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[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
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