Government-Owned Inventions; Availability for Licensing, 71625-71627 [2013-28558]
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Federal Register / Vol. 78, No. 230 / Friday, November 29, 2013 / Notices
enhance implementation of
methodologies to improve
organizational effectiveness. The main
goal of this information is to improve
program outcomes and increase the
efficiency of resource utilization. The
knowledge gained from these
collections will be used to strengthen
the planning, implementation, and
monitoring of NIH research programs, as
well as to strengthen strategy
management in NIH research programs.
The questions asked, and the data to
be collected are rooted in established
business-based paradigms but
administered in a manner that
minimizes public information collection
burden. These include, but are not
limited to, surveys, focus groups, and/
or cognitive interviews. Separate and
distinct generic clearances are requested
to facilitate the efficiency of submission
and review of these projects as required
by the OMB Office of Information and
Regulatory Affairs
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
4775.
specifically adapted for use (and
relevance) in a biomedical research
environment, in order to discern: 1)
Factors that enhance (or inhibit)
organizational effectiveness in research
programs; 2) utility and acceptance of
these kinds of efforts among biomedical
researchers and research stakeholders.
The results from this formative research
project will inform quality improvement
activities in several areas, including goal
setting, capability and resource
evaluation, operational efficiency, and
performance monitoring. Utilized data
collection methodologies will be
ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondent
Pilot Test .......................
Dated: November 21, 2013.
Brandie Taylor,
Project Clearance Liaison, Chief, Evaluation
Section, OPSIDA, NIAID, NIH.
[FR Doc. 2013–28636 Filed 11–27–13; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
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Government-Owned Inventions;
Availability for Licensing
AGENCY:
National Institutes of Health,
HHS.
ACTION:
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
SUMMARY:
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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.
Device for Vascular Dilation
National Institutes of Health
sroberts on DSK5SPTVN1PROD with NOTICES
Number of responses per
respondent
Science professional, researchers, institutional
officials, network leadership, program administrators, and research site staff..
...............................................................................
...............................................................................
...............................................................................
...............................................................................
Survey ...........................
Interview ........................
Focus group ..................
Data interpretation
meeting with stakeholders.
Description of Technology: The
invention is an enhanced vascular
dilator that eliminates the vascular
injury caused by the size mismatch
between vascular introducer sheaths
and vascular dilators, as the two are
advanced into a blood vessel. The
invention provides a ‘‘shoulder’’ to
match the diameter of the introducer
sheath so that there is a smooth
transition, without size mismatch,
between the dilator and the introducer
sheath. The invention allows the dilator
to be withdrawn in segments from the
introducer sheath. This is especially
valuable to reduce vascular injury when
using large-bore introducer sheaths for
interventional procedures including
transcatheter valves and endografts.
Potential Commercial Applications:
• Caval access.
• Vascular access.
Competitive Advantages: Nonperforating.
Development Stage: Prototype.
PO 00000
Frm 00065
Average burden per response
(in hours)
Number
of respondents
Form name
Fmt 4703
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Total annual
burden hour
Inventors: Robert Lederman (NHLBI),
Ozgur Kocaturk (NHLBI), Adam
Greenbaum (Henry Ford Hospital).
Intellectual Property: HHS Reference
No. E–759–2013/0—US Provisional
Patent Application 61/890,961 filed 15
October 2013.
Licensing Contact: Michael
Shmilovich; 301–435–5019;
shmilovm@mail.nih.gov.
Collaborative Research Opportunity:
The National Heart, Lung, and Blood
Institute is seeking statements of
capability or interest from parties
interested in collaborative research to
further develop, evaluate or
commercialize interventional catheterbased procedures to reduce vascular
injury. For collaboration opportunities,
please contact Peg Koelble at
koelblep@nhlbi.nih.gov.
Her2 Monoclonal Antibodies, Antibody
Drug Conjugates, and Site Specific
Antibody Conjugate Methods
Description of Technology: Antibody
drug conjugates (ADC) can demonstrate
high efficacy as cancer therapeutics,
however, much more can be done to
improve their efficacy and safety profile.
Site-specific antibody drug conjugation
is a promising way to do this.
