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Celldex Therapeutics, Inc (CLDX)
2012 Lazard Capital Markets Healthcare Conference
November 11, 2012 9:30 AM ET
Anthony Marucci - President & CEO
Ryan Martins – Biotech Analyst, Lazard Capital Markets
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Thank, you Ryan. Good morning everyone and thank you for joining us this morning. As always I’m pleased to have this opportunity to discuss Celldex and our story, our pipeline and how certainly we’re positioning ourselves as a leading biopharmaceutical company going forward. Before I begin this morning I just want to let you know that I will be making some statements that are forward looking in nature. So I would like to refer everybody to our SEC filings where we discussed these risks and uncertainties in more detail.
As I have said in previous presentations, Celldex is pioneering the development and application of novel recombinant therapeutic proteins in a variety of unmet needs. Our platform technology has improved several important product candidates which we are now moving into late stage clinical development.
The combination therapy approach that we have developed at Celldex allows us to selectively and optimally combine proprietary antigens, human therapeutic antibodies, drug conjugates and immunomodulators, so highly differentiated and effective targeted therapies for patient populations that will certainly benefit the most.
We have a great deal of expertise in the company from an area of development of these therapeutic proteins. We also have the infrastructure in house to develop the antibodies and the modulators ourselves. And as we discuss our pipeline today I’d like to remind everyone that we are well positioned from a cash perspective to strongly and effectively move forward this pipeline as we ended the quarter with more than $77 million in cash and certainly allows us to get well into 2014.
As you can see from the pipeline, it is very well staged, a variety of clinical development programs. For today’s presentation I’d like to focus in on four of the programs. Rindo obviously in GBM both in frontline and recurrent, discussion of CDX-011 which is our antibody drug conjugate, just finished up a study in metastatic breast, 1127, which is a proprietary human antibody that targets CD-27 and then briefly I’ll touch on CDX-1135 which is an ultra orphan indication and dense deposit disease using our viable complement inhibitor targeting C-3 and C5.
So let’s get started by talking about why Rindo is important to us and why the target EGFRvIII is important as well. As I’ve said in previous discussion, vIII is highly tumor specific. It’s only expressed in tumors and not in normal tissues. The target has been validated now and several clinical trials that we have conducted and also is gaining greater importance as a tumor marker by outside researchers.
Historically, these vIII patients have not done very well at all. The median survival has been in the area 13 to 15 months, with very few surviving beyond 3 years. With our validated assay which we are currently developing with LabCorp for the Phase III study, we’re comfortable with saying that 31% of patients do express vIII and you can see the incidents rates in the US and in the EU bring it to approximately 13,000 new incidences every year.
We are the only drug that are developing this specifically for vIII that’s targeting this disease. We have a strong proprietary IP position for the target as well as combination therapies and mechanisms of actions. We have fast track status in the US as well as often drug status in both the EU and the US.
These are data here that we first presented in 2010 and then obviously updated data last year and again this year we will update this data at the Society of Neuro-Oncology meeting, which will be held in Washington DC later on this week.
As you can see from this chart, all three studies from Rindo, Act III, Act II and Activate have shown very consistent survival data and very consistent survival data at two years as opposed to where you can see this historically matched control where the survival was approximately 15 months and the two year survival was 6%.
What we plan on presenting this year as Celldex to give heads ups to everyone is more long term survival. So these two years, three years and potentially even longer will be updated. We will also have data presented from outside consortiums that have run studies that include vIII patients and you’ll see some data from those studies as well. So this historically matched control group will certainly be updated with a much larger data set population.
I go to the Capital Meyer curves, again this important from our perspective that these curves will also be updated. So what we’re looking to see is how our data match out long term. I think these tails that had been formed from the Activate study in green, the Act II data from the blue curves and now the ACT III study in the red curve. We want to see how those match out and we’re comfortable that this drug is really having an impact on patients’ longer term and you can see much large, longer than the historical match control groups.