and U.S. and foreign of a sensitive nature, such as sexual behavior and attitudes, religious beliefs, An agency may not conduct or patent applications claiming priority to and other matters that are commonly sponsor, and a person is not required to the aforementioned applications. considered private. respond to, a collection of information The patent rights in these inventions Current Actions: Extension of unless it displays a currently valid have been assigned and/or exclusively Office of Management and Budget licensed to the government of the sradovich on DSK3GMQ082PROD with NOTICES approval for a collection of information. Type of Review: Extension. control number. United States of America. Affected Public: Individuals, The prospective exclusive license Terry S. Clark, territory may be worldwide and the households, professionals, public/ private sector. Asst. Information Collection Clearance field of use may be limited to the Estimated Number of Respondents: Officer. following: Below we provide projected average [FR Doc. 2017–27399 Filed 12–19–17; 8:45 am] ‘‘The development of a CD30 chimeric estimates for the next three years: BILLING CODE 4150–45–P antigen receptor (CAR)-based VerDate Sep<11>2014 21:36 Dec 19, 2017 Jkt 244001 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 E:\FR\FM\20DEN1.SGM 20DEN1

Federal Register / Vol. 82, No. 243 / Wednesday, December 20, 2017 / Notices 60407 immunotherapy using autologous (meaning DEPARTMENT OF HEALTH AND DEPARTMENT OF HEALTH AND one individual is both the donor and the HUMAN SERVICES HUMAN SERVICES recipient) T cells transfected with a retroviral vector (including lentiviral vectors), wherein National Institutes of Health National Institutes of Health the vector expresses a CAR having: (1) a single antigen specificity; and National Institute of Neurological Proposed Collection; 60-Day Comment (2) comprising at least: Request Division of Cancer (a) the complementary determining region Disorders and Stroke Notice of Closed Meetings Epidemiology and Genetics Fellowship (CDR) sequences of the anti-CD30 antibody known as 5F11; and Program and Summer Student (b) a T cell signaling domain; Pursuant to section 10(d) of the Applications (DCEG) (National Cancer for the prophylaxis and treatment of CD30- Federal Advisory Committee Act, as Institute) expressing human cancers.’’ amended, notice is hereby given of the AGENCY: National Institutes of Health. following meetings. This technology discloses the ACTION: Notice. The meetings will be closed to the development of chimeric antigen public in accordance with the SUMMARY: In compliance with the receptors that recognize the CD30 provisions set forth in sections requirement of the Paperwork protein (also known as tumor necrosis 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Reduction Act of 1995 to provide factor receptor superfamily member 8 as amended. The grant applications and opportunity for public comment on (TNFRSF8)). CD30 is expressed on the the discussions could disclose proposed data collection projects, the cell surface of several rare forms of confidential trade secrets or commercial National Cancer Institute (NCI) will cancer, including Hodgkin lymphoma property such as patentable material, publish periodic summaries of propose (HL), Non-Hodgkin’s Lymphoma (NHL), and personal information concerning projects to be submitted to the Office of diffuse large B cell lymphoma (DLBCL), individuals associated with the grant Management and Budget (OMB) for peripheral T cell lymphoma not applications, the disclosure of which review and approval. otherwise specified (PTCL–NOS), would constitute a clearly unwarranted DATES: Comments regarding this anaplastic large cell lymphoma (ALCL), invasion of personal privacy. information collection are best assured and angioimmunoblastic T cell of having their full effect if received lymphoma (AITL). The development of Name of Committee: National Institute of Neurological Disorders and Stroke within 60 days of the date of this a new therapeutic targeting CD30 will publication. benefit public health by offering up a Technologies for Large-Scale Recording and Modulation in the Nervous System. FOR FURTHER INFORMATION CONTACT: To treatment for these rare cancers in Date: January 18–19, 2018. obtain a copy of the data collection instances when conventional first line