Government-Owned Inventions; Availability for Licensing, 6910-6912 [E9-2822]
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Federal Register / Vol. 74, No. 27 / Wednesday, February 11, 2009 / Notices
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family interacting protein 3 (FIP3)
expressed in the pGEX2T vector.
Application: Research tool to detect
and quantify activated Arf5 in various
laboratory procedures to analyze
intracellular trafficking and cellular
motility.
Advantages: To the best of our
knowledge, this technology represents
the first reported assay for the detection
of activated Arf5.
Inventors: Paul A. Randazzo and Vi L.
Ha (NCI).
Publications:
1. H Inoue et al. Arf GTPase-activating
protein ASAP1 interacts with Rab11
effector FIP3 and regulates
pericentrosomal localization of
transferrin receptor-positive recycling
endosome. Mol Biol Cell. 2008
Oct;19(10):4224–4237.
2. HY Yoon et al. In vitro assays of
Arf1 interaction with GGA proteins.
Methods Enzymol. 2005;404:316–332.
Patent Status: HHS Reference No. E–
064–2009/0—Research Tool. Patent
protection is not being pursued for this
technology.
Related Technologies: Antibodies and
Antisera Recognizing Members of the
ArfGap Family of Proteins:
• HHS Reference No. E–220–2008/
0—Research Tool.
• HHS Reference No. E–220–2008/
1—Research Tool.
• HHS Reference No. E–220–2008/
2—Research Tool.
• HHS Reference No. E–221–2008/
0—Research Tool.
• HHS Reference No. E–221–2008/
1—Research Tool.
• HHS Reference No. E–221–2008/
2—Research Tool.
• HHS Reference No. E–222–2008/
0—Research Tool.
• HHS Reference No. E–242–2008/
0—Research Tool.
• HHS Reference No. E–243–2008/
0—Research Tool.
• HHS Reference No. E–244–2008/
0—Research Tool.
• HHS Reference No. E–245–2008/
0—Research Tool.
• HHS Reference No. E–245–2008/
1—Research Tool.
• HHS Reference No. E–252–2008/
0—Research Tool.
Licensing Status: Available for
licensing under a Biological Materials
License Agreement.
Licensing Contact: Samuel E. Bish,
PhD; 301–435–5282;
bishse@mail.nih.gov.
developed mouse monoclonal
antibodies against the human spindle
assembly checkpoint protein, MAD1.
The spindle assembly checkpoint in
mitotic cell division regulates the
fidelity of chromosome segregation
during cell division. MAD1 is an
important component of this checkpoint
control, which if compromised, can lead
to the initiation of cancer cell growth.
These monoclonal antibodies are the
first available antibodies against MAD1
and can be used in laboratory research
and diagnostics.
Applications:
• Research tool in various laboratory
procedures to identify and detect
MAD1.
• Diagnostic tool for aneuploidy, the
condition of having an abnormal
number of chromosomes, which results
in birth and developmental defects,
such as Down syndrome.
Inventor: Kuan-Teh Jeang (NIAID).
Publication: K Haller et al. The Nterminus of rodent and human MAD1
confers species-specific stringency to
spindle assembly checkpoint. Oncogene
2006 Apr 6;25(15):2137–2147.
Patent Status: HHS Reference No. E–
119–2003/0—Research Tool. Patent
protection is not being pursued for this
technology.
Licensing Status: Available for
licensing under a Biological Materials
License Agreement.
Licensing Contact: Samuel E. Bish,
PhD; 301–435–5282;
bishse@mail.nih.gov.
Collaborative Research Opportunity:
The NIAID Office of Technology
Development is seeking statements of
capability or interest from parties
interested in collaborative research to
further develop, evaluate, or
commercialize reagents for studying cell
cycle checkpoint factors. Please contact
Agnes Rooke at rookeab@niaid.nih.gov
or by phone at 301–594–1697 for more
information.
Mouse Monoclonal Antibodies to
MAD1, a Human Spindle Assembly
Checkpoint Protein for Maintaining
Chromosomal Segregation
Description of Technology: Scientists
at the National Institutes of Health have
National Institutes of Health
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Dated: January 30, 2009.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. E9–2821 Filed 2–10–09; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Government-Owned Inventions;
Availability for Licensing
AGENCY: National Institutes of Health,
Public Health Service, HHS.
PO 00000
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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.
