Government-Owned Inventions; Availability for Licensing, 18831-18833 [2012-7420]
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Federal Register / Vol. 77, No. 60 / Wednesday, March 28, 2012 / Notices
FOR FURTHER INFORMATION CONTACT:
Gerie Voss, Center for Tobacco
Products, Food and Drug
Administration, 9200 Corporate Blvd.,
Rockville, MD 20850–3229, 877–287–
1373, gerie.voss@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
In the Federal Register of February 2,
2012 (77 FR 5171), FDA issued a final
rule regarding further amendments to
the general regulations of the FDA to
incorporate tobacco products. FDA
examined the economic implications of
the final rule as required by the
Regulatory Flexibility Act (5 U.S.C.
601–612) and determined that the rule
would have a significant economic
impact on a substantial number of small
entities. In compliance with section 212
of the Small Business Regulatory
Enforcement Fairness Act (Pub. L. 104–
121), FDA is making available this SECG
stating in plain language the legal
requirements of the February 2, 2012,
final rule, set forth in 21 CFR parts 1,
7, and 16, amending the FDA’s general
regulations to ensure that tobacco
products are subject to the same general
requirements that apply to other FDAregulated products.
FDA is issuing this SECG as level 2
guidance consistent with FDA’s good
guidance practices regulation (21 CFR
10.115(c)(2)). The SECG represents the
Agency’s current thinking on this topic.
It does not create or confer any rights for
or on any person and does not operate
to bind FDA or the public. An
alternative approach may be used if
such approach satisfies the
requirements of the applicable statutes
and regulations.
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tkelley on DSK3SPTVN1PROD with NOTICES
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17:29 Mar 27, 2012
Jkt 226001
[FR Doc. 2012–7455 Filed 3–27–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
I. Background
VerDate Mar<15>2010
Dated: March 23, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
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:
Lenalidomide Analogs for the
Treatment of Neurodegenerative
Disorders and Cancer
Description of Technology:
Inflammatory processes associated with
the over-production of tumor necrosisalpha (TNF-a), a potent activator of the
immune system accompany numerous
neurodegenerative diseases. TNF-a has
been validated as a drug target with the
development of the inhibitors Enbrel
and Remicade (fusion antibodies) as
prescription medications. Both,
however, are large macromolecules that
require direct injection and have limited
brain access. The classical drug,
thalidomide is being increasingly used
in the clinical management of a wide
spectrum of immunologically-mediated
and infectious diseases, and cancers.
The NIA inventors developed and
assessed novel thio analogs of
lenalidomide (Celegene’s Revlimid and
an analog of thalidomide) as
immunomodulatory agents, with the
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18831
potential to reduce chronic systemic
and central nervous system
inflammation. These compounds were
synthesized and evaluated for their
TNF-a inhibitory activity. This
invention was extended from the
inventors’ prior work to develop potent
compounds to reduce
neuroinflammation as a treatment
strategy for neurodegenerative
disorders. The current studies focus the
compounds activity in classical models
of neurodegeneration as well as cancer.
Potential Commercial Applications:
• Treatment for blood disorders
(myelodysplastic syndrome), cancer
(multiple myeloma), inflammatory
processes and erythema
• Immunomodulatory agents
• Reduce chronic systemic and
central nervous system inflammation
Competitive Advantages:
• Effective smaller molecular weight
compound that can enter brain among
current agents
• Experimental therapeutic to reduce
inflammation systematically and within
the brain
• Effective in reducing
proinflammatory cytokines than existing
agents
Development Stage:
• Prototype
• Clinical
• In vitro data available
• In vivo data available (animal)
Inventors: Nigel H. Greig, Weiming
Luo, David Tweedie, Harold W.
Holloway, Qian-sheng Yu (all of NIA).
Publication: Luo W, et al. Design,
synthesis and biological assessment of
novel N-substituted 3-(phthalimidin-2yl)-2,6-dioxopiperidines and 3substituted 2,6-dioxopiperidines for
TNF-alpha inhibitory activity. Bioorg
Med Chem. 2011 Jul 1;19(13):3965–
3972. [PMID 21658960]
Intellectual Property: HHS Reference
No. E–045–2012/0—U.S. Patent
Application No. 13/310,242 filed 02 Dec
2011.
