Government-Owned Inventions; Availability for Licensing, 44941-44942 [2011-18965]
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Federal Register / Vol. 76, No. 144 / Wednesday, July 27, 2011 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
AGENCY:
The inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing in the U.S. in accordance with
35 U.S.C. 207 to achieve expeditious
commercialization of results of federally
funded research and development.
Foreign patent applications are filed on
selected inventions to extend market
coverage for companies and may also be
available for licensing.
ADDRESSES: Licensing information and
copies of the U.S. patent applications
listed below may be obtained by writing
to the indicated licensing contact at the
Office of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville,
Maryland 20852–3804; telephone: 301–
496–7057; fax: 301–402–0220. A signed
Confidential Disclosure Agreement will
be required to receive copies of the
patent applications.
SUMMARY:
sroberts on DSK5SPTVN1PROD with NOTICES
Monoclonal Antibodies for Rare
Diseases
Description of Technology: Available
for licensing are three monoclonal
antibodies (mAb) that bind with high
specificity and affinity to the tumor cell
surface antigen tyrosine kinase-like
orphan receptor 1 (ROR1). ROR1 is
expressed in chronic lymphocytic
leukemia (CLL) and mantle cell
lymphoma (MCL), two incurable B-cell
malignancies that are designated as rare
diseases by NIH’s Office of Rare
Diseases Research. Therapeutics for rare
diseases can qualify for orphan drug
status and receive expedited review by
the FDA. Currently, there are no
therapeutic mAbs that target CLL or
MCL but not healthy cells.
Investigators from the National Cancer
Institute developed chimeric antibodies
that selectively target ROR1 malignant
B-cells but not normal B-cells.
Additionally, this technology allows for
mAb derivatives with potentially higher
pharmacokinetic and/or
pharmacodynamic activity, including
humanized mAb in an IgG and IgM
format, antibody-drug conjugates,
immunotoxins, and bispecific
antibodies. These three mAbs have been
characterized in vitro for mediating
antibody-dependent cellular
VerDate Mar<15>2010
17:08 Jul 26, 2011
Jkt 223001
cytotoxicity, complement-dependent
cytotoxicity, apoptosis, and
internalization. Results show that these
mAbs bind with high specificity and
affinity to three different epitopes on
human ROR1, and ROR1-expressing
primary CLL cells from untreated CLL
patients and MCL cell lines. Moreover,
as these antibodies selectively target
ROR1, they can also be used to diagnose
B-cell malignancies.
Applications:
• Antibody treatments for B–CLL and
MCL
• Diagnostics for B–CLL and MCL
Advantages:
• Therapeutics that can qualify for an
orphan drug status by the FDA and
receive expedited FDA review
• Antibodies that selectively target
malignant B-cells and not healthy cells
Development Status: The technology
is currently in the pre-clinical stage of
development.
Market:
• Global orphan drugs market
reached $58.7 billion in 2006 and it is
expected to reach $81.8 billion by 2011
• Biologic drugs account for over
60% of the orphan drug market with
sales of $35.3 billion in 2006 and it is
projected to be worth $53.4 billion by
2011
Inventors: Christoph Rader and Jiahui
Yang (NCI)
Relevant Publication: Yang J et al.
Therapeutic potential and challenges of
targeting receptor tyrosine kinase ROR1
with monoclonal antibodies in B-cell
malignancies. PLoS ONE
2011;6(6):e21018. Epub 2011 Jun 15.
[PMID: 21698301]
Patent Status: U.S. Provisional
Application No. 61/418,550 filed
December 1, 2010 (HHS Reference No.
E–039–2011/0–US–01)
Licensing Status: Available for
licensing.
Licensing Contact: Jennifer Wong;
Phone No.: 301–435–4633; E-mail
Address: wongje@mail.nih.gov.
Collaborative Research Opportunity:
The National Cancer Institute, Center for
Cancer Research, Experimental
Transplantation and Immunology
Branch is seeking statements of
capability or interest from parties
interested in collaborative research to
further develop, evaluate, or
commercialize anti-ROR1 monoclonal
antibodies and their derivatives. Please
contact Dr. Christoph Rader at (301)
451–2235 or raderc@mail.nih.gov for
more information.
