05-2394. Government-Owned Inventions; Availability for Licensing

AGENCY:

National Institutes of Health, Public Health Service, DHHS.

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 Boulevard, Suite 325, Rockville, Maryland 20852-3804; telephone: [phone]; fax: [phone]. A signed Confidential Disclosure Agreement will be required to receive copies of the patent applications.

Methods for Prophylaxis and Treatment of HER-2/neu Tumors

John C Morris, Jay A. Berzofsky, Yoshio Sakai, Jong-Myun Park, Masake Terabe (all of NCI).

Serial Nos. PCT/US2003/034362 filed 29 Oct 2003 (DHHS Reference No. E-025-2003/1-PCT-1) and 60/422,395 filed 30 Oct 2002 (DHHS Reference No. E-025-2003/0-US-01).

Licensing Contact: Susan S. Rucker; [phone]; [e-mail].

This application relates to methods for cancer prophylaxis and treatment. More particularly, the application relates to methods for the treatment and prophylaxis of cancers caused by the activity of the HER-2/neu/erbB-2 gene employing immunotherapy. Such cancers include breast cancers, cancers of the female genital tract and some cancers of the gastrointestinal tract.

The methods claimed involve the use of a HER-2/neu vaccine employing recombinant non-replicating adenovirus expressing a HER-2/neu/erbB-2 gene. In a preferred embodiment the vaccine comprises a recombinant non-replicating adenoviral vector encoding a HER-2/neu/erbB-2 gene that is expressed as a truncated HER-2/neu/erbB-2 protein. Antigen presenting cells, such as dendritic cells infected with the recombinant adenoviral vector, process and present the truncated HER-2/neu/erbB-2 protein, thereby stimulating an immune response. Preferred HER-2/neu/erbB-2 proteins contain regions of the extracellular domain and the transmembrane domain of the intact HER-2/neu/erbB-2 gene product and do not contain any tyrosine kinase domains.

This work has been published in part in Sakai, Y, et al. Cancer Research 64(21): 8022 (Nov 1 2004) and as WO 2004/041065 (May 21 2004).

Antibodies and Polypeptides to AAMP-1 for Use in Diagnosis and Therapy of AAMP-1-Expressing Cancers

Lance Liotta et al. (NCI).

U.S. Patent No. 6,274,134 issued 14 Aug 2001 (DHHS Reference No. E-084-1991/1-US-01); Australian Patent No. 684806 issued 23 Apr 1998 (DHHS Reference No. E-084-1991/1-AU-05).

Licensing Contact: Thomas Clouse; [phone]; [e-mail].

Angio-associated migratory cell protein (AAMP-1) was first isolated from a human melanoma cell line as a motility-associated cell protein. AAMP-1 contains two immunoglobin domains, six WD40 repeats, and a heparin-binding domain. In vitro, over expression of AAMP-1 promotes tumor cell invasion and metastasis as well as angiogenesis. AAMP-1 was later found to be over expressed in endothelial cells, cytotrophoblasts, and poorly differentiated colon adenocarcinoma cells found in lymphatics. In addition, gene expression studies have shown that AAMP-1 is over expressed in breast and gastrointestinal tumors.

The issued patents claim proteins, polypeptides, and recombinant polyclonal antibodies specific to AAMP-1 and their use in diagnostic and therapeutic applications. The antibodies are specific and can detect formalin-fixed antigen and SDS-denatured antigen.

These antibodies can be used for detailed expression studies of AAMP-1 in different cancer cell lines. The antibodies could also be used to promote cell adhesion to a substrate, promote tissue acceptance of prostheses, and promote wound healing. The antibodies could also be used to detect AAMP-1 in patient's sera as a useful diagnostic marker for multiple carcinomas including high nuclear grade ductal carcinoma in situ (Clinical Cancer Research Dec 2002 8:3788-95).

Dated: January 31, 2005.

Steven M. Ferguson,

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