81 FR 23737 - Prospective Grant of Exclusive License: The Development of Anti-CD70 Chimeric Antigen Receptors (CARs) for the Treatment of Chronic Myelogenous Leukemia

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 81, Issue 78 (April 22, 2016)

Page Range		23737-23737
FR Document		2016-09324

This is notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the National Cancer Institute, National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to Dedalus Pharma, LLC (``Dedalus'') located in Maryland, USA.

Federal Register, Volume 81 Issue 78 (Friday, April 22, 2016)

[Federal Register Volume 81, Number 78 (Friday, April 22, 2016)]
[Notices]
[Page 23737]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-09324]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: The Development of Anti-
CD70 Chimeric Antigen Receptors (CARs) for the Treatment of Chronic 
Myelogenous Leukemia

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: This is notice, in accordance with 35 U.S.C. 209 and 37 CFR 
part 404, that the National Cancer Institute, National Institutes of 
Health, Department of Health and Human Services, is contemplating the 
grant of an exclusive patent license to Dedalus Pharma, LLC 
(``Dedalus'') located in Maryland, USA.

Intellectual Property

    United States Provisional Patent Application No. 62/088,882, filed 
December 8, 2014, entitled ``Anti-CD70 Chimeric Antigen Receptors'' 
[HHS Reference No. E-021-2015/0-US-01]; and PCT Application No. PCT/
US2015/025047 filed April 9, 2015 entitled ``Anti-CD70 Chimeric Antigen 
Receptors'' [HHS Reference No. E-021-2015/0-PCT-02].
    The patent rights in these inventions have been assigned to the 
government of the United States of America.
    The patent rights in these inventions have been assigned 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 development and commercialization of CD70 chimeric antigen 
receptor (CAR)-based autologous peripheral blood T cell therapy 
products as set forth in the Licensed Patent Rights for the treatment 
of chronic myelogenous leukemia in humans.

DATES: Only written comments and/or applications for a license which 
are received by the Technology Transfer Center at the National Cancer 
Institute on or before May 9, 2016 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
and comments relating to the contemplated exclusive license should be 
directed to: Andrew Burke, Ph.D., Licensing and Patenting Manager, 
Technology Transfer Center, National Cancer Institute, 9609 Medical 
Center Drive, MSC 9702, Rockville, MD 20852; Telephone: (240) 276-5484; 
Email: [email protected].

SUPPLEMENTARY INFORMATION: The present invention describes chimeric 
antigen receptors (CARs) targeting CD70. CARs are hybrid proteins 
comprised of extracellular antigen binding domains and intracellular 
signaling domains designed to activate the cytotoxic functions of CAR-
transduced T cells upon antigen stimulation.
    CD70 is a co-stimulatory molecule that provides proliferative and 
survival cues to competent cells upon binding to its cognate receptor, 
CD27. Its expression is primarily restricted to activated lymphoid 
cells; however, recent research has demonstrated that several cancers, 
including renal cell carcinoma, glioblastoma, non-Hodgkin's lymphoma, 
and chronic myelogenous leukemia also express CD70 under certain 
circumstances. Due to its limited expression in normal tissues, CARs 
targeting CD70 may be useful in adoptive cell therapy protocols for the 
treatment of select cancers.
    The prospective exclusive license will be royalty bearing and will 
comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR part 
404. The prospective exclusive license may be granted unless within 
fifteen (15) days from the date of this published notice, the NCI 
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.
    Complete applications for a license in an appropriate field of use 
that are timely filed in response to this notice will be treated as 
objections to the grant of the contemplated exclusive license. Comments 
and objections submitted to this notice will not be made available for 
public inspection and, to the extent permitted by law, will not be 
released under the Freedom of Information Act, 5 U.S.C. 552.

     Dated: April 18, 2016.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2016-09324 Filed 4-21-16; 8:45 am]
 BILLING CODE 4140-01-P

Federal Register / Vol. 81, No. 78 / Friday, April 22, 2016 / Notices 23737

Estimates of annualized total hour
burden are summarized in Table A.12–
1.4 Below.

Number of Average time
Number of Total annual
Type of respondent responses per per response
respondents burden hour
respondent (in hours)

Participants ...................................................................................................... 4580 1 90/60 7,653
Non-Participants .............................................................................................. 3030 1 15/60 729

Totals ........................................................................................................ 7610 2 8,382
(Note: reported and calculated numbers differ slightly due to rounding.)

