Celldex Therapeutics, Inc. (NASDAQ: CLDX) today announced the results of
a positive Phase 2 study of CDX-011 (formerly CR011-vcMMAE), in patients
with heavily pre-treated, locally advanced or metastatic breast cancers.
As presented today at the 32nd Annual CTRC-AACR San Antonio Breast
Cancer Symposium, the primary efficacy endpoint for the study has been
met with significant antitumor activity in patients whose tumors express
the target GPNMB. In addition, encouraging results were seen in patients
with “triple-negative disease” where treatment options are relatively
limited due to lack of hormone receptor or HER2-neu expression.
CDX-011 is the first candidate from the Company’s antibody-drug
conjugate (ADC) platform, which utilizes fully human monoclonal
antibodies to deliver the potent cellular toxin, MMAE, directly to tumor
cells by targeting GPNMB. GPNMB is a glycoprotein frequently expressed
in a number of tumor types and associated with cancer progression and
recurrence. CDX-011 uses the Seattle Genetics MMAE ADC technology, which
has established a very promising antitumor effect in advanced clinical
studies.
“As seen in this study, treatment with CDX-011 can induce disease
regression and stabilization,” said Thomas Davis, M.D., Senior Vice
President and Chief Medical Officer of Celldex Therapeutics. “We are
very encouraged to see such positive results in patients with triple
negative disease – or those with advanced, refractory and heavily
pre-treated breast cancers -- where there is a clear unmet medical need.
Moving forward, we are planning expanded Phase 2 development focused on
patients with tumors expressing GPNMB.”