Celldex Announces Plans to Release Topline Results from the EMERGE Study in Advanced Breast Cancer
--Webcast scheduled for May 23--
NEEDHAM, Mass.--(BUSINESS WIRE)--
Celldex Therapeutics, Inc. (NASDAQ: CLDX - News) today announced that interim, topline results of the Phase 2b EMERGE study of CDX-011 in patients with advanced breast cancer will be presented in a webcast on May 23, 2012. Linda Vahdat, MD, Professor of Medicine, Chief of Solid Tumor Service and Director of the Breast Cancer Research Program at Weill Cornell Medical College and the lead investigator of the EMERGE study, will join Celldex on the webcast to discuss data from the study. Webcast details will be provided at a later date.
Celldex anticipated presenting these topline results at the American Society of Clinical Oncology (ASCO) 2012 Annual Meeting. Due to a clerical error in which the incorrect submission category was inadvertently selected in the on-line ASCO submission form, the abstract for the EMERGE study was not considered for acceptance. Celldex attempted to rectify this clerical error but was informed that no exceptions are made to the submission policy.
The randomized, multi-center, controlled EMERGE study was initiated in September 2010 and completed enrollment in December 2011. 124 patients were enrolled and randomized (2:1) to receive CDX-011 or “Investigator’s Choice” single agent, approved chemotherapy. The primary endpoint of the study is overall response rate. Secondary endpoints include duration of response, progression-free survival, overall survival, safety, and pharmacokinetics and pharmacodynamics analyses. The data in the study continue to mature and the Company expects final data will be presented at a future medical meeting.
CDX-011 is a first-in-class, next generation antibody drug conjugate that targets a Celldex proprietary target, glycoprotein NMB (GPNMB). GPNMB is believed to promote breast cancer metastases and its expression is generally associated with a poor prognosis. Patients in the Phase 2b study were stratified for GPNMB expression patterns and a significant portion of the patients enrolled in the study had triple-negative disease.
About CDX-011:
CDX-011 (glembatumumab vedotin) is an antibody drug conjugate (ADC) that consists of a fully-human monoclonal antibody, CR011, linked to a potent cell-killing drug, monomethyl-auristatin E (MMAE). The ADC technology, comprised of MMAE and a stable linker system for attaching it to CR011, was licensed from Seattle Genetics, Inc. The ADC is designed to be stable in the bloodstream. Following intravenous administration, CDX-011 targets and binds to GPNMB, a specific protein that is expressed in breast cancer and other tumor types, and which promotes the migration, invasion and metastasis of breast cancer. Upon internalization into the targeted cell, CDX-011 is designed to release MMAE from CR011 to produce a cell-killing effect. CDX-011 has been shown to be well tolerated and active, with observed objective responses in two positive Phase 1/2 trials in metastatic breast cancer and advanced melanoma. In May 2010, the U.S Food and Drug Administration (FDA) granted Fast Track designation to Celldex’s CDX-011 for the treatment of advanced, refractory/resistant GPNMB-expressing breast cancer.
Looks like they won't be at ASCO but we will get the data earlier.
