Celldex Therapeutics, Inc. Announces Presentation Of New EGFRvIII Expression And Clinical Data At The Targeted Immunotherapeutics And Vaccine Summit
Dr. Wong presented data around his novel and sensitive polymerase chain reaction (PCR) detection method to identify patients whose tumors might benefit from the use of CDX-110 investigational immunotherapy. Specifically, Dr. Wong's data demonstrate a high incidence of the EGFRvIII mutation in tumors from patients with colon, breast, and ovarian cancer. Dr. Wong also reported on the Phase 1 studies in patients with ovarian and prostate cancer at the University of Washington led by Dr. Bruce Montgomery. This trial demonstrated that active immunotherapy with EGFRvIII peptide was well tolerated and induced specific immune responses in patients that expressed the mutant receptor.
"These findings, that utilized a novel and clinically-relevant detection method, indicate the presence of EGFRvIII in other cancers in addition to glioblastoma. Further clinical trials to evaluate immunotherapy targeting the tumor specific EGFRvIII mutant are strongly suggested," said Dr. Wong.
"We are very encouraged by Dr. Wong's findings, as they confirm our belief that an immunotherapy targeting the tumor-specific EGFRvIII mutant has the potential to provide a therapeutic benefit across various cancers beyond glioblastoma," said Robert F. Burns, Ph.D., President and CEO of Celldex Therapeutics. "We plan to submit a protocol for a definitive Phase 2/3 clinical study in glioblastoma as well as a Phase 2 clinical trial in ovarian cancer with our lead product, CDX-110. We plan to commence these two clinical trials by early next year."
About EGFRvIII
EGFRvIII is a tumor-specific variant of the EGF receptor, originally found and cloned from glioblastoma multiforme tumors. Subsequent clinical work has demonstrated that EGFRvIII can also be found in other types of solid tumors. EGFRvIII has been detected in non-small cell lung, breast, ovarian and metastatic prostate cancers; however, it has minimal expression in normal human tissues. EGFRvIII is uniquely found in tumors with no significant presence in normal tissues; a characteristic considered to make it an ideal target for tumor immunotherapy.
About Celldex Therapeutics, Inc.
Celldex Therapeutics, Inc. is a biotechnology company focused on developing fully human antibody-based products that target and stimulate the body's immune system for the treatment of cancer, infectious and autoimmune diseases. The Company's lead product, CDX-110, is scheduled to have entered a definitive Phase 2/3 clinical trial for the treatment of newly diagnosed glioblastoma by early 2007. Celldex has three product candidates already in or about to enter clinical development targeting multiple cancers as well as Hepatitis B. Four additional product candidates are in preclinical development for cancer and autoimmune disease. Celldex's proprietary technology platform uses fully human monoclonal antibodies administered directly to patients to target and stimulate dendritic cells -- key cells within the immune system. Celldex was formed in 2004 as a spin-out from Medarex, Inc (Nasdaq: MEDX - News) and in October 2005, acquired Lorantis Limited and the assets of Alteris Therapeutics, Inc. The Company has operations in Phillipsburg, New Jersey and Cambridge, UK. For more information, please visit the website: http://www.celldextherapeutics.com
Source: Celldex Therapeutics, Inc.