Related Technologies: HHS Reference
No. E–189–2003/0—
• U.S. Patent No. 7,973,057 issued 05
Jul 2011
• U.S. Application No. 13/153,355
filed 03 Jun 2011
• and related international patents/
patent applications
Licensing Contact: Whitney Hastings,
Ph.D.; 301–451–7337;
hastingw@mail.nih.gov.
Use of Englerin A, a Small Molecule
HSF1 Activator, for the Treatment of
Diabetes, Obesity, and Other Diseases
Associated With Insulin Resistance
Description of Technology: Insulin
resistance is a causative factor for type
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tkelley on DSK3SPTVN1PROD with NOTICES
18832
Federal Register / Vol. 77, No. 60 / Wednesday, March 28, 2012 / Notices
2 diabetes, obesity and a number of
other conditions. This technology
claims methods for treating diseases or
conditions associated with insulin
resistance using the small molecule
epoxy-guaiane derivative englerin A and
related compounds. The compounds are
claimed separately in a related NIH
technology.
The inventors have shown that
englerin A, a compound originally
isolated from the Phyllanthus plant and
previously identified as an anti-cancer
agent, can also be used to treat insulin
resistance. Insulin resistance is
associated with reduced gene
expression and production of heat shock
protein 70 (HSP70). Using a mouse with
tumor model, the inventors discovered
that administration of englerin A
decreases blood glucose levels by
activating transcription of HSF1,
thereby increasing the expression and
secretion of HSP70. Thus, englerin A
and related compounds represent
potential drugs for the treatment of a
variety of conditions associated with
insulin resistance.
Potential Commercial Applications:
Treatment of diseases or conditions
associated with insulin resistance, such
as type 2 diabetes, obesity,
inflammation, metabolic syndrome,
polycystic ovary disease,
arteriosclerosis, non-alcoholic fatty liver
disease, reproductive abnormality of a
female, and growth abnormality.
Competitive Advantages: Use of
small-molecule compounds targeting
HSF1 represents a novel approach to the
treatment of type 2 diabetes and other
conditions caused by insulin resistance.
Development Stage:
• In vitro data available
• In vivo data available (animal)
Inventors: Leonard Neckers et al.
(NCI).
Publication: Ratnayake R, et al.
Englerin A, a selective inhibitor of renal
cancer cell growth, from Phyllanthus
engleri. Org Lett. 2009 Jan 1;11(1):57–
60. [PMID 19061394]
Intellectual Property: HHS Reference
No. E–042–2012/0—U.S. Application
No. 61/584,526 filed 09 Jan 2012.
Related Technologies: HHS Reference
No. E–064–2008/2—U.S. Application
No. 12/811,245 filed 29 Jul 2010 and
related international applications.
Licensing Contact: Tara Kirby, Ph.D.;
301–435–4426; tarak@mail.nih.gov.
Collaborative Research Opportunity:
The NCI Urologic Oncology Branch is
seeking statements of capability or
interest from parties interested in
collaborative research to further
develop, evaluate, or commercialize
epoxyguaianes as anti-type 2 diabetes
agents. For collaboration opportunities,
VerDate Mar<15>2010
17:29 Mar 27, 2012
Jkt 226001
please contact John Hewes, Ph.D. at
hewesj@mail.nih.gov.
A Novel, Non-invasive Test for the
Detection of Chromaffin Cell Tumors
Associated With SDHB Mutation
Description of Technology:
Pheochromocytomas/paragangliomas
(PHEOs/PGLs) are hormone producing
tumors of the sympathetic nervous
system located in the adrenal glands
(which sit atop the kidneys) or the
paraganglia, which are distributed
throughout the upper body. Mutations
in the gene of a mitochondrial protein,
succinate dehydrogenase B (SDHB), can
cause PHEOs/PGLs that have a high rate
of malignancy. Normally, PHEOs/PGLs
can be diagnosed by measuring
increased stress hormone metabolites in
blood or urine. However, detection of
SDHB-related PHEOs/PGLs can be
difficult as up to ten percent do not
show elevated stress hormone
metabolites, and thus proper diagnosis
requires expensive and often notwidely-available imaging. In addition,
SDHB-PHEO/PGL patients need regular
imaging to rule out development of
metastases and family members of
patients with SDHB-PHEOs/PGLs need
genetic testing for risk evaluation. A
significant need remains for additional
diagnostic methods to prevent
misdiagnosis of patients with nonsecreting or metastatic SDHB-PHEOs/
PGLs and risk evaluation of family
members.
