[Federal Register Volume 71, Number 188 (Thursday, September 28, 2006)]
[Notices]
[Pages 56991-56993]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-15975]


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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.

Mammalian Cell Surface Display of Fvs for Rapid Antibody Maturation

    Description of Technology: This technology describes a new method 
of cell surface display of single chain antibodies for affinity 
maturation in a mammalian system. Cells expressing a rare mutant 
antibody with higher affinity were enriched about 240 fold by a single-
pass cell sorting from a large excess of cells expressing wild-type 
antibodies with slightly lower affinity. Additionally, a highly 
enriched mutant with increased binding affinity for CD22 after a single 
selection of a combinatory library randomizing an intrinsic antibody 
hotspot was successfully obtained. The system is compatible with other 
mammalian expression systems and it is a rapid, simple and robust 
procedure. The method can be useful in isolating high affinity 
antibodies for cancer, AIDS and other diseases.
    Applications: (1) A new method of displaying Fvs on human cells; 
(2) A new method useful to isolate new high affinity antibodies for 
cancer, AIDS and other diseases.
    Market: The method has a potential several billion dollar market as 
it can be potentially used in immunotherapeutic approaches for the 
treatment of cancer, AIDS and other diseases.
    Development Status: The technology is currently in pre-clinical 
stage of development.
    Inventors: Drs. Ira Pastan and Mitchell Ho (NCI).
    Publication: Mo Ho, S Nagata, I Pastan. Isolation of anti-CD22 Fv 
with high affinity by Fv display on human cells. Proc Natl Acad Sci 
USA. Jun 20;103(25):9637-9642. Epub 2006 Jun 8, doi 10.1073/
pnas.0603653103.
    Patent Status: U.S. Provisional Application No. 60/794,212 filed 21 
Apr 2006 (HHS Reference No. E-200-2006/0-US-01)
    Licensing Status: Available for non-exclusive or exclusive 
licensing.
    Licensing Contact: Jesse S. Kindra, J.D.; 301/435-5559; 
[email protected].
    Collaborative Research Opportunity: The National Cancer Institute 
Laboratory of Molecular Biology is seeking statements of capability or 
interest from parties interested in collaborative research to further 
develop, evaluate, or commercialize Mammalian Cell Surface Display of 
Fvs

[[Page 56992]]

for Rapid Antibody Maturation. Please contact Betty Tong, PhD at 301-
496-0477 or [email protected] for more information.

Methods of Identifying and Treating Tumors that Express Erythropoietin 
Receptor Protein (EPO R)

    Description of Invention: The inventors have discovered that EPO 
and EPOR are co-expressed in tumors of von Hippel-Lindau (VHL) patients 
and in tumors of sporadic renal tumor patients. Ligands that bind to 
EPOR but do not activate the receptor can target specific tumor cells 
with minimal detrimental effect on normal cells.
    Applications: (1) Treatment and diagnosis of renal tumors in 
sporadic and kidney dialysis patients; (2) Treatment and diagnosis of 
multiple tumors in different organs in patients with von Hippel-Landau 
patients; (3) Treatment and diagnosis of pheochromocytomas; (4) 
Treatment and diagnosis of eye and CNS hemangioblastomas.
    Inventors: Zhengping Zhuang et al. (NINDS).
    Patent Status: International Patent Application No. PCT/US2005/
033850 filed 20 Sep 2005, which published as WO 2006/034354 on 30 Mar 
2006 (HHS Reference No. E-274-2004/0-US-02).
    Licensing Status: Available for non-exclusive or exclusive 
licensing.
    Licensing Contact: Thomas P. Clouse, J.D.; 301/435-4076; 
[email protected].
    Collaborative Research Opportunity: In addition to licensing, the 
technology is available for further development through collaborative 
research opportunities with the inventors. For further information 
regarding collaborative research opportunities, please contact Dr. 
Martha Lubet at e-mail: [email protected] or telephone: 301/435-3120.