Prognostic Test for Breast Cancer Based
on a 12 Gene Expression Signature
Description of Technology: The
clinical course and survival times of
patients with breast cancer varies
greatly, consequently it is difficult to
establish a prognosis for the disease. To
improve patient prognosis, much effort
has been made to identify biological
markers that would allow precise
staging of the cancer. When cells cannot
repair minor damage to their DNA it
leads to genetic instability which can
produce gross abnormalities in
chromosomes and the onset of a cancer.
It is known that the magnitude of the
abnormalities is strongly correlated with
a negative prognosis for cancer. Thus,
genetic instability can serve as a useful
biomarker for establishing a prognosis
for breast cancer patients. Presently,
genetic instability is not directly
accounted for in established prognostic
tests.
Investigators at the National Cancer
Institute (NCI) have developed a
compact gene signature that detects
genome instability in breast cancer cells.
By comparing changes in expression
levels of only 12 genes in malignant
tissue to levels in normal breast tissue
it is possible to detect the genetic
abnormalities that are indicative of a
poor prognosis. This method has
potential to improve markedly the
forecasting of clinical outcomes for
breast cancer and help improve
treatment of this disease.
Applications:
• Precise staging of women with
breast cancer prior to commencing
treatment.
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• Discovery of therapeutics that alter
genomic instability and improve breast
cancer prognosis.
Advantages:
• Reduced number of genes to
measure compared to available
technologies.
• Prognosis independent of other
cancer indicators, such as lymph node
status.
• Improved prediction in low risk
patients.
Market: It is estimated that in 2008
more than 184,000 Americans would be
diagnosed with breast cancer. After lung
cancer, breast cancer is the second most
lethal cancer in women.
Development Status: Pre-clinical or
clinical data available.
Inventors: Thomas Ried (NCI) et al.
Publications: Presently, none related
to this invention.
Patent Status: U.S. Provisional
Application No. 61/097,101 filed 15 Sep
2008 (HHS Reference No. E–215–2008/
0-US–01).
Licensing Status: Available for
exclusive or non-exclusive licensing.
Licensing Contact: Surekha Vathyam,
PhD; 301–435–4076;
vathyams@mail.nih.gov.
Collaborative Research Opportunity:
The National Cancer Institute Genetics
Branch is seeking statements of
capability or interest from parties
interested in collaborative research to
further develop, evaluate, or
commercialize Prognostic Test for
Breast Cancer Based on a 12 Gene
Expression Signature. Please contact
John D. Hewes, Ph.D. at 301–435–3121
or hewesj@mail.nih.gov for more
information.
HMGN Polypeptides as Immune
Enhancers and HMGN Antagonists as
Immune Suppressants
Description of Technology: HMGN
polypeptides are multidomain proteins
known to function by binding DNA to
regulate the transcription of certain
genes inside cells. However, when a
HMGN polypeptide is released
extracellularly, it distinctly acts as a
potent activator of the immune system.
Because of this activity, it has potential
use as a biological therapeutic for
stimulating an immune response as well
as a promising target for antagonist
drugs to suppress a pathological
inflammatory response.
Secreted HMGN acts as a potent
recruiter and activator of dendritic cells,
the cell principally responsible for
initiating the immune response.
Furthermore, it enables dendritic cells
to preferentially induce a Th1-type T
lymphocyte response that leads to
enduring cellular immunity. Therefore,
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HMGN has potential use as a clinically
effective immunoadjuvant for use in
vaccines against tumors and many
intracellular pathogens.
Investigators at the National Institutes
of Health have developed compositions
and methods for using HMGN and its
derivatives as immunoadjuvants in
combination, as mixtures or as chemical
conjugates, with microbial or tumor
antigens. HMGN has the advantage of
being gene encoded so it can be fused
to an antigen gene to produce
recombinant fusion proteins or
administered as a DNA vaccine.
Conversely, HMGN could be exploited
as a drug target to treat diseases that
would benefit from shifting away the
Th1-type immune response towards a
Th2-type or humoral immune response.
This would be beneficial for treatment
of parasitic infections and inflammatory
or autoimmune disorders.
Applications:
• As an immunostimulatory adjuvant
to increase efficacy of preventive or
therapeutic vaccinations against
microbes or cancers.
• As an attractant and activator of
dendritic cells.
• Antagonist drug development for
suppressing Th1-type response.
Advantages:
• Less adverse effects expected
compared to current immunoadjuvants
since HMGN is produced by the human
body.
• Highly effective polarizer of the
immune response towards Th1-type
immunity.
Development Status: Pre-clinical data
available.
