Government-Owned Inventions; Availability for Licensing, 15790-15791 [2015-06845]
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Federal Register / Vol. 80, No. 57 / Wednesday, March 25, 2015 / Notices
Obtaining Copies of Proposals:
Requesters may obtain a copy of the
information collection documents from
the General Services Administration,
Regulatory Secretariat Division (MVCB),
1800 F Street NW., Washington, DC
20405, telephone 202–501–4755. Please
cite OMB Control No. 9000–0054,
Submission for OMB Review; U.S.-Flag
Air Carriers Statement, in all
correspondence.
Dated: March 19, 2015.
Edward Loeb,
Acting Director, Office of Government-wide
Acquisition Policy, Office of Acquisition
Policy, Office of Government-wide Policy.
Period of Employment: April 10, 1951
through December 31, 1979.
John Howard,
Director, National Institute for Occupational
Safety and Health.
[FR Doc. 2015–06786 Filed 3–24–15; 8:45 am]
BILLING CODE 4163–19–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
[FR Doc. 2015–06818 Filed 3–24–15; 8:45 am]
AGENCY:
BILLING CODE 6820–EP–P
HHS.
ACTION:
Decision To Evaluate a Petition To
Designate a Class of Employees From
the Argonne National Laboratory-West
in Scoville, Idaho, To Be Included in
the Special Exposure Cohort
National Institute for
Occupational Safety and Health
(NIOSH), Centers for Disease Control
and Prevention, Department of Health
and Human Services.
AGENCY:
Notice.
NIOSH gives notice of a
decision to evaluate a petition to
designate a class of employees from the
Argonne National Laboratory-West in
Scoville, Idaho, to be included in the
Special Exposure Cohort under the
Energy Employees Occupational Illness
Compensation Program Act of 2000.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Stuart L. Hinnefeld, Director, Division
of Compensation Analysis and Support,
National Institute for Occupational
Safety and Health, 1090 Tusculum
Avenue, MS C–46, Cincinnati, OH
45226–1938, Telephone 877–222–7570.
Information requests can also be
submitted by email to DCAS@CDC.GOV.
SUPPLEMENTARY INFORMATION:
rljohnson on DSK3VPTVN1PROD with NOTICES
Authority: 42 CFR 83.9–83.12.
Pursuant to 42 CFR 83.12, the initial
proposed definition for the class being
evaluated, subject to revision as
warranted by the evaluation, is as
follows:
Facility: Argonne National
Laboratory-West.
Location: Scoville, Idaho.
Job Titles and/or Job Duties: All
workers who worked in any location.
VerDate Sep<11>2014
15:26 Mar 24, 2015
Jkt 235001
Notice.
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. 209 and 37 CFR part 404 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.
FOR FURTHER INFORMATION CONTACT:
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.
SUPPLEMENTARY INFORMATION:
Technology descriptions follow.
SUMMARY:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
ACTION:
National Institutes of Health,
Engineered Antibody Domains With
Increased FcRn Binding and in vivo
Half-Life
Description of Technology:
Monoclonal antibodies (mAbs) are a fast
growing class of new therapeutic
molecules. However, their large size
remains a significant challenge,
preventing them from targeting
sterically restricted epitopes and
efficiently penetrating into tissues.
Smaller antibody fragments and
engineered variants are under
development to address this challenge,
but to date their therapeutic
applications have been limited due to
rapid clearance and short half-life
which greatly decrease their efficacy in
vivo.
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
This technology describes two
antibody constant domains or binders
with increased FcRn binding and in vivo
half-life. In addition, these binders are
small in size (16kDa), very stable, and
can be efficiently expressed in E. coli.
As a result, the binders are particularly
well suited as scaffolds for the
generation of antibody libraries, from
which a desired antigen binders could
be developed into therapeutic products
with much greater potency compared to
existing mAbs. They could also be used
as fusion partners to extend the half-life
of candidate protein therapeutics.