The scientists at the NIH have
identified a fully human monoclonal
antibody, m860, that binds to cell
surface-associated Her2 with affinity
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comparable to that of Trastuzumab
(Herceptin) but to a different epitope. In
addition, the scientist developed a sitespecific glycan engineering method to
conjugate the antibody to the small
molecule drug auristatin F. The ADC
prepared though this site-specific
approach shows very good stability, cell
surface binding activity and also potent
specific cell killing activity against Her2
positive cancer cells, including
Trastuzumab resistant breast cancer
cells. This ADC has the potential to be
developed as a targeted therapeutic for
Her2-overexpressing cancers and this
site-specific strategy could be readily
applied to develop ADCs targeting other
cancers that express cell surface markers
or other disease targets.
Potential Commercial Applications:
• Therapeutic for the treatment of
Her2 positive cancers.
• Method for producing safer and
more effective ADCs.
Competitive Advantages:
• Could be used in combination with
Trastuzumab or for patients who have
developed resistance to Trastuzumab
treatment, since this antibody targets a
different epitope.
• Site specific conjugation provides
better efficacy and less side effects than
ADCs produced using traditional
strategies.
• Can be readily applied to develop
ADCs targeting other cancers that
express cell surface markers or other
disease targets, such as HIV.
Development Stage:
• Pre-clinical.
• In vitro data available.
• In vivo data available (animal).
Inventors: Dimiter S. Dimitrov (NCI),
Zhu Zhongyu (NCI), Pradman K. Qasba
(NCI), Boopathy Ramakrishnan (NCI).
Intellectual Property: HHS Reference
No. E–351–2013/0—US Provisional
Application No. 61/833,732 filed 11
June 2013.
Licensing Contact: Whitney A.
Hastings; 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 monoclonal antibodies,
ADCs, and methods. For collaboration
opportunities, please contact John D.
Hewes, Ph.D. at hewesj@mail.nih.gov.
urine samples. Urine samples minimize
patient discomfort unlike current early
detection methods that are highly
invasive, such as a biopsy or
bronchoscopy, or utilize expensive
computer tomography (CT) scans that
expose patients to harmful radiation.
Although the sensitivity of low dose CT
scans is high, the specificity is low,
resulting in high false positive rates.
Utilizing metabolic profiling of urine
samples obtained from 1,005 people, the
scientists have developed and validated
this unique metabolite profile that
diagnoses early stage lung cancer and
predicts patient survival with a high
accuracy.
Potential Commercial Applications:
• Diagnostic test for early stage lung
cancer.
• Prognostic test for patient survival.
• Method to help physicians make
informed treatment decisions.
Competitive Advantages: Urinary
patient samples—no need for needles,
invasive surgery, or claustrophobic
tests.
Development Stage:
• Early-stage.
• In vivo data available (human).
Inventors: Curtis Harris (NCI), Majda
Haznadar (NCI), Frank Gonzalez (NCI),
Ewy Mathe (NCI), Kristopher Krausz
(NCI), Soumen Manna (NCI), and
Andrew Patterson (Pennsylvania State
University)
Intellectual Property: HHS Reference
No. E–121–2013/0—US Patent
Application No. 61/845,055 filed 11 July
2013
Related Technology: HHS Reference
No. E–248–2002/0—US Patent
Application No. 10/533,459 filed 02
May 2005; PCT Application No. PCT/
US2013/055746 filed 20 August 2013
Licensing Contact: Jennifer Wong,
M.S.; 301–435–4633;
wongje@mail.nih.gov.
Collaborative Research Opportunity:
The National Cancer Institute,
Laboratory of Human Carcinogenesis, is
seeking statements of capability or
interest from parties interested in
collaborative research to further
develop, evaluate or commercialize
Non-invasive Urinary Biomarkers
Highly Predictive of Non-small Cell
Lung Cancer Status and Survival. For
collaboration opportunities, please
contact John D. Hewes, Ph.D. at
hewesj@mail.nih.gov.
Non-invasive Early Stage Lung Cancer
Diagnostic and Prognostic Assays
Intravenous Water Soluble Formulation
of MJC13—A Novel Lead Compound for
the Treatment of Castrate-Resistant
Prostate Cancer
Description of Technology: Normal
prostate growth and maintenance is
dependent on androgens acting through
Description of Technology: The
present invention provides a unique
non-invasive diagnostic to detect early
stage lung cancer and predict patient
survival through a simple assay utilizing
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the androgen receptor (AR). AR
expression is maintained and plays an
important role throughout prostate
cancer progression. A lead molecule,
MJC13, has been identified and has
higher potency and better selectivity for
AR than any other compound tested. It
has been shown to effectively block ARdependent gene expression in cellular
models of prostate cancer at micromolar
concentrations.
