Government-Owned Inventions; Availability for Licensing, 53430-53432 [E8-21506]
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53430
Federal Register / Vol. 73, No. 180 / Tuesday, September 16, 2008 / 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:
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.
ebenthall on PROD1PC60 with NOTICES
Monoclonal Antibodies Against
Bordetella pertussis Filamentous
Hemagglutinin (FHA) Protein
Description of Technology:
Filamentous hemagglutinin (FHA) is
one of the major adhesion molecules of
Bordetella pertussis, a bacterial
infection that causes whopping cough.
Once thought to be primarily a
childhood disease, B. pertussis infection
shows an increasing incidence among
adults as well as infants. Recent CDC
reports show an almost 19-fold increase
in the number of cases among 10–19
year olds and an almost 16-fold increase
among those 20 and older. These data
underscore the need for a new
generation of vaccines and detailed
studies focused on the pathways of B.
pertussis infectivity.
Available for licensing are three
hybridoma cell lines capable of
expressing monoclonal antibodies
against FHA. ELISA and Western blot
analyses have shown that these
antibodies, map to specific epitopes, can
successfully bind to FHA as well as
prevent binding of the purified FHA to
various cells. The additional studies
showed that one antibody was able to
prevent the adhesion of B. pertussis to
epithelial cell monolayers. These
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findings show that monoclonal
antibodies expressed in featured
hybridoma cell lines can be successfully
used for studies of infectivity
mechanisms as well as development of
new diagnostics and acellular vaccines
against B. pertussis.
Applications:
• New generation of diagnostics.
• Acellular vaccine development.
Inventor: Michael Brennan (CBER/
FDA).
Relevant Publications:
1. Leininger E, Probst PG, Brennan
MJ, Kenimer JG. Inhibition of Bordetella
pertussis filamentous hemagglutininmediated cell adherence with
monoclonal antibodies. FEMS Microbiol
Lett. 1993 Jan 1;106(1):31–38.
2. Leininger E, Bowen S, Renauld´
Mongenie G, Rouse JH, Menozzi FD,
Locht C, Heron I, Brennan MJ.
Immunodominant domains present on
the Bordetella pertussis vaccine
component filamentous hemagglutinin.
J Infect Dis. 1997 Jun;175(6):1423–1431.
Patent Status: HHS Reference No. E–
044–2008/0—Research Tool. Patent
protection is not being sought for this
technology.
Licensing Status: Available for nonexclusive licensing.
Licensing Contact: Susan Ano, PhD;
301–435–5515; anos@mail.nih.gov.
Automated Method for Rapid Detection
of Sickle Cell Disease Inhibitors
Description of Technology: Available
for licensing is a rapid and automated
method for discovering potential drugs
for the treatment of sickle cell anemia
by determining the sickling times for a
large population of red blood cells. The
method uses a combination of laser
photolysis and statistical processing of
digital images. Sickle cell disease is an
inherited disorder that affects over
70,000 Americans. The disease is
characterized by presence of mutant
hemoglobin S in red blood cells, which
polymerizes to form fibers when
deoxygenated. Such fibers lead to
distortion of red blood cells into the
shape of a sickle and alter the
mechanical properties of these cells.
Studies demonstrate that the time to
polymerization involves a delay time
and rapid growth phase and is
particularly sensitive to hemoglobin
concentration. As a result, identification
of drugs that inhibit sickle cell disease
is accomplished using an assay for delay
times for populations of red blood cells.
The invention creates a uniform time at
which polymerization is initiated for all
red blood cells in the sample region and
accurately determines the time at which
cellular distortion begins for each cell.
Potential drugs are those compounds
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that significantly increase the delay time
of sickling time, i.e. the time at which
the cell changes shape due to
intracellular polymerization.
Applications:
• Rapid automated detection of
compounds that inhibit sickling and are
therefore potential drugs for sickle cell
disease.
• Objective assay for monitoring
disease severity.
Development Status: The technology
is capable of determining the
distribution of cellular delay times in a
large number of samples in series in a
48 well plate format
Inventors: Jeffrey F. Smith, H. James
Hofrichter, and William A. Eaton
(NIDDK).
Patent Status:
• U.S. Patent Application No. 11/
652,843, filed 11 Jan 2007 (HHS
Reference No. E–021–2007/0–US–01).