Potential Commercial Applications
• Antibody scaffolds for library
construction, and the generation of
therapeutics against various diseases.
• Fusion partners to extend the halflife of candidate protein therapeutics.
Competitive Advantages
• Small (16kD) size for better tissue
penetration, and in the case of fusion
proteins, reduced steric hindrance for
therapeutic activity.
• Superior stability compared to
isolated CH2 domains and stability
comparable to or higher than that of an
isolated Fc fragment.
• Exhibit greatly enhanced FcRn
binding abilities, including more potent
transcytosis and longer in vivo half-life.
• Can be efficiently expressed in E.
coli.
Development Stage
• Early-stage
• In vitro data available
• In vivo data available (animal)
Inventors: Dimiter Dimitrov and
Tianlei Ying (NCI).
Intellectual Property: HHS Reference
No. E–136–2014/0—US Provisional
Application No. 62/022,810 filed July
10, 2014.
Licensing Contact: Whitney Hastings,
Ph.D.; 301–451–7337; hastingw@
mail.nih.gov.
Collaborative Research Opportunity:
The National Cancer Institute is seeking
statements of capability or interest from
parties interested in collaborative
research to further develop, evaluate or
commercialize Engineered Antibody
Domains. For collaboration
opportunities, please contact John D.
Hewes, Ph.D. at john.hewes@nih.gov or
240–276–5515.
CXCR4 Reduction Leads to
Enhancement of Engraftment of
Hematopoietic Stem Cells
Description of Technology: Methods
of enhancing engraftment of donor
hematopoietic stem cells (HSCs) by
reducing expression or activity of
E:\FR\FM\25MRN1.SGM
25MRN1
Federal Register / Vol. 80, No. 57 / Wednesday, March 25, 2015 / Notices
CXCR4 in HSCs is described. HSC are
the only cells in the bone marrow that
are both pluripotent and long lived.
Bone marrow transplantation (BMT)
using HSC is an increasingly common
medical therapy for severe hematologic
cancers and primary hematologic
immunodeficiencies. However, for
significant HSC engraftment to occur
there must usually be pre-transplant
conditioning with either irradiation or
chemotherapy or both. The technology
described herein shows that it is
possible to replace HSC without the
need for pre-transplant conditioning
regimen. It is known that the chemokine
receptor CXCR4 plays a critical role in
HSC homing to the bone marrow and in
HSC quiescence. The inventors have
identified a patient in which one copy
of CXCR4 had been deleted in a somatic
mutation of an HSC and this cell had
clonally repopulated the bone marrow.
This led to experiments in mice where
the inventors clearly demonstrated in a
bone marrow transplantation model,
that donor cells with a single copy of
the Cxcr4 gene repopulate recipient
mice much faster and last much longer
than donor cells having two copies of
the Cxcr4 gene. This technology which
shows that HSCs with one copy of the
CXCR4 gene have a durable selective
advantage in bone marrow repopulation
can solve the problem frequently
encountered in gene therapy, i.e., the
short-lived nature of gene-corrected
cells, by utilizing recently discovered
gene editing methods that can be used
to delete one copy of CXCR4 gene in
gene-corrected cells.
Potential Commercial Applications
• Improvement of engraftment in
gene therapy protocols and in HSC
transplantation.
• Improved bone marrow
transplantation, enhancing the
efficiency and durability of donor cell
repopulation.
rljohnson on DSK3VPTVN1PROD with NOTICES
Competitive Advantages
• This technology potentially
facilitates HSC transplantation without
the need of radiation or chemotherapy
conditioning.
• This technology may uniquely
overcome a major hurdle limiting all
gene therapy applications, namely the
failure to correct the gene defect over a
long time.
Development Stage
• Early-stage
• In vitro data available
• In vivo data available (animal)
Inventors: Jiliang Gao, Philip M.
