05-8967. Prospective Grant of an Exclusive License: Cancer Diagnostic Based on Detecting Expression of Human Brother of Regulator of Imprinted Sites (“BORIS”) and BORIS Antibodies

AGENCY:

National Institutes of Health, Public Health Service, DHHS.

ACTION:

Notice.

SUMMARY:

This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR Part 404.7(a)(1)(i), announces that the Department of Health and Human Services is contemplating the grant of an exclusive license to practice the inventions embodied in U.S. Provisional Patent Application Serial No. 60/611,789, entitled “Method of Detecting Cancer Based On Immune Reaction To BORIS” filed September 21, 2004 (E-241-2004/0-US-01); U.S. Provisional Patent Application Serial No. 60/358,889, entitled “Brother of The Regulator of Imprinted Sites (BORIS)” filed February 22, 2001 (E-227-2001/0-US-01); PCT Application No. PCT/US03/05186, entitled “Brother of The Regulator of Imprinted Sites (BORIS)” filed February 21, 2003 (E-227-2001/0-PCT-02); and U.S. Patent Application Serial No. 10/505,377, entitled “Brother of The Regulator of Imprinted Sites (BORIS)” filed August 19, 2004 (E-227-2001/-0-US-03), to NewLink Genetics Corporation, having a place of business in Ames, Iowa.

The prospective exclusive territory may be United States, Canada, Europe and Japan, and the field of use may be limited to manufacture and sale of Analyte Specific Reagents or FDA-approved in vitro diagnostics for cancer and cancer predisposition.

DATES:

Only written comments and/or license applications which are received by the National Institutes of Health on or before July 5, 2005 will be considered.

ADDRESSES:

Requests for copies of the patent and/or patent applications, inquiries, comments and other materials relating to the contemplated exclusive license should be directed to: Mojdeh Bahar, J.D., Technology Licensing Specialist, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804. Telephone: [phone]; Facsimile: [phone]; E-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

The above-mentioned patent applications describe the human protein Brother of Regulator of Imprinted Sites (“BORIS”), and a method of detecting cancer by monitoring BORIS expression or by detecting anti-BORIS antibodies. Dr. Victor V. Lobanenkov and colleagues at the National Institute of Allergy and Infectious Diseases discovered BORIS and its potential application as a cancer diagnostic. BORIS is a paralog of CCCTC-binding factor (“CTCF”), a transcription factor that also functions in chromatin insulation. The amino acid sequences of BORIS and CTCF contain eleven conserved zinc fingers each of which binds to DNA. BORIS protein can be detected in cancer cells, and importantly, it is one of a few cancer-testis antigens that are immunogenic in humans.

BORIS resides in 20q13.2, a region that is commonly amplified in many human cancers. Normally, BORIS mRNA can be detected in testis, but not in other human tissues. However, BORIS mRNA is detectable in over one hundred cancer cell lines representing most of the major forms of human tumors and is also detectable in primary breast cancer tumor samples, but not in controls. BORIS protein is mis-expressed in cancer cell lines, and antibodies against BORIS have been detected in serum from patients with gliomas, lung, breast, or prostate cancers but not in serum from controls.

The correlation between cancer and BORIS expression indicates that detection of aberrantly expressed BORIS and/or anti-BORIS antibodies could serve as a method of screening or diagnosing cancer. In patients already known to have cancer, expression of BORIS could be monitored to measure a patient's response to a particular therapeutic regimen.

The prospective exclusive license will be royalty-bearing and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7. The prospective exclusive license may be granted unless within sixty (60) days from the date of this published notice, the NIH receives written evidence and argument that establish that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR 404.7.

Applications for a license in the field of use filed in response to this notice will be treated as objections to the grant of the contemplated exclusive license. Comments and objections submitted to this notice will not be made available for public inspection and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552.

Dated: April 27, 2005.

Steven M. Ferguson,

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