• PCT Application No. PCT/US2008/
000427 filed 11 Jan 2008 (HHS
Reference No. E–021–2007/0–PCT–02).
Licensing Status: Available for
licensing.
Licensing Contact: Cristina
Thalhammer-Reyero, PhD, M.B.A.; 301–
435–4507; thalhamc@mail.nih.gov.
Collaborative Research Opportunity:
The NIDDK Laboratory of Chemical
Physics is seeking statements of
capability or interest from parties
interested in collaborative research to
further develop, evaluate, or
commercialize this technology. Please
contact Rochelle S. Blaustein, J.D. at
301–451–3636 or
rochelle.blaustein@nih.gov for more
information.
Dated: September 9, 2008.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. E8–21505 Filed 9–15–08; 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:
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
E:\FR\FM\16SEN1.SGM
16SEN1
Federal Register / Vol. 73, No. 180 / Tuesday, September 16, 2008 / Notices
ebenthall on PROD1PC60 with NOTICES
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.
Bifunctional Compounds That Bind to
Hormone Receptors
Description of Technology: The
development and progression of
prostate cancer is dependent on the
androgen receptor (AR), a liganddependent transcription factor. In the
inactive form AR resides in the cytosolic
region of the cell and when activated,
AR is imported into the nucleus. Initial
hormonal therapy for prostate cancer
involves lowering serum levels of
testosterone to shut down AR activity.
Despite initial patient responses to
testosterone-depleting therapies,
prostate cancer becomes refractory to
hormonal therapy. Notably, AR is
reactivated in hormone-refractory
prostate cancer and reinstates its
proliferative and survival activity.
Available for licensing is a novel
chemical compound which is
bifunctional and binds to AR. This
compound is comprised of tubulinbinding and steroid receptor-binding
moieties. This compound is designed to
antagonize AR function in a
nonclassical manner by several
mechanisms and kills hormonerefractory prostate cells better than both
functional moieties. This compound is a
first-in-class of bifunctional steroid
receptor binding agents that can
antagonize steroid receptors in a variety
of hormone-dependent diseases, such as
breast and prostate cancer.
Applications:
• Therapeutic compounds that
selectively target steroid receptorexpressing cancer cells resulting in
minimal patient toxicity.
• Method to treat hormone resistant
prostate cancer and potentially other
steroid receptor dependent diseases
such as breast cancer.
Market:
• Prostate cancer is the second most
common type of cancer among men,
wherein one in six men will be
diagnosed.
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• An estimated 186,320 new
diagnosed cases and 28,660 deaths due
to prostate cancer in the U.S. will occur
in 2008.
Development Status: The technology
is currently in the pre-clinical stage of
development.
Inventors: Nima Sharifi et al. (NCI).
Publication: N Sharifi et al. A
bifunctional colchicinoid that binds to
the androgen receptor. Mol Can Ther.
2007 Aug;6(8):2328–2336.
Patent Status: PCT Application No.
PCT/US2008/008299 filed 02 Jul 2008,
claiming priority to 03 Jul 2007 (HHS
Reference No. E–163–2007/0–PCT–02).
Availability: Available for exclusive
or non-exclusive licensing.
Licensing Contact: Jennifer Wong;
301–435–4633; wongje@mail.nih.gov.
Vitamin D Receptor Antagonists for
Treating Breast Cancer
Description of Technology: Vitamin D
receptor (VDR) is a nuclear receptor that
is activated by calcitriol, the active form
of vitamin D. It is best known for
regulating dietary calcium uptake
necessary for bone growth, but it also
affects cell proliferation and
differentiation. Therefore, it was
thought that treatment with calcitriol or
its derivatives could be useful to treat
the uncontrolled proliferation typical of
cancer cells. However, this approach
has been unsuccessful to date because it
leads to toxic levels of calcium in the
blood.
This invention relates to derivatives
of calcitriol that can block cell growth
without harmfully raising calcium
levels. Specifically, these compounds
act as antagonists of VDR blocking its
ability to stimulate cell proliferation.
This technology can be useful in
treating breast cancer or other
malignancies.
Applications:
• Potential drugs for treating breast
cancer and possibly also prostate
cancer, colorectal cancer, leukemia,
melanoma, or glioma.
• Prevention of cancer in high-risk
population.
• Research on vitamin D receptor
functions and cancer.
Market: About 182,460 American
women will be diagnosed with invasive
breast cancer in 2008.
