[Federal Register Volume 70, Number 6 (Monday, January 10, 2005)]
[Notices]
[Pages 1726-1728]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-391]


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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

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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.

Methods and Composition for Development of Preclinical Testing of 
Anticancer Therapies Using Transgenic Animals

Lyuba Varticovski (NCI), DHHS Reference No. E-017-2005/0--Research Tool
    Licensing Contact: John Stansberry; 301-435-5236; 
[email protected].
    Mouse models are valuable tools for screening anticancer agents 
during the preclinical stage of drug development. The methods and 
composition described here provide a versatile system for testing drug 
therapies in an in vivo setting. This invention combines a unique 
flexibility for testing therapeutic interventions for tumor prevention, 
progression, and development of metastasis in tumors with specific 
genetically defined backgrounds. Because these tumors can be 
transplanted into immuno-compromised recipients, this invention 
provides an opportunity for testing the role of host immune system, 
angiogenesis and stromal cells in tumor development, progression, and 
metastasis. The tumors that develop in this model system mimic the 
heterogeneity of human disease and genetic instability associated with 
tumor progression and metastasis. The combination of these applications 
makes this method of testing anticancer therapies superior to any 
currently available in vivo preclinical models.

Mabs to IRTA2 for Use in Diagnosis and Therapy of IRTA-Expressing 
Cancers

Ira Pastan (NCI), U.S. Provisional Application No. 60/615,406 filed 30 
Sep 2004 (DHHS Reference No. E-287-2004/0-US-01)
    Licensing Contact: Brenda Hefti; 301-435-4632; [email protected].
    Immunoglobulin superfamily receptor translocation associated 2 
(IRTA2) is a cell surface receptor that is normally expressed in mature 
B cells. ITRA2 expression is deregulated in multiple myeloma and 
Burkitt lymphoma cell lines. The invention discloses monoclonal 
antibodies specific for the extracellular domain of IRTA2 and their use 
in diagnostic and therapeutic applications. The antibodies can detect 
ITRA2 expression on non-Hodgkin's B-cell lymphoma cell lines and can 
detect hairy cell leukemia cells in blood samples taken from patients. 
The antibodies are specific for IRTA2, and can detect formalin-fixed 
antigen and SDS-denatured antigen.
    These antibodies could be used for detailed expression studies of 
IRTA2 in different cancer cells lines. The antibodies could be also be 
used to treat B cell malignancies. In a diagnostic application the 
antibodies could be employed to investigate the presence of a residual 
number of malignant cells following a therapeutic regimen. The IRTA2 
gene is known to produce alternative spliced products that encode 
soluble forms of IRTA2. The antibodies could be used to construct 
immunoassays to detect soluble IRTA2s in patients' sera as a useful 
diagnostic maker for B-cell malignancies.

The UBE2G2 Binding Domain in the Ubiquitin Ligase GP78 and Methods of 
Use Thereof

Allan Weissman et al. (NCI), U.S. Provisional Application No. 60/
583,263 filed 26 Jun 2004 (DHHS Reference No. E-244-2004/0-US-01)
    Licensing Contact: Thomas Clouse; 301-435-4076; 
[email protected].
    Cytosolic and nuclear proteins are targeted for proteosomal 
degradation by the addition of multiubiquitin chains. The specificity 
of this process is largely conferred by ubiquitin protein ligases (E3s) 
that interact with specific ubiquitin conjugating enzymes (E2s). One 
important role for ubiquitylation is in quality control in the 
secretory pathway, targeting proteins for degradation through a set of 
processes known as endoplasmic reticulum (ER) -associated degradation 
(ERAD). ERAD is important in many diseases including cystic fibrosis, 
neurodegenerative disorders, alpha-1 antitrypsin deficiency, tyrosinase 
deficiency and cancer. ERAD is also important in controlling levels of 
cell surface receptors and in regulation crucial enzymes involved in 
cholesterol metabolism. gp78, also known as the autocrine motility 
factor receptor, is an E3 implicated in ERAD. This invention relates to 
the identification of a discrete domain within gp78 that encodes a 
binding site specific for gp78's cognate E2, Ube2g2. Ube2g2 is the most 
widely implicated E2 in ERAD. Expression of the Ube2g2 binding region 
provides a means of blocking ERAD by preventing interactions between 
gp78 and Ube2g2 and has the potential to provide diagnostic and 
therapeutic methods of intervening in modulating ERAD with consequences 
for disease processes and for generating recombinant secreted proteins 
in mammalian cells.