Diagnostic and Therapeutic Use of SPANX-N Genes in Cancer and Fertility

    Description of Technology: Cancer is the second leading cause of 
death in United States and it is estimated that there will be 
approximately 600,000 deaths caused by cancer in 2006. In spite of the 
success of cancer screening and early diagnosis cancer still remains a 
life threatening disease. There is a great need for the development of 
new markers and new therapeutic strategies that would more accurately 
predict the outcome of the disease and aid in the proper management of 
cancer. Antibody-based strategies have taken a lead among the new 
cancer therapeutic approaches.
    This technology describes the identification of the link between 
expression of individual members of the SPANX-gene cluster and 
malignancies including prostate cancer. SPANX-genes consist of two 
subfamilies, SPANX-A/D and SPANX-N1/N5. The invention provides SPANX 
polypeptides, nucleic acids and antibodies that could be useful for 
detecting and treating prostate or other cancers. The SPANX-N genes are 
a family of related genes that are expressed in normal testis and in 
tumor cells in humans including melanoma, bladder carcinomas and 
myelomas. The SPANX cancer/testis antigens thus represent good 
candidates for diagnosis or treatment of several cancers. The present 
invention also describes a new approach for mutation screen of the 
SPANX gene cluster, including gene amplification, linking 
predisposition to prostate cancer with a specific architecture of the 
SPANX gene cluster. Additionally, due to the differential localization 
of SPANX-proteins in the spermatozoa, the mutational screen can be also 
used for diagnostics of infertility. Developed antibodies against 
SPANX-A/D and SPANX-N1/N5 proteins can be used for (i) diagnostics of 
cancer, (ii) diagnostics of infertility and iii) for the development of 
new contraceptives.
    Applications: (1) Novel antibodies to SPANX-A/D and SPANX-N1/N5; 
(2) New approach for mutation screen of SPANX gene cluster; (3) 
Antibodies can be used for diagnosis and development of 
immunotherapeutics for several cancers including prostate; (4) 
Compounds can also be used for the diagnosis of infertility and 
development of new contraceptives.
    Market: (1) 600,000 deaths from cancer related diseases estimated 
in 2006; (2) The technology platform involving novel antibodies for the 
diagnosis and therapeutics of several cancers has a potential market of 
more than 7 billion U.S. dollars; (3) The technology platform has 
additional market in fertility related diagnostics and therapeutics.
    Development Status: The technology is currently in the pre-clinical 
stage of development.
    Inventors: Natalay Kouprina (NCI) et al.
    Publications:
    1. N Kouprina et al. The SPANX gene family of cancer/testis-
specific antigens: rapid evolution and amplification in African great 
apes and hominids. Proc Natl Acad Sci USA. 2004 Mar 2;101(9):3077-3082. 
Epub 2004 Feb 18, doi 10.1073/pnas.0308532100.
    2. N Kouprina et al. Dynamic structure of the SPANX gene cluster 
mapped to the prostate cancer susceptibility locus HPCX at Xq27. Genome 
Res. 2005 Nov;15(11):1477-1486.
    3. N Kouprina and V Larionov. TAR cloning: Insights into gene 
function, long-range haplotypes, and genome structure and evolution. 
Nature Reviews Genetics, 7: In press, 2006.
    4. N Kouprina et al. SPANX-N gene cluster at Xq27: A new group of 
cancer-testis antigen genes encoding acrosomal proteins. Submitted to 
Cancer Research, 2006.
    Patent Status: U.S. Provisional Application No. 60/636,811 filed 15 
Dec 2004 (HHS Reference No. E-212-2004/0-US-01); PCT Application No. 
PCT/US2005/045317 filed 15 Dec 2005, which published a WO 2006/065938 
on 22 Jun 2006 (HHS Reference No. E-212-2004/1-PCT-01)
    Licensing Status: Available for exclusive and non-exclusive 
licensing.
    Licensing Contact: Mojdeh Bahar, J.D.; 301/435-2950; 
[email protected].
    Collaborative Research Opportunity: The National Cancer Institute 
Laboratory of Biosystems and Cancer is seeking statements of capability 
or interest from parties interested in collaborative research to 
further develop, evaluate, or commercialize this new diagnostic marker 
for malignancy and infertility and new targets for immuno-cancer 
therapy. Please contact Betty Tong, Ph.D. at 301-594-4263 or 
[email protected] for more information.

Cancer Peptides of NY-ESO-1/CAG-3

    Description of Technology: The current invention embodies the 
identification, isolation and cloning of a gene encoding a novel tumor 
antigen, NY ESO-1/CAG-3, as well as cancer peptides thereof and 
antigenic cancer epitopes contained within the cancer peptides. This 
novel antigen is recognized by cytotoxic T lymphocyte clones derived 
from the TIL586 (tumor infiltrating lymphocyte) cell line in an HLA 
restricted manner.
    The inventors believe that cancer peptides which are encoded by the 
NY ESO-1/CAG-3 gene represent potential cancer vaccines, protecting an 
individual from development of cancer by inhibiting the growth of cells 
or tumors which express the NY ESO-1/CAG-3 antigen. Also embodied in 
the invention are pharmaceutical compositions comprising the NY ESO-1/
CAG-3 antigen, peptide, or an antigenic cancer epitope thereof in 
combination with one or more immunostimulatory molecules. These 
compositions represent potential anticancer therapeutics, stimulating 
NY

[[Page 56993]]

ESO-1/CAG-3-specific T cells to elicit an anti-cancer immunogenic 
response and thereby eliminating or reducing the cancer. While these 
vaccines and pharmaceutical compositions may be developed for use 
against a variety of cancers, data obtained to date indicate that they 
may be of particular value for use against melanoma.
    Methods for diagnosing cancer via the detection of NY ESO-1/CAG-3 
are also embodied in the invention.
    Inventors: Steven A. Rosenberg (NCI) et al.
    Patent Status: U.S. Patent No. 7,084,239 issued 01 Aug 2006 (HHS 
Reference No. E-265-1997/0-US-04).
    Licensing Status: Available for non-exclusive licensing or 
exclusive licensing.
    Licensing Contact: Jesse S. Kindra, J.D.; 301/435-5559; 
[email protected].

    Dated: September 20, 2006.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E6-15975 Filed 9-27-06; 8:45 am]
BILLING CODE 4140-01-P