Prospective Grant of Exclusive License: The Development of an Anti-CD19 Chimeric Antigen Receptor (CAR) for the Treatment of Human Cancers, 36828-36829 [2015-15657]
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Federal Register / Vol. 80, No. 123 / Friday, June 26, 2015 / Notices
Panel Review of R25 Research Training Grant
Applications.
Date: July 17, 2015.
Time: 8:30 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Courtyard by Marriott Chevy Chase,
5520 Wisconsin Avenue, Chevy Chase, MD
20815
Contact Person: Lisa A. Dunbar, Ph.D.,
Scientific Review Officer, Office of Scientific
Review, National Institute of General Medical
Sciences, National Institutes of Health, 45
Center Drive, Room 3An.12F, Bethesda, MD
20892, 301–594–2849, dunbarl@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.375, Minority Biomedical
Research Support; 93.821, Cell Biology and
Biophysics Research; 93.859, Pharmacology,
Physiology, and Biological Chemistry
Research; 93.862, Genetics and
Developmental Biology Research; 93.88,
Minority Access to Research Careers; 93.96,
Special Minority Initiatives, National
Institutes of Health, HHS)
Dated: June 22, 2015.
Melanie J. Gray,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2015–15659 Filed 6–25–15; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive
License Agreement: Development of
Bispecific and Multi-Specific Fusion
Proteins for the Treatment of ROR1
Expressing Human Cancers
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 Institutes of Health,
Department of Health and Human
Services, is contemplating the grant of
an exclusive license agreement to
practice the inventions embodied in US
Provisional Application No. 61/418,550
entitled, ‘‘Chimeric rabbit/human ROR1
antibodies’’ filed December 1, 2010
[HHS Ref. E–039–2011/0–US–01]; PCT
Application No. PCT/US2011/062670
entitled, ‘‘Chimeric rabbit/human ROR1
antibodies’’ filed November 30, 2011
[HHS Ref. E–039–2011/0–PCT–02];
Australian Patent Application No.
2011336650 entitled, ‘‘Chimeric rabbit/
human ROR1 antibodies’’ filed
November 30, 2011 [HHS Ref. E–039–
2011/0–AU–03]; Canadian Patent
Application No. 2818992 entitled,
‘‘Chimeric rabbit/human ROR1
antibodies’’ filed November 30, 2011
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SUMMARY:
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[HHS Ref. E–039–2011/0–CA–04];
European Patent Application No.
11791733.6 entitled, ‘‘Chimeric rabbit/
human ROR1 antibodies’’ filed
November 30, 2011 [HHS Ref. E–039–
2011/0–EP–05]; and U.S. Patent
Application No. 13/990,977 entitled,
‘‘Chimeric rabbit/human ROR1
antibodies’’ filed May 31, 2013 [HHS
Ref. E–039–2011/0–US–06] and all
related continuing and foreign patents/
patent applications for the technology
family to Emergent BioSolutions. 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 use
of the Licensed Patent Rights to
develop, make, have made, sell, have
sold, import and export bi-specific and
multi-specific fusion proteins that are
capable of eliciting redirected T-cell
cytotoxicity for the treatment of human
receptor tyrosine kinase-like orphan
receptor 1 (ROR1) expressing cancers,
wherein said fusion proteins comprise
one or more single-chain variable
fragment (scFv) ROR1 binding domains
from the anti-ROR1 antibodies
designated as R11 or R12, one or more
of Licensee’s proprietary scFv CD3
binding domains, and optionally a
fragment crystallizable (Fc) domain.
DATES: Only written comments and/or
applications for a license which are
received by the NIH Office of
Technology Transfer on or before July
27, 2015 will be considered.
ADDRESSES: Requests for copies of the
patent applications, inquiries,
comments, and other materials relating
to the contemplated exclusive
evaluation option license should be
directed to: Jennifer Wong, M.S., Senior
Licensing and Patenting Manager, Office
of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville, MD
20852–3804; Telephone: (301) 435–
4633; Facsimile: (301) 402–0220; Email:
wongje@od.nih.gov.
SUPPLEMENTARY INFORMATION: Tyrosine
kinase-like orphan receptor 1 (ROR1) is
a signature cell surface antigen for B-cell
malignancies, most notably, B-cell
chronic lymphocytic leukemia (B–CLL)
and mantle cell lymphoma (MCL) cells,
two incurable diseases. The
investigators have developed a portfolio
of chimeric anti-ROR1 monoclonal
antibodies that selectively target ROR1
malignant B-cells but not normal Bcells. These antibodies may be linked to
chemical drugs or biological toxins thus
providing targeted cytotoxic delivery to
malignant B-cells while sparing normal
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cells. Moreover, as these antibodies
selectively target ROR1, they can also be
used to diagnose B-cell malignancies.
The prospective exclusive license will
comply with the terms and conditions
of 35 U.S.C. 209 and 37 CFR part 404.