MJC13, although an attractive drug
candidate, has low aqueous solubility.
This has hindered the clinical
development of MJC13. Scientists at
NIH, University of Texas-El-Paso and
Texas Southern University have
developed a water soluble and stable
MJC13 liquid dosage formulation that is
suitable for intravenous administration.
The solubility of this formulation has
increased over 25,000 times compared
to MJC13 itself. Additionally, a sensitive
LC/MS/MS method to analyze MJC13
has also been developed, which can
detect as little as 1 ng/mL of MJC13 in
solution or plasma. These studies are of
great importance for future pre-clinical
and clinical studies of MJC13.
Potential Commercial Applications:
Develop MJC13 as a clinical drug
product for the treatment of castrateresistant prostate cancer (CRPC), in
which current treatment options are
ineffective.
Competitive Advantages: Water
soluble formulation of the lead
compound, MJC13, that will enable
further pharmacokinetic/
pharmacodynamic studies and clinical
studies required for commercial
development of the drug.
Development Stage:
• Pre-clinical.
• In vitro data available.
• In vivo data available (animal).
Intellectual Property: HHS Reference
No. E–065–2013/0—US Provisional
Application No. 61/788,716 filed 15
March 2013.
Related Technology: HHS Reference
No. E–162–2009/0—US Patent
Application No. 13/395,976 filed 14
March 2012.
Licensing Contact: Eggerton
Campbell, Ph.D.; 301–435–5282;
campbellea2@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 this technology with an
initial goal of preclinical evaluation and
an ultimate goal of clinical testing. For
collaboration opportunities, please
contact John D. Hewes, Ph.D. at
hewesj@mail.nih.gov.
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Federal Register / Vol. 78, No. 230 / Friday, November 29, 2013 / Notices
Methods of Modulating
Chemotherapeutic Cytotoxicity
Description of Technology:
Investigators at the National Cancer
Institute (NCI) have discovered that
blockade of the signalling activity of a
single cell-surface receptor, CD47, in
cancer cells results in enhanced
sensitivity of cancer cells to
chemotherapy treatment and in healthy
tissues reduces damage to normal cells.
Many chemotherapeutic agents cause
significant cytotoxicity to non-cancer
(‘‘normal’’) cells, resulting in
undesirable side-effects and often
limiting the dose and/or duration of
chemotherapy that can be administered
to a patient. The present invention
relates to a method of using CD47modulating compounds in combination
with a chemotherapeutic agent to
increase the efficacy of that agent
against inhibiting tumor growth. The
invention also relates to methods for
preventing damage to heart tissue
associated with the use of anthracycline
chemotherapy. The current invention
builds on the NIH’s previous discoveries
of antibodies, antisense morpholino
oligonucleotides, and peptide
compounds that modulate CD47.
Potential Commercial Applications:
Combination Chemotherapy
Competitive Advantages:
• Enhance effectiveness of
chemotherapeutic agents.
• Limit off target effects on normal
tissue.
• Reduces cytotoxicity of normal
cells.
• Provides cardioprotection for
anthracyclines.
Development Stage:
• Early-stage.
• Pre-clinical.
• In vitro data available.
• In vivo data available (animal).
Inventors: David D. Roberts and David
R. Soto Pantoja (NCI).
Publication: Soto-Pantoja DR, et al.
CD47 deficiency confers cell and tissue
radioprotection by activation of
autophagy. Autophagy. 2012
Nov;8(11):1628–42. [PMID 22874555]
Intellectual Property: HHS Reference
No. E–296–2011/0—US Application No.
61/779,587 filed 13 March 2013
Related Technology: HHS Reference
No. E–227–2006/5–
• US Application No. 12/444,364
filed 03 April 2009.
• CA Application No. 2,665,287 filed
05 October 2007.
• EP Application No. 07868382.8
filed 27 March 2009.
• US Application No. 13/546,941
filed 11 July 2012.
• US Application No. 13/546,931
filed 11 July 2012.
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Licensing Contact: Charlene Maddox,
Ph.D.; 301–435–4689;
sydnorc@mail.nih.gov.
Collaborative Research Opportunity:
The National Cancer Institute,
Laboratory of Pathology, is seeking
statements of capability or interest from
parties interested in collaborative
research to further develop, evaluate or
commercialize CD47 targeting
therapeutics, cardioprotection,
autophagy modulation. For
collaboration opportunities, please
contact John D. Hewes, Ph.D. at
hewesj@mail.nih.gov.
