01-6271. Government-Owned Inventions; Availability for Licensing

AGENCY:

National Institutes of Health, Public Health Service, DHHS

ACTION:

Notice.

SUMMARY:

The invention listed below is owned by an agency of the U.S. Government and is 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.

ADDRESSES:

Licensing information and a copy of the U.S. patent application referenced below may be obtained by contacting Richard U. Rodriguez, M.B.A., at the Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852-3804 (telephone [phone] ext 287; fax [phone]; e-mail [e-mail]). A signed Confidential Disclosure Agreement is required to receive a copy of any patent application.

Entitled: “GHEP, A Gene Highly Expressed in Normal and Neoplastic Prostate, and Uses Therefor.”

Inventors: Drs. Ira H. Pastan (NCI), Par Olsson (NCI), Tapan K. Bera (NCI), Magnus Essand (NCI), and Byungkook Lee (NCI).

DHHS Ref. No. E-144-00/0 Filed: October 10, 2000.

Two types of immunotherapy are currently being intensively pursued for the treatment of cancer. One is the development of antibodies that recognize cell surface antigens. These antibodies can be useful by themselves or can be armed with radioisotopes, drugs or toxins to kill cancer cells. The second approach is to develop vaccines that target intracellular proteins presented as peptides on the cell surface bound to the major histocompatability complex. For these therapies to be effective it is important that the antigen is present on tumor cells and is not expressed in substantial amounts on essential normal cells such as liver, heart, brain or kidney. Recent work has focused on the identification of new differentiation antigens that are present in normal prostate and continue to be expressed in prostate cancer.

The claimed invention provides a Gene Highly Expressed in Prostate (“GHEP”). The gene is found in normal and neoplastic prostate, and encodes two short proteins, one 34 amino acids (“ghep34”) in length and one 35 amino acids in length (“ghep35”). Detection of the transcript or of the proteins in tissues other than the prostate is indicative of prostate cancer. The nucleic acids, proteins, and immunogenic fragments thereof can be used to raise an immune response, for example, via a vaccine, to prostate cancer. This approach could involve active in vivo treatments as well as passive ex vivo approaches to slow or inhibit the growth of GHEP-expressing cancers.

The invention further provides methods of detecting the proteins or the gene transcript in a biological sample. If the biological sample is from a tissue other than the prostate, detection of either of the protein or of the gene transcript is indicative of the presence of prostate cancer in the subject from whom the sample was taken. The invention further provides antibodies that specifically recognize ghep34 and antibodies that specifically recognize ghep35, as well as kits for the detection of one or both of the proteins in a sample.

The above mentioned invention is available for licensing on an exclusive or non-exclusive basis.

Dated: March 6, 2001.

Jack Spiegel,

Director, Division of Technology Development & Transfer, Office of Technology Transfer.