[Federal Register Volume 76, Number 37 (Thursday, February 24, 2011)]
[Notices]
[Pages 10375-10378]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-4170]
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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.
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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.
Terahertz Spatial Light Modulator System for Adaptive Near-Field
Imaging
Description of Technology: The invention offered for licensing is
in the field of imaging microscopes and relates to a terahertz light
modulator system, and in particular to a terahertz spatial light
modulator system for adaptive near-field imaging.
More specifically, the invention relates to a spatial light
modulator system for adaptive near-field imaging having an optical
source for transmitting an optical beam through a filter which is
controlled to convert the optical light beam into a filtered optical
light beam to define one or more transmission pathways through a
photoconductive material. The system further includes a terahertz light
source for transmitting a terahertz beam through one or more
transmission pathways defined by the filtered optical light beam
through the photoconductive material for illuminating and scanning the
sample without the use of moving structural components. The device
would allow micron-scale spatial resolution, would remove the need to
mechanically scan a sample, and would allow automatic adjustment of
image resolution and transmitted terahertz power. The near-field
terahertz microscope of the invention could have a compact, fiber-
coupled sensor head with no moving parts--ideal for scientific,
medical, and industrial applications like crystal growth optimization,
skin cancer diagnosis, and semiconductor chip inspection. In one
application, such as ``one-cut'' surgery, the compact sensor
[[Page 10376]]
head of the terahertz imaging system has the capability of
distinguishing healthy cells from cancerous cells with micron-scale
spatial resolution by immediately identifying a skin cancer margin
without the need for laboratory work or additional surgery. In another
application, the terahertz imaging system may be used in nondestructive
semiconductor chip inspection since the terahertz imaging system
provides micron-scale spatial resolution.
Applications:
Biomedical research applications (living tissues have
distinctive terahertz absorption signals)
Clinical applications like diagnostics of skin cancer
(skin cancer and normal skin reflect terahertz radiation differently)
Industrial applications like crystal growth optimization
Industrial applications like semiconductor chip
inspection.
Advantages: The system provides micron-scale spatial resolution,
while removing any need to mechanically scan samples (it is equipped
with a fiber-coupled sensor head), and at the same time allows
automatic adjustment of image resolution and transmitted terahertz
power.
Development Status: In development. Prototype is being built.
Inventors: Hari Shroff et al. (NIBIB).
Relevant Publications:
1. Mair S, Gompf B, Dressel M. Microspectroscopy and imaging in the
THz range using coherent CW radiation. Phys Med Biol. 2002 Nov
7;47(21):3719-3725. [PubMed: 12452559]
2. Chen Q, Jiang Z, Xu GX, Zhang XC. Near-field terahertz imaging
with a dynamic aperture. Opt Lett. 2000 Aug 1;25(15):1122-1124.
[PubMed: 18064291]
3. Wallace VP, Fitzgerald AJ, Shankar S, Flanagan N, Pye R, Cluff
J, Arnone DD. Terahertz pulsed imaging of basal cell carcinoma ex vivo
and in vivo. Br J Dermatol. 2004 Aug;151(2):424-432. [PubMed: 15327550]
4. Hu BB, Nuss MC. Imaging with terahertz waves. Opt Lett. 1995 Aug
15;20(16):1716-1718.
Patent Status: U.S. Provisional Application No. 61/425,007 filed 20
Dec 2010 (HHS Reference No. E-243-2010/0-US-01).
Licensing Status: Available for licensing.
Licensing Contact:
Uri Reichman, PhD, MBA; 301-435-4616; [email protected].
Michael Shmilovich, Esq.; 301-435-5019;
[email protected].
Collaborative Research Opportunity: The National Institute of
Biomedical Imaging and Bioengineering is seeking statements of
capability or interest from parties interested in collaborative
research to further develop, evaluate, or commercialize this
technology. Please contact Hari Shroff at [email protected] or 301-
435-1995 for more information.
Versatile Melanoma Antigen Family A3 (MAGE-A3) Specific Human T Cell
Receptors To Treat Cancer That Also Recognize Other MAGE-A Antigen
Superfamily Members
Description of Technology: Current approaches for treating cancer
can also generate harsh side effects in patients and many cancer
patients do not respond to generalized chemotherapy and radiation. New
and improved therapeutic strategies need to be characterized by reduced
side-effects and enhancements in specific anti-tumor activity in
individual patients. Adoptive immunotherapy is a promising new approach
to cancer treatment that engineers an individual's innate and adaptive
immune system to fight against specific diseases, such as cancer.
