Notice: Government-Owned Inventions; Availability for Licensing

Federal Register: May 1, 2008 (Volume 73, Number 85)            
                  Page 24076-24078

AGENCY: National Institutes of Health, Public Health Service, HHS.

ACTION: Notice.

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

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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.

Human and Improved Murine Monoclonal Antibodies Against CD22

    Description of Technology: CD22 is a cell surface protein that is 
highly expressed in a number of B cell lymphomas, such as hairy cell 
leukemia (HCL), non-Hodgkins lymphoma (NHL) and chronic lymphocytic 
leukemia (CLL). Several clinical trials using anti-CD22 antibodies are 
ongoing. However, all of these antibodies are murine in nature, and 
have the potential to elicit immune responses in patients. The 
immunogenicity may adversely affect the ability to provide patients 
with repeated doses of a therapeutic comprising the antibody, limiting 
the clinical application of those therapeutics.
    In order to address the issue of immunogenicity in a patient, NIH 
inventors have generated two anti-CD22 antibodies of human origin. Each 
antibody has the ability to recognize CD22 on the surface of Raji 
cells. Thus, these antibodies represent an attractive alternative to 
the murine anti-CD22 antibodies currently being tested in clinical 
trials.
    Additionally, the inventors have generated a modified murine anti-
CD22 antibody with increased binding affinity and solubility. This 
antibody could also be a suitable alternative for the murine antibodies 
currently available.
    Applications:
    Use as an antibody therapeutic for B cell lymphomas.
    Use in an immunotoxin therapeutic for B cell lymphomas.
    Diagnostic for the detection of CD22 positive tumors.
    Advantages:
    Antibody against a proven target for immunotherapy.
    Fully human antibody reduces potential immunogenicity, thereby 
allowing repeated dosing.
    Murine antibody has increased binding affinity and solubility 
relative to current murine anti-CD22 antibodies.
    Benefits: The antibody based therapeutic market is likely to grow 
steadily in the next decade, with the present estimate of the market at 
more than ten billion U.S. dollars. Approximately five billion U.S. 
dollars are spent annually for treatment of lymphoma. The development 
of a successful antibody therapeutic for B cell lymphomas would occupy 
a significant portion of that market as approximately eighty-five 
percent of all lymphomas are B cell-linked.
    Inventors: Dimiter S. Dimitrov et al. (NCI).
    Patent Status: U.S. Provisional Application No. 61/042,329 filed 04 
Apr 2008 (HHS Reference No. E-080-2008/0-US-01).
    Licensing Status: Available for licensing.
    Licensing Contact: David A. Lambertson, PhD; 301-435-4632; 
lambertsond@mail.nih.gov.
    Collaborative Research Opportunity: The NCI CCR Nanobiology Program 
is seeking statements of capability or interest from parties interested 
in collaborative research to further develop, evaluate, or 
commercialize anti-CD22 human monoclonal antibodies. Please contact 
John D. Hewes, PhD at 301-435-3121 or hewesj@mail.nih.gov for more 
information.

Human Monoclonal Antibody Against Mesothelin

    Description of Technology: Mesothelin is a cell surface protein 
that is naturally expressed at very low levels. However, the expression 
of mesothelin is significantly increased in aggressive tumors, such as 
mesotheliomas and pancreatic and ovarian tumors. As a result, 
mesothelin is an excellent candidate for tumor targeted 
immunotherapeutics.
    Currently, the only antibodies against mesothelin that are 
available for clinical trials are of murine origin. These antibodies 
have the potential to elicit immune responses in patients, which may 
adversely affect the ability to provide patients with repeated doses. 
As a result, the clinical application of the antibodies may be limited.
    In order to address the issue of immunogenicity in patients, NIH 
inventors have generated an anti-mesothelin antibody of human origin. 
The antibody has the ability to efficiently recognize mesothelin on the 
surface of cells, and induce ADCC in mesothelin-positive cells. Thus, 
this antibody represents an attractive alternative to the murine anti-
mesothelin antibodies currently available.
    Applications:
    Use as an antibody therapeutic for mesotheliomas and pancreatic and 
ovarian tumors.
    Use in an immunotoxin therapeutic for mesotheliomas and pancreatic 
and ovarian tumors.
    Diagnostic for the detection of mesothelin positive tumors.
    Research agent for the detection of mesothelin.
    Advantages:
    Fully human antibody reduces potential immunogenicity, thereby 
allowing repeated dosing.
    First human antibody against mesothelin.
    Benefits: The antibody based therapeutic market is likely to grow 
steadily in the next decade, with the present estimate of the market at 
more than ten billion U.S. dollars. The development of a successful 
antibody therapeutic for mesotheliomas and pancreatic and ovarian 
cancers would occupy a significant portion of that market.
    Inventors: Dimiter S. Dimitrov et al. (NCI).
    Patent Status: U.S. Provisional Application filed 27 Mar 2008 (HHS 
Reference No. E-079-2008/0-US-01)
    Licensing Status: Available for licensing.
    Licensing Contact: David A. Lambertson, PhD; 301-435-4632; 
lambertsond@mail.nih.gov.
    Collaborative Research Opportunity: The NCI CCR Nanobiology Program 
is seeking statements of capability or interest from parties interested 
in collaborative research to further develop, evaluate, or 
commercialize the antibody. Please contact John D. Hewes, PhD at 301-
435-3121 or hewesj@mail.nih.gov for more information.