Murphy, David H. McDermott, Marie
VerDate Sep<11>2014
15:26 Mar 24, 2015
Jkt 235001
Siwicki, Harry L. Malech, and Joy Liu
(all of NIAID).
Publication: McDermott DH, et al.
Chromothriptic cure of WHIM
syndrome. Cell. 2015 Feb
12;160(4):686–99. [PMID 25662009].
Intellectual Property: HHS Reference
No. E–173–2014/0—US Patent
Application No. 62/026,138 filed July
18, 2014.
Licensing Contact: Sury Vepa, Ph.D.,
J.D.; 301–435–5020; vepas@
mail.nih.gov.
Development of GPR124 Wildtype and
Knockout Brain Endothelial Reporter
Cells
Description of Technology: There is
currently no effective way to block betacatenin signaling specifically in brain
endothelial cells. There is neither an
effective way to block beta-catenin
signaling stimulated by a particular Wnt
family member such as WNT7. The
reporter cells created by the NIH
investigator from GPR124 knockout
mice provide a unique and effective tool
to screen for drugs that can specifically
interfere with the Wnt7/GPR124
signaling pathway. Such drugs have
potential for widespread therapeutic
application in the treatment of
cerebrovascular diseases, the third
leading cause of death in the United
States, and a variety of
neurodegenerative disorders such as
Alzheimer’s disease, Parkinson disease,
amyotrophic lateral sclerosis, multiple
sclerosis, and others.
Potential Commercial Applications:
Research tools for drug screening.
Competitive Advantages: The reporter
cells are ideal for screening for drugs
that specifically interfere with the
Wnt7/GPR124 signaling pathway as the
cells have no inherent low level Gpr124
expression.
Development Stage: Prototype.
Inventor: Brad St. Croix (NCI).
Publication: Posokhova E, et al.
GPR124 functions as a WNT7-specific
coactivator of canonical beta-catenin
signaling. Cell Rep. 2015 Jan 13;10
(2):123–30. [PMID 25558062].
Intellectual Property: HHS Reference
No. E–079–2015/0—Research Tool.
Patent protection is not being pursued
for this technology.
Licensing Contact: Betty B. Tong,
Ph.D.; 301–594–6565; tongb@
mail.nih.gov.
Collaborative Research Opportunity:
The National Cancer Institute is seeking
statements of capability or interest from
parties interested in collaborative
research to further develop, evaluate, or
commercialize agents that antagonize or
promote Gpr124 function. For
collaboration opportunities, please
PO 00000
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Fmt 4703
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15791
contact John D. Hewes, Ph.D. at hewesj@
mail.nih.gov.
Dated: March 20, 2015.
Richard U. Rodriguez,
Acting Director, Office of Technology
Transfer, National Institutes of Health.
[FR Doc. 2015–06845 Filed 3–24–15; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–15–15IG]
Agency Forms Undergoing Paperwork
Reduction Act Review
The Centers for Disease Control and
Prevention (CDC) publishes a list of
information collection requests under
review by the Office of Management and
Budget (OMB) in compliance with the
Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
requests, call (404) 639–7570 or send an
email to omb@cdc.gov. Send written
comments to CDC Desk Officer, Office of
Management and Budget, Washington,
DC or by fax to (202) 395–5806. Written
comments should be received within 30
days of this notice.
Proposed Project
Public Health Associate Program
(PHAP) Alumni Assessment—New –Office for State, Tribal, Local, and
Territorial Support (OSTLTS), Centers
for Disease Control and Prevention
(CDC).
Background and Brief Description
The Centers for Disease Control and
Prevention (CDC) works to protect
America from health, safety and security
threats, both foreign and in the U.S.
CDC strives to fulfill this mission, in
part, through a competent and capable
public health workforce. One
mechanism to developing the public
health workforce is through training
programs like the Public Health
Associate Program (PHAP).
The mission of the Public Health
Associate Program (PHAP) is to train
and provide experiential learning to
early career professionals who
contribute to the public health
workforce. PHAP targets recent
graduates with bachelors or masters
degrees who are beginning a career in
public health. Each year, a new cohort
of up to 200 associates is enrolled in the
program.
