[Federal Register Volume 72, Number 230 (Friday, November 30, 2007)]
[Notices]
[Pages 67740-67741]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-23194]


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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 United States 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.

Monoclonal Antibody to a Specific Peptide-MHC Class II Complex

    Description of Invention: T lymphocytes play an important role in 
the immune system by recognizing foreign protein motifs on cells. T 
lymphocytes are stimulated to recognize these motifs through their 
interactions with peptide-MHC complexes (pMHC). Thus, studying pMHC is 
an important aspect of understanding how the immune system works, 
particularly with regard to the development of vaccines. Unfortunately, 
the detection of pMHC is largely dependent on indirect assays, due to 
the difficulty of producing antibodies for specific pMHC.
    This invention regards the development of hybridomas (C4H3) for the 
production of antibodies that are highly specific for a particular pMHC 
complex consisting of hen egg lysozyme peptide 46-61 (HEL) and the I-
A\k\ MHC class II molecule. These antibodies can be used for a myriad 
of purposes which include studying how cells form pMHC.
    Applications: Discovery of methods for antigen delivery in the 
development of vaccines.
    Quantitation and distribution of pMHC complexes on cells.
    Study antigen processing in experimental immunological research 
systems.
    Advantages: High specificity for the pMHC complex of HEL-I-A\k\ MHC 
class II molecule.
    HEL-I-A\k\ is widely used in experimental immunological research 
systems, giving the hybridoma and antibodies great applicability.
    Inventors: Ronald N. Germain et al. (NIAID).
    Publications: 1. G Zhong et al. Production, specificity, and 
functionality of monoclonal antibodies to specific peptide-major 
histocompatibility complex class II complexes formed by processing of 
exogenous protein. Proc Natl Acad Sci U S A. 1997 Dec 9; 94(25):13856-
13861.
    2. A Porgador et al. Localization, quantitation, and in situ 
detection of specific peptide-MHC class I complexes using a monoclonal 
antibody. Immunity. 1997 Jun; 6(6):715-726.
    Patent Status: HHS Reference No. E-021-2008/0-Research Tool. Patent 
protection is not being pursued for this technology.
    Licensing Contact: David A. Lambertson, Ph.D.; 301-435-4632; 
[email protected].
    Collaborative Research Opportunity: The NIAID Lymphocyte Biology 
Section, Laboratory of Immunology is seeking statements of capability 
or interest from parties interested in collaborative research to 
further develop, evaluate, or commercialize monoclonal antibody C4H3, 
specific for HEL (46-61) bound to the MHC class II molecule I-A\k\. 
Please contact Ronald N. Germain, M.D., Ph.D., at [email protected] for 
more information.

Bifunctional Compounds that Bind to Hormone Receptors

    Description of Technology: The development and progression of 
prostate cancer is dependent on the androgen receptor (AR), a ligand-
dependent transcription factor. In the inactive form AR resides in the 
cytosolic region of the cell and when activated, AR is imported into 
the nucleus. Initial hormonal therapy for prostate cancer involves 
lowering serum levels of testosterone to shut down AR activity. Despite 
initial patient responses to testosterone-depleting therapies, prostate 
cancer becomes refractory to hormonal therapy. Notably, AR is 
reactivated in hormone-refractory prostate cancer and reinstates its 
proliferative and survival activity.
    Available for licensing is a novel chemical compound which is 
bifunctional and binds to AR. This compound is comprised of tubulin-
binding and steroid receptor-binding moieties. This compound is 
designed to antagonize AR function in a nonclassical manner by several 
mechanisms and kills hormone-refractory prostate cells better than both 
functional moieties. This compound is a first-in-class of bifunctional 
steroid receptor binding agents that can antagonize steroid receptors 
in a variety of hormone-dependent diseases, such as breast and prostate 
cancer.
    Applications: Therapeutic compounds that selectively target steroid 
receptor-expressing cancer cells resulting in decreased toxicity.
    Method to treat hormone resistant prostate cancer and potentially 
other steroid receptor dependent diseases such as breast cancer.
    Market: Prostate cancer is the second most common type of cancer 
among men, wherein one in six men will be diagnosed with prostate 
cancer.
    An estimated 218,890 new cases of prostate cancer and 27,050 deaths 
due to prostate cancer in the United States in 2007.

[[Page 67741]]

    An estimated 180,510 new cases of breast cancer and 40,060 deaths 
due to breast cancer in the United States in 2007.
    Development Status: The technology is currently in the pre-clinical 
stage of development.
    Inventors: Nima Sharifi et al. (NCI).
    Patent Status: U.S. Provisional Application No. 60/958,351 filed 03 
Jul 2007 (HHS Reference No. E-163-2007/0-US-01).
    Licensing Status: Available for exclusive or non-exclusive 
licensing.
    Licensing Contact: Jennifer Wong; 301-435-4633; 
[email protected].
    Collaborative Research Opportunity: The Medical Oncology Branch, 
National Cancer Institute is seeking statements of capability or 
interest from parties interested in collaborative research to further 
develop, evaluate, or commercialize--treatments of resistant prostate 
cancer. Please contact John D. Hewes, Ph.D. at 301-435-3121 or 
[email protected] for more information.

