REDWOOD CITY, Calif., Dec. 8 /PRNewswire-FirstCall/ -- Genitope Corporation today announced the filing of two patents for the composition and use of a panel of monoclonal antibodies directed against specific epitopes in the variable regions of the B-cell receptor (BCR). The methods and materials described in these patents potentially represent a novel, personalized approach for treating non-Hodgkin’s lymphoma (NHL).
Genitope’s approach is based on the finding that even though each NHL patient’s B-cell tumor expresses a unique idiotypic surface immunoglobulin (the BCR), those immunoglobulins nevertheless have characteristics that are shared across predictable patient subsets. Genitope has developed antibodies that are reactive within patient subpopulations and are anticipated to be therapeutic.
“What’s particularly exciting about this approach is that it is more personalized and more targeted than current monoclonal antibody therapies for NHL, but lends itself to an off-the-shelf therapy that does not require customization,” said Dan W. Denney, Jr., Ph.D., chief executive officer of Genitope.
The concepts in these patents stem from Genitope’s commitment to developing personalized therapies for the treatment of NHL, and build on work performed in the laboratory of Dr. Ronald Levy at Stanford University Medical Center in the 1980s. Dr. Levy and colleagues demonstrated the ability of anti-BCR monoclonal antibodies to reduce tumor burden and induce remissions in NHL patients. A number of these have been long term remissions. Dr. Levy’s original approach, however, was not commercially feasible.
Genitope has developed a panel of monoclonal antibodies that bind to BCR proteins based on their particular genetic makeup. Because there are a finite number of variable-region genes that B-cells draw on to form the mature BCR, it is possible to classify NHL patients into subsets based on which variable region is used by their particular tumor. This allows for the production of monoclonal antibodies that are off-the-shelf while still personalizing the treatment for each patient.
“We believe this is the next generation of passive immunotherapy for treating B-cell NHL,” said Denney. “Our approach targets only the subpopulation of the patient’s B-cells that share the same variable region as the lymphoma, which should leave the majority of the B-cell repertoire of the patient’s immune system intact. We believe this approach represents a significant advance over current monoclonal antibody therapies.”
The patent filings specifically cover the panel of BCR-reactive monoclonal antibodies as well as aspects related to their development, the diagnostic screening and sub-classification of patients based on BCR variable-region utilization, and the therapeutic use of the monoclonal antibodies alone and in synergistic combination with MyVax(R) Personalized Immunotherapy.
“If the monoclonal antibodies developed at Genitope prove to have anti-tumor effects similar to those seen at Stanford, they could eventually be used in conjunction with MyVax(R) Personalized Immunotherapy and might reduce or eliminate the need for chemotherapy in the early treatment of NHL,” Denney said.
In addition to these patent filings, Genitope is actively working to complete the initial development of the monoclonal antibody panel and production of clinical-grade material. The company intends to file an investigational new drug (IND) application in 2006 and initiate clinical trials thereafter.
About Genitope Corporation
Genitope Corporation (Redwood City, Calif.) is a biotechnology company focused on the research and development of novel immunotherapies for the treatment of cancer. Genitope Corporation’s lead product candidate, MyVax(R) Personalized Immunotherapy, is a patient-specific active immunotherapy based on the unique genetic makeup of a patient’s tumor and is designed to activate the patient’s immune system to identify and attack cancer cells. For more information on the company, please log on to http://www.genitope.com.
Forward-Looking Statements
This news release contains “forward-looking statements.” For this purpose, any statements contained in this press release that are not statements of historical fact may be deemed forward-looking statements, including all statements regarding the potential clinical development and efficacy of Genitope Corporation’s proposed monoclonal antibody panel and the potential for this monoclonal antibody panel to represent an advance over current monoclonal antibody therapies. Words such as “believes,” “anticipates,” “plans,” “expects,” “will,” “intends” and similar expressions are intended to identify forward-looking statements. There are a number of important factors that could cause Genitope Corporation’s results to differ materially from those indicated by these forward-looking statements, including without limitation, risks related to: the fact that Genitope Corporation has not yet begun clinical testing of its proposed monoclonal antibody panel, the progress, timing and results of Genitope Corporation’s proposed clinical trials, Genitope Corporation’s need for additional funding, the manufacturing of Genitope Corporation’s proposed monoclonal antibody panel, Genitope Corporation’s and third parties’ intellectual property positions, competition from other pharmaceutical or biotechnology companies, growth and dependence on key personnel and the need for regulatory approval for the commencement of clinical trials and potential commercialization of any product candidates, as well as other risks detailed in Genitope Corporation’s filings with the Securities and Exchange Commission, including the Quarterly Report for the fiscal quarter ended September 30, 2005. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Genitope Corporation undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof.
Genitope Corporation
CONTACT: Media: Lisa Waters, +1-323-202-1051, C: +1-310-593-3443,lisa.waters@edelman.com, for Genitope Corporation; or Investors: John Vuko,Chief Financial Officer of Genitope Corporation, +1-650-482-2000,IR@genitope.com
Web site: http://www.genitope.com/