Market: Very few immunoadjuvants
have reached clinical approval since the
introduction of alum over half a decade
ago. Currently, there is a need for safe
and effective vaccine adjuvants to
increase the effectiveness of preventive
and therapeutic vaccines.
Inventors: De Yang et al. (NCI).
Publications: Presently, none related
to this invention.
Patent Status: U.S. Provisional Patent
No. 61/083,781 filed 25 Jul 2008 (DHHS
Reference No. E–185–2008/0-US–01).
Licensing Status: Available for
exclusive or non-exclusive licensing.
Licensing Contact: Surekha Vathyam,
Ph.D.; 301–435–4076;
vathyams@mail.nih.gov.
Collaborative Research Opportunity:
The National Cancer Institute
Laboratory of Molecular
Immunoregulation is seeking statements
of capability or interest from parties
interested in collaborative research to
further develop, evaluate, or
commercialize HMGN1. Please contact
John D. Hewes, Ph.D. at 301–435–3121
PO 00000
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or hewesj@mail.nih.gov for more
information.
Substituted IL–15
Description of Technology:
Interleukin-15 (IL–15) is an immune
system modulating protein (cytokine)
that stimulates the proliferation and
differentiation of T-lymphocytes. In the
clinical context, IL–15 is being
investigated for use in the treatment of
diseases such as cancer. In vitro
manufacture of IL–15 can be
problematic.
The invention relates to substituted
IL–15 amino acid sequences of one or
more amino acids that are predicted to
reduce or eliminate deamidation of a
specific aspargine amino acid residue
found within the IL–15 protein.
Deamidation can lead to protein
degradation and interfere with the
pharmaceutical purification and
processing of IL–15. The invention also
provides potential substituted gene
sequences that encode the substituted
IL–15 amino acid sequences. The
substituted IL–15 amino acid sequences
may advantageously facilitate the
refolding, purification, storage,
characterization, and clinical testing of
IL–15.
Applications: IL–15
immunotherapies.
Advantages: Potential decreased
immunogenicity of pharmacologically
active IL–15 expressed in E. coli.
Development Status: Concept
Development Phase.
Market: Cancer immunotherapy; IL–
15 based immunotherapies.
Inventors: David F. Nellis et al. (NCI/
SAIC).
Patent Status: U.S. Provisional
Application No. 61/049,165 filed 30 Apr
2008 (HHS Reference No. E–123–2008/
0–US–01).
Licensing Status: Available for
licensing.
Licensing Contact: Kevin W. Chang,
Ph.D.; 301–435–5018;
changke@mail.nih.gov
Collaborative Research Opportunity:
The National Cancer Institute Biological
Research Branch is seeking statements
of capability or interest from parties
interested in collaborative research to
further develop, evaluate, or
commercialize the topic of this U.S.
Provisional Patent Application. Please
contact John D. Hewes, Ph.D. at 301–
435–3121 or hewesj@mail.nih.gov for
more information.
Novel Protein Delivery System for
Mammalian Cells
Description of Technology: Virus-like
particles (VLPs) consist of viral
structural proteins that are capable of
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6912
Federal Register / Vol. 74, No. 27 / Wednesday, February 11, 2009 / Notices
self-assembly into a nanoparticle, but
are non-infectious because they lack
viral nucleic acids. VLPs have been
used in viral vaccines, such as those for
human papilloma virus and hepatitis B.
However, they also have great potential
in other applications, such as cancer
vaccines, transport of nucleic acids into
target cells (gene therapy), and transport
of biologics or other large molecules
into target cells for therapeutic
purposes. The present technology
discloses a chimeric VLP containing a
GAG-Cre recombinase fusion protein.
This recombinase fusion protein retains
Cre recombinase activity, and can excise
a LOX-flanked gene in a transduced
target cell. Experiments by Drs.
Kaczmarczyk and Chatterjee have
demonstrated that chimeric VLPs can be
used to deliver functional fusion
proteins into cells. The technology also
provides for a two-VLP protein delivery
system designed to deliver a protein of
interest into a target cell. The present
technology also discloses VLPs
containing GAG-protein of interest (ex.
GAG-Cre) co-packaged with GAGprotease to deliver protein of interest in
target site as a fully-processed protein
rather than as a fusion protein.
The claims in the pending patent
application provide for virus-like
particles, methods of making virus-like
particles, and methods of using viruslike particles to deliver proteins to a
cell. The claims also provide for
methods of targeting a protein to a cell,
methods of protein therapy and
methods of treating diseases or
disorders.
Applications:
• Intracellular targeted delivery of
therapeutic proteins.
