$$CLDX Upcoming Phase 2b data for CDX-011 on 12/8

I've been holding Celldex $5 December Call options for about a month now, they took a bit of a hit during the recent Biotech sell off but have rebounded very nicely. 



For others in $CLDX I've tried to collect as much data as I could find.  If you have additional data or comments please let me know and I can add it.

At their last quarterly review Celldex stated they would be presenting further (more mature) data from the randomized Phase 2b Emerge study of CDX-011 at the San Antonio Breast Cancer Symposium in December.  At the recent Lazard Capital Markets Healthcare conference, Celldex CEO, stated

" ... So I think at San Antonio we will present the more mature datasets as well as more data as what we can find from the study. We will also then talk about your plans for going forward with this program, and in addition besides metastatic growth we also believe that there is activity in melanoma as we saw in the phase I, II study. We saw a 15% response rate there. Now that Yervoy and Roche’s drug have gone through the melanoma pipeline, we see a space for ‘11 perhaps in third line of melanoma. We also see opportunities in lymphoma, Osteosarcoma in small cell lung as GPNMB expression in those three indications seems appropriate." 


For transcripts of the conference and other Celldex drugs under development go here:  Lazard Conference Celldex Transcripts

Based on the schedule from the San Antonio Breast Cancer Conference website seems that he poster session will occur on December 8th at 7:00 CST.  Please see below for more details on the schedule.

http://sabcs.org/ProgramSchedule/PosterSessions.asp?SessionGroupID=125

P6-10-01 A randomized phase 2 study of the antibody-drug conjugate CDX-011 in advanced GPNMB-overexpressing breast cancer: The EMERGE study 

Some background:

Celldex's CDX-011 is their leading drug candidate presently in ph2b trials for treatment of metastatic breast cancer.



CDX-011: Consists of an antibody attached to a drug, monomethyl auristatin E (MMAE), that can kill cancer cells. The antibody delivers the drug to cancer cells by attaching to a protein called glycoprotein NMB (GPNMB) that is expressed on the cancer cell. The MMAE is then released inside of the cell, where it interferes with cell growth and may lead to cell death.

Phase II trial of CDX-011 versus Investigator's Choice (IC) in patients with GPNMB-positive advanced/refractory breast cancer.

http://clinicaltrials.gov/show/NCT01156753

Initial PR Released by Celldex in May 2012
Celldex May 2012 PR

from the PR "Preliminary results suggest that CDX-011 induces impressive response rates compared to current, available therapies in patients with advanced, refractory breast cancers with high GPNMB expression (expression in e25% of tumor cells). In this high expressing patient population, treatment with CDX-011 resulted in a 32% overall response rate (ORR; includes confirmed and unconfirmed responses), whereas treatment with Investigators Choice (IC) single-agent chemotherapy resulted in a 13% ORR. CDX-011 also demonstrated strong response rates in patients with triple negative breast cancer across all levels of GPNMB expression (CDX-011 ORR of 21%; IC ORR of 0%), where treatment options are extremely limited."


Below is a link to a nice technical summary article from Chimera research published on seeking alpha.

Seeking Alpha article

Financially as of September 30th Celldex reported cash, cash equivalents and marketable securities of $77.6 million, which the Company believes will be sufficient to meet estimated working capital requirements and fund planned program development into 2014.

Disclaimer:  I'm Long CLDX