Researchers at the Eunice Kennedy
Shriver National Institute of Child
Health and Human Development
(NICHD) have developed methods to
identify SDHB mutation based on the
presence/absence of just four urinary
peptides. Further data from the
researchers suggests that metastatic
PGLs can also be identified in patients
based on their urinary peptide pattern.
Potential Commercial Applications:
Diagnostic kits for non-secreting or
metastatic PHEOs/PGLs in patients, or
for risk assessment of their family
members.
Competitive Advantages:
• Cost-effective
• Non-invasive
• Sample collection could occur at
home or doctor’s office
Inventors: Karel Pacak (NICHD) et al.
Intellectual Property: HHS Reference
No. E–201–2011/0 — U.S. Provisional
Application No. 61/498,428 filed 17 Jun
2011.
Licensing Contact: Patrick P. McCue,
Ph.D.; 301–435–5560;
mccuepat@mail.nih.gov.
Collaborative Research Opportunity:
The Eunice Kennedy Shriver National
Institute of Child Health and Human
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Development is seeking statements of
capability or interest from parties
interested in collaborative research to
further develop, evaluate or
commercialize a urine-based diagnostic
to detect proteins associated with
pheochromocytoma/paraganglioma
(PHEO/PGL). For collaboration
opportunities, please contact Joseph M.
Conrad III, Ph.D., J.D. at
jmconrad@mail.nih.gov.
T Lymphocyte (T Cell) Clones That
Recognize the Tumor Associated
Antigens gp100 and MART–1
Description of Technology: Scientists
at the National Institutes of Health (NIH)
have developed cytotoxic, CD8+ T
lymphocyte (T cell) clones, designated
R6C12 and JKF6, derived from tumor
infiltrating lymphocytes (TIL) of cancer
patients. The R6C12 clone recognizes
the tumor associated antigen (TAA)
gp100 and has been shown to be
specific for amino acids 209–217 of the
gp100 protein, known as the 210M or
g209–2M peptide. The JKF6 clone
recognizes the TAA MART–1,
specifically the peptide represented by
amino acids 27–35 of the MART–1
protein. TIL are a subset of T cells found
within tumors that have high specificity
for the antigen(s) expressed by that
tumor.
MART–1 (also known as Melan-A)
and gp100 are TAAs expressed
primarily by melanomas and at low
levels in normal melanocytes. MART–1
is a melanocyte differentiation antigen
found on the surface of these cells and
gp100 is a transmembrane glycoprotein.
Both proteins are located in the
melanosomes of normal melanocytes,
the melanin producing organelle of
these cells. In cancer patients with
gp100+ and or MART–1+ tumors, T
cells, such as TIL, have been identified
that recognize particular epitopes of
these TAAs to mediate tumor cell
killing. Cancer vaccines and adoptive T
cell immunotherapies have been
developed to generate immune
responses to target one or both of these
antigens for cancer regression.
Potential Commercial Applications:
• Characterize and develop T cell
receptors for use in adoptive
immunotherapy of MART–1+ and
gp100+ cancers
• Develop molecular screens to
characterize tumor antigen expression of
patient samples and/or laboratory cell
lines
• Develop research materials to better
understand T cell functions, including
antigen recognition, cell signaling, and
immune responses
• Positive controls for T cells with
high reactivity to gp100 and MART–1
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Federal Register / Vol. 77, No. 60 / Wednesday, March 28, 2012 / Notices
Competitive Advantages:
• These T cell clones were isolated
and selected from the bulk TIL cultures
of the respective patients from which
they were derived due to their superior
reactivity to their TAA antigen.
• Significant data has been collected
on their characteristics, including
identification of the tumor associated
antigen and specific cancer peptide
recognized by the T cell receptor of each
clone.
