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Celldex Therapeutics' CEO Discusses Q2 2012 Results - Earnings Call Transcript

GPNMB is an internalized glycoprotein that has been identified in multiple malignancies and has been reported to be presented specifically in 40% to 75% of all breast cancers. In breast cancer there has been a marked correlation with high expression and poor outcomes including metastases and death. This is particularly true in the triple negative breast cancer population.

The Phase IIb study of randomized EMERGE study was designed by Celldex to help us understand the role of CDX-011 could play in treating patients with GPNMB expressing breast cancer. Earlier work in both breast cancer and melanoma clearly signal that CDX-011 could play an important role in GPNMB expressing cancers. A further study was needed to identify the most responsive patient populations and their corresponding GPNMB expression pattern.

While CDX-011 demonstrated a consistent response profile in comparison to our prior studies in breast cancer, we now have new insight in for the drug’s ability to elicit more pronounce response rates in the predicted patient substance.

Preliminary results from the EMERGE study suggests that CDX-011 induces impressive response rates compared to the commonly available therapies in patients with advanced refractory breast cancer and with high GPNMB expression defining as expression equal to greater than 25% of tumor cells and in patients with triple negative.

In the high GPNMB expressing patient population, treatment with CDX-011 resulted in a 32% overall response rate which includes both confirmed and unconfirmed responses, whereas treatment in the Investigator’s Choice single-agent chemotherapy ARM resulted in the 13% response rate. CDX-011 also demonstrated strong response rate in patients with the extremely difficult to treat diagnosis of triple negative breast cancer across all levels of GPNMB expression with a CDX-011 overall response rate of 21% compared to a 0% response rate for Investigator’s Choice.

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