Prospective Grant of Exclusive License: Development of AAV5 Based Therapeutics To Treat Human Diseases, 55808-55809 [2010-22833]
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Federal Register / Vol. 75, No. 177 / Tuesday, September 14, 2010 / Notices
Dated: September 8, 2010.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Nursing Research;
Notice of Closed Meetings
jlentini on DSKJ8SOYB1PROD with NOTICES
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Nursing Research Special Emphasis Panel;
National Research Service Award
Institutional Research Training Grants.
Date: October 20, 2010.
Time: 8 a.m. to 2 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bethesda Marriott Suites, 6711
Democracy Boulevard, Bethesda, MD 20817.
Contact Person: Weiqun Li, MD, Scientific
Review Administrator, National Institute of
Nursing Research, National Institutes of
Health, 6701 Democracy Blvd., Ste. 710,
Bethesda, MD 20892, (301) 594–5966,
wli@mail.nih.gov.
Name of Committee: National Institute of
Nursing Research Special Emphasis Panel;
Informed-Decision Making in Young
Adolescent At-Risk for HIV/AIDS.
Date: November 2, 2010.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bethesda Marriott Suites, 6711
Democracy Boulevard, Bethesda, MD 20817.
Contact Person: Mario Rinaudo, MD,
Scientific Review Officer, Office of Review,
National Inst of Nursing Research, National
Institutes of Health, 6701 Democracy Blvd
(DEM 1), Suite 710, Bethesda, MD 20892,
301–594–5973, mrinaudo@mail.nih.gov.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.361, Nursing Research,
National Institutes of Health, HHS)
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2010–22832 Filed 9–13–10; 8:45 am]
Prospective Grant of Exclusive
License: Development of AAV5 Based
Therapeutics To Treat Human
Diseases
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Nursing Research;
Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Nursing Research Special Emphasis Panel,
Clinical Trial Review.
Date: October 14, 2010.
Time: 2 p.m. to 3:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, One
Democracy Plaza, 6701 Democracy
Boulevard, Bethesda, MD 20892. (Telephone
Conference Call).
Contact Person: Tamizchelvi Thyagarajan,
PhD, Scientific Review Officer, National
Institute of Nursing Reserach, National
Institutes of Health, 6701 Democracy Blvd,
Rm. 710, Bethesda, MD 20892, (301) 594–
0343, tamizchelvi.thyagarajan@nih.gov.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.361, Nursing Research,
National Institutes of Health, HHS)
Dated: September 8, 2010.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2010–22831 Filed 9–13–10; 8:45 am]
BILLING CODE 4140–01–P
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National Institutes of Health
National Institutes of Health,
Public Health Service, DHHS.
ACTION: Notice.
AGENCY:
This is notice, in accordance
with 35 U.S.C. 209(c)(1) and 37 CFR
Part 404.7(a)(1)(i), that the National
Institutes of Health, Department of
Health and Human Services, is
contemplating the grant of an exclusive
patent license to practice the invention
embodied in U.S. Patent 6, 984, 517,
entitled ‘‘AAV5 and Uses Thereof,’’ U.S.
Patent 7, 479, 554, entitled ‘‘AAV5
Nucleic Acids’’ and PCT Application
Serial No. PCT/US99/11958 and foreign
equivalents thereof, entitled ‘‘AAV5 and
Uses Thereof’’ [HHS Ref. No. E–127–
1998/0]; and U.S. Patent 6, 855, 314
entitled ‘‘AAV5 Vector for Transducing
Brain Cells and Lung Cells’’ [HHS Ref.
No. E–072–2000/0] to Amsterdam
Molecular Therapeutics, which is
located in Amsterdam, The Netherlands.
The Government of the United States of
America has the right to license these
patent rights.
The prospective exclusive license
territory may be worldwide, and the
field of use may be limited to the
development and sale of AAV5 based
therapeutic products to be delivered to
the brain, eyes and liver for treatment of
diseases originated from these organs, as
claimed in the Licensed Patent Rights.
DATES: Only written comments and/or
applications for a license which are
received by the NIH Office of
Technology Transfer on or before
October 14, 2010 will be considered.
ADDRESSES: Requests for copy of the
patent, inquiries, comments, and other
materials relating to the contemplated
exclusive license should be directed to:
Betty B. Tong, PhD., Senior Licensing
and Patenting Manager, Office of
Technology Transfer, National Institutes
of Health, 6011 Executive Boulevard,
Suite 325, Rockville, MD 20852–3804;
Telephone: (301) 594–6565; Facsimile:
(301) 402–0220; E-mail:
tongb@mail.nih.gov.