A Clinically Proven Therapeutic Treatment and Diagnostic Tool for 
Mesothelin Expressing Cancers: A Novel Recombinant Immunotoxin SS1P 
(anti-mesothelin dsFv-PE38)

    Description of Technology: Mesothelin is a glycoprotein, whose 
expression has been largely restricted to mesothelial cells in normal 
tissues. Mesothelin has been shown to be expressed in several cancers 
including mesothelioma, lung cancer, pancreatic cancers, gastric 
cancers and ovarian cancers, and has the potential of being used as a 
novel target for the development of new treatments.
    The technology relates to the SSIP immunotoxin that can be used to 
kill cells expressing mesothelin on their surfaces, such as 
mesothelioma, ovarian cancer, lung cancer, ovarian cancer and stomach 
cancer. Additionally, it can be used for the detection of mesothelin 
expressing cells present in a biological sample.
    The SSIP immunotoxin is a recombinant immunotoxin generated by the 
fusion of a high affinity anti-mesothelin Fv (SS1) with a 38 kDa 
portion of Pseudomonas Exotoxin A (PE38).
    Applications: SS1P can be used as a therapy for mesothelin 
expressing cancers.
    The immunotoxin can be used as a stand alone treatment and in 
combination with standard chemotherapy.
    Advantage: SS1P immunotoxin is available for use and has been 
successfully tested clinically for the treatment of mesothelioma and 
ovarian cancer with low side effects.
    Development Status: Phase 1 studies have been completed for 
mesothelin expressing cancers such as mesothelioma, ovarian cancer and 
pancreatic cancer.
    Phase 2 studies to begin shortly for combination therapy using SS1P 
and standard chemotherapy.
    Inventors: Ira Pastan (NCI) et al.
    Relevant Publications: 1. R Hassan et al. Phase I study of SS1P, a 
recombinant anti-mesothelin immunotoxin given as a bolus I.V. infusion 
to patients with mesothelin-expressing mesothelioma, ovarian, and 
pancreatic cancers. Clin Cancer Res. 2007 Sep 1;13 (17):5144-5149.
    2. Y Zhang et al. Synergistic antitumor activity of taxol and 
immunotoxin SS1P in tumor-bearing mice. Clin Cancer Res. 2006 Aug 
1;12(15):4695-4701.
    Patent Status: U.S. Patent No. 7,081,518 issued 25 Jul 2006, 
entitled ``Anti-Mesothelin Antibodies Having High Binding Affinity'' 
(HHS Reference No. E-139-1999/0-US-07)
    Related Intellectual Property: 1. U.S. Patent No. 4,892,827 
entitled ``Recombinant Pseudomonas Exotoxin: Construction of an Active 
Immunotoxin with Low Side Effects'' [HHS Ref. No. E-385-1986/0];
    2. U.S. Patent Nos. 6,051,405, 5,863,745, and 5,696,237 
``Recombinant Antibody-Toxin Fusion Protein'' [HHS Ref. No. E-135-1989/
0];
    3. U.S. Patents 5,747,654, 6,147,203, and 6,558,672 entitled 
``Recombinant Disulfide-Stabilized Polypeptide Fragments Having Binding 
Specificity'' [HHS Ref. No. E-163-1993/0];
    4. U.S. Patent No. 6,153,430, and U.S. Patent Application No. 09/
684,599 ``Nucleic Acid Encoding Mesothelin, a Differentiation Antigen 
Present on Mesothelium, Mesotheliomas and Ovarian Cancers'' [HHS Ref. 
No. E-002-1996/0];
    5. U.S. Patent 6,083,502 entitled ``Mesothelium Antigen and Methods 
and Kits for Targeting It'' [HHS Ref. No. E-002-1996/1];
    6. U.S. Patent Application 09/581,345: ``Antibodies, Including Fv 
Molecules, and Immunoconjugates Having High Binding Affinity for 
Mesothelin and Methods for Their Use'' [HHS Ref. No. E-021-1998/0];
    7. PCT Application No. PCT/US01/18503, ``Pegylation of Linkers 
Improves Antitumor Activity and Reduces Toxicity of Immunoconjugates'' 
[HHS Ref. No. E-216-2000/2];
    8. PCT Application No. PCT/US2006/018502 and U.S. Patent 
Application No. 60/681,104, entitled ``Anti-Mesothelin Antibodies 
Useful For Immunological Assays'' [HHS Ref. No. E-015-2005/0-US-01]; 
and
    9. Any related foreign filed national stage applications claiming 
priority to such patent applications and patents listed above.
    Licensing Status: Available for exclusive and non-exclusive 
licensing.
    Licensing Contact: David A. Lambertson, Ph.D.; 301-435-4632; 
[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, immunotoxin SS1P. Please contact John D. Hewes, Ph.D. at 301-
435-3121 or [email protected] for more information.

    Dated: November 16, 2007.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E7-23194 Filed 11-29-07; 8:45 am]
BILLING CODE 4140-01-P