Dated: November 21, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2013–28558 Filed 11–27–13; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Biomedical
Imaging and Bioengineering; 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
Biomedical Imaging and Bioengineering
Special Emphasis Panel; NIBIB 2014–05
Reducing Health Disparity SBIR Review.
Date: March 6, 2014.
Time: 10:00 a.m. to 5:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Two
Democracy Plaza, Suite 920, 6707 Democracy
Boulevard, Bethesda, MD 20892 (Virtual
Meeting).
Contact Person: Ruixia Zhou, Ph.D.,
Scientific Review Officer, 6707 Democracy
Boulevard, Suite 957, Bethesda, MD 20892,
301–496–4773, zhour@mail.nih.gov.
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71627
Dated: November 22, 2013.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2013–28559 Filed 11–27–13; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; 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 Cancer
Institute Special Emphasis Panel; K22 Grant
Applications for PAR–12–121.
Date: December 3, 2013.
Time: 9:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Cancer Institute Shady
Grove, 9609 Medical Center Drive, Room
7W030, Rockville, MD 20850 (Telephone
Conference Call).
Contact Person: Sergei Radaev, Ph.D.,
Scientific Review Officer, Resources and
Training Review Branch, Division of
Extramural Activities, National Cancer
Institute, NIH, 9609 Medical Center Drive,
Room 7W634, Bethesda, MD 20892, 240–
276–6466, sradaev@mail.nih.gov.
This notice is being published less than 15
days prior to the meeting date due to
scheduling conflicts.
Information is also available on the
Institute’s/Center’s home page: https://
deainfo.nci.nih.gov/advisory/sep/sep.htm,
where an agenda and any additional
information for the meeting will be posted
when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.392, Cancer Construction;
93.393, Cancer Cause and Prevention
Research; 93.394, Cancer Detection and
Diagnosis Research; 93.395, Cancer
Treatment Research; 93.396, Cancer Biology
Research; 93.397, Cancer Centers Support;
93.398, Cancer Research Manpower; 93.399,
Cancer Control, National Institutes of Health,
HHS).
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]]>Agencies
[Federal Register Volume 78, Number 230 (Friday, November 29, 2013)]
[Notices]
[Pages 71625-71627]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-28558]
-----------------------------------------------------------------------
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.
Device for Vascular Dilation
Description of Technology: The invention is an enhanced vascular
dilator that eliminates the vascular injury caused by the size mismatch
between vascular introducer sheaths and vascular dilators, as the two
are advanced into a blood vessel. The invention provides a ``shoulder''
to match the diameter of the introducer sheath so that there is a
smooth transition, without size mismatch, between the dilator and the
introducer sheath. The invention allows the dilator to be withdrawn in
segments from the introducer sheath. This is especially valuable to
reduce vascular injury when using large-bore introducer sheaths for
interventional procedures including transcatheter valves and
endografts.
Potential Commercial Applications:
Caval access.
Vascular access.
Competitive Advantages: Non-perforating.
Development Stage: Prototype.
Inventors: Robert Lederman (NHLBI), Ozgur Kocaturk (NHLBI), Adam
Greenbaum (Henry Ford Hospital).
Intellectual Property: HHS Reference No. E-759-2013/0--US
Provisional Patent Application 61/890,961 filed 15 October 2013.
Licensing Contact: Michael Shmilovich; 301-435-5019;
shmilovm@mail.nih.gov.
Collaborative Research Opportunity: The National Heart, Lung, and
Blood Institute is seeking statements of capability or interest from
parties interested in collaborative research to further develop,
evaluate or commercialize interventional catheter-based procedures to
reduce vascular injury. For collaboration opportunities, please contact
Peg Koelble at koelblep@nhlbi.nih.gov.
Her2 Monoclonal Antibodies, Antibody Drug Conjugates, and Site Specific
Antibody Conjugate Methods
Description of Technology: Antibody drug conjugates (ADC) can
demonstrate high efficacy as cancer therapeutics, however, much more
can be done to improve their efficacy and safety profile. Site-specific
antibody drug conjugation is a promising way to do this.