The exclusive license may be granted
unless within thirty (30) days from the
date of this published notice, the NIH
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.
Any additional, properly filed, and
complete applications for a license in
the field of use 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: June 22, 2015.
Richard U. Rodriguez,
Acting Director, Office of Technology
Transfer, National Institutes of Health.
[FR Doc. 2015–15655 Filed 6–25–15; 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 an AntiCD19 Chimeric Antigen Receptor
(CAR) for the Treatment of Human
Cancers
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 Institutes of Health,
Department of Health and Human
Services, is contemplating the grant of
an exclusive license to practice the
inventions embodied in U.S. Provisional
Patent Application 62/006,313 entitled
‘‘Chimeric Antigen Receptors Targeting
CD–19’’ [HHS Ref. E–042–2014/0–US–
01], and all related continuing and
foreign patents/patent applications for
the technology family, to Kite Pharma,
Inc. The patent rights in these
inventions have been assigned to and/or
exclusively licensed to the Government
of the United States of America.
The prospective exclusive licensed
territory may be worldwide, and the
field of use may be limited to: ‘‘All
prophylactic and therapeutic uses for
SUMMARY:
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Federal Register / Vol. 80, No. 123 / Friday, June 26, 2015 / Notices
CD19-associated diseases, states and
conditions in humans.’’
DATES: Only applications for a license
which are received by the NIH Office of
Technology Transfer on or before July
27, 2015 will be considered.
ADDRESSES: Requests for copies of the
patent application, inquiries, comments,
and other materials relating to the
contemplated exclusive license should
be directed to: David A. Lambertson,
Ph.D., Senior Licensing and Patenting
Manager, Office of Technology Transfer,
National Institutes of Health, 6011
Executive Boulevard, Suite 325,
Rockville, MD 20852–3804; Telephone:
(301) 435–4632; Facsimile: (301) 402–
0220; Email: lambertsond@mail.nih.gov.
SUPPLEMENTARY INFORMATION: This
invention concerns an anti-CD19
chimeric antigen receptor (CAR) and
methods of using the CAR for the
treatment of CD19-expressing cancers,
including B cell malignancies.
CD19 is a cell surface antigen that is
preferentially expressed on certain types
of cancer cells, particularly cancers of B
cell origin such as Non-Hodgkin’s
Leukemia (NHL), acute lymphoblastic
leukemia (ALL) and chronic
lymphocytic leukemia (CLL). The antiCD19 CARs of this technology contain
(1) antigen recognition sequences that
bind specifically to CD19 and (2)
signaling domains that can activate the
cytotoxic functions of a T cell. The antiCD19 CAR can be transduced into T
cells that are harvested from a cancer
patient; from there, T cells expressing
the anti-CD19 CAR are selected,
expanded and then be reintroduced into
the patient. Once the anti-CD19 CARexpressing T cells are reintroduced into
the patient, the T cells can selectively
bind to CD19-expressing cancer cells
through its antigen recognition
sequences, thereby activating the T cell
through its signaling domains to
selectively kill the cancer cells. Through
this mechanism of action, the selectivity
of the a CAR allows the T cells to kill
cancer cells while leaving healthy,
essential cells unharmed. This can
result in an effective therapeutic
strategy with fewer side effects due to
less non-specific killing of cells.
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 the NIH 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
within thirty (30) days from the date of
this published notice.
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18:15 Jun 25, 2015
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Complete applications for a license in
an appropriate field of use that are 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: June 22, 2015.
Richard U. Rodriguez,
Acting Director, Office of Technology
Transfer, National Institutes of Health.
[FR Doc. 2015–15657 Filed 6–25–15; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HOMELAND
SECURITY
U.S. Citizenship and Immigration
Services
[OMB Control Number 1615–0023]
Agency Information Collection
Activities: Application To Register
Permanent Residence or Adjust
Status, Form I–485 Supplement A, and
Instruction Booklet for Filing Form I–
485 and Supplement A, Form I–485;
Revision of a Currently Approved
Collection
36829
omb.eop.gov. Comments may also be
submitted via fax at 202–395–5806.
(This is not a toll free number.) All
submissions received must include the
agency name and the OMB Control
Number 1615–0023.
You may wish to consider limiting the
amount of personal information that you
provide in any voluntary submission
you make. For additional information,
please read the Privacy Act notice that
is available via the link in the footer of
https://www.regulations.gov.
If
you need a copy of the information
collection instrument with instructions
or additional information, please
contact us at: USCIS, Office of Policy
and Strategy, Regulatory Coordination
Division, Laura Dawkins, Chief, 20
Massachusetts Avenue NW.,
Washington, DC 20529–2140,
Telephone number 202–272–8377. (This
is not a toll free number.) Please note
contact information provided here is
solely for questions regarding this
notice. It is not for individual case
status inquiries. Applicants seeking
information about the status of their
individual cases can check Case Status
Online, available at the USCIS Web site
at https://www.uscis.gov, or call the
USCIS National Customer Service
Center at 800–375–5283 (TTY 800–767–
1833).
