Treatment and Diagnosis of Chronic Lymphocytic Leukemia (CLL), Breast Cancer, and Other Cancers through Use of a Monoclonal Antibody

CHALLENGE:
Today there are a variety of treatment options for cancer, but many are non-specific, which results in normal cells being destroyed along with the malignant ones. Anemia, fatigue, immunodeficiency, and vomiting are just a few side effects of chemotherapy. Current monoclonal antibody lymphoma treatments most B cells in the patient, thus crippling the immune system. Rare infections and skin cancers can result. Moreover, a specific marker for Chronic Lymphocytic Leukemia (CLL) does not exist on the market today. Patients ‘wait and see’ if the symptoms progress in the early stages of the disease before a diagnosis is made. Instead of being treated immediately, the disease could lurk for years. Detection of residual disease after therapy is problematic as well.

SOLUTION/TECHNOLOGY DESCRIPTION:

• This novel technology is a way to diagnose and treat CLL, breast cancer, and other cancers. A monoclonal antibody has been generated by UCSD against a receptor which is implicated in the progression of cancer. This protein named ROR1 is expressed on CLL B cells, but it is not present in normal lymphocytes.

BENEFITS:

• Potential to diagnosis cancer at an earlier stage and residual disease due to the increased efficiency by detection of a single, specific marker rather than multiple nonspecific antigens
• Potential cancer therapy with a reduction of side effects due to the increased specificity
• Potential more effective cancer therapy due to the disruption of the receptor in the pathogenesis of the disease
• Potential method for monitoring the course of a cancer therapy and for detecting minimal residual disease

• Potential vehicle for the delivery of current drugs due to the specificity
• Potential combination with AD-CD154 gene therapy

FEATURES:

• Monoclonal antibody reacts with ROR1 on the surface of CLL cells
• ROR1 is expressed on lymphoma cells, including in CLL, small lymphocytic lymphoma, marginal cell B-Cell lymphoma, Burkett’s lymphoma, and other cancers (e.g. breast cancer), but not on normal cells.
• ROR1 is implicated in the pathogenesis of cancer
• Humanized antibody for monoclonal antibody therapy

MARKET POTENTIAL/APPLICATIONS:
The American Cancer Society reported that 10.1 million people in the US have or had cancer. Moreover, another 1.4 million patients will be diagnosed this year. While there are many therapy options available, the long term survival rate for most forms of cancer is still below 40%.

Another source estimated the total global cancer market to be worth over $42 billion (US dollars) in 2005 with a growth rate of 12.6%. By 2010, the market is expected to surpass $60 billion (US dollars)*.

Of the total market, breast cancer is one of the most prevalent with 1.2 million cases in the world**. The US alone spends $8.1 billion dollars for the treatment of breast cancer each year.

There are approximately 300,000 cases of leukemia in the world**. CLL is the most common form of leukemia in the western world, and the number of patients who are affected is growing by 1.9% per year. In the US alone, the CLL market was worth $153 million in 2005***.

* Researchmarkets.com; ** International Agency for Research on Cancer (IARC); *** The Gale Group

DEVELOPMENT STATUS:
This technology is offered exclusively or nonexclusively in the US and/or worldwide territories. A commercial sponsor for potential future research is sought.

United States Patent Application: 20070207510

UCSD RESEARCHER:
Dr. Thomas Kipps, M.D., Ph.D., is a professor of medicine, the chief of the Division of Hematology/ Oncology at the UCSD School of Medicine, and the Deputy Director of research at the Moores UCSD Cancer Center. He is also the director of the National CLL Research Consortium and associate director of the UCSD Gene Therapy Program.

TECHNOLOGY-RELEVANT PAPERS AND WEB LINKS:
Tetsuya Fukuda, Liguang Chen, Tomoyuki Endo, Li Tang, Desheng Lu, Januario E. Castro, George F. Widhopf, Laura Z. Rassenti, Mark J. Cantwell, Charles E. Prussak, Dennis A. Carson, and Thomas J. Kipps. Antisera Induced By Infusions of Autologous Ad-CD154-Leukemia B Cells Identifies ROR1 as an Oncofetal Antigen and Receptor for Wnt5a. Proc Natl Acad Sci U S A. 2008 Feb 26; 105(8):3047-52.

Bedside-to-Laboratory Translational Work Identifies Novel Tumor-Specific Antigen, by John C. Byrd, M.D. The Hematologist Ash News and Reports, May 2008.

http://cll.ucsd.edu/biographies/kipps.htm
http://health.ucsd.edu/news/2008/2-12-cll.htm

Case No: SD2005-212
Key Words: cancer, therapy, chronic lymphocytic leukemia, CLL, lymphoma, breast cancer, diagnostic, diagnosis, treatment, monoclonal, antibody, drug, ROR1.
Inquiries To: invent@ucsd.edu