Celldex Therapeutics' CEO Presents at Deutsche Bank 39th Annual Health Care Conference - Transcript

May.11.14 | About: Celldex Therapeutics, (CLDX)

Celldex Therapeutics, Inc. (NASDAQ:CLDX)

Deutsche Bank 39th Annual Health Care Conference

May 7, 2014 11:20 AM ET

Executives

Anthony Marucci - Founder, President & CEO

Tom Davis - SVP & CMO

Analysts

Alethia Young - Deutsche Bank

Question-and-Answer Session

Alethia Young - Deutsche Bank

Alethia Young here one of the analysts on Deutsche Bank's biotechnology team. I am very happy to have with me Celldex Therapeutics and to my left I have Anthony Marucci, Founder, President and CEO; and to my right I have Tom Davis, SVP and Chief Medical Officer.

So we are going to be doing the fireside chat. So if there are any questions feel free on the webcast or in the room if you want to ask them anomalously email me at alethia.young@db.com -- a-l-e-t-h-i-a.young@db.com and also we will kind of be filled in for questions along the time. And we have some sort of random app, which I have not learned how to use yet, that's called doran.com/db. So if you would like to use that to offer up your comments feel free, I will figure how to use it along the way.

So with that I guess, I kind of just wanted to talk about like what your general views are and both of you on the immunotherapy things because it just keeps getting harder and harder. So just I know you guys have had a lot of experience in this space and for your own personal background may be I will start with you Anthony?

Anthony Marucci

Sure. I think we're at I think a real exciting time in the immunotherapy space. First, with the approval of the Yervoy a couple of years ago and now with these PD-1 that are poised to get approved and I think that's just the beginning. I mean, I said that on a number of occasions now we're just starting to scratch to surface what these kinds of agents can do and I think the next logical step as we've been saying all along is combination therapy. And that would include things like varli and other molecules both in our portfolio and outside our portfolio. So I just think it's an exciting time and I think over the next three to five years you can see a lot of important data points coming up.

Alethia Young - Deutsche Bank

And your view, Tom?

Tom Davis

When we first saw responses with Yervoy at Medarex it was clear that for the first time a single agent could actually impact the tumor quite dramatically, but it was a small percentage of patients. The 20% long-term survival that was announced recently from those Yervoy studies is quite exciting but there is plenty of room for improvement. So we are certainly very focused on the side of creating immune responses in order to make those checkpoints work better. Obviously a lot of people are very excited about it. I think it's a great time to be doing research in this area.

Alethia Young - Deutsche Bank

So just kind of talking on whether about -- where you're positioned and just a kind it will be broad question I'm talking about your asset and just given everyone in the room an overview and a reminder of the platform?

Tom Davis

Sure so rindo -- rindopepimut which is our lead candidate and GBM is currently in Phase III development that's in the registration study. We fully anticipate completing the full of that study middle towards the second half of the year. It's going to present 220 centers around the world in 25 different countries. Also we are using rindo into the current setting in a study called ReAct. So the Group 1 data well should be shown at Society of Neural Oncology in November and that's the randomized portion of the study.

Beyond those glembatumumab is an accelerated approval study in triple negative that study was initiated last December that's still on track to complete accrual in the first half of '15 with data readouts in the second half of 2015. And then as the year goes on with varli we will introduce a number of Phase II studies and expansion both in solid tumors and other indications we would like to work with the checkpoints there are other molecules that we are certainly looking at to start studies there as well.

1401, which is one of our vaccines is starting a Phase II study both in combinations with other molecules as well as chemo. So it's a really an exciting time for us and then lastly with glemba we are also looking beyond breast cancer and going into squamous cell lung and melanoma. So the pipeline is going to grow by leaps and bounce over the next 12 to 18 months.

Alethia Young - Deutsche Bank

And from a business perspective, do you think about kind of partnering assets or do you kind of like keep all the remaining of the assets you have in house?

Tom Davis

Well, certainly, strategically, you like to keep the assets for as long as you can, but also understanding that companies like ours and companies in general have bandwidth, which is certainly the assets are all owned at this point in time. We have probably stated that with rindo. We were going to take it over the goal line ourselves in the U.S. and North America and possibly look for partners outside of those areas and that I think will do the same thing with glamba.