• Ex vivo use for expansion of stem
cells for transplantation.
• Antigen loading of dendritic cells
for cancer vaccination.
Market: The therapeutic protein
market segment will have a projected
$52.2 billion in sales in 2010.
Development Status: In vivo
feasibility studies are in progress.
Patent Status: U.S. Patent Application
No. 61/195,084 filed 03 Oct 2008 (HHS
Reference No. E–010–2008/0–US–01).
Inventors: Deb K. Chatterjee and
Stanislaw J. Kaczmarcyk (NCI/SAIC).
Licensing Status: Available for
licensing.
Licensing Contact: Suryanarayana
(Sury) Vepa, Ph.D., J.D.; 301–435–5020;
vepas@mail.nih.gov.
Collaborative Research Opportunity:
The National Cancer Institute Advanced
Technology Program, Protein
Expression Laboratory, is seeking
statements of capability or interest from
parties interested in collaborative
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research to further develop, evaluate, or
commercialize this technology. Please
contact John D. Hewes, Ph.D. at 301–
435–3121 or hewesj@mail.nih.gov for
more information.
Dated: January 30, 2009.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. E9–2822 Filed 2–10–09; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Diabetes and
Digestive and Kidney Diseases; Notice
of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), 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 contract proposals and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the contract
proposals, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel, Islet Cell
Distribution Coordinating Center.
Date: March 23, 2009.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate contract
proposals.
Place: Holiday Inn National Airport Hotel,
2650 Jefferson Davis Highway, Arlington, VA
22202.
Contact Person: Michael W. Edwards,
PhD., Scientific Review Officer, Review
Branch, DEA, NIDDK, National Institutes of
Health, Room 750, 6707 Democracy
Boulevard, Bethesda, MD 20892–5452, (301)
594–8886, edwardsm@extra.niddk.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.847, Diabetes,
Endocrinology and Metabolic Research;
93.848, Digestive Diseases and Nutrition
Research; 93.849, Kidney Diseases, Urology
and Hematology Research, National Institutes
of Health, HHS)
Dated: February 4, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–2824 Filed 2–10–09; 8:45 am]
BILLING CODE 4140–01–P
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Mental Health;
Notice of Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of the following
meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Mental Health Special Emphasis Panel;
Time-Sensitive Review.
Date: February 20, 2009.
Time: 1 p.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852, (Telephone
Conference Call).
Contact Person: Aileen Schulte, PhD,
Scientific Review Officer, Division of
Extramural Activities, National Institute of
Mental Health, NIH, Neuroscience Center,
6001 Executive Blvd, Room 6140, MSC 9608,
Bethesda, MD 20892–9608, 301–443–1225,
aschulte@mail.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Name of Committee: National Institute of
Mental Health Special Emphasis Panel;
Trauma in High-Risk Occupations.
Date: March 6, 2009.
Time: 10 a.m. to 12 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852, (Telephone
Conference Call).
Contact Person: Serena P. Chu, PhD,
Scientific Review Officer, Division of
Extramural Activities, National Institute of
Mental Health, NIH, Neuroscience Center,
6001 Executive Blvd., Room 6154, MSC 9609,
Rockville, MD 20892–9609, 301–443–0004,
sechu@mail.nih.gov.
Name of Committee: National Institute of
Mental Health Special Emphasis Panel;
Fellowships and Dissertation Grants.
Date: March 10, 2009.
Time: 12 p.m. to 4 p.m.
Agenda: To review and evaluate grant
applications.
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]]>Agencies
[Federal Register Volume 74, Number 27 (Wednesday, February 11, 2009)]
[Notices]
[Pages 6910-6912]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-2822]
-----------------------------------------------------------------------
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.
Prognostic Test for Breast Cancer Based on a 12 Gene Expression
Signature
Description of Technology: The clinical course and survival times
of patients with breast cancer varies greatly, consequently it is
difficult to establish a prognosis for the disease. To improve patient
prognosis, much effort has been made to identify biological markers
that would allow precise staging of the cancer. When cells cannot
repair minor damage to their DNA it leads to genetic instability which
can produce gross abnormalities in chromosomes and the onset of a
cancer. It is known that the magnitude of the abnormalities is strongly
correlated with a negative prognosis for cancer. Thus, genetic
instability can serve as a useful biomarker for establishing a
prognosis for breast cancer patients. Presently, genetic instability is
not directly accounted for in established prognostic tests.