FOR FURTHER INFORMATION CONTACT:
U.S. Citizenship and
Immigration Services, Department of
Homeland Security.
ACTION: 30-Day notice.
Comments
The Department of Homeland
Security (DHS), U.S. Citizenship and
Immigration Services (USCIS) will be
submitting the following information
collection request to the Office of
Management and Budget (OMB) for
review and clearance in accordance
with the Paperwork Reduction Act of
1995. The information collection notice
was previously published in the Federal
Register on March 10, 2015, at 80 FR
12647, allowing for a 60-day public
comment period. USCIS received eight
comments in connection with the 60day notice.
DATES: The purpose of this notice is to
allow an additional 30 days for public
comments. Comments are encouraged
and will be accepted until July 27, 2015.
This process is conducted in accordance
with 5 CFR 1320.10.
ADDRESSES: Written comments and/or
suggestions regarding the item(s)
contained in this notice, especially
regarding the estimated public burden
and associated response time, must be
directed to the OMB USCIS Desk Officer
via email at oira_submission@
Written comments and suggestions
from the public and affected agencies
should address one or more of the
following four points:
(1) Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility;
(2) Evaluate the accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
(3) Enhance the quality, utility, and
clarity of the information to be
collected; and
(4) Minimize the burden of the
collection of information on those who
are to respond, including through the
use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology
(e.g., permitting electronic submission
of responses).
AGENCY:
SUMMARY:
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SUPPLEMENTARY INFORMATION:
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]]>Agencies
[Federal Register Volume 80, Number 123 (Friday, June 26, 2015)]
[Notices]
[Pages 36828-36829]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-15657]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive License: The Development of an
Anti-CD19 Chimeric Antigen Receptor (CAR) for the Treatment of Human
Cancers
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 Institutes of Health, Department of Health
and Human Services, is contemplating the grant of an exclusive license
to practice the inventions embodied in U.S. Provisional Patent
Application 62/006,313 entitled ``Chimeric Antigen Receptors Targeting
CD-19'' [HHS Ref. E-042-2014/0-US-01], and all related continuing and
foreign patents/patent applications for the technology family, to Kite
Pharma, Inc. The patent rights in these inventions have been assigned
to and/or exclusively licensed to the Government of the United States
of America.
The prospective exclusive licensed territory may be worldwide, and
the field of use may be limited to: ``All prophylactic and therapeutic
uses for
[[Page 36829]]
CD19-associated diseases, states and conditions in humans.''
DATES: Only applications for a license which are received by the NIH
Office of Technology Transfer on or before July 27, 2015 will be
considered.
ADDRESSES: Requests for copies of the patent application, inquiries,
comments, and other materials relating to the contemplated exclusive
license should be directed to: David A. Lambertson, Ph.D., Senior
Licensing and Patenting Manager, Office of Technology Transfer,
National Institutes of Health, 6011 Executive Boulevard, Suite 325,
Rockville, MD 20852-3804; Telephone: (301) 435-4632; Facsimile: (301)
402-0220; Email: lambertsond@mail.nih.gov.
SUPPLEMENTARY INFORMATION: This invention concerns an anti-CD19
chimeric antigen receptor (CAR) and methods of using the CAR for the
treatment of CD19-expressing cancers, including B cell malignancies.
CD19 is a cell surface antigen that is preferentially expressed on
certain types of cancer cells, particularly cancers of B cell origin
such as Non-Hodgkin's Leukemia (NHL), acute lymphoblastic leukemia
(ALL) and chronic lymphocytic leukemia (CLL). The anti-CD19 CARs of
this technology contain (1) antigen recognition sequences that bind
specifically to CD19 and (2) signaling domains that can activate the
cytotoxic functions of a T cell. The anti-CD19 CAR can be transduced
into T cells that are harvested from a cancer patient; from there, T
cells expressing the anti-CD19 CAR are selected, expanded and then be
reintroduced into the patient. Once the anti-CD19 CAR-expressing T
cells are reintroduced into the patient, the T cells can selectively
bind to CD19-expressing cancer cells through its antigen recognition
sequences, thereby activating the T cell through its signaling domains
to selectively kill the cancer cells. Through this mechanism of action,
the selectivity of the a CAR allows the T cells to kill cancer cells
while leaving healthy, essential cells unharmed. This can result in an
effective therapeutic strategy with fewer side effects due to less non-
specific killing of cells.
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 the NIH
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 within thirty (30) days from the date of
this published notice.
Complete applications for a license in an appropriate field of use
that are 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: June 22, 2015.
Richard U. Rodriguez,
Acting Director, Office of Technology Transfer, National Institutes of
Health.
[FR Doc. 2015-15657 Filed 6-25-15; 8:45 am]
BILLING CODE 4140-01-P