Composition for Detecting the Response of Rectal Adenocarcinomas to 
Radiochemotherapy

Thomas Ried et al. (NCI), U.S. Provisional Application No. 60/535,491 
filed 12 Jan 2004 (DHHS Reference No. E-269-2003/0-US-01)
    Licensing Contact: Thomas Clouse; 301-435-4076; 
[email protected].
    Rectal adenocarcinomas are among the most frequent malignant 
tumors. Surgery, including total mesorectal resection, is the primary 
treatment. Radiation or combined radiochemotherapy can be necessary 
before or after resection of the primary tumor. However, the response 
of individual tumors to radiochemotherapy is not uniform, and patients 
with radiochemotherapy resistant tumors are needlessly exposed to 
radiation, chemotherapy drugs, and the associated side effects thereof. 
The invention discloses the identification of genes and gene products, 
e.g., molecular markers or molecular signatures that are differentially 
expressed in responders and non-responders to radiochemotherapy 
treatment of rectal adenocarcinoma. The detection of differential 
expression levels of these genes can serve as a basis for diagnostic 
assays to predict the response to radiochemotherapy and can be used to 
identify the appropriate agent to be administered to enhance the 
effectiveness of the radiochemotherapy.

Peptide Agonists of Prostate-Specific Antigen and Uses Thereof

Kwong-yok Tsang and Jeffrey Schlom (NCI), U.S. Provisional Application 
No. 60/334,575 filed 30 Nov 2001 (DHHS Reference No. E-123-2001/0-US-
01); PCT Application No. PCT/US02/37805 filed 26 Nov 2003 (DHHS 
Reference No. E-124-2001/1-PCT-01); and subsequent National Stage 
filings in the United States, Europe, Canada, Australia, and Japan
    Licensing Contact: Jeff Walenta; 301-435-4633; 
[email protected].
    Current treatment for prostate cancer involves surgery, radiation, 
chemotherapy, and/or hormonal therapy. In spite of these treatments, 
over 40,000 men die of prostate cancer each year in the United States 
alone. A promising new treatment modality for prostate cancer involves 
harnessing the body's own immune response to eliminate a cancer. 
Traditional and non-traditional vaccine therapies have been shown to 
stimulate an immune response against commonly expressed tumor-
associated antigens. One such common tumor-associated antigen expressed 
on a

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majority of prostate cancer cells is Prostate Specific Antigen (PSA).
    The present invention relates to isolated peptides comprising 
immunogenic peptides derived from PSA. These immunogenic peptides are 
considered agonist epitopes of the wild-type PSA-3 cytotoxic T 
lymphocyte (CTL) epitope: an agonist epitope is modified from the wild 
type epitope and shows greater immune stimulating characteristics. This 
invention claims the physical composition and use of the PSA-3 agonist 
epitopes, including peptide, nucleic acid, pharmaceutical composition, 
and method of treatment. The PSA-3 agonist epitopes would have 
application in a number of traditional and non-traditional vaccine 
delivery systems for the treatment of cancer.
    Some vaccine delivery fields of use for the PSA-3 epitope have been 
exclusively licensed. However, a number of fields are available for 
other traditional and non-traditional vaccine delivery systems. This 
invention has been published in Schlom, et al., ``Identification and 
Characterization of a Human Agonist Cytotoxic T-Lymphocyte Epitope of 
Human Prostate-specific Antigen.'' Clinical Cancer Research, Vol. 8, 
41-53, January 2002.
    In addition to licensing, the technology is available for further 
development through collaborative research with the inventors via a 
Cooperative Research and Development Agreement (CRADA).

    Dated: December 29, 2004.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 05-391 Filed 1-7-05; 8:45 am]
BILLING CODE 4140-01-P