[Federal Register Volume 77, Number 117 (Monday, June 18, 2012)]
[Notices]
[Pages 36282-36284]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-14703]
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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.
FOR FURTHER INFORMATION CONTACT: Licensing information and copies of
the U.S. patent applications listed below may be obtained by writing to
the indicated licensing contact at the Office of Technology Transfer,
National Institutes of Health, 6011 Executive Boulevard, Suite 325,
Rockville, Maryland 20852-3804; telephone: 301-496-7057; fax: 301-402-
0220. A signed Confidential Disclosure Agreement will be required to
receive copies of the patent applications.
Endothelial Cell Line To Study Prevention of Atherosclerosis
Description of Technology: Atherosclerosis underlies most cases of
cardiovascular disease (CVD), which is now the major cause of morbidity
and mortality in developed countries. An inflammatory reaction is an
essential component in the appearance and development of an
atherosclerotic lesion. The inflammatory process is associated with the
expression of adhesion molecules such as vascular cell adhesion
molecule (VCAM) at the surface of endothelial cells. Antiatherogenic
lipoprotein, high density lipoprotein (HDL), is known to down regulate
the expression of VCAM. Increasing levels of HDL is a promising way to
reduce the risk of CVD.
This technology is directed to the generation of a stable
endothelial cell line expressing a luciferase reporter construct driven
by the VCAM promoter. This reporter system enables an easier
measurement of VCAM expression and determination of the effect of HDL
on endothelial cell inflammation. This technology can be used to screen
for the effect of drugs that modulate HDL metabolism and it is more
convenient than doing Western blots.
Potential Commercial Applications:
Study of prevention of atherosclerosis
Screen serum for the effect of HDL on endothelial cell
inflammation
Screen for the effect of drugs that modulate HDL
metabolism
Competitive Advantages:
Easy monitoring of down regulation of VCAM with luciferase
More convenient than doing Western blots
Development Stage: In vitro data available.
Inventor: Alan T. Remaley (NHLBI).
Publication: D'Souza W, et al. Structure/function relationships of
apolipoprotein a-I mimetic peptides: Implications for antiatherogenic
activities of high-density lipoprotein. Circ Res. 2010 Jul
23;107(2):217-27. [PMID 20508181].
Intellectual Property: HHS Reference No. E-149-2012/0--Research
Tool. Patent protection is not being pursued for this technology.
Licensing Contact: Fatima Sayyid, M.H.P.M.; 301-435-4521;
[email protected].
Collaborative Research Opportunity: The Cardiovascular & Pulmonary
Branch, NHLBI/NIH, is seeking statements of capability or interest from
parties interested in collaborative research to further develop,
evaluate or commercialize endothelial cells to study prevention of
atherosclerosis. For collaboration opportunities, please contact Dr.
Alan Remaley at [email protected].
Software for Modeling Tumor Delivery and Penetration of Antibody-Toxin
Anti-Cancer Conjugates
Description of Technology: Available for licensing is software for
modeling permeability and concentration of intravenously administered
antibody anti-cancer agent conjugates in solid tumor. The models can be
used to determine optimal dosing regimen of a therapeutic in a
particular cancer type. Thirty factors that affect delivery rates and
efficiencies are analyzed as variables in generating the models.
Potential Commercial Applications:
Drug Design
Combination Therapy
Personalized Medicine
Competitive Advantages:
Accurate permeability modeling of anti-cancer therapeutics
Personalized Medicine
Development Stage:
Early-stage
Pre-clinical
Inventors: Byungkook Lee (NCI), Youngshang Pak (EM), Ira Pastan
(NCI).
Publications:
1. Fujimori K, et al. A modeling analysis of monoclonal antibody
percolation through tumors: a binding-site barrier. J Nucl Med. 1990
Jul;31(7):1191-1198. [PMID 2362198]
2. Jain RK. Delivery of molecular and cellular medicine to solid
tumors. Adv Drug Deliv Rev. 2001 Mar 1;46(1-3):149-168. [PMID 11259838]
3. Thurber GM, et al. Antibody tumor penetration: transport opposed by
systemic and antigen-mediated clearance. Adv Drug Deliv Rev. 2008
Sep;60(12):1421-1434. [PMID 18541331]
4. Li Y, et al. Delivery of nanomedicines to extracellular and
intracellular compartments of a solid tumor. Adv Drug Deliv Rev. 2012
Jan;64(1):29-39. [PMID 21569804]
5. http://www.accelereyes.com/examples/drug_delivery_model
6. Pak Y, et al. Antigen shedding may improve efficiencies for delivery
of antibody-based anticancer agents in solid tumors. Can Res. 2012 May
4; Epub ahead of print, doi: 10.1158/0008-5472.CAN-11-3925. [PMID
22562466]
Intellectual Property: HHS Reference No. E-060-2012/0--Software.