Time: 8:00 a.m. to 2:00 p.m. plans and instruments, submit therapies are ineffective. Agenda: To review and evaluate grant comments in writing, or request more This notice is made in accordance applications. information on the proposed project, with 35 U.S.C. 209 and 37 CFR part 404. Place: Hilton Alexandria Old Town, 1767 contact: Jackie Lavigne, Ph.D., M.P.H., The prospective exclusive license will King Street, Alexandria, VA 22314. Chief, Office of Education, Division of be royalty bearing, and the prospective Contact Person: Ernest Lyons, Ph.D., Cancer Epidemiology and Genetics, exclusive license may be granted unless Scientific Review Officer; Scientific Review 9609 Medical Center Drive, MSC, within fifteen (15) days from the date of Branch; NINDS/NIH/DHHS; Neuroscience Bethesda, Maryland 20892 or call non- this published notice, the National Center; 6001 Executive Blvd., Suite 3204, MSC 9529, Bethesda, MD 20892–9529; 301– toll-free number 240.276.7237or Email Cancer Institute receives written your request, including your address to: 496–4056; lyonse@ninds.nih.gov. evidence and argument that establishes lavignej@mail.nih.gov. Formal requests that the grant of the license would not Name of Committee: Neurological Sciences for additional plans and instruments Training Initial Review Group; NST–1 be consistent with the requirements of must be requested in writing. Subcommittee. 35 U.S.C. 209 and 37 CFR part 404. SUPPLEMENTARY INFORMATION: Section Date: January 29–30, 2018. In response to this Notice, the public Time: 8:00 a.m. to 6:00 p.m. 3506(c)(2)(A) of the Paperwork may file comments or objections. Agenda: To review and evaluate grant Reduction Act of 1995 requires: Written Comments and objections, other than applications. comments and/or suggestions from the those in the form of a completed license Place: Hilton Alexandria Old Town, 1767 public and affected agencies are invited application, will not be treated King Street, Alexandria, VA 22314. to address one or more of the following confidentially, and may be made Contact Person: William Benzing, Ph.D., points: (1) Whether the proposed publicly available. Scientific Review Officer, Scientific Review collection of information is necessary Branch, NINDS/NIH/DHHS, Neuroscience for the proper performance of the License applications submitted in Center, 6001 Executive Blvd., Suite 3204, response to this Notice will be function of the agency, including MSC 9529, Bethesda, MD 20892–9529, 301– presumed to contain business whether the information will have 496–0660, benzingw@mail.nih.gov. confidential information and any release practical utility; (2) The accuracy of the (Catalogue of Federal Domestic Assistance agency’s estimate of the burden of the of information in these license Program Nos. 93.853, Clinical Research applications will be made only as proposed collection of information, Related to Neurological Disorders; 93.854, required and upon a request under the Biological Basis Research in the including the validity of the Freedom of Information Act, 5 U.S.C. Neurosciences, National Institutes of Health, methodology and assumptions used; (3) Ways to enhance the quality, utility, and sradovich on DSK3GMQ082PROD with NOTICES 552. HHS) clarity of the information to be Dated: December 8, 2017. Dated: December 14, 2017. collected; and (4) Ways to minimize’s Richard U. Rodriguez, Sylvia L. Neal, the burden of the collection of Associate Director, Technology Transfer Program Analyst, Office of Federal Advisory information on those who are to Center, National Cancer Institute. Committee Policy. respond, including the use of [FR Doc. 2017–27416 Filed 12–19–17; 8:45 am] [FR Doc. 2017–27329 Filed 12–19–17; 8:45 am] appropriate automated, electronic, BILLING CODE 4140–01–P BILLING CODE 4140–01–P mechanical, or other technological VerDate Sep<11>2014 21:36 Dec 19, 2017 Jkt 244001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 E:\FR\FM\20DEN1.SGM 20DEN1


Document Created: 2018-10-25 10:57:26
Document Modified: 2018-10-25 10:57:26
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesOnly written comments and/or complete applications for a license which are received by the National Cancer Institute's Technology Transfer Center on or before January 4, 2018 will be considered.
FR Citation82 FR 60406 
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