Government-Owned Inventions; Availability for Licensing

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Federal Register: July 9, 2010 (Volume 75, Number 131)

Notices

Page 39544-39545

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

DOCID:fr09jy10-50

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.

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.

Identification of Cancer Stem Cells

Description of Invention: Cancer stem cells (CSC) are thought to be responsible for cancer initiation, maintenance, and therapeutic failure. A hallmark of stem cells is self-renewal via asymmetric cell division (ACD) into daughter stem-cells and cells predestined for differentiation. Demonstration of fundamental stem-cell's traits such as ACD in cancers is lacking. Label retaining cells are thought to be enriched for stem-like cells. Label retaining cells are thought to be the results of either very slow cycling cells and/or cells undergoing

ACD. This invention is directed to the identification, isolation and purification of cancer stem cells by detecting asymmetrically dividing cells and/or label retaining cells. Detection of asymmetric cell division via non-random chromosomal cosegregation (ACD-NRCC) in various human cancers defines a unique and novel class of universal cancer stem cells, and potentially suggests a novel mechanism of carcinogenesis.

The isolation of CSC might be used as a basis for a potential new strategy in cancer therapeutics. The invention also might have some implications in genetics and regenerative medicine.

Applications

This invention may provide a novel way to target various cancers for treatment.

This invention maybe also useful in regenerative medicine, i.e. spinal cord injury (regeneration of neurons), Alzheimer

(regeneration of neurons) and Parkinson's disease regeneration of neurons).

Development Status: Pre-clinical stage of development.

Market

Cancer is the second leading cause of death in the U.S.

The National Cancer Institute estimates the overall annual costs for cancer in the U.S. at $107 billion; $37 billion for direct medical costs, $11 billion for morbidity costs (cost of lost productivity), and

$59 billion for mortality costs.

According to statistics gathered by the National

Institutes of Health, more than 10,000 Americans experience spinal cord injuries each year and more than 200,000 are living with permanent paralysis in their arms or legs due to spinal cord injury.

Parkinson's disease affects some four million patients worldwide. Approximately 50,000 Americans are diagnosed with

Parkinson's disease each year. Alzheimer Disease is estimated to affect 5.09 million patients by 2010.

Inventors: Itzhak Avital, Hong-Wu Xin, Danielle M. Hari (NCI)

Publication: Manuscript submitted.

Page 39545

Patent Status: U.S. Provisional Application No. 61/342,642 filed 16

Apr 2010 (HHS Reference No. E-122-2010/0-US-01).

Licensing Status: Available for licensing.

Licensing Contact: Betty B. Tong, Ph.D.; 301-594-6565; tongb@mail.nih.gov.

Collaborative Research Opportunity: The Center for Cancer Research,

Surgery Branch, National Cancer Institute, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize our unique method for isolating cancer stem cells. We are seeking interested parties who would be interested in collaboration with the goal of developing cancer stem cell cell-lines for personalized targeted therapies, drug testing and finding novel targets for cancer treatments. In addition, we would like to collaborate with parties interested in developing normal (not cancer) adult tissue stem-cell cell-lines for adult tissue regeneration such as Parkinson's disease, liver failure, Alzheimer, etc. Please contact John Hewes, Ph.D. at 301- 435-3121 or hewesj@mail.nih.gov for more information.

Human Single-Domain Antibodies (dAbs) Against Insulin-Like Growth

Factor 1 Receptor (IGF-1R) or Its Ligands, IGF-1 and IGF-2

Description of Invention: Insulin-like growth factor (IGF) mediated signaling has been implicated in the development of several epithelial cancers, such as prostate, breast, and colorectal cancers. This technology consists of human single domain antibodies (dAbs) that bind to human insulin-like growth factor 1 receptor (IGF-1R) or its ligands,

IGF-1 and IGF-2. These dAbs are comprised of only a single variable domain of an antibody with a human framework and three complementarity determining regions (CDRs). Several of these antibodies inhibit the IGF signaling pathway so they may be therapeutic candidates for the treatment of IGF-related cancers.

Applications

A cancer therapeutic agent that inhibits the IGF-mediated signaling pathway.

A diagnostic employing the detection of insulin-like growth factor 1 receptor (IGF-1R) or its ligands, IGF-1 and IGF-2, in a sample.

Advantages dAbs are about 10-fold smaller than IgG antibodies and exhibit dramatically increased penetration into solid tumors. dAbs can be produced in high yields at low cost, have favorable biophysical properties, and are well suited to engineering. dAbs are bioactive as monomers or can be linked into larger molecules to create drugs with prolonged serum half-lives or other pharmacological activities. dAbs can be fused to other polypeptides or other drugs to provide fusion proteins or conjugates.

Human framework reduces potential for host immune reactions.

Market

Cancer is the second most common cause of death in the US, exceeded only by heart disease. Survival varies greatly by cancer type and stage at diagnosis. The most recent estimate of the economic impact of cancer is that it costs the U.S. some $228.1 billion annually.

Hence, there is a need for the development of medical products that can improve the treatment of cancer patients.

In the U.S., over 2.4 million new cancer cases are diagnosed yearly. A large proportion of these diagnoses are due to carcinomas of the breast, prostate, colon, lung, pancreas, and bladder.

Monoclonal antibodies are increasingly being used to treat these cancers leading to sales of $13.6 billion in 2008 with a market share of 28.6% of total sales.

Development Status: Early-stage development.

Inventors: Dimiter S. Dimitrov and Weizao Chen (NCI).

Publications: Chen W, Zhu Z, Feng Y, Dimitrov DS. A large human domain antibody library combining heavy and light chain CDR3 diversity.

Mol Immunol. 2010 Jan;47(4):912-921. [PubMed: 19883941].

Patent Status: U.S. Provisional Application No. 61/249,476 filed 07

Oct 2009 (HHS Reference No. E-232-2009/0-US-01).

Licensing Status: Available for licensing.

Licensing Contact: Whitney Hastings; 301-451-7337;

Whitney.Hastings2@nih.gov.

Collaborative Research Opportunity: The Center for Cancer Research

Nanobiology Program (CCRNP), National Cancer Institute, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize the dAbs that exhibit potent inhibitory activities against the human

IGF signaling pathway. Please contact John Hewes, Ph.D. at 301-435-3121 or hewesj@mail.nih.gov for more information.

Dated: July 2, 2010.

Richard U. Rodriguez,

Director, Division of Technology Development and Transfer, Office of

Technology Transfer, National Institutes of Health.

FR Doc. 2010-16800 Filed 7-8-10; 8:45 am

BILLING CODE 4140-01-P

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