Associates are CDC employees who
complete two-year assignments in a host
site (i.e., a state, tribal, local, or
E:\FR\FM\25MRN1.SGM
25MRN1
]]>Agencies
[Federal Register Volume 80, Number 57 (Wednesday, March 25, 2015)]
[Notices]
[Pages 15790-15791]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-06845]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions; Availability for Licensing
AGENCY: National Institutes of Health, 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. 209 and 37 CFR part 404 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.
FOR FURTHER INFORMATION CONTACT: 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.
SUPPLEMENTARY INFORMATION: Technology descriptions follow.
Engineered Antibody Domains With Increased FcRn Binding and in vivo
Half-Life
Description of Technology: Monoclonal antibodies (mAbs) are a fast
growing class of new therapeutic molecules. However, their large size
remains a significant challenge, preventing them from targeting
sterically restricted epitopes and efficiently penetrating into
tissues. Smaller antibody fragments and engineered variants are under
development to address this challenge, but to date their therapeutic
applications have been limited due to rapid clearance and short half-
life which greatly decrease their efficacy in vivo.
This technology describes two antibody constant domains or binders
with increased FcRn binding and in vivo half-life. In addition, these
binders are small in size (16kDa), very stable, and can be efficiently
expressed in E. coli. As a result, the binders are particularly well
suited as scaffolds for the generation of antibody libraries, from
which a desired antigen binders could be developed into therapeutic
products with much greater potency compared to existing mAbs. They
could also be used as fusion partners to extend the half-life of
candidate protein therapeutics.
Potential Commercial Applications
Antibody scaffolds for library construction, and the
generation of therapeutics against various diseases.
Fusion partners to extend the half-life of candidate
protein therapeutics.
Competitive Advantages
Small (16kD) size for better tissue penetration, and in
the case of fusion proteins, reduced steric hindrance for therapeutic
activity.
Superior stability compared to isolated CH2 domains and
stability comparable to or higher than that of an isolated Fc fragment.
Exhibit greatly enhanced FcRn binding abilities, including
more potent transcytosis and longer in vivo half-life.
Can be efficiently expressed in E. coli.
Development Stage
Early-stage
In vitro data available
In vivo data available (animal)
Inventors: Dimiter Dimitrov and Tianlei Ying (NCI).
Intellectual Property: HHS Reference No. E-136-2014/0--US
Provisional Application No. 62/022,810 filed July 10, 2014.
Licensing Contact: Whitney Hastings, Ph.D.; 301-451-7337;
hastingw@mail.nih.gov.
Collaborative Research Opportunity: The National Cancer Institute
is seeking statements of capability or interest from parties interested
in collaborative research to further develop, evaluate or commercialize
Engineered Antibody Domains. For collaboration opportunities, please
contact John D. Hewes, Ph.D. at john.hewes@nih.gov or 240-276-5515.
CXCR4 Reduction Leads to Enhancement of Engraftment of Hematopoietic
Stem Cells
Description of Technology: Methods of enhancing engraftment of
donor hematopoietic stem cells (HSCs) by reducing expression or
activity of
[[Page 15791]]
CXCR4 in HSCs is described. HSC are the only cells in the bone marrow
that are both pluripotent and long lived. Bone marrow transplantation
(BMT) using HSC is an increasingly common medical therapy for severe
hematologic cancers and primary hematologic immunodeficiencies.
However, for significant HSC engraftment to occur there must usually be
pre-transplant conditioning with either irradiation or chemotherapy or
both. The technology described herein shows that it is possible to
replace HSC without the need for pre-transplant conditioning regimen.
