[Federal Register Volume 77, Number 62 (Friday, March 30, 2012)]
[Notices]
[Pages 19299-19300]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-7709]
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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.
MUC-1 Tumor Antigen Agonist Epitopes for Enhancing T-cell Responses to
Human Tumors
Description of Technology: The MUC-1 tumor associated antigen has
been shown to be overexpressed and/or underglycosylated in a wide range
of human cancers. The C-terminus region of MUC-1 (MUC-1C) has been
shown to be an oncogene and has been associated with a more aggressive
phenotype in several different cancers.
Scientists at NIH have identified 7 new agonist epitopes of the
MUC-1 tumor associated antigen. Compared to their native epitope
counterparts, peptides reflecting these agonist epitopes have been
shown to enhance the generation of human tumor cells, which in turn
have a greater ability to kill human tumor cells endogenously
expressing the native MUC-1 epitope. The agonist epitopes span both the
VNTR region of MUC-1 and the C-terminus region. The epitopes encompass
2 major MHC alleles reflecting the majority of the population.
Along with the method of use, the technology encompasses the use of
these agonist epitopes in peptide- and protein-based vaccines, with
dendritic cells or other antigen presenting cells, or encoding
sequences in DNA, viral, bacterial, yeast, or other types of vectors,
or to stimulate T-cells in vitro for adoptive immunotherapy protocols.
Potential Commercial Applications:
As a therapeutic vaccine to enhance patient's immune
responses to a range of human cancers
As a preventive vaccine for patients with preneoplastic
conditions or a high risk of developing cancer
As a preventive vaccine for cancers
For in vitro stimulation of lymphocytes for adoptive
transfer protocols for cancer
Competitive Advantages:
The agonist epitopes have been shown to be much more
potent than their natural counterparts in activating human T-cells to
MUC-1.
Compared to T-cells activated with the corresponding
native epitopes, the T-cells activated by the agonist epitopes lyse
tumor cells to a greater extent.
The technology can be used in a wide range of cancer
vaccine platforms and in adoptive immunotherapy protocols.
The technology can be combined with existing vaccine
platforms including those currently showing patient benefit, as well as
with other therapeutic modalities.
Development Stage:
Pre-clinical
In vitro data available
Inventors: Jeffrey Schlom and Kwong-Yok Tsang (NCI).
Intellectual Property: HHS Reference No. E-001-2012/0--U.S. Patent
Application No. 61/582,723 filed 03 Jan 2012.
Related Technologies:
HHS Reference No. E-154-1998/0 --PCT Application No. PCT/
US98/03693
HHS Reference No. E-321-2003/0 --PCT Application No. PCT/
US2004/41921
Licensing Contact: Sabarni Chatterjee, Ph.D., MBA; 301-435-5587;
[email protected].
Collaborative Research Opportunity: The Laboratory of Tumor
Immunology and Biology, National Cancer Institute, is seeking
statements of capability or interest from parties interested in
collaborative research to further develop, evaluate or commercialize
the use of MUC-1 tumor antigen agonist epitopes for the treatment or
prevention of cancer. For collaboration opportunities, please contact
John Hewes, Ph.D. at [email protected].
Novel Diagnostic, Prognostic and Therapeutic Biomarker for
Hepatocellular Carcinoma
Description of Technology: Scientists at the National Cancer
Institute have discovered that Stearol-CoA desaturase-1 (SCD-1) is
associated with hepatocellular carcinoma (HCC). Utilizing a microarray
to analyze HCC patient samples, the investigators found SCD-1 is
elevated in liver tumor tissues and it is a marker for a highly
aggressive form of HCC, hepatic stem cell-like HCC subtype (HpSC HCC),
which retains stem-cell features capable of cellular plasticity and
cell motility. The investigators found SCD-1 is significantly elevated
in HpSC tumors in comparison to less aggressive HCC tumors and it is
associated with poor patient survival. In vitro studies demonstrate
SCD-1 inhibition and/or addition of saturated palmitic acid reduces
HpSC HCC characteristics. In addition to diagnostic, prognostic, and
treatment applications, this technology
[[Page 19300]]
may enable clinicians to effectively stratify patients for more
aggressive cancer treatment and prioritize candidates for liver
transplantation.