Varli it's a little bit still too early to call. So we have a 100% of that asset but knowing that this is a molecule that can be combined with many different assets. So over the next year or two we will make a decision on that drug as well.

Alethia Young - Deutsche Bank

And may be just go back and talk as a background about discovery as like your discovery program and kind of how you developed just like immunotherapy platform?

Anthony Marucci

Okay. So this is basically again goes on what we did at Medarex during the early days. So by the time we spun out in '05 we were looking for different ways to use antibodies. So one of the ways was to target the dendritic cells, so we developed antibodies that targeted specific dendritic cells and that's what 1401 does it targets DEC-205 and you can conjugate an antigen to it or pathogen and have it work that way. Developing Ipi and PD-1 we would like those checkpoint type of molecules we thought that that was the future back then and so that's where 27 also came up on looked another on the other side of the T-cell.

So we look at a little bit more broadly. We don't look at one asset being the answer to the questions while we look at a number of assets that when you can combine them we will have a more comprehensive impact on the tumor. Tom, do you have anything.

Tom Davis

We certainly have lived all along with the immune system that ultimately going to give us at least part of it if not all of the best answer for cancer and ideally without toxicity and providing long-term survival the early hint is there but we just need a better understanding of many aspects of anything in response and we're trying to focus on all of those.

Alethia Young - Deutsche Bank

So and some of that rundle of it just kind of characterize where it's positioned in recurring glioblastoma and then give us an overview of kind of the Phase III that you've started with AC3 you started with a newly diagnosed population Act IV?

Anthony Marucci

Sure so in D3 it's expressed in approximately 30% of all brain cancers. So this drug will specifically go after that patient population and through literature and through our own experience we're seeing this molecule -- this target being especially aggressive in GBM regardless of whether you had a resection or surgery or not these patients tend to do worse, there is very little in the way of long-term survival, so the unmet need is there for this type of product.

And that this molecule -- what this drug does is basically wipeout those B3 cells in the tumor which therefore prolongs PFS and survival. What we saw in the ReAct study which is again now is recurrent brain cancer it was the first time that we actually went into a study setting where there was tumor burden on board. We've seen some patients on compassion that you said had tumor burden that we're able to help but this was the first study that we actually took on patients that had tumor burden. And the initial results that we showed last November show that there was a positive correlation when you combined rindo and Avastin versus Avastin alone. But again that data now needs to readout and we hope to at least show the full data set that's (inaudible) share. Okay.

Tom Davis

Certainly as far as positioning goes we are eager to see the actual data which will show us what our effect is upfront. So what I was most pleased about that with the early look at ReAct through the recurrent population is that we're getting very good immune responses and so activity in the patient population where nothing works and where people would have predicted that a vaccine like this was least likely to work.

I think we already have data that we justify using rindo in recurrent patients after they have had a front-line if our Act IV is positive. So that study has been tremendous value to us in expanding the indication over all.

Anthony Marucci

So from a positioning point of view the way the Act IV study is set up is there we're just treating to progression. What the ReAct study has shown us is that even in the recurrent setting this drug is having an impact on tumor. So perhaps the long-term use of this will be beyond progression of survival. So it just expands the potential use of the drug.

Alethia Young - Deutsche Bank

And so as far as what that correlates what's the most recent update on enrollment and how is that going to model with your expectations, Tom?

Tom Davis

So we are predicting completion of accrual by the middle of this year. So we are very close to finalizing that study. Our predictions around when data will readout are still based on relatively small numbers of events, but we believe we're right on track to have preliminary data for the first interim analysis at the end of this year early next and then final data late next year early 2016.

Alethia Young - Deutsche Bank

And then when you think about kind of the Avastin study -- study in this population kind of is that what you use as a guide to think about kind of the design of this trial or what's your guide in thinking of this trial?

Tom Davis

Well, we started to study before the Avastin data readout in front-line glioblastoma we were aware that it was coming and try to design as best we could to compensate for that. At the end of the day of course unfortunately Avastin didn't appear to have a huge impact on survival. So we ended up not having to make any changes at all. So this trial should work perfectly well in the setting of the current environment for Avastin.

