[Federal Register Volume 65, Number 233 (Monday, December 4, 2000)]
[Notices]
[Pages 75724-75725]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-30716]


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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, DHHS.

ACTION: Notice.

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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 J. R. Dixon, 
Ph.D., at the Office of Technology Transfer, National Institutes of 
Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852-
3804 (telephone 301/496-7056 ext 206; fax 301/402-0220; e-mail: 
[email protected]). A signed Confidential Disclosure Agreement is required 
to receive a copy of any patent application.
    Entitled: ``Discovery of Gene Expressed in Many Cancers and Only 
Normal Testis''
    Inventors: Drs. Ira H. Pastan (NCI), Xiu F. Liu (NCI), Byungkook 
Lee (NCI) and Lee J. Helman (NCI).
    DHHS Ref. No. E-161-00/0 Filed: September 1, 2000.
    Large numbers of expressed sequence tags (EST's) have been cloned 
from various normal and cancer tissues. Cancer-testis antigens are a 
distinct class of differentiation antigens that have a restricted 
pattern of expression in normal tissues. These genes are primarily 
expressed in the primitive germ cells, spermatogonia, in the normal 
testis. Malignant transformation is often associated with activation or 
derepression of silent Cancer-testis genes, and this results in the 
expression of Cancer-testis antigen in a variable proportion of a wide 
range of human tumors. Three related genes, termed XAGEs, were recently 
identified by homology walking using the dbEST database.
    The XAGE-1 gene is a human X-linked gene that is strongly expressed 
in

[[Page 75725]]

normal testis, Ewing's sarcoma, alveolar rhabdomyosarcoma, as well as 
breast cancer and other cancers (e.g., lung carcinoma, prostate 
adenocarcinoma, ovarian carcinoma, pancreatic adenocarcinoma, 
glioblastoma, etc.). The largest open reading frame of the XAGE-1 
transcript encodes a putative protein of 16.3 kD (p16) with a potential 
transmembrane domain at the amino terminus. In addition, the XAGE-1 
transcript contains a second ATG in the reading frame corresponding to 
residue 66, which would encode a 9 kD protein (p9). In vitro 
transfection experiments using 293T cells have revealed a 9 kD protein. 
However, the size of the protein expressed endogenously is not yet 
known. XAGE-1 shares homology with GAGE/PAGE proteins in the C-terminal 
end.
    The invention relates to the fact that the XAGE-1 gene is expressed 
in a number of human cancers, specifically: prostate, pancreatic, and 
ovarian cancers, as well as a large percentage of breast and lung 
tumors. The protein p9 and p16, immunogenic fragments thereof, analogs 
of these proteins, and nucleic acids encoding these proteins, 
fragments, or analogs, can be administered to persons with XAGE-1 
expressing cancers to raise or augment an immune response to the 
cancer. The invention further provides nucleic acid sequences encoding 
the protein, as well as expression vectors, host cells, and antibodies 
to the proteins. Further, the invention provides immunoconjugates that 
comprise an antibody to p16 or to p9, and an effector molecule, such as 
a label, a radioisotope, or a toxin. The invention also provides 
methods of inhibiting the growth of XAGE-1 expressing cells by 
contacting them with immunoconjugates of an anti-p9 or p16 antibody and 
a toxic moiety. The invention also provides kits for the detection of 
p9 or p16 proteins in a sample. The XAGE-1 gene and encoded protein 
could be of value in the development of a cancer diagnostic and cancer 
immunotherapy.
    The above mentioned invention is available for licensing on an 
exclusive or non-exclusive basis.

    Dated: November 22, 2000.
Jack Spiegel,
Director, Division of Technology Development & Transfer, Office of 
Technology Transfer.
[FR Doc. 00-30716 Filed 12-1-00; 8:45 am]
BILLING CODE 4140-01-P