Patent protection is not being pursued for this technology.
Licensing Contact: Michael Shmilovich; 301-435-5019;
[email protected].
Collaborative Research Opportunity: The NCI, CCR, Laboratory of
Molecular Biology is seeking statements of capability or interest from
parties interested in collaborative research to further develop,
evaluate or commercialize targeted delivery of anti-cancer agents in
solid tumors. For collaboration opportunities, please contact John
Hewes, Ph.D. at [email protected].
Mouse Model of STAT5 for the Drug Screen and the Research of Cancer and
Autoimmunity
Description of Technology: The invention is a STAT5 mutant mouse
that can be used in research related to cancer, autoimmunity and
infectious diseases as well as drug screening. The mouse model itself
has multiple immunological defects resulting in formation of STAT5
dimers but not tetramers.
[[Page 36283]]
It reports that only a minority of IL-2-modulated genes is
regulated by STAT5 tetramers. Therefore, selectively targeting tetramer
formation might be a relatively specific therapeutic tool wherein one
could modulate only part of the actions of a cytokine or growth factor,
which allows a new therapeutic approach to modulating immune responses,
controlling inflammation, and inhibiting tumor growth.
The STAT5 tetramer deficient mouse is an ideal tool to screen for
tetramerization inhibitors that can be used for the treatment of
cancer, autoimmunity and inflammation in addition to the basic research
applications.
Potential Commercial Applications:
To design and screen tetramerization inhibitors that are
potential new drugs for cancer, autoimmunity and transplantation.
To identify and study a key subset of STAT5A and/or
STAT5B-dependent genes without affecting viability is extremely.
To seek a new therapeutic approach to modulating immune
responses, controlling inflammation, and inhibiting tumor growth.
Competitive Advantages:
The tetramer-deficient mice of this invention are viable
while mice completely lacking expression of Stat5a and Stat5b exhibit
perinatal lethality.
A model for basic research, to study the cancer,
autoimmunity, and infectious diseases associated with STAT5 signaling.
Inventors: Warren J. Leonard and Jian-Xin Lin (NHLBI)
Publication: Lin JX, et al. Critical role of STAT5 transcription
factor tetramerization for cytokine responses and normal immune
function. Immunity. 2012 Apr 20;36(4):586-99. [PMID 22520852]
Intellectual Property: HHS Reference No. E-080-2011/0--Research
Tool. Patent protection is not being pursued for this technology.
Licensing Contact: Susan Ano, Ph.D.; 301-435-5515;
[email protected].
Fast Acting Molecular Probes for Real-Time In Vivo Study of Disease and
Therapeutics
Description of Technology: This technology is for fast acting
molecular probes made from a fluorescent quencher molecule, a
fluorophore, an enzyme cleavable oligopeptide (for example targeted by
protease) and FDA-approved polyethylene glycol (PEG) as well as
associated methods to identify cell activity with these probes.
Proteases regulate many cell processes such as inflammation as well as
pathological processes in cancer and cardiovascular disease. High
protease activity is associated with metastatic cancers. Proteases are
also active in apoptosis, and tissue remodeling in cardiovascular
disease. Although highly useful in vitro, conventional probes are
unstable, nonspecific or slow activating in vivo. This new probe is
faster than standard probes (30 min vs. 24 hrs) and has enhanced
target-to background ratios. It enables quick screening of animals in
an array of applications related to protease-associated diseases and
other diseases. It may detect specific biological targets and monitor
in vivo therapeutic efficacy in real time. Most drug candidates
identified by in vitro screening fail in vivo. Failures are costly.
Identifying in vivo drug efficacy sooner would reduce waste and
increase successful drug development.
Potential Commercial Applications:
Diagnostics
In vivo therapeutic monitoring
Competitive Advantages:
Faster than standard probes
Enhanced target-to-background ratios
Allows in vivo therapeutic efficacy study in real time
Development Stage:
Early-stage
Pre-clinical
In vivo data available (animal)
Inventors: Xiaoyuan (Shawn) Chen, Seulki Lee, Lei Zhu (all of
NIBIB)
Publications:
1. Lee S, et al. Polymeric nanoparticle-based activatable near-infrared
nanosensor for protease determination in vivo. Nano Lett.