Investigators at the National Cancer Institute (NCI) have developed
a compact gene signature that detects genome instability in breast
cancer cells. By comparing changes in expression levels of only 12
genes in malignant tissue to levels in normal breast tissue it is
possible to detect the genetic abnormalities that are indicative of a
poor prognosis. This method has potential to improve markedly the
forecasting of clinical outcomes for breast cancer and help improve
treatment of this disease.
Applications:
Precise staging of women with breast cancer prior to
commencing treatment.
[[Page 6911]]
Discovery of therapeutics that alter genomic instability
and improve breast cancer prognosis.
Advantages:
Reduced number of genes to measure compared to available
technologies.
Prognosis independent of other cancer indicators, such as
lymph node status.
Improved prediction in low risk patients.
Market: It is estimated that in 2008 more than 184,000 Americans
would be diagnosed with breast cancer. After lung cancer, breast cancer
is the second most lethal cancer in women.
Development Status: Pre-clinical or clinical data available.
Inventors: Thomas Ried (NCI) et al.
Publications: Presently, none related to this invention.
Patent Status: U.S. Provisional Application No. 61/097,101 filed 15
Sep 2008 (HHS Reference No. E-215-2008/0-US-01).
Licensing Status: Available for exclusive or non-exclusive
licensing.
Licensing Contact: Surekha Vathyam, PhD; 301-435-4076;
vathyams@mail.nih.gov.
Collaborative Research Opportunity: The National Cancer Institute
Genetics Branch is seeking statements of capability or interest from
parties interested in collaborative research to further develop,
evaluate, or commercialize Prognostic Test for Breast Cancer Based on a
12 Gene Expression Signature. Please contact John D. Hewes, Ph.D. at
301-435-3121 or hewesj@mail.nih.gov for more information.
HMGN Polypeptides as Immune Enhancers and HMGN Antagonists as Immune
Suppressants
Description of Technology: HMGN polypeptides are multidomain
proteins known to function by binding DNA to regulate the transcription
of certain genes inside cells. However, when a HMGN polypeptide is
released extracellularly, it distinctly acts as a potent activator of
the immune system. Because of this activity, it has potential use as a
biological therapeutic for stimulating an immune response as well as a
promising target for antagonist drugs to suppress a pathological
inflammatory response.
Secreted HMGN acts as a potent recruiter and activator of dendritic
cells, the cell principally responsible for initiating the immune
response. Furthermore, it enables dendritic cells to preferentially
induce a Th1-type T lymphocyte response that leads to enduring cellular
immunity. Therefore, HMGN has potential use as a clinically effective
immunoadjuvant for use in vaccines against tumors and many
intracellular pathogens.
Investigators at the National Institutes of Health have developed
compositions and methods for using HMGN and its derivatives as
immunoadjuvants in combination, as mixtures or as chemical conjugates,
with microbial or tumor antigens. HMGN has the advantage of being gene
encoded so it can be fused to an antigen gene to produce recombinant
fusion proteins or administered as a DNA vaccine. Conversely, HMGN
could be exploited as a drug target to treat diseases that would
benefit from shifting away the Th1-type immune response towards a Th2-
type or humoral immune response. This would be beneficial for treatment
of parasitic infections and inflammatory or autoimmune disorders.
Applications:
As an immunostimulatory adjuvant to increase efficacy of
preventive or therapeutic vaccinations against microbes or cancers.
As an attractant and activator of dendritic cells.
Antagonist drug development for suppressing Th1-type
response.
Advantages:
Less adverse effects expected compared to current
immunoadjuvants since HMGN is produced by the human body.
Highly effective polarizer of the immune response towards
Th1-type immunity.
Development Status: Pre-clinical data available.
Market: Very few immunoadjuvants have reached clinical approval
since the introduction of alum over half a decade ago. Currently, there
is a need for safe and effective vaccine adjuvants to increase the
effectiveness of preventive and therapeutic vaccines.
Inventors: De Yang et al. (NCI).
Publications: Presently, none related to this invention.
Patent Status: U.S. Provisional Patent No. 61/083,781 filed 25 Jul
2008 (DHHS Reference No. E-185-2008/0-US-01).
Licensing Status: Available for exclusive or non-exclusive
licensing.
Licensing Contact: Surekha Vathyam, Ph.D.; 301-435-4076;
vathyams@mail.nih.gov.
Collaborative Research Opportunity: The National Cancer Institute
Laboratory of Molecular Immunoregulation is seeking statements of
capability or interest from parties interested in collaborative
research to further develop, evaluate, or commercialize HMGN1. Please
contact John D. Hewes, Ph.D. at 301-435-3121 or hewesj@mail.nih.gov for
more information.