Alethia Young - Deutsche Bank

And then, I guess going back to like last year November why is it -- what's the confusion around kind of the scan the different scan methods and kind of explain it sounds very good.

Tom Davis

Well the problem is that glioblastoma doesn't form a solid ball or something that you can clearly measure; it ends up having fingers that extend into the normal parts of the brain I know it's sort of a decent description but that's the reality. So when you look at it on an MRI scan you can't really tell exactly where the edges are. Now that ends up being very problematic when different radiologists do the measurements they need draw different lines and the tumor size can vary quite a bit. Now if the tumor goes away you know it, so you know you had a response and you just can't quantify the degree.

So I think anytime you're looking at response rates in glioblastoma you sort of have to you understand the variability in those numbers and how they may not be absolutely reliable quantitatively, but they still can be interpreted as benefit or no benefit from the shrinkage perspective.

So we clearly show up benefit, we saw some patients who had partial responses in the ReAct study but exactly quantifying how many is going to be a challenge we have to discuss with the FDA.

Alethia Young - Deutsche Bank

Then moving just kind of out -- moving into the commercial space with rindo like how are you kind of thinking about evolving that and when do you expect to start kind of ramping and building that for?

Anthony Marucci

So we are building a commercial infrastructure now slowly but surely. So we brought some high level executives in late last year and they are building -- doing all the work now. So they're doing a lot of work on reimbursement on distribution what's the best way to sell the drug and things of that nature. And then those studies will be probably finalized in the third and fourth quarter of this year. So our mindset is I would rather bring a team in now to do all the groundwork and then hit the ground running when the drug does get approved rather than wait, so we're taking those steps now.

Alethia Young - Deutsche Bank

And then just kind of in parallel like how it's -- what's going on in Europe and what's kind of the process out there?

Anthony Marucci

So again Europe is we're looking at that as well and obviously the EU in totality but we still have to look at individual countries there and again we're looking at what the bandwidth would be, what the capabilities and what the expectations are as far as field forces and so on and so forth. So we're doing that kind of work there as well as what the reimbursements will be. So having these number of sites that are in Europe on the study will be most helpful when we decided to get that point.

Alethia Young - Deutsche Bank

What are your general views just from reimbursement right now in the EU?

Anthony Marucci

Well, I think just like anywhere else if the drug proves that it's going to work you will get reimbursed. And I think there is going to be some kind of hybrid model down the road but I think we're still trying to figure what that model is going to be. But it's in our minds if the drug does what we think it's going to do and what it's done in the past we don't think there will be any problem with the reimbursement.

Alethia Young - Deutsche Bank

Okay. So with the level 27 right now is for Varli?

Anthony Marucci

Varli, yes.

Alethia Young - Deutsche Bank

I like it. What should we expect after this year what that data set?

Tom Davis

We presented preliminary data from the Phase I trial at Varli last year at the Society for Immunotherapy of Cancer. We will have more comprehensive data at ASCO in both groups. So the study takes patients with solid tumors, we've completed dose escalation there and have completed two expansion cohorts of 15 patients each in melanoma and renal cell. We will be able to present pretty much the entire data from that portion of the study.

Even with specific malignancies, we've completed the dose escalation up to 10 milligrams per kilogram and we will have a fairly comprehensive dataset on that entire population. We will also be talking about our plans moving forward as Anthony mentioned we are planning multiple Phase II, Phase I/II studies with Varli in combination with other agents and also considering some hematologic malignancies so that ASCO will be able to clarify exactly where we're going.

Alethia Young - Deutsche Bank

And so we will go -- are we -- still what do you thinking about kind of in combinations as kind of little bit more and might helping us experience on potential combinations with Varli that we're interested?

Tom Davis

So the key thing to understand with Varli is that it's an activating molecule it turns on an immune response. But in patients with cancer those immune responses are still going to run into the checkpoints. So all along we've known that we would not necessarily be overcoming the checkpoints but as you can imagine by using a checkpoint inhibitor really any of them that are currently available we should be able to improve the outcome. Those patients who receive a checkpoint inhibitor who don't have a good response likely or simply lacking the immune response in the first place and we hope to be able to provide it.

