[Federal Register Volume 72, Number 149 (Friday, August 3, 2007)]
[Notices]
[Pages 43286-43287]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-15056]



[[Page 43286]]

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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, HHS.

ACTION: Notice.

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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: 301/496-7057; fax: 301/402-0220. A 
signed Confidential Disclosure Agreement will be required to receive 
copies of the patent applications.

Immunogenic Peptides and Methods of Use for Treating Prostate and 
Uterine Cancers

    Description of Technology: Cancer of the prostate is the most 
commonly diagnosed cancer in men and the second leading cause of cancer 
death in men. Despite the use of standard therapy, including surgery, 
radiotherapy, chemotherapy, and/or hormonal therapy more than 30,000 
men will die from prostate cancer. Moreover, current therapy has 
limited success against metastatic androgen insensitive prostate 
cancer. A potential treatment for prostate cancer is immunotherapy, 
either alone or in combination with standard therapies.
    PAGE4 is an X chromosome-linked cancer-testis antigen that is 
highly expressed in prostate and uterine cancers. To this end, Drs. 
Jeffery Schlom, Kwong Tsang, and Ira Pastan have identified and 
characterized novel PAGE4 cytotoxic T-cell lymphocyte (CTL) epitopes 
and enhanced agonist epitopes. Preclinical studies performed by Dr. 
Schlom and colleagues indicate that the PAGE4 agonist epitopes bind 
HLA-A2 molecules at lower peptide concentrations, form more stable 
peptide HLA-A2 complexes, induce higher levels of production of INF-
gamma, Granzyme B, TNF-alpha, IL-2, and lymphotactin by PAGE4 specific 
T-cell lines, and T-cell lines generated against the agonist peptide 
were more efficient at lysing human tumor cells expressing native 
PAGE4. Thus, these agonist epitopes of PAGE4 could be incorporated into 
immunotherapy protocols, and may constitute an alternative and/or 
additional approach for the treatment of PAGE4 expressing prostate and 
uterine cancers.
    Development Status: The Laboratory of Tumor Immunology and Biology 
plans to initiate clinical studies utilizing this technology and 
collaborative opportunities may be available.
    Inventors: Jeffrey Schlom, Kwong-Yok Tsang, Ira H. Pastan (NCI).
    Publications: Publications which may provide background information 
for this technology include:
    1. J Yokokawa et al., ``Identification of cytotoxic T-lymphocyte 
epitope(s) and its agonist epitope(s) of a novel target for vaccine 
therapy (PAGE4),'' Int J Cancer. 2007;121:595-605.
    2. C Iavarone et al., ``PAGE4 is a cytoplasmic protein that is 
expressed in normal prostate and in prostate cancers,'' Mol Cancer 
Ther. 2002 Mar;1(5):329-335.
    3. L Prikler et al., ``Adaptive immunotherapy of the advanced 
prostate cancer--cancer testis antigen (CTA) as possible target 
antigens,'' Aktuelle Urol. 2004 Aug;35(4):326-330. [article in German]
    Patent Status: PCT Application No. PCT/US2007/004603 filed 21 Feb 
2007 (HHS Reference No. E-104-2006/0-PCT-02), claiming priority to 24 
Feb 2006, entitled ``Immunogenic Peptides and Methods of Use.''
    Related Technology: U.S. Patent Application No. 11/704,714 filed 09 
Feb 2007 (HHS Reference No. E-028-1999/0-US-08), claiming priority to 
01 Sep 1998, entitled ``PAGE-4, An X-Linked GAGE-Like Gene Expressed in 
Normal and Neoplastic Prostate, Testis and Uterus, and Uses Therefor.''
    Licensing Status: Available for non-exclusive or exclusive 
licensing.
    Licensing Contact: Michelle A. Booden, Ph.D.; 301/451-7337; 
[email protected].
    Collaborative Research Opportunity: The Laboratory of Tumor 
Immunology and Biology, Center for Cancer Research, NCI is seeking 
statements of capability or interest from parties interested in 
collaborative research to further develop, evaluate, or commercialize 
this technology. Please contact Kevin Chang, Ph.D. in the NCI 
Technology Transfer Center at [email protected] and/or 301-496-0477 
for more information.

Diagnostic and Therapeutic Methods of Detecting and Treating Cancers of 
Reproductive Tissues

    Description of Technology: PAGE-4 is a human X-linked gene that is 
strongly expressed in prostate and prostate cancer, and is also 
expressed in other male and female reproductive tissue (e.g., testis, 
fallopian tube, placenta, uterus, and uterine cancer). PAGE-4 shows 
similarity with the GAGE protein family, but it diverges significantly 
from members of the family so that it appears to belong to a separate 
family. This, and the existence of another gene, PAGE-2, that share 
more homology with PAGE-4 than with members of the GAGE family 
indicates that the PAGE-4 protein belongs to a separate protein family.
    The specific detection of PAGE-4 might be valuable for the 
diagnosis of prostate and testicular tumors, as well as uterine tumors. 
There are sufficient differences between PAGE-4 and other members of 
the PAGE and MAGE proteins to produce specific antibodies. Analyses 
with such antibodies are needed to confirm by immunohistology the 
expression specificity that is seen in database and mRNA analyses, and 
to evaluate whether anti-PAGE-4 immunotherapy could be a promising 
therapeutic approach. One possibility of eliminating PAGE-4 expressing 
cells could be to use it as cancer vaccine. Among the many possible 
approaches to vaccination, one method is direct vaccination with 
plasmid DNA. In fact, Dr. Pastan's laboratory has been able to obtain 
good expression of the PAGE-4 protein with mammalian expression 
plasmids, and has demonstrated that DNA-immunization with such 
expression constructs leads to good immune responses. Hence, this 
method may generate anti-PAGE-4 responses, and allow us to analyze if 
``PAGE-4-vaccination'' can eliminate PAGE-4 expressing cells, as a 
therapeutic approach towards neoplasms of the prostate, testis, and 
uterus.
    Inventors: Ira H. Pastan, Ulrich Brinkmann, George Vasmatzis, 
Byungkook Lee (NCI).
    Patent Status: U.S. Patent Application No. 11/704,714 filed 09 Feb 
2007 (HHS Reference No. E-028-1999/0-US-08), claiming priority to 01 
Sep 1998, entitled ``PAGE-4, An X-Linked GAGE-Like Gene Expressed in 
Normal and Neoplastic Prostate, Testis and Uterus, and Uses Therefor.''
    Related Technology: PCT Application No. PCT/US2007/004603 filed 21 
Feb 2007 (HHS Reference No. E-104-2006/

[[Page 43287]]

0-PCT-02), claiming priority to 24 Feb 2006, entitled ``Immunogenic 
Peptides and Methods of Use.''
    Licensing Contact: Jesse S. Kindra, J.D.; 301/435-5559; 
[email protected]; or Michelle A. Booden, PhD.; 301/451-7337; 
[email protected].

    Dated: July 26, 2007.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
 [FR Doc. E7-15056 Filed 8-2-07; 8:45 am]
BILLING CODE 4140-01-P