Celldex Therapeutics commences screening in CDX-1307 Phase 2 study for bladder cancer

May 17 2010

Celldex Therapeutics, Inc. (NASDAQ: CLDX) today announced that the first patient has been screened in a randomized Phase 2 study of the Company's novel, first-in-class antibody-based vaccine candidate from its Precision Targeted Immunotherapy (PTI) platform. This study will evaluate the CDX-1307 regimen in both neoadjuvant and adjuvant settings in patients with newly diagnosed muscle-invasive bladder cancers that express hCG-beta. hCG-beta is a tumor-associated antigen (TAA) expressed by several different types of cancers, including bladder cancer. hCG-beta appears to directly facilitate cancer progression and has been shown to correlate with poor prognosis. CDX-1307 is a fully human monoclonal antibody designed to selectively deliver the hCG-beta antigen to dendritic cells. The CDX-1307 vaccine regimen, which includes a novel combination of immune stimulating adjuvants, was developed during Phase 1 trials and has been shown to generate a robust immune response against cancer cells expressing hCG-beta.

“This vaccine offers the potential for an off-the-shelf technology capable of utilizing each patient's own dendritic cells. Newly diagnosed bladder cancer is an immunologically sensitive disease, and we believe the adjuvant setting provides the best opportunity for a vaccine to interfere with the disease process.”

"Bladder cancer is an understudied disease with a real need for new therapies and hCG-beta is an important molecule in tumor biology that prevents tumor cell death," said Professor Ray Iles, Middlesex University, London. "CDX-1307 may be a very useful adjuvant therapy in this disease."

"The CDX-1307 vaccine regimen provides a personalized and targeted intervention for hCG-beta expressing bladder cancer," said Tom Davis, MD, Chief Medical Officer of Celldex Therapeutics, Inc. "This vaccine offers the potential for an off-the-shelf technology capable of utilizing each patient's own dendritic cells. Newly diagnosed bladder cancer is an immunologically sensitive disease, and we believe the adjuvant setting provides the best opportunity for a vaccine to interfere with the disease process."

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