Development Stage:
• Pre-clinical
• Clinical
• In vitro data available
• In vivo data available (human)
Inventors: Mark E. Dudley and Steven
A. Rosenberg (both of NCI).
Publications:
1. Dudley M, et al. Cancer regression
and autoimmunity in patients after
clonal repopulation with antitumor
lymphocytes. Science. 2002 Oct
25;298(5594):850–854. [PMID 12242449]
2. Dudley M, et al. Adoptive transfer
of cloned melanoma-reactive T
lymphocytes for the treatment of
patients with metastatic melanoma. J
Immunother. 2001 Jul–Aug;24(4):363–
373. [PMID 11565838]
Intellectual Property: HHS Reference
No. E–267–2010/0—Research Tool.
Patent protection is not being pursued
for this technology.
Related Technologies:
• HHS Reference No. E–057–1994—
elanoma Antigens and Their Use in
Diagnostic and Therapeutic Methods
• HHS Reference No. E–086–2001—
Peptides of a Melanoma Antigen and
Their Use in Diagnostic, Prophylactic,
and Therapeutic Methods
• HHS Reference No. E–106–2004—
Compositions Comprising T cell
Receptors and Methods of Use Thereof
• HHS Reference No. E–304–2006—
Modified T cell Receptors and Related
Materials and Methods
• HHS Reference No. E–059–2007—
gp100-specific T cell Receptors and
Related Materials and Methods
• HHS Reference No. E–312–2007—
Modified T cell Receptors and Related
Materials and Methods
• HHS Reference No. E–257–2008—
Melanoma Associated Peptide
Analogues and Vaccines Against
Melanoma
• HHS Reference No. E–261–2008—
Melanoma Associated Antigenic
Polypeptide, Epitopes Thereof and
Vaccines Against Melanoma
Licensing Contact: Samuel E. Bish,
Ph.D.; 301–435–5282;
bishse@mail.nih.gov.
VerDate Mar<15>2010
17:29 Mar 27, 2012
Jkt 226001
Dated: March 22, 2012.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2012–7420 Filed 3–27–12; 8:45 am]
BILLING CODE 4140–01–P
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:
Personalized Body Weight Management
System Using Monitoring Devices and
Mathematical Models of Metabolism
Description of Technology: Attempts
to manage body weight are often
unsuccessful or only temporary. This is,
in part, due to antiquated dieting
methods that attempt to address calorie
consumption while ignoring metabolic
and physical changes. It is becoming
clear that personalized methods to
manage body weight must be developed.
Scientists at the NIH have developed
new methods for prescribing and
monitoring personalized weight
management interventions. The system
uses validated mathematical models of
human metabolism to set weight
management goals and predict
individual body weight outcomes in the
context of changing metabolic needs
and calorie consumption. The system
uses repeated monitoring of a patient’s
body weight to assess progress and
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18833
provide specific feedback to the patient
and health care professional. Projected
outcomes and body weight goals can be
revised over time along with required
prescription modifications to meet the
body weight goals. The system is
integrated into a network of one or more
devices that may additionally monitor
various physiological parameters,
physical activities, food intake, or other
behaviors. Such an enhanced
personalized weight management
program has great promise in the
management of obesity.
Potential Commercial Applications:
• Devices—Weight management
diagnostic.
• Software for the integration of
multiple devices.
Competitive Advantages: Integrated
system provides feedback to health care
professional and patient with more
accurate predictors of weight loss
outcomes. Combined with other
devices, patient receives encouragement
to stay on track.
Inventor: Kevin D. Hall (NIDDK).
Publications:
1. Hall KD, Sacks G, Chandramohan
D, Chow CC, Wang YC, Gortmaker SL,
Swinburn BA. Quantification of the
effect of energy imbalance on
bodyweight. Lancet. 2011 378
(9793):826–837. [PMID 21872751]
2. Hall KD and Chow CC. Estimating
changes in free-living energy intake and
its confidence interval. Am J Clin Nutr.
2011 Jul;94(1):66–74. [PMID 21562087]
3. Hall KD. Predicting metabolic
adaptation, body weight change, and
energy intake in humans. Am J Physiol
Endocrinol Metab. 2010
Mar;298(3):E449–466. [PMID 19934407]
Intellectual Property: HHS Reference
No. E–063–2012/0—U.S. Provisional
Application No. 61/592,325 filed 30 Jan
2012.
Licensing Contact: Michael A.
Shmilovich, Esq., CLP; 301–435–5019;
shmilovm@mail.nih.gov.