Scientists are aiming to improve cell transfer therapies by targeting
an increasing collection of tumor antigens with more effective immune
cell cultures.
T cell receptors (TCRs) are specialized proteins that recognize
antigens in the context of infected or transformed cells and activate T
cells to mediate an immune response and destroy abnormal cells. TCRs
consist of a variable domain that recognizes the antigen and a constant
region that anchors the TCR to the membrane and transmits recognition
signals by interacting with other proteins. When a TCR is activated by
recognizing its antigen, such as a tumor antigen, signaling pathways
are triggered in the cell to produce cytokines that mediate the immune
response.
Scientists at the National Institutes of Health (NIH) have
developed T cells genetically engineered to recognize melanoma antigen
family A3 (MAGE-A3) peptide antigens. MAGE-A superfamily antigens,
including MAGE-A3, are expressed primarily by tumor cells from a
variety of cancers. Other than germ cells of the testis, normal cells
do not express MAGE-A3 and other MAGE-A proteins, which makes these
antigens ideal targets for developing cancer immunotherapies. There are
twelve (12) known MAGE-A genes designated A1-A12. The normal function
of MAGE-A3 is not completely known, but in cancerous cells it appears
to mediate fibronectin-controlled tumor growth and spreading. MAGE-A3
is one of the most widely expressed cancer testis antigens (CTAs) on
human tumors and its expression increases as the cancer progresses to
more advanced stages. The T cell receptors (TCRs) developed by these
NIH scientists have specificity for MAGE-A3 and MAGE-A12 and deliver a
robust immune response when they encounter tumor cells expressing these
antigens. These TCRs also recognize MAGE-A2 and/or MAGE-A6, but to a
lesser extent that MAGE-A3 and MAGE-A12. The ability to recognize
antigens from multiple MAGE-A family members could allow these TCRs to
be utilized in the treatment of multiple types of cancer in a wide
array of cancer patients. Infusing cancer patients with MAGE-A3
specific T cells via adoptive immunotherapy could prove to be a
powerful approach for selectively attacking tumors without generating
toxicity against noncancerous cells.
Applications:
Immunotherapeutics to treat and/or prevent the recurrence
of a variety of human cancers, including melanoma, lung cancers, head
and neck cancers, liver cancers, and multiple myeloma, by adoptively
transferring the gene-modified T cells into patients whose tumors
express a MAGE-A family member protein recognized by this TCR.
A drug component of a combination immunotherapy regimen
aimed at targeting specific tumor-associated antigens, including MAGE-
A3, MAGE-A12, and MAGE-A2 and/or MAGE-A6 expressed by cancer cells
within individual patients.
A research tool to investigate signaling pathways in MAGE-
A antigen expressing cancer cells.
An in vitro diagnostic tool to screen for cells expressing
a MAGE-A antigens.
Advantages:
Selective toxicity for tumor cells--MAGE-A3 and other
MAGE-A proteins are only expressed on testis germ cells and tumor
cells. Thus, infused cells expressing an anti-MAGE-A3 TCR should target
MAGE-A3-expressing tumor cells with little or no toxicity to normal
cells. Immunotherapy with these T cells should yield little or no harsh
side effects to patients.
Ability to recognize multiple MAGE-A antigens--Since these
MAGE-A3 directed TCRs can also recognize up to three (3) additional
MAGE-A antigens (MAGE-A12, A2, and A6), cells expressing these TCRs are
expected to be able to fight a larger range of tumor types. During
treatment, if an infused anti-MAGE-A3 T cell culture encounters tumor
cells expressing other recognized MAGE-A antigens, these T cells would
not only
[[Page 10377]]
be capable of eliminating the MAGE-A3 expressing tumor cells, but MAGE-
A12, MAGE-A2, and MAGE-A6 expressing cells as well. This versatility
should allow these TCRs to be utilized to treat a broader range of
cancer patients.
Expression on a majority of tumors --MAGE-A3 is one of the
most highly expressed cancer testis antigens (CTAs) on human tumors.
For example, over half of melanoma tumors and non-small cell lung
cancer cells express MAGE-A3. A large spectrum of cancer patients
should be eligible for treatment with these MAGE-A3 TCRs should they
prove successful in clinical studies.
Development Status: This technology is in an early clinical stage
of development.
Inventors: Richard A. Morgan, et al. (NCI).