Development Status: Pre-clinical data
available.
Inventors: Julianna Barsony (NIDDK).
Publication: J Barsony et al.
Development of a biologically active
fluorescent-labeled calcitriol and its use
to study hormone binding to the vitamin
D receptor. Anal Biochem. 1995 Jul
20;229(1):68–79.
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53431
Patent Status: U.S. Patent No.
7,361,664 issued 22 Apr 2008 (HHS
Reference No. E–213–2001/2–US–02).
Licensing Status: Available for
exclusive or non-exclusive licensing.
Licensing Contact: Whitney Hastings;
301–451–7337; hastingw@mail.nih.gov.
A Novel Recombinant Immunotoxin
SS1P (anti-mesothelin dsFv-PE38): A
Therapeutic Treatment for Lung Cancer
and Other Mesothelin Expressing
Cancers
Description of Technology:
Mesothelin is a cell surface glycoprotein
whose expression is largely restricted to
mesothelial cells in normal tissues.
Significantly, mesothelin is also highly
expressed in many cancers (including
malignant mesothelioma, ovarian
cancer, lung cancer, pancreatic
carcinomas, gastric carcinomas, etc.). As
a result, mesothelin is an excellent
target for immunotherapy.
NIH inventors have generated high
affinity antibodies to mesothelin (SS1)
and fused them to various functional
fragments of Pseudomonas Exotoxin A
(PE) to produce the immunotoxin SSIP.
New SS1P constructs include PE
fragments and mutants with reduced
immunogenicity, resulting in
immunotoxins with greater efficacy.
SS1P activity was previously shown in
patients suffering from mesothelioma
and ovarian cancer; laboratory studies
now demonstrate cytotoxicity against
lung carcinoma cells. Additionally,
SS1P has shown synergy with front line
cancer therapeutics in a mouse model,
making SS1P an excellent candidate
both a stand-alone therapeutic and a
combination therapeutic.
Applications:
• SS1P can be used as a therapy for
mesothelin expressing cancers,
including mesothelioma, ovarian cancer
and lung adenocarcinoma.
• The immunotoxin can be used in
combination with standard
chemotherapy.
Advantages:
• Immunotoxins are highly selective
for cancer cells, reducing side-effects
due to the non-specific killing of normal
cells.
• Strong synergy has been shown
between SS1P and standard front line
cancer therapies in the treatment on
lung adenocarcinoma.
• Less immunogenic PE variants
increase the efficacy of the
immunotoxin.
Inventors: Ira Pastan (NCI) et al.
Patent Status: U.S. Patent 7,081,518,
entitled ‘‘Anti-mesothelin antibodies
having high binding affinity’’ issued on
25 July 2006 [HHS Ref. E–139–1999/0].
Related Technologies:
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53432
Federal Register / Vol. 73, No. 180 / Tuesday, September 16, 2008 / Notices
ebenthall on PROD1PC60 with NOTICES
• U.S. Patents 6,051,405, 5,863,745,
and 5,696,237 ‘‘Recombinant AntibodyToxin Fusion Protein’’ [HHS Ref. E–
135–1989/0];
• U.S. Patents 5,747,654, 6,147,203,
and 6,558,672 entitled ‘‘Recombinant
Disulfide-Stabilized Polypeptide
Fragments Having Binding Specificity’’
[HHS Ref. E–163–1993/0];
• U.S. Patent 6,153,430, and U.S.
Patent Application 09/684,599 ‘‘Nucleic
Acid Encoding Mesothelin, a
Differentiation Antigen Present on
Mesothelium, Mesotheliomas and
Ovarian Cancers’’ [HHS Ref. E–002–
1996/0];
• U.S. Patent 6,083,502 entitled
‘‘Mesothelium Antigen and Methods
and Kits for Targeting It’’ [HHS Ref. E–
002–1996/1];
• U.S. Patent Application 09/581,345:
‘‘Antibodies, Including Fv Molecules,
and Immunoconjugates Having High
Binding Affinity for Mesothelin and
Methods for Their Use’’ [HHS Ref. E–
021–1998/0];
• U.S. Patent Application 10/297,337,
‘‘Pegylation of Linkers Improves
Antitumor Activity and Reduces
Toxicity of Immunoconjugates’’ [HHS
Ref. E–216–2000/2];
• U.S. Patent Application 11/920,222
entitled ‘‘Anti-Mesothelin Antibodies
Useful For Immunological Assays’’
[HHS Ref. E–015–2005/0];
• U.S. Patent Application 11/997,202
‘‘Mutated Pseudomonas Exotoxins with
Reduced Antigenicity’’ [HHS Ref E–
262–2005/0]; and
• U.S. Patent Application 60/969,929
‘‘Deletions in Domain II of
Pseudomonas Exotoxin A that Remove
Immunogenic Epitopes without
Affecting Cytotoxic Activity’’ [HHS Ref.