2009;9(12):4412-6. [PMID 19842672]
2. Lee S, et al. Activatable molecular probes for cancer imaging. Curr
Top Med Chem. 2010;10(11):1135-44. [PMID 20388112]
Intellectual Property: HHS Reference No. E-079-2011/0--U.S.
Provisional Application No. 61/533,014 filed 09 Sep 2011
Licensing Contact: Tedd Fenn; 301-435-5031; [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 fast acting
molecular probes for real-time in vivo study of disease and
therapeutics. For collaboration opportunities, please contact Cecilia
Pazman at [email protected].
New Ammunition to Fight Cancer: The Rapid Isolation of Central Memory T
Cells for Adoptive Immunotherapy
Description of Technology: This technology is a new technique to
rapidly isolate tumor-reactive central memory T cells in a highly
enriched, non-invasive manner from the peripheral blood of cancer
patients for cancer adoptive cell immunotherapy. Cells are drawn from a
patient's blood, divided into subsets, and contacted with the tumor
antigen of interest to identify T cells whose T cell receptor (TCR)
recognizes the tumor antigen. Such T cells are identified by measuring
the levels of interleukin-2 (IL-2) and interferon-gamma (IFN-gamma)
produced by the cells (i.e., the IL-2 index) using high-throughput
quantitative PCR (HT-qPCR). NIH scientists have identified that cells
with a specific IL-2 index consistently contain central memory T cells
for the tumor antigen of interest.
Preclinical animal studies have suggested that central memory T
cells can proliferate, persist, and survive better after adoptive
transfer compared to other T cell types. They also show increased anti-
cancer activity. Clinical trials using central memory T cells represent
an important extension of these studies. Adoptive immunotherapy is
showing promise as a cancer treatment, but one drawback to this method,
prior to this invention, was the laborious and time consuming nature of
the cell isolation process and the unpredictable and sometimes
ineffective nature of the cells infused into patients.
Potential Commercial Applications:
An improved adoptive immunotherapy approach to treat and/
or prevent the recurrence of a variety of human cancers, infectious
diseases, and autoimmune diseases by identifying central memory T cells
to better fight these diseases.
A valuable component to a combination therapy to treat
diseases where improving immune response quality is critical, such as
introducing central memory T cells into a vaccine regimen for longer
term immune responses or to treat malignancies that thrive by
circumventing the patient's immune system.
Competitive Advantages:
Eliminate the need for invasive surgery to eliminate
tumors.
Isolate better cell cultures for adoptive immunotherapy
than previously available.
Predict and isolate central memory T cell populations
consistently using the IL-2 index.
[[Page 36284]]
Expands the number of patients where adoptive
immunotherapy can become a cancer treatment option.
Sensitive, efficient, and rapid approach to identify and
isolate Central Memory T cells for various therapeutic applications.
Development Stage:
Early-stage
Pre-clinical
Clinical
In vitro data available
In vivo data available (human)
Inventor: Udai S. Kammula (NCI)
Publication: Kammula US, Serrano OK. Use of high throughput qPCR
screening to rapidly clone low frequency tumour specific T-cells from
peripheral blood for adoptive immunotherapy. J Transl Med. 2008 Oct
20;6:60. [PMID 18937837]
Intellectual Property: HHS Reference No. E-228-2010/0--
U.S. Provisional Patent Application No. 61/374,699 filed
18 Aug 2010
PCT Patent Application No. PCT/US2011/047719 filed 15 Aug
2011
Related Technology: HHS Reference No. E-003-2000/0--
U.S. Patent Application No. 12/866,919 filed 10 Aug 2010
Foreign counterparts in Europe and Australia
Licensing Contact: Samuel E. Bish, Ph.D.; 301-435-5282;
[email protected].
Collaborative Research Opportunity: The Center for Cancer Research,
Surgery Branch, is seeking statements of capability or interest from
parties interested in collaborative research to further develop,
evaluate or commercialize this novel technology. For collaboration
opportunities, please contact John Hewes, Ph.D. at [email protected].