Collaborative Research Opportunity:
The NIDDK Laboratory of Biological
Modeling is seeking statements of
capability or interest from parties
interested in collaborative research to
further develop, evaluate or
commercialize this technology. For
collaboration opportunities, please
contact Marguerite J. Miller at 301–496–
9003 or millermarg@niddk.nih.gov.
Direct Impact Spark Ionization (DISI)
Mass Spectrometry (MS) for
Identification of Microbes
Description of Technology: Generating
reproducible mass spectra from bacterial
samples in a timely fashion at
atmospheric pressure remained
problematic for many years. FDA/NCTR
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]]>Agencies
[Federal Register Volume 77, Number 60 (Wednesday, March 28, 2012)]
[Notices]
[Pages 18831-18833]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-7420]
-----------------------------------------------------------------------
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.
Lenalidomide Analogs for the Treatment of Neurodegenerative Disorders
and Cancer
Description of Technology: Inflammatory processes associated with
the over-production of tumor necrosis-alpha (TNF-[alpha]), a potent
activator of the immune system accompany numerous neurodegenerative
diseases. TNF-[alpha] has been validated as a drug target with the
development of the inhibitors Enbrel and Remicade (fusion antibodies)
as prescription medications. Both, however, are large macromolecules
that require direct injection and have limited brain access. The
classical drug, thalidomide is being increasingly used in the clinical
management of a wide spectrum of immunologically-mediated and
infectious diseases, and cancers. The NIA inventors developed and
assessed novel thio analogs of lenalidomide (Celegene's Revlimid and an
analog of thalidomide) as immunomodulatory agents, with the potential
to reduce chronic systemic and central nervous system inflammation.
These compounds were synthesized and evaluated for their TNF-[alpha]
inhibitory activity. This invention was extended from the inventors'
prior work to develop potent compounds to reduce neuroinflammation as a
treatment strategy for neurodegenerative disorders. The current studies
focus the compounds activity in classical models of neurodegeneration
as well as cancer.
Potential Commercial Applications:
Treatment for blood disorders (myelodysplastic syndrome),
cancer (multiple myeloma), inflammatory processes and erythema
Immunomodulatory agents
Reduce chronic systemic and central nervous system
inflammation
Competitive Advantages:
Effective smaller molecular weight compound that can enter
brain among current agents
Experimental therapeutic to reduce inflammation
systematically and within the brain
Effective in reducing proinflammatory cytokines than
existing agents
Development Stage:
Prototype
Clinical
In vitro data available
In vivo data available (animal)
Inventors: Nigel H. Greig, Weiming Luo, David Tweedie, Harold W.
Holloway, Qian-sheng Yu (all of NIA).
Publication: Luo W, et al. Design, synthesis and biological
assessment of novel N-substituted 3-(phthalimidin-2-yl)-2,6-
dioxopiperidines and 3-substituted 2,6-dioxopiperidines for TNF-alpha
inhibitory activity. Bioorg Med Chem. 2011 Jul 1;19(13):3965-3972.
[PMID 21658960]
Intellectual Property: HHS Reference No. E-045-2012/0--U.S. Patent
Application No. 13/310,242 filed 02 Dec 2011.
Related Technologies: HHS Reference No. E-189-2003/0--
U.S. Patent No. 7,973,057 issued 05 Jul 2011
U.S. Application No. 13/153,355 filed 03 Jun 2011
and related international patents/patent applications
Licensing Contact: Whitney Hastings, Ph.D.; 301-451-7337;
hastingw@mail.nih.gov.
Use of Englerin A, a Small Molecule HSF1 Activator, for the Treatment
of Diabetes, Obesity, and Other Diseases Associated With Insulin
Resistance
Description of Technology: Insulin resistance is a causative factor
for type
[[Page 18832]]
2 diabetes, obesity and a number of other conditions. This technology
claims methods for treating diseases or conditions associated with
insulin resistance using the small molecule epoxy-guaiane derivative
englerin A and related compounds. The compounds are claimed separately
in a related NIH technology.
The inventors have shown that englerin A, a compound originally
isolated from the Phyllanthus plant and previously identified as an
anti-cancer agent, can also be used to treat insulin resistance.
