[Federal Register Volume 72, Number 245 (Friday, December 21, 2007)]
[Notices]
[Pages 72742-72744]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-24784]


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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

[[Page 72743]]

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.

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 cell surface 
glycoprotein, whose expression is largely restricted to mesothelial 
cells in normal tissues. Mesothelin has been shown to be highly 
expressed in many cancers including malignant mesothelioma, ovarian 
cancer, lung cancer, pancreatic carcinomas, gastric carcinomas, and 
other cancers. Mesothelin has been shown to be a target for 
immunotherapy and is also being used as a tumor marker.
    The technology relates to the SS1P immunotoxin that can be used to 
kill cells expressing mesothelin on their surface, such as 
mesothelioma, ovarian cancer, lung cancer, pancreatic cancer and 
stomach cancer. Additionally, it can be used for the detection of 
mesothelin expressing cells present in a biological sample.
    The SSIP protein is an immunotoxin generated by the fusion of an 
anti-mesothelin antibody Fv fragment with a particularly high affinity 
(SS1), and 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 standalone 
treatment and in combination with standard chemotherapy.
    Advantage: SS1P immunotoxin is available for use and has been 
successfully tested clinically for the treatment of several mesothelin 
expressing cancers, such as mesothelioma and ovarian cancer with low 
side effects.
    Development Status: Phase 1 studies have been completed for 
mesothelin expressing cancers such as mesothelioma and ovarian cancer. 
Phase 2 studies to begin shortly for combination therapy using SS1P and 
standard chemotherapy.
    In addition to an active Investigational New Drug (IND) 
application, there are two associated orphan drug designations with 
this agent.
    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. And 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].

cDNA Encoding a Gene BOG and Its Protein Product

    Description of Invention: Available for licensing is BOG (B5t Over-
Expressed Gene) with the gene product pRb of the well-known tumor 
suppressor gene RB, retinoblastoma susceptibility gene. The complex 
formed between Rb and BOG typically does not contain E2F-1 in vivo. 
This binding property suggests that cells which are transformed/
transfected with cDNA or other functional nucleotide sequences which 
encode the BOG gene product will be useful as tools for studying cell 
cycle control and oncogenesis.
    Studies using rat liver epithelial cell (RLE) lines which are 
resistant to the growth inhibitory effects of TGF-beta1 and primary 
liver tumors have been shown to over-express BOG. Moreover, when normal 
RLE continuously over-express BOG the cells become transformed and the 
transformed cells are able to form hepatoblastoma-like tumors when 
transplanted into nude mice. Therefore, biologics derived from BOG may 
be useful as diagnostics or therapeutics.
    Applications: Method to diagnose and treat liver cancer; Method to 
study cell cycle control and oncogenesis; Liver cancer therapeutics.
    Development Status: The technology is currently in the pre-clinical 
stage of development.
    Market: Liver cancer is the third leading cause of cancer death 
worldwide, and the fifth most common cancer in the world; Post-
operative five year survival rate of HCC patients is 30-40%.
    Inventors: Snorri S. Thorgeirsson et al. (NCI).
    Relevant Publication: JT Woitach et al. A retinoblastoma-binding 
protein that affects cell-cycle control and confers transforming 
ability. Nat Genet. 1998 Aug;19(4):371-374.
    Patent Status: U.S. Patent No. 6,727,079 issued 27 Apr 2004 (HHS 
Reference No. E-009-1998/2-US-02).
    Licensing Status: Available for exclusive or non-exclusive 
licensing.
    Licensing Contact: Jennifer Wong, 301-435-4633; 
[email protected].
    Collaborative Research Opportunity: The National Cancer Institute 
(NCI), Center for Cancer Research, Laboratory of Experimental 
Carcinogenesis, is seeking statements of capability or interest from 
parties interested in collaborative research to further develop, 
evaluate, or commercialize BOG (B5t Over-Expressed Gene) with the gene 
product pRb. Please contact John Hewes, Ph.D. at the NCI Technology 
Transfer Center at

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[email protected] or (301) 496-0477 for more information.

    Dated: December 14, 2007.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E7-24784 Filed 12-20-07; 8:45 am]
BILLING CODE 4140-01-P