Prospective Grant of Exclusive License: The Development of Anti-CD70 Chimeric Antigen Receptors (CARs) for the Treatment of Chronic Myelogenous Leukemia, 23737 [2016-09324]
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23737
Federal Register / Vol. 81, No. 78 / Friday, April 22, 2016 / Notices
Estimates of annualized total hour
burden are summarized in Table A.12–
1.4 Below.
Number of
respondents
Type of respondent
Number of
responses per
respondent
Participants ......................................................................................................
Non-Participants ..............................................................................................
4580
3030
1
1
Totals ........................................................................................................
7610
Average time
per response
(in hours)
Total annual
burden hour
90/60
15/60
2
7,653
729
8,382
(Note: reported and calculated numbers differ slightly due to rounding.)
Dated: April 18, 2016.
Valery Gheen,
NHLBI Project Clearance Liaison, National
Institutes of Health.
[FR Doc. 2016–09313 Filed 4–21–16; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive
License: The Development of AntiCD70 Chimeric Antigen Receptors
(CARs) for the Treatment of Chronic
Myelogenous Leukemia
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
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.
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
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
VerDate Sep<11>2014
20:03 Apr 21, 2016
Jkt 238001
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: andy.burke@nih.gov.
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 CARtransduced 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
PO 00000
Frm 00064
Fmt 4703
Sfmt 4703
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]
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HUMAN SERVICES
National Institutes of Health
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SUMMARY:
E:\FR\FM\22APN1.SGM
22APN1
Agencies
[Federal Register Volume 81, Number 78 (Friday, April 22, 2016)]
[Notices]
[Page 23737]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-09324]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: andy.burke@nih.gov.
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