Oral Vaccine for Inducing Mucosal
Immunity
Description of Technology: Available
for licensing is a micro/nanoparticle
PO 00000
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44941
oral vaccine delivery system that
specifically targets the large intestine for
vaccine deposition and in situ immune
activation, with minimal perturbation in
the upper part of the gastrointestinal
(GI) tract.
Vaccine delivery to the large intestine
has been experimentally demonstrated
as an effective means for inducing
mucosal immunity against infections
transmitted through the recto-genital
mucosal area such as sexually
transmitted disease as well as fungal
and parasitic infections. In this system,
the vaccine components are
encapsulated by nanometer-sized
particles to allow optimal uptake once
it reaches the lumen and makes contact
with the intestinal mucosal surface. To
protect from premature degradation and
uptake in the upper GI, these particles
are coated within micrometer-sized
particles. This coating is designed with
a pH- and time-dependent release
profile that is optimized for vaccine
uptake to occur within the large
intestine. This particular feature may
also make this technology a potential
delivery system for recto-colon cancer
therapies.
Applications:
• Vaccine delivery system for
inducing mucosal immunity against a
variety of infections transmitted through
the recto-genital mucosal area
• Potential delivery system for rectocolon cancer therapeutics
• Potential delivery system for rectocolon immunotherapies or controlled
drug release
Advantages:
• Oral delivery provides a more
practical and less invasive means of
vaccine delivery to the large intestine
compared to intrarectal or
intracolorectal routes
• Delivery system can be used against
a variety of diseases transmitted through
the recto-genital mucosa
• Proof of concept has been
demonstrated in vivo.
Development Status:
• Early-stage
• Pre-clinical
• In vitro data available
• In vivo data available (animal)
Market: Global vaccine market is
expected to be worth an estimated $23.8
billion by 2012
Inventors: Qing Zhu (NCI), Jay A.
Berzofsky (NCI), James Talton
(Nanotherapeutics Inc.)
Relevant Publication: Manuscript
submitted, under review.
Patent Status: HHS Reference Number
E–132–2009/0 —
• US Application No. 61/238,361
filed 31 Aug 2009
• PCT Application No. PCT/US2010/
047338 filed 31 Aug 2010
E:\FR\FM\27JYN1.SGM
27JYN1
44942
Federal Register / Vol. 76, No. 144 / Wednesday, July 27, 2011 / Notices
Licensing Status: Available for
licensing.
Licensing Contact: Jennifer Wong;
301–435–4633; wongje@mail.nih.gov.
Collaborative Research Opportunity:
The Center for Cancer Research, Vaccine
Branch, is seeking statements of
capability or interest from parties
interested in collaborative research to
further develop, evaluate, or
commercialize Oral Delivery of a
Vaccine to the Large Intestine to Induce
Mucosal Immunity. Please contact John
Hewes, Ph.D. at 301–435–3121 or
hewesj@mail.nih.gov for more
information.
Dated: July 21, 2011.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2011–18965 Filed 7–26–11; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
sroberts on DSK5SPTVN1PROD 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: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Sensation and Perception.
Date: August 17–18, 2011.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: John Bishop, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5182,
MSC 7844, Bethesda, MD 20892, (301) 408–
9664, bishopj@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; ADHD and
Brain Development.
Date: August 19, 2011.
Time: 1 p.m. to 3:30 p.m.
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17:08 Jul 26, 2011
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Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call)
Contact Person: Samuel C. Edwards, PhD,
Chief, Center for Scientific Review, National
Institutes of Health, 6701 Rockledge Drive,
Room 5210, MSC 7846, Bethesda, MD 20892,
(301) 435–1246, edwardss@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Kidney and Urological Diseases.
Date: August 24, 2011.
Time: 2 p.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call)
Contact Person: Chantal A Rivera, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 2186,
MSC 7818, Bethesda, MD 20892, 301–435–
1243, riveraca@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: July 21, 2011.