New Insect SF-9ET Cell Line for Determining Baculovirus Titers

    Description of Technology: The baculovirus based protein expression 
system has gained increased prominence as a method for expressing 
recombinant proteins that are used in a wide range of biomedical 
applications. An important step in the use of this system is the 
ability to determine the virus infectious titer, i.e., the number of 
active baculovirus particles produced during an infection of the insect 
host cell. The current ``gold standard'' methods used for determining 
baculovirus titers, such as the plaque and end point dilution assays, 
can be costly, take a long time to complete (up to 7-8 days), and are 
sometimes difficult to interpret as they involve observing the 
cytopathic effects (CPE) that baculovirus infection has on the infected 
insect host cell. To solve these problems, a modified insect cell line, 
SF-9ET, was developed to genetically express the green fluorescent 
protein (GFP) when infected with baculovirus. In these cells, the gene 
for GFP is placed

[[Page 24078]]

under the control of a baculovirus promoter so that the cells express 
GFP when they are infected with the virus. The baculovirus titer can 
then be quantitated from the level of GFP expression in the insect host 
cell. The results are obtained within 3 days compared to the 7-8 day 
period typical of the traditional CPE based methods.
    The GFP based system is capable of replacing the traditional 
methods as it is faster, more accurate and may be less expensive than 
the currently used systems. This proprietary technology can become an 
indispensible tool for the quantitation of baculovirus titers; a step 
that is important in the production of recombinant proteins and vaccine 
like particles (VLPs) for academic and commercial purposes.
    Applications: Baculovirus based recombinant protein expression.
    Advantages: Fast, accurate, and inexpensive determination of 
baculovirus titers for protein expression.
    Inventors: Ralph F. Hopkins III and Dominic Esposito (SAIC/NCI).
    Patent Status: U.S. Provisional Application No. 61/019,562 filed 07 
Jan 2008 (HHS Reference No. E-009-2008/0-US-01).
    Licensing Status: Available for exclusive or non-exclusive 
licensing.
    Licensing Contact: Jasbir (Jesse) S. Kindra, J.D., M.S.; 301-435-
5170; kindraj@mail.nih.gov.

A Molecular Grading System for Ductal Carcinoma In Situ (DCIS) of the 
Breast: A New Molecular Diagnostic To Determine Disease Stages of DCIS

    Description of Technology: The technology describes the 
comprehensive profiling of Ductal Carcinoma in situ (DCIS) in breast 
cancer patients. The inventors have developed a molecular grading 
system for DCIS utilizing both gene expression profiling and genomic 
change profiling. The inventors have identified molecular profiles that 
identify early stage patients at risk of disease progression requiring 
more aggressive therapy. These observations suggest that a clinical 
assay could be developed for the grading of DCIS. Furthermore, the 
invention demonstrates that the profiles correlate with the molecular 
grade and with cell proliferation, suggesting that a clinical assay 
using routine methods, based on the nuclear grade and staining for Ki67 
as a measure of proliferation, could also potentially be developed.
    Advantages and Applications:
    The technology has the potential of being developed into an 
accurate diagnostic test for DCIS patients according to their risk of 
tumor progression.
    The diagnostic profiling can assist physicians in making clinically 
informed and personalized therapy decisions for DCIS patients.
    In the studies, tissue samples collected via laser capture micro-
dissection from in situ breast cancer patients were used, which 
validate and authenticate the relevance of the study.
    Development Status: Larger clinical study is currently being 
planned.
    Inventors: Paul S. Meltzer et al. (NCI).
    Patent Status: U.S. Provisional Application No. 60/936,526 filed 20 
Jun 2007 (HHS Reference No. E-192-2007/0-US-01).
    Licensing Status: Available for exclusive and non-exclusive 
licensing.
    Licensing Contact: Mojdeh Bahar, J.D.; 301-435-2950; 
baharm@mail.nih.gov.
    Collaborative Research Opportunity: The National Cancer Institute, 
Genetics Branch, is seeking statements of capability or interest from 
parties interested in collaborative research to further develop, 
evaluate, or commercialize molecular grading of DCIS. Please contact 
John D. Hewes, Ph.D. at 301-435-3121 or hewesj@mail.nih.gov for more 
information.

    April 24, 2008.
David Sadowski,
Deputy Director, Division of Technology Development and Transfer, 
Office of Technology Transfer, National Institutes of Health.
 [FR Doc. E8-9535 Filed 4-30-08; 8:45 am]

BILLING CODE 4140-01-P