Substituted IL-15
Description of Technology: Interleukin-15 (IL-15) is an immune
system modulating protein (cytokine) that stimulates the proliferation
and differentiation of T-lymphocytes. In the clinical context, IL-15 is
being investigated for use in the treatment of diseases such as cancer.
In vitro manufacture of IL-15 can be problematic.
The invention relates to substituted IL-15 amino acid sequences of
one or more amino acids that are predicted to reduce or eliminate
deamidation of a specific aspargine amino acid residue found within the
IL-15 protein. Deamidation can lead to protein degradation and
interfere with the pharmaceutical purification and processing of IL-15.
The invention also provides potential substituted gene sequences that
encode the substituted IL-15 amino acid sequences. The substituted IL-
15 amino acid sequences may advantageously facilitate the refolding,
purification, storage, characterization, and clinical testing of IL-15.
Applications: IL-15 immunotherapies.
Advantages: Potential decreased immunogenicity of pharmacologically
active IL-15 expressed in E. coli.
Development Status: Concept Development Phase.
Market: Cancer immunotherapy; IL-15 based immunotherapies.
Inventors: David F. Nellis et al. (NCI/SAIC).
Patent Status: U.S. Provisional Application No. 61/049,165 filed 30
Apr 2008 (HHS Reference No. E-123-2008/0-US-01).
Licensing Status: Available for licensing.
Licensing Contact: Kevin W. Chang, Ph.D.; 301-435-5018;
changke@mail.nih.gov
Collaborative Research Opportunity: The National Cancer Institute
Biological Research Branch is seeking statements of capability or
interest from parties interested in collaborative research to further
develop, evaluate, or commercialize the topic of this U.S. Provisional
Patent Application. Please contact John D. Hewes, Ph.D. at 301-435-3121
or hewesj@mail.nih.gov for more information.
Novel Protein Delivery System for Mammalian Cells
Description of Technology: Virus-like particles (VLPs) consist of
viral structural proteins that are capable of
[[Page 6912]]
self-assembly into a nanoparticle, but are non-infectious because they
lack viral nucleic acids. VLPs have been used in viral vaccines, such
as those for human papilloma virus and hepatitis B. However, they also
have great potential in other applications, such as cancer vaccines,
transport of nucleic acids into target cells (gene therapy), and
transport of biologics or other large molecules into target cells for
therapeutic purposes. The present technology discloses a chimeric VLP
containing a GAG-Cre recombinase fusion protein. This recombinase
fusion protein retains Cre recombinase activity, and can excise a LOX-
flanked gene in a transduced target cell. Experiments by Drs.
Kaczmarczyk and Chatterjee have demonstrated that chimeric VLPs can be
used to deliver functional fusion proteins into cells. The technology
also provides for a two-VLP protein delivery system designed to deliver
a protein of interest into a target cell. The present technology also
discloses VLPs containing GAG-protein of interest (ex. GAG-Cre) co-
packaged with GAG-protease to deliver protein of interest in target
site as a fully-processed protein rather than as a fusion protein.
The claims in the pending patent application provide for virus-like
particles, methods of making virus-like particles, and methods of using
virus-like particles to deliver proteins to a cell. The claims also
provide for methods of targeting a protein to a cell, methods of
protein therapy and methods of treating diseases or disorders.
Applications:
Intracellular targeted delivery of therapeutic proteins.
Ex vivo use for expansion of stem cells for
transplantation.
Antigen loading of dendritic cells for cancer vaccination.
Market: The therapeutic protein market segment will have a
projected $52.2 billion in sales in 2010.
Development Status: In vivo feasibility studies are in progress.
Patent Status: U.S. Patent Application No. 61/195,084 filed 03 Oct
2008 (HHS Reference No. E-010-2008/0-US-01).
Inventors: Deb K. Chatterjee and Stanislaw J. Kaczmarcyk (NCI/
SAIC).
Licensing Status: Available for licensing.
Licensing Contact: Suryanarayana (Sury) Vepa, Ph.D., J.D.; 301-435-
5020; vepas@mail.nih.gov.
Collaborative Research Opportunity: The National Cancer Institute
Advanced Technology Program, Protein Expression Laboratory, is seeking
statements of capability or interest from parties interested in
collaborative research to further develop, evaluate, or commercialize
this technology. Please contact John D. Hewes, Ph.D. at 301-435-3121 or
hewesj@mail.nih.gov for more information.
Dated: January 30, 2009.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
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