Dated: April 18, 2016. therapy products as set forth in the argument that establishes that the grant
Valery Gheen, Licensed Patent Rights for the treatment of the license would not be consistent
NHLBI Project Clearance Liaison, National of chronic myelogenous leukemia in with the requirements of 35 U.S.C. 209
Institutes of Health. humans. and 37 CFR part 404.
[FR Doc. 2016–09313 Filed 4–21–16; 8:45 am] DATES: Only written comments and/or
Complete applications for a license in
BILLING CODE 4140–01–P applications for a license which are an appropriate field of use that are
received by the Technology Transfer timely filed in response to this notice
Center at the National Cancer Institute will be treated as objections to the grant
DEPARTMENT OF HEALTH AND on or before May 9, 2016 will be of the contemplated exclusive license.
HUMAN SERVICES considered. Comments and objections submitted to
this notice will not be made available
National Institutes of Health ADDRESSES: Requests for copies of the for public inspection and, to the extent
patent application, inquiries, and permitted by law, will not be released
Prospective Grant of Exclusive comments relating to the contemplated under the Freedom of Information Act,
License: The Development of Anti- exclusive license should be directed to: 5 U.S.C. 552.
CD70 Chimeric Antigen Receptors Andrew Burke, Ph.D., Licensing and
(CARs) for the Treatment of Chronic Dated: April 18, 2016.
Patenting Manager, Technology Transfer
Myelogenous Leukemia Center, National Cancer Institute, 9609 Richard U. Rodriguez,
Medical Center Drive, MSC 9702, Associate Director, Technology Transfer
AGENCY: National Institutes of Health, Center, National Cancer Institute.
Rockville, MD 20852; Telephone: (240)
HHS. [FR Doc. 2016–09324 Filed 4–21–16; 8:45 am]
276–5484; Email: andy.burke@nih.gov.
ACTION: Notice. BILLING CODE 4140–01–P
SUPPLEMENTARY INFORMATION: The
SUMMARY: This is notice, in accordance present invention describes chimeric
with 35 U.S.C. 209 and 37 CFR part 404, antigen receptors (CARs) targeting
DEPARTMENT OF HEALTH AND
that the National Cancer Institute, CD70. CARs are hybrid proteins
HUMAN SERVICES
National Institutes of Health, comprised of extracellular antigen
Department of Health and Human binding domains and intracellular National Institutes of Health
Services, is contemplating the grant of signaling domains designed to activate
an exclusive patent license to Dedalus the cytotoxic functions of CAR- Submission for OMB Review; 30-Day
Pharma, LLC (‘‘Dedalus’’) located in transduced T cells upon antigen Comment Request; The Agricultural
Maryland, USA. stimulation. Health Study: A Prospective Cohort
CD70 is a co-stimulatory molecule Study of Cancer and Other Diseases
Intellectual Property that provides proliferative and survival Among Men and Women in Agriculture
United States Provisional Patent cues to competent cells upon binding to (NIEHS)
Application No. 62/088,882, filed its cognate receptor, CD27. Its
December 8, 2014, entitled ‘‘Anti-CD70 expression is primarily restricted to SUMMARY: Under the provisions of
Chimeric Antigen Receptors’’ [HHS activated lymphoid cells; however, section 3507(a)(1)(D) of the Paperwork
Reference No. E–021–2015/0–US–01]; recent research has demonstrated that Reduction Act of 1995, the National
and PCT Application No. PCT/US2015/ several cancers, including renal cell Institutes of Health (NIH), has submitted
025047 filed April 9, 2015 entitled carcinoma, glioblastoma, non-Hodgkin’s to the Office of Management and Budget
‘‘Anti-CD70 Chimeric Antigen lymphoma, and chronic myelogenous (OMB) a request for review and
Receptors’’ [HHS Reference No. E–021– leukemia also express CD70 under approval of the information collection
2015/0–PCT–02]. certain circumstances. Due to its limited listed below. This proposed information
The patent rights in these inventions expression in normal tissues, CARs collection was previously published in
have been assigned to the government of targeting CD70 may be useful in the Federal Register on November 27,
the United States of America. adoptive cell therapy protocols for the 2015, Pages 74115–74116, and allowed
The patent rights in these inventions treatment of select cancers. 60-days for public comment. No public
mstockstill on DSK4VPTVN1PROD with NOTICES

have been assigned to the government of The prospective exclusive license will comments were received. The purpose
the United States of America. The be royalty bearing and will comply with of this notice is to allow an additional
prospective exclusive license territory the terms and conditions of 35 U.S.C. 30 days for public comment. The
may be worldwide and the field of use 209 and 37 CFR part 404. The National Institute of Environmental
may be limited to the development and prospective exclusive license may be Health Sciences (NIEHS), National
commercialization of CD70 chimeric granted unless within fifteen (15) days Institutes of Health, may not conduct or
antigen receptor (CAR)-based from the date of this published notice, sponsor, and the respondent is not
autologous peripheral blood T cell the NCI receives written evidence and required to respond to, an information

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Document Created: 2017-08-22 23:36:26
Document Modified: 2017-08-22 23:36:26

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Only written comments and/or applications for a license which are received by the Technology Transfer Center at the National Cancer Institute on or before May 9, 2016 will be considered.
FR Citation		81 FR 23737

81 FR 23737 - Prospective Grant of Exclusive License: The Development of Anti-CD70 Chimeric Antigen Receptors (CARs) for the Treatment of Chronic Myelogenous Leukemia

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 81, Issue 78 (April 22, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health