E–292–2007/0].
Licensing Status: The technology is
available for exclusive and nonexclusive licensing.
Licensing Contact: David A.
Lambertson, PhD; 301–435–4632;
lambertsond@mail.nih.gov.
Collaborative Research Opportunity:
The National Cancer Institute
Laboratory of Molecular Biology is
seeking statements of capability or
interest from parties interested in
collaborative research to further develop
immunotoxin SS1P. Please contact John
D. Hewes, PhD at 301–435–3121 or
hewesj@mail.nih.gov for more
information.
Dated: September 9, 2008.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. E8–21506 Filed 9–15–08; 8:45 am]
BILLING CODE 4140–01–P
VerDate Aug<31>2005
13:43 Sep 15, 2008
Jkt 214001
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:
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.
Compositions and Methods for
Increasing Recombinant Protein Yields
Through the Modification of Cellular
Properties
Description of Technology: This
technology relates to compositions and
methods for improving the growth
characteristics of cells engineered to
produce biologically active products
such as antibodies or glycosylated
proteins. Featured is a method that uses
gene candidates (e.g., cdkl3, siat7e, or
lama4), or their expressed or inhibited
products in cell lines, such as Human
Embryonic Kidney (including HEK–
293), HeLa, or Chinese Hamster Ovary
(CHO). The gene expression modulates
growth characteristics, such as adhesion
properties, of the cell lines thereby
increasing recombinant protein yields
and reducing product production costs.
Applications: This technology may be
used to improve production of
therapeutic and/or diagnostic
compounds, including therapeutic
proteins or monoclonal antibodies from
mammalian cells. Optimization of
mammalian cells for use as expression
systems in the production of
biologically active products is very
difficult. For certain applications,
anchorage-independent cell lines may
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be preferred, whereas for other
applications, a cell line that adheres to
a surface, e.g., is anchorage-dependent,
may be preferable. This technology
provides a method for identifying a gene
whose expression modulates such
cellular adhesion characteristics. This
method thus leads to an increase in the
expression or yield of polypeptides,
including therapeutic biologicals, such
as antibodies, cytokines, growth factors,
enzymes, immunomodulators,
thrombolytics, glycosylated proteins,
secreted proteins, and DNA sequences
encoding such polypeptides and a
reduction in the associated costs of such
biological products.
Advantages: This technology offers
the ability to improve yields and reduce
the cost associated with the production
of recombinant protein products
through the selection of cell lines
having:
• Altered growth characteristics.
• Altered adhesion characteristics.
• Altered rate of proliferation.
• Improvement in cell density
growth.
• Improvement in recombinant
protein expression level.
Market: Biopharmaceuticals,
including recombinant therapeutic
proteins and monoclonal antibodybased products used for in vivo medical
purposes and nucleic acid based
medicinal products now represent
approximately one in every four new
pharmaceuticals on the market. The
market size has been estimated at $33
billion in 2004 and is projected to reach
$70 billion by the end of the decade.
The list of approved biopharmaceuticals
includes recombinant hormones and
growth factors, mAB-based products
and therapeutic enzymes as well as
recombinant vaccines and nucleic acid
based products.
Mammalian cells are widely used
expression systems for the production of
biopharmaceuticals. Human embryo
kidney (including HEK–293) and
Chinese hamster ovary (CHO) are host
cells of choice. The genes identified in
this technology (e.g., cdkl3, sia7e, or
lama4) can be used to modify these
important cell based systems.
This technology is ready for use in
drug/vaccine discovery, production and
development. The technology provides
methods for identification of specific
gene targets useful for altering the
production properties of either existing
cell lines to improve yields or with new
cell lines for the production of
therapeutic and/or diagnostic
compounds from mammalian cells.