So our highest priority would be a combination with the PD-1 targeted agents those are probably the least toxic and most active agents out there right now, but obviously we need to establish a relationship in order to do that. We're actively doing it at this point but we don't have a clear story that we can tell you.

However, Ipilimumab is a very active drug in the space, we can and will combine with Ipilimumab in a dose escalation Phase II type trial and they will be looking for activity in the way of higher response rates, fast responses, and hopefully more patients with durable responses with long-term survival. That study will also include our 1401 vaccine. So we will be taking in NY-ESO positive patients vaccinating them in combination with 27 and then combing in with Ipi.

I'm personally quite excited about a combination with the B-raf neck inhibitors in melanoma you probably are familiar with the fact that they had very high response rates although not durable responses and that setting the treatment is killing tumor but the tumor can grow back however in killing the tumor it's releasing a lot of mutations and antigens that fairly could potentially create immune responses against. So by combining with the B-raf neck inhibitor we can create immune responses that are freed from freshly killed tumor but those patients will then go on to receive a checkpoint inhibitor and we could have an even more prudent effect in that setting.

We are also looking combining with chemotherapy in lung cancer combining with antigenic therapy in renal cell and again they are multiple possibilities in hematologic malignancies that we will decide upon when we results from the Phase I trial.

Alethia Young - Deutsche Bank

So we can expect a lot there by combination development over the next 12 months to 18 months?

Tom Davis

So I would think the end of next year or earlier the year after we will have a very comprehensive dataset in all of these indications and really how we think Varli works and where it can best be tested for approval.

Alethia Young - Deutsche Bank

Interesting. So as far 1401 which I think it's talked about a little just give us the basics one-on-one on it and the rationale and then we can go little more into the Phase I data? Hi, gentlemen.

Tom Davis

So people have known for some time now that dendritic cells were critical in generating an immune response. Actually Ralph Steinman form New York received a Nobel Prize for that several years ago. We had worked very closely with him and he had identified this protein on the surface of the dendritic cell called DEC-205 if something binds the DEC-205 its rapidly taken into the dendritic cell and very efficiently presented 10 times or 20 times more efficiently than the normal process where the dendritic cell has to find a target and basically heated and then presented. So this appeared to be a very efficient and practical way to target dendritic cells against tumor antigens and most importantly it's an off-the-shelf approach. So you can simply take a monoclonal antibody, we use the Medarex technology manufacture it with an antigen on the end 1401 specifically uses NY-ESO-1, which is a tumor target that's been recognized for quite some time now. It carries it to the dendritic cells inside the patients, activates them, and then creates NY-ESO immune responses.

We recently published manuscript of our Phase I study which showed that by doing this we did not generate toxicity and we generated very good humoral and cellular responses in advanced patients. What was most interesting in that study is that several patients went on to receive checkpoint inhibitors after completing the Phase I trial. Of six patients with melanoma who had NY-ESO positive melanoma and good immune responses four went on to have very good clinical responses, one complete response which is rarely seen with people in varlilumab and three partial responses.

And then there are also two patients with NY-ESO positive lung cancer who were shown that they were PDL-1 negative so population who is unlikely to respond to PD-1 targeted agents. Both of those patients had objective responses when they went on to receive a PD-1 targeted agent. So anecdotes that progress that was quite exciting to have initial signal suggesting the 1401 could also prime patients for treatment with checkpoint inhibitors and our goal is perform a similar study where 1401 could be combined with 27 and checkpoint inhibitors or could be used to create immune responses before the patients go on to get checkpoint inhibitors.

Alethia Young - Deutsche Bank

And so what's the next step of that program and when should we expect more data on 1401?

Tom Davis

So we will be doing a study that treats patients with 1401 first and then they go on to a PD-1 targeted agents again the specifics of that have yet to be released. But we are also working with the Natural Cancer Institute on the study that will combine 1401 with our dendritic cell growth factor and ultimately with 1127 in order to hopefully generate more prudent immune responses. Timelines on those we hope to start them both by the end of the year and we would hope to have data within 18 months to 24 months.