Publications:
1. N Chinnasamy et al. A TCR Targeting the HLA-A*0201-Restricted
Epitope of MAGE-A3 Recognizes Multiple Epitopes of the MAGE-A Antigen
Superfamily in Several Types of Cancer. J Immunol. 2011 Jan
15;186(2):685-696. [PubMed: 21149604]
2. V Cesson et al. MAGE-A3 and MAGE-A4 specific CD4(+) T cells in
head and neck cancer patients: Detection of naturally acquired
responses and identification of new epitopes. Cancer Immunol
Immunother. 2010 Sept. 21, E-pub ahead of print, doi: 10.1007/s00262-
010-0916-z. [PubMed: 20857101]
Patent Status: U.S. Provisional Application No. 61/405,668 filed 22
October 2010 (HHS Reference No. E-236-2010/0-US-01).
Related Technologies: T cell receptor technologies developed
against other CTAs: E-304-2006/0 and E-312-2007/1 (anti-NY-ESO-1) and
E-269-2010/0 (anti-SSX-2).
Licensing Status: Available for licensing.
Licensing Contact: Samuel E. Bish, PhD; 301-435-5282;
[email protected].
Collaborative Research Opportunity: The National Cancer Institute
Surgery Branch is seeking statements of capability or interest from
parties interested in collaborative research to further develop,
evaluate, or commercialize the use of anti-MAGE-A T-cell receptors for
the adoptive immunotherapy of cancer. Please contact John Hewes, PhD at
301-435-3121 or [email protected] for more information.
Selective 12-Human Lipoxygenase Inhibitors for the Treatment of
Diabetes and Clotting
Description of Technology: This invention discloses small molecule
inhibitors of human 12-lipoxygenase (12-hLO). 12-lipoxygenase
expression, activation, and lipid metabolites have been implicated in
type 1 and type 2 diabetes, cardiovascular disease, hypertension,
Alzheimer's, and Parkinson's disease. The development of 12-hLO
inhibitors may be a potent intracellular approach to decreasing the
ability of platelets to form large clots in response to vessel injury
or activation of the coagulation pathway. Thus, 12-hLO inhibition has
the potential to attenuate platelet-mediated clot formation caused by
diabetes and/or cardiovascular disease and significantly decrease the
occurrence of myocardial infarction and death. Moreover, Type 1 and
Type 2 diabetes are serious disorders that can lead to major
complications and reduced lifespan. An unmet medical need is to
identify new ways to protect beta cells in these metabolic disorders. A
selective 12-hLO inhibitor could provide a new therapeutic approach to
prevent or treat either form of diabetes.
Applications:
Therapeutic developments (blood clots; Type 1 and Type 2
diabetes, cardiovascular disease, and neurodegenerative diseases)
Inflammatory responses
Advantages:
Small molecule (series of analogs can be derived in search
of improved performances and/or different functions)
Selective inhibitor of human 12-lipoxygenase
Market:
Metabolic disorders
Neurodegeneration
Research tool--screening for 12-lipoxygenase-mediated
responses in various human cell lines
Development Status: Pre-clinical; no animal data.
Inventors: David J Maloney (NHGRI); Ajit Jadhav (NHGRI); Ganesha
Rai (NHGRI); Anton Simeonov (NHGRI); Theodore Holman (University
California Santa Cruz); Jerry Nadler (Eastern Virginia Medical School);
Michael Holinstat (Thomas Jefferson University).
Patent Status: U.S. Provisional Application No. 61/345,708 filled
18 May 2010 (HHS Reference No. E-134-2010/0-US-01).
Licensing Status: Available for licensing.
Licensing Contact: Steven H. Standley, PhD 301-435-4074;
[email protected].
Gene Expressed in Prostate Cancer and Methods of Use
Description of Technology: Prostate cancer is the second leading
cause of cancer-related deaths among males in the United States. There
are approximately two hundred and fifteen thousand (215,000) newly
diagnosed cases of prostate cancer and thirty thousand (30,000)
prostate cancer-related deaths each year, underscoring the importance
of addressing this deadly disease. Although there are diagnostic tests
in place for identifying the potential for developing prostate cancer,
even the most widely accepted diagnostic for detecting cancer
(prostate-specific antigen or PSA) is capable of producing a false
negative result. Furthermore, current treatments are invasive and may
produce deleterious side-effects. Therefore, there is a clear need to
identify and develop new and effective diagnostics and treatments for
prostate cancer.