Companies that are actively seeking
production platforms based on
mammalian cell lines that offer high
E:\FR\FM\16SEN1.SGM
16SEN1
]]>Agencies
[Federal Register Volume 73, Number 180 (Tuesday, September 16, 2008)]
[Notices]
[Pages 53430-53432]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-21506]
-----------------------------------------------------------------------
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
[[Page 53431]]
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.
Bifunctional Compounds That Bind to Hormone Receptors
Description of Technology: The development and progression of
prostate cancer is dependent on the androgen receptor (AR), a ligand-
dependent transcription factor. In the inactive form AR resides in the
cytosolic region of the cell and when activated, AR is imported into
the nucleus. Initial hormonal therapy for prostate cancer involves
lowering serum levels of testosterone to shut down AR activity. Despite
initial patient responses to testosterone-depleting therapies, prostate
cancer becomes refractory to hormonal therapy. Notably, AR is
reactivated in hormone-refractory prostate cancer and reinstates its
proliferative and survival activity.
Available for licensing is a novel chemical compound which is
bifunctional and binds to AR. This compound is comprised of tubulin-
binding and steroid receptor-binding moieties. This compound is
designed to antagonize AR function in a nonclassical manner by several
mechanisms and kills hormone-refractory prostate cells better than both
functional moieties. This compound is a first-in-class of bifunctional
steroid receptor binding agents that can antagonize steroid receptors
in a variety of hormone-dependent diseases, such as breast and prostate
cancer.
Applications:
Therapeutic compounds that selectively target steroid
receptor-expressing cancer cells resulting in minimal patient toxicity.
Method to treat hormone resistant prostate cancer and
potentially other steroid receptor dependent diseases such as breast
cancer.
Market:
Prostate cancer is the second most common type of cancer
among men, wherein one in six men will be diagnosed.
An estimated 186,320 new diagnosed cases and 28,660 deaths
due to prostate cancer in the U.S. will occur in 2008.
Development Status: The technology is currently in the pre-clinical
stage of development.
Inventors: Nima Sharifi et al. (NCI).
Publication: N Sharifi et al. A bifunctional colchicinoid that
binds to the androgen receptor. Mol Can Ther. 2007 Aug;6(8):2328-2336.
Patent Status: PCT Application No. PCT/US2008/008299 filed 02 Jul
2008, claiming priority to 03 Jul 2007 (HHS Reference No. E-163-2007/0-
PCT-02).
Availability: Available for exclusive or non-exclusive licensing.
Licensing Contact: Jennifer Wong; 301-435-4633;
wongje@mail.nih.gov.
Vitamin D Receptor Antagonists for Treating Breast Cancer
Description of Technology: Vitamin D receptor (VDR) is a nuclear
receptor that is activated by calcitriol, the active form of vitamin D.
It is best known for regulating dietary calcium uptake necessary for
bone growth, but it also affects cell proliferation and
differentiation. Therefore, it was thought that treatment with
calcitriol or its derivatives could be useful to treat the uncontrolled
proliferation typical of cancer cells. However, this approach has been
unsuccessful to date because it leads to toxic levels of calcium in the
blood.
This invention relates to derivatives of calcitriol that can block
cell growth without harmfully raising calcium levels. Specifically,
these compounds act as antagonists of VDR blocking its ability to
stimulate cell proliferation. This technology can be useful in treating
breast cancer or other malignancies.
Applications:
Potential drugs for treating breast cancer and possibly
also prostate cancer, colorectal cancer, leukemia, melanoma, or glioma.
Prevention of cancer in high-risk population.
Research on vitamin D receptor functions and cancer.
Market: About 182,460 American women will be diagnosed with
invasive breast cancer in 2008.
Development Status: Pre-clinical data available.
Inventors: Julianna Barsony (NIDDK).
Publication: J Barsony et al. Development of a biologically active
fluorescent-labeled calcitriol and its use to study hormone binding to
the vitamin D receptor. Anal Biochem. 1995 Jul 20;229(1):68-79.
Patent Status: U.S. Patent No. 7,361,664 issued 22 Apr 2008 (HHS
Reference No. E-213-2001/2-US-02).
Licensing Status: Available for exclusive or non-exclusive
licensing.
Licensing Contact: Whitney Hastings; 301-451-7337;
hastingw@mail.nih.gov.