Anthony Marucci

So by the end of the year you could see a number of additional studies headed on to our pipeline including check points, vaccines and some other dendritic cell growth factors.

Alethia Young - Deutsche Bank

And then a little bit on 301, can you give us some mathematic rationale then we will go a little further? I guess its going to be Tom Davis?

Tom Davis

So 301 is a molecule that's otherwise known as Flt3-ligand it's not Flt3 (inaudible). It activates a growth pathway for hematopoietic stem cells, blood stem cells and dendritic cells. It's a very, very potent growth factor that has been used in the clinic and we've completed the Phase I with it ourselves that can increase the number of dendritic cells by 30 to 50 fold. Based on what I just described, I'm sure you can all imagine how while targeting dendritic cells you could benefit the net effect by vastly increasing the number of dendritic cells in the patient. And again with a 30 to 50 fold increase in DC we could have a much more potent presentation to create that immune response. But it also generates hematopoietic stem cells that are used for bone marrow transplantation and we clearly saw a 30-fold increase in those stem cells in our Phase I study.

So we now planning separately to use it has a single agent and in combination with Mozobil a stem cell mobilizer in hematopoietic transplantation space to see whether we can generate graphs more efficiently and graphs that will take into patients with less toxicity down the line. So there are dual pathways there the immune one and then the narrow transplantation setting but we will be starting those studies also this year with data reading out in about the same timeframe. As you probably figure it out it is going to be a very active year at the end of 2015 for us.

Alethia Young - Deutsche Bank

Any question from the audience. What is the potential for CDX-11 triple negative breast cancer product?

Anthony Marucci

Potential market wise or potential?

Alethia Young - Deutsche Bank

By pricing market wise?

Anthony Marucci

Sure. So our initial analysis that we have done market wise in the U.S. is between $400 million and $750 million of this drug. Triple, high expressing triple negatives makeup about 6% of the total breast cancer population and then when we go on to the do the full approval study high expressing gpNMBs and all breast cancers are going to be makeup about 20% of the population. So we think that that's a good market size for the drug.

Tom Davis

It's about to keep in mind the gpNMB is an independent marker from the other markers in breast cancer as best we can tell. So we are targeting triple negative because of the unmet need in that space and also because triple negative patients appear to preferentially over express gpNMB. But ultimately the drug should be effective in all high expressers in breast cancer, it's also highly expressed in melanoma and in lung cancer and we will be evaluating that in separate clinical trials in the next two years as well.

Alethia Young - Deutsche Bank

Here is another question. What is the hurdle for signing deals to do combination trials or CDX-1127?

Tom Davis

I mean as always it's a just a question of getting basically two companies to agree on terms and that's certainly been the key challenge. Anthony?

Anthony Marucci

It's a challenge and again these things take on life of their own. So that's why we never give timing on when any of these things will be done so when they're done they're done.

Alethia Young - Deutsche Bank

Can you think it's something that happens over the next 12 months?

Anthony Marucci

Again when it happens I will let you know.

Alethia Young - Deutsche Bank

A question for you kind of what's next on the platform over you have a lot of stuff going on but just kind of what's the next early stuff kind of coming on the platform.

Anthony Marucci

Yes, so the next early program coming out next year, which we think will be in the clinic is another antibody drug kind of gets called CDX-14. Again it's a fully human antibody it's conjugated to the CGEN; it's a product just the same as that Seterus. And the molecule is TIM-1 which is expressed pretty highly in both ovarian and renal cell carcinomas but I will let Tom talk about that science though.

Tom Davis

So again it's very similar to glembatumumab we would be delivering a toxin to these specifics in the types and we know that TIM-1 internalizes quite rapidly after an antibody binding. So it would seem to be an ideal target for this kind of technology that has already been validated with the Seterus and we hope it will be validated again with glembatumumab in the not so distant future.

So certainly in ovarian cancer, renal cell cancers still have unmet need space and we would be looking to see if we have single agent activity that could provide accelerated approval with this. So we are planning to file the IND and start the Phase I study next year.

Alethia Young - Deutsche Bank

In general the varying type of technology you believe that you need to acquire or license them?

