CLDX

Celldex Therapeutics, Inc. (CLDX)

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Celldex Therapeutics, Inc. (CLDX)

Deutsche Bank dbAccess BioFEST

December 3, 2012 2:50 pm ET

Executives

Anthony Marucci - President, Chief Executive Officer and Director

Analysts

Robyn Karnauskas - Deutsche Bank

Presentation

Robyn Karnauskas - Deutsche Bank

Thank you for joining us. My name is Robyn Karnauskas. I am the Deutsche Bank biotechnology analyst. Thank you so much. We have with us Anthony Marucci, the President and CEO of Celldex Therapeutics. This is a company that maybe some people don’t know very well but they do have a data rich year, a catalyst rich here. So it's definitely a company that will have a lot of news over 2013. So thank you very much for joining us.

Anthony Marucci

Thank you, Robyn. Thank you for having us.

Robyn Karnauskas - Deutsche Bank

For those of you on the webcast who are listening, if you have any questions you would like to email me, please e-mail me at robyn.karnauskas@db.com and I am happy to read it anonymously.

So since, maybe, this is a company that some people are less familiar with that you have been around a long time, maybe give a little bit of your background since Medarex.

Anthony Marucci

Sure. So prior to our time here at Celldex, I was the treasurer at Medarex. Tibor Keller who is the cofounder of Celldex along with myself was head of preclinical development. So we spun the company out in late 2005. We took some of the Medarex technology with us to develop vaccines targeting dendritic cells.

We also have some licenses from the Medarex technology to create human monoclonal antibodies and then along the line through several acquisitions, one of them AVANT and another of CuraGen, we brought both soluble and complement inhibitors in-house as well as antibody-drug conjugates. So with that, six years into our existence, we have products now in Phase III, a couple in Phase II, and several others in earlier stages. So the pipeline is rounding up nicely.

Question-and-Answer Session

Robyn Karnauskas - Deutsche Bank

So your lead program in glioblastoma, you have two clinical trials ongoing Act IV and ReACT. Can you talk a little bit about, first of all, I guess, we should describe EGFRVIII as a target and then the timeline for those two trials so far.

Anthony Marucci

Sure. So, EGFRVIII is the most common mutation of EGFR. As we all know, it is a commercial molecule. It's an oncogene. So it's constituently active. The patients that have just used VIII have a worse prognosis of survival and on averages it's anywhere between 13 and 16 months of survival. We have run three Phase II studies in front-line glioblastoma and the results are quite consistent reaching 24 month timeframe.

Importantly, the long-term survival in the front-line glioblastoma has been very consistent as well. We just presented additional data at the Society for Neuro-Oncology in November where we showed the three-year survival rate for our three studies of in the high 20% to low 30% range versus historical controls which are in the 10% range. So we are getting that long-term tail that we believe could be very important in approval of the drug going forward.

Robyn Karnauskas - Deutsche Bank

When you think about little bit of the reactor, the refractory glioblastoma, what are your thoughts on the market opportunities there?

Anthony Marucci

We think the market opportunity in the recurrent could be as high as $300 million worldwide. Certainly with a 31% expression rate of VIII of these previous cancers we think that the market is very achievable as well as because we are the only ones going after VIII, especially in the vaccine setting. It's an area where we can control if we are successful.

Robyn Karnauskas - Deutsche Bank

So the 31%, like what population is that?

Anthony Marucci

So it turns out, in the U.S. to be approximately 4,000 patients that have VIII. Worldwide, it's much larger than that, according to Europe and other parts of the world.

Robyn Karnauskas - Deutsche Bank

Are there more greater percentage of the refractory patient population?

Anthony Marucci

What we are seeing is about consistent.

Robyn Karnauskas - Deutsche Bank

It’s the same.

Anthony Marucci

Yes. It's pretty consistent.

Robyn Karnauskas - Deutsche Bank

Perfect. Can you talk a little bit about the side effects with your therapy and any risk toward seeing any new side effects developed beyond what we have seen?

Anthony Marucci

Yes, the biggest side effect we see is that every patient who gets an injection site reaction, gets a fairly large swell. But it has been a pretty safe drug in the three studies that we have run, nothing is a showstoppers. So the toxicity profile on this program is very, very good.

Robyn Karnauskas - Deutsche Bank

What would be clinically meaningful for ReACT? What would be the great expectation for data?

Anthony Marucci

If we, obviously, can extend survival in this area. Avastin, they get approved on a 9.3 months survival in that point recurrent brain cancer. So the ReACT study has three arms to it. Group one being those patients that are both naïve to both Rindo and Avastin. So that would be the first recurrent arm.

Then the second arm is those patients that have recurred through Avastin and historically their survival has been four months. So if we can improve upon that that certainly would be a win for us.

Robyn Karnauskas - Deutsche Bank

And which patients are they around? Is the duration long enough when in the ongoing trial, do you think they actually see benefit?

Anthony Marucci

Read the rest of this transcript for free on seekingalpha.com