SUPPLEMENTARY INFORMATION: The
technology describes an adenoassociated virus 5 (AAV5), vectors and
particles derived from the virus; as well
as methods of delivering nucleic acids
to a cell by using the AAV5 vectors and
particles. More specifically, the
SUMMARY:
E:\FR\FM\14SEN1.SGM
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Federal Register / Vol. 75, No. 177 / Tuesday, September 14, 2010 / Notices
technology provides the methods of
delivering nucleic acids to cells of
specific regions, tissues and cell types of
the central nervous system (CNS); as
well as to cells of the lung, by using
AAV5 vectors and particles. The
specific brain cells that are targeted by
AAV5 belong to both non-neuronal/glial
cells and neuronal cells, such as
cerebellar cells and ependymal cells.
The specific lung cells targeted by
AAV5 are the apical surfaces of the
airway such as alveolar 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 404.7. The prospective
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 404.7.
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: September 7, 2010.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2010–22833 Filed 9–13–10; 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
Immunotoxins/Targeted Toxins for the
Treatment of Human Cancers
National Institutes of Health,
Public Health Service, DHHS.
ACTION: Notice.
AGENCY:
This is notice, in accordance
with 35 U.S.C. 209(c)(1) and 37 CFR
404.7(a)(1)(i), that 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 U.S. Patent Application
61/241,620 entitled ‘‘Development of an
Immunotoxin in Which All B–Cell
Epitopes Have Been Removed and
jlentini on DSKJ8SOYB1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
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Which Has High Cytotoxic Activity’’
[HHS Ref. E–269–2009/0–US–01], U.S.
Patent Application 60/969,929 entitled
‘‘Deletions in Domain II of Pseudomonas
Exotoxin A That Reduce Non-Specific
Toxicity’’ [HHS Ref. E–292–2007/0–US–
01], U.S. Patent Application 60/703,798
entitled ‘‘Mutated Pseudomonas
Exotoxins with Reduced Antigenicity’’
[HHS Ref. E–262–2005/0–US–01], U.S.
Patent Application 60/160,071 entitled
‘‘Immunoconjugates Having High
Binding Affinity’’ [HHS Ref. E–139–
1999/0–US–01], U.S. Patent Application
60/067,175 entitled ‘‘Antibodies,
Including Fv Molecules, and
Immunoconjugates Having High
Binding Affinity for Mesothelin and
Methods for Their Use’’ [HHS Ref. E–
021–1998/0–US–01], U.S. Patent
Application 60/010,166 entitled
‘‘Molecular Cloning of Mesothelin, a
Differentiation Antigen Present on
Mesothelium, Mesotheliomas and
Ovarian Cancers’’ [HHS Ref. E–002–
1996/0–US–01], PCT Application PCT/
US97/00224 entitled ‘‘Mesothelin
Antigen and Methods and Kits for
Targeting It’’ [HHS Ref. E–002–1996/1–
PCT–01], U.S. Patent 5,747,654 entitled
‘‘Recombinant Disulfide-Stabilized
Polypeptide Fragments Having Binding
Specificity’’ [HHS Ref. E–163–1993/0–
US–01], PCT application PCT/US96/
16327 entitled ‘‘Immunotoxin
Containing A Disulfide-Stabilized
Antibody Fragment’’ [HHS Ref. E–163–
1993/2–PCT–01], U.S. Patent
Application 07/596,291 entitled ‘‘A
Monoclonal Antibody’’ [HHS reference
E–195–1990/0–US–01], and all
continuing applications and foreign
counterparts, to Morphotek, 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 license
territory may be worldwide, and the
field of use may be limited to:
The use of the MORAb-009–PE–LR/8X
immunotoxin for the treatment of
mesothelin-expressing cancers, the use of the
anti-CD300LF–PE/LR/8X immunotoxin for
the treatment of CD300LF-expressing cancers
such as acute myelogenous leukemia (AML),
and the use of annexin A2-targeted PE–LR/
8X toxin for the treatment of annexin A2expressing cancers such as glioma, ovarian
cancer and pancreatic cancer.
Only written comments and/or
applications for a license which are
received by the NIH Office of
Technology Transfer on or before
October 14, 2010 will be considered.
ADDRESSES: Requests for copies of the
patent application, inquiries, comments,
and other materials relating to the
contemplated exclusive license should
DATES:
PO 00000
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55809
be directed to: David A. Lambertson,
PhD., 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; E-mail: lambertsond@od.nih.gov.
