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Government-Owned Inventions; Availability for Licensing

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AGENCY:

National Institutes of Health, Public Health Service, HHS.

ACTION:

Notice.

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 Start Printed Page 1727Boulevard, 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; stansbej@mail.nih.gov.

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; heftib@mail.nih.gov.

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; clouset@mail.nih.gov.

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; clouset@mail.nih.gov.

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; walentaj@mail.nih.gov.

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 Start Printed Page 1728majority 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).

Start Signature

Dated: December 29, 2004.

Steven M. Ferguson,

Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health.

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[FR Doc. 05-391 Filed 1-7-05; 8:45 am]

BILLING CODE 4140-01-P