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Celldex: Preparing To EMERGE


In the United States, the most common cancer among women is breast cancer, and it is the second leading cause of cancer death in women. The American Cancer Society estimates that about 39,510 women will die from breast cancer this year.

Developing a targeted immunotherapy for advanced breast cancer is biotechnology company Celldex Therapeutics Inc. (CLDX), and given the fact that there is a clinical trial catalyst event coming up, the stock is worth watching.

For readers who are new to Celldex, here's what to expect...

The company is scheduled to announce interim, topline results of a phase 2b study of CDX-011 in patients with advanced breast cancer on May 23.

CDX-011 is the company's first antibody-drug conjugate product candidate for the treatment of locally advanced or metastatic breast cancer and stage III and IV melanoma. CDX-011 targets glycoprotein NMB, or GPNMB, a protein overexpressed by multiple tumor types, including melanoma, breast cancer and glioma. CDX-011 has a fast track designation from the FDA for the treatment of advanced, refractory or resistant GPNMB-expressing breast cancer.

The phase 2b study of CDX-011 in patients with advanced breast cancer, dubbed EMERGE, was initiated in September 2010. The study is fully recruited with 124 patients who were randomized to receive CDX-011 or an approved chemotherapy. The primary endpoint of the study is overall response rate while secondary endpoints include, duration of response, progression-free survival, overall survival, safety, and pharmacokinetics and pharmacodynamics analyses.

The final data from the study will be presented at a future medical meeting.

Apart from CDX-011, the other compounds in Celldex pipeline are:

* Rindopepimut (CDX-110), an immunotherapeutic vaccine for glioblastoma multiforme, the most common and aggressive form of brain cancer. A phase III study of Rindopepimut in patients with surgically resected EGFRvIII (epidermal growth factor receptor variant III)-positive glioblastoma, dubbed ACT IV, was initiated last December. The same month, a phase II study of Rindopepimut in combination with Avastin in patients with recurrent EGFRvIII-positive GB, dubbed ReACT, was also initiated.

* CDX-1127, a fully human monoclonal antibody that targets CD27, which is over-expressed in certain lymphomas and leukemias. An open label, dose-escalating phase I study of CDX-1127 in patients with selected malignant solid tumors or hematologic cancers was initiated in November of 2011. This year, Celldex anticipates completing the phase I study and initiating a phase II study of CDX-1127.

* CDX-1401, which is under phase I/II testing for multiple solid tumors. Exploring the potential for collaboration with academic/research institutions for future development of CDX-1401 is on the cards this year.

* CDX-301, a protein that stimulates the growth of bone marrow stem cells and certain immune cells. The company is focused on developing CDX-301 for hematopoietic stem cell transplant. A phase 1 study of CDX-301 in healthy subjects was initiated this January.

* CDX-1135, which is being assessed for renal disease, and CDX-014 for ovarian and renal cancer, are under preclinical testing.

A quick look at the company's balance sheet...

Celldex has had no commercial revenue to date from sales of its human therapeutic or vaccine products. Revenue is recognized from product development and licensing agreements, product royalties, and contracts and grants.

In 2011, the company incurred a net loss of $44.79 million or $1.13 per share on revenue of $9.26 million. That compares with a net loss of $2.53 million or $0.08 per share on revenue of $46.79 million in 2010.

As of December 31, 2011, the company had an accumulated deficit of $205 million, and cash of $53.3 million.

Shares of Celldex have traded in the range of $2.05 to $5.66 in the last one year. The stock is currently trading at $4.59, up 0.67%.

by RTTNews Staff Writer

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