It is known that the chemokine receptor CXCR4 plays a critical role in
HSC homing to the bone marrow and in HSC quiescence. The inventors have
identified a patient in which one copy of CXCR4 had been deleted in a
somatic mutation of an HSC and this cell had clonally repopulated the
bone marrow. This led to experiments in mice where the inventors
clearly demonstrated in a bone marrow transplantation model, that donor
cells with a single copy of the Cxcr4 gene repopulate recipient mice
much faster and last much longer than donor cells having two copies of
the Cxcr4 gene. This technology which shows that HSCs with one copy of
the CXCR4 gene have a durable selective advantage in bone marrow
repopulation can solve the problem frequently encountered in gene
therapy, i.e., the short-lived nature of gene-corrected cells, by
utilizing recently discovered gene editing methods that can be used to
delete one copy of CXCR4 gene in gene-corrected cells.
Potential Commercial Applications
Improvement of engraftment in gene therapy protocols and
in HSC transplantation.
Improved bone marrow transplantation, enhancing the
efficiency and durability of donor cell repopulation.
Competitive Advantages
This technology potentially facilitates HSC
transplantation without the need of radiation or chemotherapy
conditioning.
This technology may uniquely overcome a major hurdle
limiting all gene therapy applications, namely the failure to correct
the gene defect over a long time.
Development Stage
Early-stage
In vitro data available
In vivo data available (animal)
Inventors: Jiliang Gao, Philip M. Murphy, David H. McDermott, Marie
Siwicki, Harry L. Malech, and Joy Liu (all of NIAID).
Publication: McDermott DH, et al. Chromothriptic cure of WHIM
syndrome. Cell. 2015 Feb 12;160(4):686-99. [PMID 25662009].
Intellectual Property: HHS Reference No. E-173-2014/0--US Patent
Application No. 62/026,138 filed July 18, 2014.
Licensing Contact: Sury Vepa, Ph.D., J.D.; 301-435-5020;
vepas@mail.nih.gov.
Development of GPR124 Wildtype and Knockout Brain Endothelial Reporter
Cells
Description of Technology: There is currently no effective way to
block beta-catenin signaling specifically in brain endothelial cells.
There is neither an effective way to block beta-catenin signaling
stimulated by a particular Wnt family member such as WNT7. The reporter
cells created by the NIH investigator from GPR124 knockout mice provide
a unique and effective tool to screen for drugs that can specifically
interfere with the Wnt7/GPR124 signaling pathway. Such drugs have
potential for widespread therapeutic application in the treatment of
cerebrovascular diseases, the third leading cause of death in the
United States, and a variety of neurodegenerative disorders such as
Alzheimer's disease, Parkinson disease, amyotrophic lateral sclerosis,
multiple sclerosis, and others.
Potential Commercial Applications: Research tools for drug
screening.
Competitive Advantages: The reporter cells are ideal for screening
for drugs that specifically interfere with the Wnt7/GPR124 signaling
pathway as the cells have no inherent low level Gpr124 expression.
Development Stage: Prototype.
Inventor: Brad St. Croix (NCI).
Publication: Posokhova E, et al. GPR124 functions as a WNT7-
specific coactivator of canonical beta-catenin signaling. Cell Rep.
2015 Jan 13;10 (2):123-30. [PMID 25558062].
Intellectual Property: HHS Reference No. E-079-2015/0--Research
Tool. Patent protection is not being pursued for this technology.
Licensing Contact: Betty B. Tong, Ph.D.; 301-594-6565;
tongb@mail.nih.gov.
Collaborative Research Opportunity: The National Cancer Institute
is seeking statements of capability or interest from parties interested
in collaborative research to further develop, evaluate, or
commercialize agents that antagonize or promote Gpr124 function. For
collaboration opportunities, please contact John D. Hewes, Ph.D. at
hewesj@mail.nih.gov.
Dated: March 20, 2015.
Richard U. Rodriguez,
Acting Director, Office of Technology Transfer, National Institutes of
Health.
[FR Doc. 2015-06845 Filed 3-24-15; 8:45 am]
BILLING CODE 4140-01-P