Potential Commercial Applications:
Method to diagnose HCC
Method to prognose patient survival
Method to stratify HCC for appropriate treatment
Method to treat HCC
Competitive Advantages:
Retrospective studies performed on human samples
Modulation of SCD-1 reduces HpSC HCC characteristics
Development Stage:
Early-stage
In vitro data available
In vivo data available (human)
Inventors: Anuradha Budhu and Xin W. Wang (NCI).
Intellectual Property: HHS Reference No. E-205-2011/0--U.S.
Provisional Application No. 61/533,392 filed 12 Sep 2011.
Related Technology: HHS Reference No. E-139-2010/0--PCT Application
No. PCT/US2011/032285 filed 13 Apr 2011.
Licensing Contact: Jennifer Wong; 301-435-4633;
[email protected].
Collaborative Research Opportunity: The National Cancer Institute
is seeking statements of capability or interest from parties interested
in collaborative research to further develop, evaluate or commercialize
biomarkers for liver cancer. For collaboration opportunities, please
contact John Hewes, Ph.D. at [email protected].
Potential Use of Anti-IgE in the Treatment of Lupus Nephritis
Description of Technology: Systemic lupus erythematosus (SLE) is a
multi-organ inflammatory disease characterized by a significant
morbidity and mortality related to both disease evolution as well as
therapeutic side effects. At least half of SLE patients develop lupus
nephritis.
The inventors have used a Lyn -/- mouse model that develops an
autoimmune disease exhibiting some features of human SLE. Using this
model the inventors identified basophils and self-reactive IgEs as
important components in the development of autoantibody-mediated kidney
disease. The inventors found that depletion of basophils or the absence
of IgE causes a considerable reduction in autoantibody production and
preserves kidney function in the Lyn -/- mice. The inventors' work
demonstrates that IgE immune complexes can activate basophils and that
removal of self-reactive IgEs that form functional circulating immune
complexes prevents kidney disease. Further, the inventors have shown
that basophils are contributors to the production of the self-reactive
antibodies that cause lupus-like nephritis in the Lyn -/- mice.
Accordingly, reducing circulating IgE levels or reducing basophil
activation may be of therapeutic benefit.
Potential Commercial Applications: Further research and development
of therapeutic approach to treat lupus nephritis.
Competitive Advantages: Current treatment of lupus has not advanced
for many years. This finding is of importance for its potential in
advancing treatment of the disease.
Development Stage:
Early-stage
Pre-clinical
Inventors: Juan Rivera and Nicolas Charles (NIAMS).
Publications:
1. Charles N, et al. Basophils and the T helper 2 environment can
promote the development of lupus nephritis. Nat Med. 2010
Jun;16(6):701-707. [PMID 20512127].
2. Brightbill HD, et al. Antibodies specific for a segment of human
membrane IgE deplete IgE-producing B cells in humanized mice. J Clin
Invest. 2010 Jun;120(6):2218-2229. [PMID 20458139].
3. Mack M, et al. Basophils and mast cells in renal injury. Kidney
Int. 2009 Dec;76(11):1142-1147. [PMID 19692999].
4. Busse W, et al. Omalizumab, anti-IgE recombinant humanized
monoclonal antibody for the treatment of severe allergic asthma. J
Allergy Clin Immunol. 2001 Aug;108(2):184-90. [PMID: 11496232].
Intellectual Property: HHS Reference No. E-216-2010/0--PCT
Application No. PCT/US2010/058077 filed 24 Nov 2010.
Licensing Contact: Jaime M. Greene; 301-435-5559;
[email protected].
Collaborative Research Opportunity: The National Institute of
Arthritis and Musculoskeletal and Skin Diseases is seeking statements
of capability or interest from parties interested in collaborative
research to further develop, evaluate or commercialize the technology
for the use of anti-IgE in the treatment of Lupus Nephritis. For
collaboration opportunities, please contact Cecilia Pazman at
[email protected].
Dated: March 27, 2012.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2012-7709 Filed 3-29-12; 8:45 am]
BILLING CODE 4140-01-P