Anna P. Snouffer,
Deputy Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2011–18969 Filed 7–26–11; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; 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: Center for Scientific
Review Special Emphasis Panel; Molecular
Neuroscience.
Date: August 5, 2011.
Time: 12 p.m. to 2 p.m.
Agenda: To review and evaluate grant
applications.
PO 00000
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Fmt 4703
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Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call)
Contact Person: Toby Behar, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4136,
MSC 7850, Bethesda, MD 20892, (301) 435–
4433, behart@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: July 21, 2011.
Anna P. Snouffer,
Deputy Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2011–18968 Filed 7–26–11; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Agency Information Collection
Activities: Proposed Collection;
Comment Request
In compliance with Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 concerning
opportunity for public comment on
proposed collections of information, the
Substance Abuse and Mental Health
Services Administration (SAMHSA)
will publish periodic summaries of
proposed projects. To request more
information on the proposed projects or
to obtain a copy of the information
collection plans, call the SAMHSA
Reports Clearance Officer on (240) 276–
1243.
Comments are invited on: (a) Whether
the proposed collections of information
are necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) ways to enhance the
quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
E:\FR\FM\27JYN1.SGM
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]]>Agencies
[Federal Register Volume 76, Number 144 (Wednesday, July 27, 2011)]
[Notices]
[Pages 44941-44942]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-18965]
[[Page 44941]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions; Availability for Licensing
AGENCY: National Institutes of Health, Public Health Service, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The inventions listed below are owned by an agency of the U.S.
Government and are available for licensing in the U.S. in accordance
with 35 U.S.C. 207 to achieve expeditious commercialization of results
of federally funded research and development. Foreign patent
applications are filed on selected inventions to extend market coverage
for companies and may also be available for licensing.
ADDRESSES: Licensing information and copies of the U.S. patent
applications listed below may be obtained by writing to the indicated
licensing contact at the Office of Technology Transfer, National
Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville,
Maryland 20852-3804; telephone: 301-496-7057; fax: 301-402-0220. A
signed Confidential Disclosure Agreement will be required to receive
copies of the patent applications.
Monoclonal Antibodies for Rare Diseases
Description of Technology: Available for licensing are three
monoclonal antibodies (mAb) that bind with high specificity and
affinity to the tumor cell surface antigen tyrosine kinase-like orphan
receptor 1 (ROR1). ROR1 is expressed in chronic lymphocytic leukemia
(CLL) and mantle cell lymphoma (MCL), two incurable B-cell malignancies
that are designated as rare diseases by NIH's Office of Rare Diseases
Research. Therapeutics for rare diseases can qualify for orphan drug
status and receive expedited review by the FDA. Currently, there are no
therapeutic mAbs that target CLL or MCL but not healthy cells.
Investigators from the National Cancer Institute developed chimeric
antibodies that selectively target ROR1 malignant B-cells but not
normal B-cells. Additionally, this technology allows for mAb
derivatives with potentially higher pharmacokinetic and/or
pharmacodynamic activity, including humanized mAb in an IgG and IgM
format, antibody-drug conjugates, immunotoxins, and bispecific
antibodies. These three mAbs have been characterized in vitro for
mediating antibody-dependent cellular cytotoxicity, complement-
dependent cytotoxicity, apoptosis, and internalization. Results show
that these mAbs bind with high specificity and affinity to three
different epitopes on human ROR1, and ROR1-expressing primary CLL cells
from untreated CLL patients and MCL cell lines. Moreover, as these
antibodies selectively target ROR1, they can also be used to diagnose
B-cell malignancies.
Applications:
Antibody treatments for B-CLL and MCL
Diagnostics for B-CLL and MCL
Advantages:
Therapeutics that can qualify for an orphan drug status by
the FDA and receive expedited FDA review
Antibodies that selectively target malignant B-cells and
not healthy cells
Development Status: The technology is currently in the pre-clinical
stage of development.