SUPPLEMENTARY INFORMATION: These
inventions concern immunotoxins and
targeted toxins, and methods of using
the immunotoxins/targeted toxins for
the treatment of (a) mesothelinexpressing cancers (such as
mesothelioma, ovarian cancer and
pancreatic cancer), (b) CD300LFexpressing cancers (such as acute
myelogenous leukemia (AML)) or (c)
Annexin A2-expressing cancers (such as
glioma, ovarian cancer and pancreatic
cancer). Several specific immunotoxins/
targeted toxins are covered by this
technology, including MORAb-009–PE–
LR/8X, anti-CD300LF–PE–LR/8X and
Annexin A2-targeted PE–LR/8X.
Each of these immunotoxins/targeted
toxins comprises (1) a toxin moiety (PE–
LR/8X) that is a modified version of the
Pseudomonas exotoxin A (‘‘PE’’) and (2)
either (a) an antibody fragment domain
that is capable of binding to mesothelin,
(b) an antibody fragment domain that is
capable of binding to CD300LF, or (c) a
peptide that is capable of binding to
Annexin A2. The toxin moiety been
modified in various manners in order
reduce immunogenicity, thereby
improving the therapeutic value of PE
while maintaining its ability to trigger
cell death. Since mesothelin, CD300LF
and Annexin A2 are each preferentially
expressed on certain types of cancer
cells, the targeting domains of the
immunotoxins/targeted toxins (MORAb009, anti-CD300LF and Annexin A2
binding peptide) allows the
immunotoxins/targeted toxins to
selectively bind to certain cancer cells
so that only the cancer cells are killed.
This results 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 404.7. 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 404.7 within thirty (30)
days from the date of this published
notice.
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.
E:\FR\FM\14SEN1.SGM
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]]>Agencies
[Federal Register Volume 75, Number 177 (Tuesday, September 14, 2010)]
[Notices]
[Pages 55808-55809]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-22833]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive License: Development of AAV5 Based
Therapeutics To Treat Human Diseases
AGENCY: National Institutes of Health, Public Health Service, DHHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37
CFR Part 404.7(a)(1)(i), that the National Institutes of Health,
Department of Health and Human Services, is contemplating the grant of
an exclusive patent license to practice the invention embodied in U.S.
Patent 6, 984, 517, entitled ``AAV5 and Uses Thereof,'' U.S. Patent 7,
479, 554, entitled ``AAV5 Nucleic Acids'' and PCT Application Serial
No. PCT/US99/11958 and foreign equivalents thereof, entitled ``AAV5 and
Uses Thereof'' [HHS Ref. No. E-127-1998/0]; and U.S. Patent 6, 855, 314
entitled ``AAV5 Vector for Transducing Brain Cells and Lung Cells''
[HHS Ref. No. E-072-2000/0] to Amsterdam Molecular Therapeutics, which
is located in Amsterdam, The Netherlands. The Government of the United
States of America has the right to license these patent rights.
The prospective exclusive license territory may be worldwide, and
the field of use may be limited to the development and sale of AAV5
based therapeutic products to be delivered to the brain, eyes and liver
for treatment of diseases originated from these organs, as claimed in
the Licensed Patent Rights.
DATES: Only written comments and/or applications for a license which
are received by the NIH Office of Technology Transfer on or before
October 14, 2010 will be considered.
ADDRESSES: Requests for copy of the patent, inquiries, comments, and
other materials relating to the contemplated exclusive license should
be directed to: Betty B. Tong, PhD., Senior Licensing and Patenting
Manager, Office of Technology Transfer, National Institutes of Health,
6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804;
Telephone: (301) 594-6565; Facsimile: (301) 402-0220; E-mail:
tongb@mail.nih.gov.
SUPPLEMENTARY INFORMATION: The technology describes an adeno-associated
virus 5 (AAV5), vectors and particles derived from the virus; as well
as methods of delivering nucleic acids to a cell by using the AAV5
vectors and particles. More specifically, the
[[Page 55809]]
technology provides the methods of delivering nucleic acids to cells of
specific regions, tissues and cell types of the central nervous system
(CNS); as well as to cells of the lung, by using AAV5 vectors and
particles. The specific brain cells that are targeted by AAV5 belong to
both non-neuronal/glial cells and neuronal cells, such as cerebellar
cells and ependymal cells. The specific lung cells targeted by AAV5 are
the apical surfaces of the airway such as alveolar 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 404.7.
The prospective 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 404.7.
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: September 7, 2010.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2010-22833 Filed 9-13-10; 8:45 am]
BILLING CODE 4140-01-P