The scientists at the NIH have identified a fully human monoclonal
antibody, m860, that binds to cell surface-associated Her2 with
affinity
[[Page 71626]]
comparable to that of Trastuzumab (Herceptin) but to a different
epitope. In addition, the scientist developed a site-specific glycan
engineering method to conjugate the antibody to the small molecule drug
auristatin F. The ADC prepared though this site-specific approach shows
very good stability, cell surface binding activity and also potent
specific cell killing activity against Her2 positive cancer cells,
including Trastuzumab resistant breast cancer cells. This ADC has the
potential to be developed as a targeted therapeutic for Her2-
overexpressing cancers and this site-specific strategy could be readily
applied to develop ADCs targeting other cancers that express cell
surface markers or other disease targets.
Potential Commercial Applications:
Therapeutic for the treatment of Her2 positive cancers.
Method for producing safer and more effective ADCs.
Competitive Advantages:
Could be used in combination with Trastuzumab or for
patients who have developed resistance to Trastuzumab treatment, since
this antibody targets a different epitope.
Site specific conjugation provides better efficacy and
less side effects than ADCs produced using traditional strategies.
Can be readily applied to develop ADCs targeting other
cancers that express cell surface markers or other disease targets,
such as HIV.
Development Stage:
Pre-clinical.
In vitro data available.
In vivo data available (animal).
Inventors: Dimiter S. Dimitrov (NCI), Zhu Zhongyu (NCI), Pradman K.
Qasba (NCI), Boopathy Ramakrishnan (NCI).
Intellectual Property: HHS Reference No. E-351-2013/0--US
Provisional Application No. 61/833,732 filed 11 June 2013.
Licensing Contact: Whitney A. Hastings; 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
monoclonal antibodies, ADCs, and methods. For collaboration
opportunities, please contact John D. Hewes, Ph.D. at
hewesj@mail.nih.gov.
Non-invasive Early Stage Lung Cancer Diagnostic and Prognostic Assays
Description of Technology: The present invention provides a unique
non-invasive diagnostic to detect early stage lung cancer and predict
patient survival through a simple assay utilizing urine samples. Urine
samples minimize patient discomfort unlike current early detection
methods that are highly invasive, such as a biopsy or bronchoscopy, or
utilize expensive computer tomography (CT) scans that expose patients
to harmful radiation. Although the sensitivity of low dose CT scans is
high, the specificity is low, resulting in high false positive rates.
Utilizing metabolic profiling of urine samples obtained from 1,005
people, the scientists have developed and validated this unique
metabolite profile that diagnoses early stage lung cancer and predicts
patient survival with a high accuracy.
Potential Commercial Applications:
Diagnostic test for early stage lung cancer.
Prognostic test for patient survival.
Method to help physicians make informed treatment
decisions.
Competitive Advantages: Urinary patient samples--no need for
needles, invasive surgery, or claustrophobic tests.
Development Stage:
Early-stage.
In vivo data available (human).
Inventors: Curtis Harris (NCI), Majda Haznadar (NCI), Frank
Gonzalez (NCI), Ewy Mathe (NCI), Kristopher Krausz (NCI), Soumen Manna
(NCI), and Andrew Patterson (Pennsylvania State University)
Intellectual Property: HHS Reference No. E-121-2013/0--US Patent
Application No. 61/845,055 filed 11 July 2013
Related Technology: HHS Reference No. E-248-2002/0--US Patent
Application No. 10/533,459 filed 02 May 2005; PCT Application No. PCT/
US2013/055746 filed 20 August 2013
Licensing Contact: Jennifer Wong, M.S.; 301-435-4633;
wongje@mail.nih.gov.
Collaborative Research Opportunity: The National Cancer Institute,
Laboratory of Human Carcinogenesis, is seeking statements of capability
or interest from parties interested in collaborative research to
further develop, evaluate or commercialize Non-invasive Urinary
Biomarkers Highly Predictive of Non-small Cell Lung Cancer Status and
Survival. For collaboration opportunities, please contact John D.
Hewes, Ph.D. at hewesj@mail.nih.gov.
Intravenous Water Soluble Formulation of MJC13--A Novel Lead Compound
for the Treatment of Castrate-Resistant Prostate Cancer
Description of Technology: Normal prostate growth and maintenance
is dependent on androgens acting through the androgen receptor (AR). AR
expression is maintained and plays an important role throughout
prostate cancer progression. A lead molecule, MJC13, has been
identified and has higher potency and better selectivity for AR than
any other compound tested. It has been shown to effectively block AR-
dependent gene expression in cellular models of prostate cancer at
micromolar concentrations.