Market:
Global orphan drugs market reached $58.7 billion in 2006
and it is expected to reach $81.8 billion by 2011
Biologic drugs account for over 60% of the orphan drug
market with sales of $35.3 billion in 2006 and it is projected to be
worth $53.4 billion by 2011
Inventors: Christoph Rader and Jiahui Yang (NCI)
Relevant Publication: Yang J et al. Therapeutic potential and
challenges of targeting receptor tyrosine kinase ROR1 with monoclonal
antibodies in B-cell malignancies. PLoS ONE 2011;6(6):e21018. Epub 2011
Jun 15. [PMID: 21698301]
Patent Status: U.S. Provisional Application No. 61/418,550 filed
December 1, 2010 (HHS Reference No. E-039-2011/0-US-01)
Licensing Status: Available for licensing.
Licensing Contact: Jennifer Wong; Phone No.: 301-435-4633; E-mail
Address: wongje@mail.nih.gov.
Collaborative Research Opportunity: The National Cancer Institute,
Center for Cancer Research, Experimental Transplantation and Immunology
Branch is seeking statements of capability or interest from parties
interested in collaborative research to further develop, evaluate, or
commercialize anti-ROR1 monoclonal antibodies and their derivatives.
Please contact Dr. Christoph Rader at (301) 451-2235 or
raderc@mail.nih.gov for more information.
Oral Vaccine for Inducing Mucosal Immunity
Description of Technology: Available for licensing is a micro/
nanoparticle oral vaccine delivery system that specifically targets the
large intestine for vaccine deposition and in situ immune activation,
with minimal perturbation in the upper part of the gastrointestinal
(GI) tract.
Vaccine delivery to the large intestine has been experimentally
demonstrated as an effective means for inducing mucosal immunity
against infections transmitted through the recto-genital mucosal area
such as sexually transmitted disease as well as fungal and parasitic
infections. In this system, the vaccine components are encapsulated by
nanometer-sized particles to allow optimal uptake once it reaches the
lumen and makes contact with the intestinal mucosal surface. To protect
from premature degradation and uptake in the upper GI, these particles
are coated within micrometer-sized particles. This coating is designed
with a pH- and time-dependent release profile that is optimized for
vaccine uptake to occur within the large intestine. This particular
feature may also make this technology a potential delivery system for
recto-colon cancer therapies.
Applications:
Vaccine delivery system for inducing mucosal immunity
against a variety of infections transmitted through the recto-genital
mucosal area
Potential delivery system for recto-colon cancer
therapeutics
Potential delivery system for recto-colon immunotherapies
or controlled drug release
Advantages:
Oral delivery provides a more practical and less invasive
means of vaccine delivery to the large intestine compared to
intrarectal or intracolorectal routes
Delivery system can be used against a variety of diseases
transmitted through the recto-genital mucosa
Proof of concept has been demonstrated in vivo.
Development Status:
Early-stage
Pre-clinical
In vitro data available
In vivo data available (animal)
Market: Global vaccine market is expected to be worth an estimated
$23.8 billion by 2012
Inventors: Qing Zhu (NCI), Jay A. Berzofsky (NCI), James Talton
(Nanotherapeutics Inc.)
Relevant Publication: Manuscript submitted, under review.
Patent Status: HHS Reference Number E-132-2009/0 --
US Application No. 61/238,361 filed 31 Aug 2009
PCT Application No. PCT/US2010/047338 filed 31 Aug 2010
[[Page 44942]]
Licensing Status: Available for licensing.
Licensing Contact: Jennifer Wong; 301-435-4633;
wongje@mail.nih.gov.
Collaborative Research Opportunity: The Center for Cancer Research,
Vaccine Branch, is seeking statements of capability or interest from
parties interested in collaborative research to further develop,
evaluate, or commercialize Oral Delivery of a Vaccine to the Large
Intestine to Induce Mucosal Immunity. Please contact John Hewes, Ph.D.
at 301-435-3121 or hewesj@mail.nih.gov for more information.
Dated: July 21, 2011.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2011-18965 Filed 7-26-11; 8:45 am]
BILLING CODE 4140-01-P
