Prospective Grant of an Exclusive License Agreement: Development of Bispecific and Multi-Specific Fusion Proteins for the Treatment of ROR1 Expressing Human Cancers, 36828 [2015-15655]
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36828
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
tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:15 Jun 25, 2015
Jkt 235001
[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
PO 00000
Frm 00072
Fmt 4703
Sfmt 4703
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:
E:\FR\FM\26JNN1.SGM
26JNN1
]]>Agencies
[Federal Register Volume 80, Number 123 (Friday, June 26, 2015)]
[Notices]
[Page 36828]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-15655]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
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 [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 B-cells.
These antibodies may be linked to chemical drugs or biological toxins
thus providing targeted cytotoxic delivery to malignant B-cells while
sparing normal 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