Insulin resistance is associated with reduced gene expression and
production of heat shock protein 70 (HSP70). Using a mouse with tumor
model, the inventors discovered that administration of englerin A
decreases blood glucose levels by activating transcription of HSF1,
thereby increasing the expression and secretion of HSP70. Thus,
englerin A and related compounds represent potential drugs for the
treatment of a variety of conditions associated with insulin
resistance.
Potential Commercial Applications: Treatment of diseases or
conditions associated with insulin resistance, such as type 2 diabetes,
obesity, inflammation, metabolic syndrome, polycystic ovary disease,
arteriosclerosis, non-alcoholic fatty liver disease, reproductive
abnormality of a female, and growth abnormality.
Competitive Advantages: Use of small-molecule compounds targeting
HSF1 represents a novel approach to the treatment of type 2 diabetes
and other conditions caused by insulin resistance.
Development Stage:
In vitro data available
In vivo data available (animal)
Inventors: Leonard Neckers et al. (NCI).
Publication: Ratnayake R, et al. Englerin A, a selective inhibitor
of renal cancer cell growth, from Phyllanthus engleri. Org Lett. 2009
Jan 1;11(1):57-60. [PMID 19061394]
Intellectual Property: HHS Reference No. E-042-2012/0--U.S.
Application No. 61/584,526 filed 09 Jan 2012.
Related Technologies: HHS Reference No. E-064-2008/2--U.S.
Application No. 12/811,245 filed 29 Jul 2010 and related international
applications.
Licensing Contact: Tara Kirby, Ph.D.; 301-435-4426;
tarak@mail.nih.gov.
Collaborative Research Opportunity: The NCI Urologic Oncology
Branch is seeking statements of capability or interest from parties
interested in collaborative research to further develop, evaluate, or
commercialize epoxyguaianes as anti-type 2 diabetes agents. For
collaboration opportunities, please contact John Hewes, Ph.D. at
hewesj@mail.nih.gov.
A Novel, Non-invasive Test for the Detection of Chromaffin Cell Tumors
Associated With SDHB Mutation
Description of Technology: Pheochromocytomas/paragangliomas (PHEOs/
PGLs) are hormone producing tumors of the sympathetic nervous system
located in the adrenal glands (which sit atop the kidneys) or the
paraganglia, which are distributed throughout the upper body. Mutations
in the gene of a mitochondrial protein, succinate dehydrogenase B
(SDHB), can cause PHEOs/PGLs that have a high rate of malignancy.
Normally, PHEOs/PGLs can be diagnosed by measuring increased stress
hormone metabolites in blood or urine. However, detection of SDHB-
related PHEOs/PGLs can be difficult as up to ten percent do not show
elevated stress hormone metabolites, and thus proper diagnosis requires
expensive and often not-widely-available imaging. In addition, SDHB-
PHEO/PGL patients need regular imaging to rule out development of
metastases and family members of patients with SDHB-PHEOs/PGLs need
genetic testing for risk evaluation. A significant need remains for
additional diagnostic methods to prevent misdiagnosis of patients with
non-secreting or metastatic SDHB-PHEOs/PGLs and risk evaluation of
family members.
Researchers at the Eunice Kennedy Shriver National Institute of
Child Health and Human Development (NICHD) have developed methods to
identify SDHB mutation based on the presence/absence of just four
urinary peptides. Further data from the researchers suggests that
metastatic PGLs can also be identified in patients based on their
urinary peptide pattern.
Potential Commercial Applications: Diagnostic kits for non-
secreting or metastatic PHEOs/PGLs in patients, or for risk assessment
of their family members.
Competitive Advantages:
Cost-effective
Non-invasive
Sample collection could occur at home or doctor's office
Inventors: Karel Pacak (NICHD) et al.
Intellectual Property: HHS Reference No. E-201-2011/0 -- U.S.
Provisional Application No. 61/498,428 filed 17 Jun 2011.
Licensing Contact: Patrick P. McCue, Ph.D.; 301-435-5560;
mccuepat@mail.nih.gov.
Collaborative Research Opportunity: The Eunice Kennedy Shriver
National Institute of Child Health and Human Development is seeking
statements of capability or interest from parties interested in
collaborative research to further develop, evaluate or commercialize a
urine-based diagnostic to detect proteins associated with
pheochromocytoma/paraganglioma (PHEO/PGL). For collaboration
opportunities, please contact Joseph M. Conrad III, Ph.D., J.D. at
jmconrad@mail.nih.gov.