A3 Adenosine Receptor Agonists To Treat Chemotherapy-Induced
Peripheral Neuropathy
Description of Technology: This invention claims species-
independent agonists of A3AR, specifically (N)-methanocarba
adenine nucleosides and related pharmaceutical compositions. The
A3 adenosine receptor (A3AR) subtype has been
linked with helping protect the heart from ischemia, controlling
inflammation, and regulating cell proliferation. Agonists of the human
A3AR subtype have been developed that are also selective for
the mouse A3AR while retaining selectivity for the human
receptor. This solves a problem for clinical development because animal
model testing is important for pre-clinical validation of drug
function. Novel agonists have been made that exhibit as much as 6000x
selectivity for A3 versus A1 in humans while
retaining at least 400x selectivity for A3 versus
A1 in mice. In addition, the molecules of the invention
exhibit very low nanomolar affinity. This innovation will not only
facilitate moving A3 agonists into the clinical phase of
drug development by being more amenable to animal studies, but also
provide much greater selectivity in humans, and thereby potentially
fewer side effects than drugs currently undergoing clinical trials.
Potential Commercial Applications:
Cardiac arrhythmias or ischemia
Inflammation
Stroke
Diabetes
Asthma
Cancer
Pain
Competitive Advantages: Oral dosing as these A3AR
agonists are selective and not associated with cardiac or hemodynamic
effects that may result from stimulation of A1 or
A2A receptors.
Development Stage:
Early-stage
In vivo data available (animal)
Inventors: Kenneth Jacobson and Dilip K. Tosh (NIDDK)
Publications:
1. Tosh DK, et al. Structure-guided design of A(3) adenosine receptor
selective nucleosides: combination of 2-arylethynyl and
bicyclo[3.1.0]hexane substitutions. J Med Chem. 2012 May 16; Epub ahead
of print. [PMID 22559880]
2. Chen Z, et al. Controlling murine and rat chronic pain through A3
adenosine receptor activation. FASEB J. 2012 May;26(5):1855-65. [PMID
22345405]
Intellectual Property: HHS Reference No. E-140-2008/1--US Patent
Application No. 13/371,081 filed 10 Feb 2012
Related Technologies:
HHS Reference No. E-140-2008/0--US Patent Application No.
12/935,461 filed 01 Nov 2010
HHS Reference No. E-285-2008/0--US Patent Application No.
13/056,997 filed 18 Mar 2011
HHS Reference No. E-075-2012/0
Licensing Contact: Betty B. Tong, Ph.D.; 301-594-6565;
[email protected].
Collaborative Research Opportunity: The National Institute of
Diabetes and Digestive and Kidney Diseases 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 [email protected].
Use of CD97 Alpha Subunit Antibodies for Treatment of Angiogenesis,
Atherosclerosis, and Inflammation
Description of Technology: CD97 is a T-cell glycoprotein that is
upregulated in activated T-cells and is involved in the onset and
maintenance of inflammation and angiogenesis. It is a seven-span
transmembrane heterodimer consisting of one variant alpha subunit,
which is soluble, and one invariant beta subunit, which is membrane-
bound. Upon activation of T-cells, expression of the alpha subunit is
dramatically upregulated and it is shed into the extracellular medium.
The inventors have demonstrated in in vitro and in vivo studies that
CD97 plays an important role in angiogenesis, inflammation, and
atherosclerosis.
This technology describes isolated soluble CD97 alpha subunit
proteins, selected from three alternatively spliced isoforms, as well
as antibodies that bind to these subunits. The technology also
describes methods of inhibiting angiogenesis, CD97-associated chronic
inflammation, and atherosclerosis in mammals.
Potential Commercial Applications: This technology may be useful
for the treatment of angiogenesis-related diseases, as well as
inflammation and atherosclerosis. It can also be utilized in studies of
inflammation and angiogenesis.
Competitive Advantages: CD97 represents a novel target for
treatment of angiogenesis- and inflammation-mediated diseases.
Development Stage:
Early-stage
In vitro data available
In vivo data available (animal)
Inventor: Kathleen Kelly (NCI)
Publication: Gray J, et al. CD97 is a processed, seven-
transmembrane, heterodimeric receptor associated with inflammation. J
Immunol.1996 Dec 15;157(12):5438-47. [PMID 8955192]
Intellectual Property: HHS Reference No. E-009-1996/0--
US Patent No. 6,365,712 issued 02 Apr 2002
US Patent No. 6,846,911 issued 25 Jan 2005
Licensing Contact: Tara L. Kirby, Ph.D.; 301-435-4426;
[email protected].
Dated: June 12, 2012.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2012-14703 Filed 6-15-12; 8:45 am]
BILLING CODE 4140-01-P