This technology concerns the identification of a novel protein that
is specifically expressed on prostate tissue: Novel Gene Expressed in
Prostate (NGEP). Because of its selective expression on prostate
tissue, NGEP represents a potential target in the fight against
prostate cancer. Monoclonal antibodies that specifically recognize NGEP
have been developed in conjunction with the identification of the
protein. These antibodies can be used as both diagnostic agents and
therapeutic agents.
Applications:
Antibodies to NGEP can be used as diagnostic agents to
identify metastatic prostate tissue, either alone or in combination
with other diagnostic antibodies
Antibodies to NGEP can also be used therapeutically to
specifically target cytotoxic agents to prostate cancer cells or to
induce antibody-dependent cell-mediated cytotoxicity (ADCC)
Antibodies to NGEP can be used as research reagents for
identifying prostate tissue, including cancerous tissue
Advantages:
The selective expression of NGEP allows the specific
detection and recognition of prostate tissue, which is useful in both
diagnostic and therapeutic applications
Combining the detection of NGEP with other prostate cancer
diagnostic agents may reduce the incidence of a false negative
diagnosis
The use of NGEP antibodies in targeted therapy can
decrease the non-specific killing of non-cancerous cells, thereby
decreasing side-effects
[[Page 10378]]
associated with current prostate cancer therapies
Development Status: Preclinical stage of development.
Inventors: Pastan (NCI) et al.
Patent Status:
US Patent 7,816,087 (E-005-2002/0-US-03)--Issued
US Patent Application 12/193,604 (E-005-2002/0-US-05)--
Allowed
EP Patent Application 02795643.2 (E-005-2002/0-EP-04)--
Pending
For more information, see:
Das et al. ``Topology of NGEP, a prostate-specific
cell:cell junction protein widely expressed in many cancers of
different grade level.'' Cancer Res. 2008 Aug 1; 68(15):6306-12
Das et al. ``NGEP, a prostate-specific plasma membrane
protein that promotes the association of LNCaP cells.'' Cancer Res.
2007 Feb 15; 67(4):1594-601
Bera et al. ``NGEP, a gene encoding a membrane protein
detected only in prostate cancer and normal prostate.'' Proc Natl Acad
Sci U S A. 2004 Mar 2; 101(9):3059-64.
Licensing Status: Available for licensing
Licensing Contact: David A. Lambertson, PhD; 301-435-4632;
[email protected].
Stem Cells That Transform To Beating Cardiomyocytes
Description of Technology: Many people die each year of congestive
heart failure occurring from a variety of causes including
cardiomyopathy, myocardial ischemia, congenital heart disease and
valvular heart disease resulting in cardiac cell death and myocardial
dysfunction. When cardiomyocytes are not replaced in adult myocardial
tissue, physiologic demands on existing, healthy cardiomyocytes can
lead to hypertrophy. Heart transplants have been the only recourse for
patients in end-stage heart disease however this is complicated by lack
of donors, tissue incompatibility and high cost.
An alternative approach to heart transplantation is to generate
cardiomyocytes from stem cells in vitro that can be used in the
treatment of cardiac diseases characterized by myocardial cell death or
dysfunction.
This invention discloses a novel isolated population of stem cells,
called spoc cells, isolated from skeletal muscle, that can be induced,
either in vivo or in vitro, to differentiate into cardiomyocytes. Spoc
cells may be differentiated and utilized for screening agents that
affect cardiomyocytes and as therapeutic agents in the treatment of
cardiac MI.
Potential Applications and Advantages: This invention is an
alternative approach to heart transplantation which is typically
complicated by lack of donors, tissue incompatibility and high cost.
Inventors: Neal D. Epstein (NHLBI), et al.
Related Publication: SO Winitsky, et al. Adult murine skeletal
muscle contains cells that can differentiate into beating
cardiomyocytes in vitro. PLoS Biol. 2005 Apr;3(4):e87, doi:10.1371/
journal.pbio.0030087. [PubMed: 15757365]
Patent Status:
Issued Australian Patent No. 2002337949 (HHS Ref. No. E-
329-2001/0-AU-03)
Issued Japanese Patent No. 4377690 (HHS Ref. No. E-329-
2001/0-JP-04)
Allowed Canadian Patent Appl. No. 2464088 (HHS Ref. No. E-
329-2001/0-CA-05)
Licensing Status: Available for licensing.
Licensing Contact: Fatima Sayyid, M.H.P.M.; 301-435-4521;
[email protected].
Dated: February 16, 2011.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2011-4170 Filed 2-23-11; 8:45 am]
BILLING CODE 4140-01-P