Celldex commences CDX-011 Phase 2b trial in advanced breast cancer patients expressing GPNMB

Celldex Therapeutics, Inc. (NASDAQ: CLDX) today announced that the first patient has been treated in a randomized Phase 2b study of the Company's CDX-011 (glembatumumab vedotin) antibody drug conjugate in glycoprotein NMB (GPNMB) expressing advanced, refractory breast cancer patients. CDX-011 targets the protein GPNMB, which is over expressed in a variety of cancers including breast cancer, melanoma, and brain tumors.

“This Phase 2b trial will target patients whose tumors express GPNMB and is anticipated to include a significant proportion of patients with difficult-to-treat triple-negative tumors. It will build upon the positive Phase 1/2 trial which demonstrated encouraging activity in both of these patient subsets.”

"The CDX-011 antibody drug conjugate provides a targeted intervention for GPNMB expressing breast cancer, including patients with triple-negative disease" said Tom Davis, MD, Chief Medical Officer of Celldex Therapeutics, Inc. "This Phase 2b trial will target patients whose tumors express GPNMB and is anticipated to include a significant proportion of patients with difficult-to-treat triple-negative tumors. It will build upon the positive Phase 1/2 trial which demonstrated encouraging activity in both of these patient subsets."

The study is a randomized, multi-center, controlled trial that will enroll 120 patients with heavily pre-treated, advanced breast cancer who are unlikely to benefit from any approved therapies and whose tumors are confirmed to express GPNMB via a validated, centralized diagnostic assay. It is anticipated that a significant portion of the enrolled patients will have triple-negative disease, since GPNMB is frequently expressed in this patient population. Patients will be randomized (2:1) to receive either CDX-011 or single-agent "Investigator's Choice" chemotherapy. Activity endpoints will include response rate, progression-free survival (PFS) and overall survival (OS). The study will be conducted in approximately 25 academic and community sites across the U.S. Preliminary results are expected in Q4 2011.

In May, the U.S Food and Drug Administration (FDA) granted Fast Track designation to CDX-011 for the treatment of advanced, refractory or resistant GPNMB-expressing breast cancer.