MJC13, although an attractive drug candidate, has low aqueous
solubility. This has hindered the clinical development of MJC13.
Scientists at NIH, University of Texas-El-Paso and Texas Southern
University have developed a water soluble and stable MJC13 liquid
dosage formulation that is suitable for intravenous administration. The
solubility of this formulation has increased over 25,000 times compared
to MJC13 itself. Additionally, a sensitive LC/MS/MS method to analyze
MJC13 has also been developed, which can detect as little as 1 ng/mL of
MJC13 in solution or plasma. These studies are of great importance for
future pre-clinical and clinical studies of MJC13.
Potential Commercial Applications: Develop MJC13 as a clinical drug
product for the treatment of castrate-resistant prostate cancer (CRPC),
in which current treatment options are ineffective.
Competitive Advantages: Water soluble formulation of the lead
compound, MJC13, that will enable further pharmacokinetic/
pharmacodynamic studies and clinical studies required for commercial
development of the drug.
Development Stage:
Pre-clinical.
In vitro data available.
In vivo data available (animal).
Intellectual Property: HHS Reference No. E-065-2013/0--US
Provisional Application No. 61/788,716 filed 15 March 2013.
Related Technology: HHS Reference No. E-162-2009/0--US Patent
Application No. 13/395,976 filed 14 March 2012.
Licensing Contact: Eggerton Campbell, Ph.D.; 301-435-5282;
campbellea2@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
this technology with an initial goal of preclinical evaluation and an
ultimate goal of clinical testing. For collaboration opportunities,
please contact John D. Hewes, Ph.D. at hewesj@mail.nih.gov.
[[Page 71627]]
Methods of Modulating Chemotherapeutic Cytotoxicity
Description of Technology: Investigators at the National Cancer
Institute (NCI) have discovered that blockade of the signalling
activity of a single cell-surface receptor, CD47, in cancer cells
results in enhanced sensitivity of cancer cells to chemotherapy
treatment and in healthy tissues reduces damage to normal cells. Many
chemotherapeutic agents cause significant cytotoxicity to non-cancer
(``normal'') cells, resulting in undesirable side-effects and often
limiting the dose and/or duration of chemotherapy that can be
administered to a patient. The present invention relates to a method of
using CD47-modulating compounds in combination with a chemotherapeutic
agent to increase the efficacy of that agent against inhibiting tumor
growth. The invention also relates to methods for preventing damage to
heart tissue associated with the use of anthracycline chemotherapy. The
current invention builds on the NIH's previous discoveries of
antibodies, antisense morpholino oligonucleotides, and peptide
compounds that modulate CD47.
Potential Commercial Applications: Combination Chemotherapy
Competitive Advantages:
Enhance effectiveness of chemotherapeutic agents.
Limit off target effects on normal tissue.
Reduces cytotoxicity of normal cells.
Provides cardioprotection for anthracyclines.
Development Stage:
Early-stage.
Pre-clinical.
In vitro data available.
In vivo data available (animal).
Inventors: David D. Roberts and David R. Soto Pantoja (NCI).
Publication: Soto-Pantoja DR, et al. CD47 deficiency confers cell
and tissue radioprotection by activation of autophagy. Autophagy. 2012
Nov;8(11):1628-42. [PMID 22874555]
Intellectual Property: HHS Reference No. E-296-2011/0--US
Application No. 61/779,587 filed 13 March 2013
Related Technology: HHS Reference No. E-227-2006/5-
US Application No. 12/444,364 filed 03 April 2009.
CA Application No. 2,665,287 filed 05 October 2007.
EP Application No. 07868382.8 filed 27 March 2009.
US Application No. 13/546,941 filed 11 July 2012.
US Application No. 13/546,931 filed 11 July 2012.
Licensing Contact: Charlene Maddox, Ph.D.; 301-435-4689;
sydnorc@mail.nih.gov.
Collaborative Research Opportunity: The National Cancer Institute,
Laboratory of Pathology, is seeking statements of capability or
interest from parties interested in collaborative research to further
develop, evaluate or commercialize CD47 targeting therapeutics,
cardioprotection, autophagy modulation. For collaboration
opportunities, please contact John D. Hewes, Ph.D. at
hewesj@mail.nih.gov.
Dated: November 21, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2013-28558 Filed 11-27-13; 8:45 am]
BILLING CODE 4140-01-P