T Lymphocyte (T Cell) Clones That Recognize the Tumor Associated
Antigens gp100 and MART-1
Description of Technology: Scientists at the National Institutes of
Health (NIH) have developed cytotoxic, CD8+ T lymphocyte (T cell)
clones, designated R6C12 and JKF6, derived from tumor infiltrating
lymphocytes (TIL) of cancer patients. The R6C12 clone recognizes the
tumor associated antigen (TAA) gp100 and has been shown to be specific
for amino acids 209-217 of the gp100 protein, known as the 210M or
g209-2M peptide. The JKF6 clone recognizes the TAA MART-1, specifically
the peptide represented by amino acids 27-35 of the MART-1 protein. TIL
are a subset of T cells found within tumors that have high specificity
for the antigen(s) expressed by that tumor.
MART-1 (also known as Melan-A) and gp100 are TAAs expressed
primarily by melanomas and at low levels in normal melanocytes. MART-1
is a melanocyte differentiation antigen found on the surface of these
cells and gp100 is a transmembrane glycoprotein. Both proteins are
located in the melanosomes of normal melanocytes, the melanin producing
organelle of these cells. In cancer patients with gp100+ and or MART-1+
tumors, T cells, such as TIL, have been identified that recognize
particular epitopes of these TAAs to mediate tumor cell killing. Cancer
vaccines and adoptive T cell immunotherapies have been developed to
generate immune responses to target one or both of these antigens for
cancer regression.
Potential Commercial Applications:
Characterize and develop T cell receptors for use in
adoptive immunotherapy of MART-1+ and gp100+ cancers
Develop molecular screens to characterize tumor antigen
expression of patient samples and/or laboratory cell lines
Develop research materials to better understand T cell
functions, including antigen recognition, cell signaling, and immune
responses
Positive controls for T cells with high reactivity to
gp100 and MART-1
[[Page 18833]]
Competitive Advantages:
These T cell clones were isolated and selected from the
bulk TIL cultures of the respective patients from which they were
derived due to their superior reactivity to their TAA antigen.
Significant data has been collected on their
characteristics, including identification of the tumor associated
antigen and specific cancer peptide recognized by the T cell receptor
of each clone.
Development Stage:
Pre-clinical
Clinical
In vitro data available
In vivo data available (human)
Inventors: Mark E. Dudley and Steven A. Rosenberg (both of NCI).
Publications:
1. Dudley M, et al. Cancer regression and autoimmunity in patients
after clonal repopulation with antitumor lymphocytes. Science. 2002 Oct
25;298(5594):850-854. [PMID 12242449]
2. Dudley M, et al. Adoptive transfer of cloned melanoma-reactive T
lymphocytes for the treatment of patients with metastatic melanoma. J
Immunother. 2001 Jul-Aug;24(4):363-373. [PMID 11565838]
Intellectual Property: HHS Reference No. E-267-2010/0--Research
Tool. Patent protection is not being pursued for this technology.
Related Technologies:
HHS Reference No. E-057-1994--elanoma Antigens and Their
Use in Diagnostic and Therapeutic Methods
HHS Reference No. E-086-2001--Peptides of a Melanoma
Antigen and Their Use in Diagnostic, Prophylactic, and Therapeutic
Methods
HHS Reference No. E-106-2004--Compositions Comprising T
cell Receptors and Methods of Use Thereof
HHS Reference No. E-304-2006--Modified T cell Receptors
and Related Materials and Methods
HHS Reference No. E-059-2007--gp100-specific T cell
Receptors and Related Materials and Methods
HHS Reference No. E-312-2007--Modified T cell Receptors
and Related Materials and Methods
HHS Reference No. E-257-2008--Melanoma Associated Peptide
Analogues and Vaccines Against Melanoma
HHS Reference No. E-261-2008--Melanoma Associated
Antigenic Polypeptide, Epitopes Thereof and Vaccines Against Melanoma
Licensing Contact: Samuel E. Bish, Ph.D.; 301-435-5282;
bishse@mail.nih.gov.
Dated: March 22, 2012.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2012-7420 Filed 3-27-12; 8:45 am]
BILLING CODE 4140-01-P