A Novel Recombinant Immunotoxin SS1P (anti-mesothelin dsFv-PE38): A
Therapeutic Treatment for Lung Cancer and Other Mesothelin Expressing
Cancers
Description of Technology: Mesothelin is a cell surface
glycoprotein whose expression is largely restricted to mesothelial
cells in normal tissues. Significantly, mesothelin is also highly
expressed in many cancers (including malignant mesothelioma, ovarian
cancer, lung cancer, pancreatic carcinomas, gastric carcinomas, etc.).
As a result, mesothelin is an excellent target for immunotherapy.
NIH inventors have generated high affinity antibodies to mesothelin
(SS1) and fused them to various functional fragments of Pseudomonas
Exotoxin A (PE) to produce the immunotoxin SSIP. New SS1P constructs
include PE fragments and mutants with reduced immunogenicity, resulting
in immunotoxins with greater efficacy. SS1P activity was previously
shown in patients suffering from mesothelioma and ovarian cancer;
laboratory studies now demonstrate cytotoxicity against lung carcinoma
cells. Additionally, SS1P has shown synergy with front line cancer
therapeutics in a mouse model, making SS1P an excellent candidate both
a stand-alone therapeutic and a combination therapeutic.
Applications:
SS1P can be used as a therapy for mesothelin expressing
cancers, including mesothelioma, ovarian cancer and lung
adenocarcinoma.
The immunotoxin can be used in combination with standard
chemotherapy.
Advantages:
Immunotoxins are highly selective for cancer cells,
reducing side-effects due to the non-specific killing of normal cells.
Strong synergy has been shown between SS1P and standard
front line cancer therapies in the treatment on lung adenocarcinoma.
Less immunogenic PE variants increase the efficacy of the
immunotoxin.
Inventors: Ira Pastan (NCI) et al.
Patent Status: U.S. Patent 7,081,518, entitled ``Anti-mesothelin
antibodies having high binding affinity'' issued on 25 July 2006 [HHS
Ref. E-139-1999/0].
Related Technologies:
[[Page 53432]]
U.S. Patents 6,051,405, 5,863,745, and 5,696,237
``Recombinant Antibody-Toxin Fusion Protein'' [HHS Ref. E-135-1989/0];
U.S. Patents 5,747,654, 6,147,203, and 6,558,672 entitled
``Recombinant Disulfide-Stabilized Polypeptide Fragments Having Binding
Specificity'' [HHS Ref. E-163-1993/0];
U.S. Patent 6,153,430, and U.S. Patent Application 09/
684,599 ``Nucleic Acid Encoding Mesothelin, a Differentiation Antigen
Present on Mesothelium, Mesotheliomas and Ovarian Cancers'' [HHS Ref.
E-002-1996/0];
U.S. Patent 6,083,502 entitled ``Mesothelium Antigen and
Methods and Kits for Targeting It'' [HHS Ref. E-002-1996/1];
U.S. Patent Application 09/581,345: ``Antibodies,
Including Fv Molecules, and Immunoconjugates Having High Binding
Affinity for Mesothelin and Methods for Their Use'' [HHS Ref. E-021-
1998/0];
U.S. Patent Application 10/297,337, ``Pegylation of
Linkers Improves Antitumor Activity and Reduces Toxicity of
Immunoconjugates'' [HHS Ref. E-216-2000/2];
U.S. Patent Application 11/920,222 entitled ``Anti-
Mesothelin Antibodies Useful For Immunological Assays'' [HHS Ref. E-
015-2005/0];
U.S. Patent Application 11/997,202 ``Mutated Pseudomonas
Exotoxins with Reduced Antigenicity'' [HHS Ref E-262-2005/0]; and
U.S. Patent Application 60/969,929 ``Deletions in Domain
II of Pseudomonas Exotoxin A that Remove Immunogenic Epitopes without
Affecting Cytotoxic Activity'' [HHS Ref. E-292-2007/0].
Licensing Status: The technology is available for exclusive and
non-exclusive licensing.
Licensing Contact: David A. Lambertson, PhD; 301-435-4632;
lambertsond@mail.nih.gov.
Collaborative Research Opportunity: The National Cancer Institute
Laboratory of Molecular Biology is seeking statements of capability or
interest from parties interested in collaborative research to further
develop immunotoxin SS1P. Please contact John D. Hewes, PhD at 301-435-
3121 or hewesj@mail.nih.gov for more information.
Dated: September 9, 2008.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. E8-21506 Filed 9-15-08; 8:45 am]
BILLING CODE 4140-01-P