Anthony Marucci

Well we are always looking at new technology and again depending on how we view them in combinations with some of the drugs we have we will certainly take a good look at them. But at this point we haven't seen anything that's bringing yet, but we're always looking.

Alethia Young - Deutsche Bank

And maybe I was just like but you kind of offer kind of your view vision for the company over the next couple of months and then also maybe I will just do the same thing with you Tom just kind of talk about your view and vision, because I mean you guys have a lot of different ways to target with the stuff going on. Sure may be I will start with Anthony.

Anthony Marucci

Sure our philosophy has always been that we thing the future is going to be a combination therapies. And I think now our portfolio is certainly going to come to provision as these combination studies come into play. We've always believed that we want to be able to fully immigrate this company become a commercial company at the end of the day. We were never interested in forming Celldex to do partnerships and license out our technology and just sit there to collect milestones and royalties.

So certainly we've always had the philosophy that the future of cancer is going to be these combination therapies in order to really control and have a comprehensive effect on these cancers and at the same time maintain economics as much as we can. So we've done that slowly but surely. We've been in existence since 2008 -- 2005, I'm sorry. We started out with six people and now we have 150 people in the company really good professionals that are expert in this area of both cancer development and immunotherapy development. So I think we are just hitting our stride now and I think over the next 12 months to 24 months we will see this really come to provision.

Tom Davis

Well certainly rindo and glemba have the potential to be single agent products in themselves in a proportion to have the data to apply for approval in the next two years then we can be a profitable company. But really Varli I think is most exciting because it does have the potential to augment with any treatment out there right now. And again our pre-clinical data suggest that we can improve our outcomes with chemotherapies with antigenic agents with small molecules as well as with checkpoint inhibiters and other immune mediated effects.

So there I hope that this next round of Phase II studies will give us a clear picture of what the true potential is and that could end up being a very, very important drug more broadly. And again 1401 and 301 I think fit in very nicely there we will be testing those combinations to see whether we can make a regimen two years is going to improve the outcomes.

Alethia Young - Deutsche Bank

Thank you possibly it's a super combination.

Tom Davis

Well I think we have our regimen in itself that could ultimately be the primary therapy from any different types of tumors.

Alethia Young - Deutsche Bank

So may be just couple about your discovery platform and like more looked under the shelf and the hurdle of it (inaudible)?

Anthony Marucci

Well, we don't necessarily have a discovery platform per se. I mean we have access to this human technology through our spin out of Medarex. The targets we have obviously came through us through an acquisition of CuraGen back in 2009. While we really have the ability to do is to make antibodies and that antibody is very, very well. So what we are in the lookout for now are companies that do have targets that are navel that we think are important and then we can make antibodies throughout the molecules to them. So I think what the real strength of Celldex is looking through and seeing what would be important as far as targets and other molecules that making those things happen, making the antibodies manufacturing them doing the pre-clinical testing them getting them into the clinic. And I think that's where our real strength is but a platform in and of itself we don't have a discovery platform.

Tom Davis

Well thank you for reminding me I would like to mention again around 1401 the vaccine that I described against NY-ESO that is the platform in itself, the platform technology wherein we can attach most any antigen that can be made in cells and we already have 1402 and 1403 which are next generation products that include multiple antigens.

Anthony Marucci

Right. And that's the separation. So we have technology but we don't have a discovery platform per se.

Alethia Young - Deutsche Bank

Thank you. And then just after coming up what are you guys kind of looking at what are you kind of have your eyes on as well as here in your space?

Anthony Marucci

Well it's going to be more data on these and we know oncology drugs so that will be interesting. We would also be looking at what other molecules have data as well. So because we're -- again we're looking to put some combinations together down the road and if not just going to be checkpoint inhibitors but there will be others, so we would be interested to see what kind of data comes out, but Tom can certainly talk about that in more detail.

Tom Davis

I think everyone agrees that the latest PD-1 data from all the companies will be most interesting there the IDO-inhibitors I think there is a lot of immune oncology that will be the focus of the meeting for the most part.

Alethia Young - Deutsche Bank

Great. So Anthony or Tom and if you have anything else to offer really appreciate your participation there.

Anthony Marucci

Thank you. We really appreciate you having us with you. Thank you.

Tom Davis

Thank you.

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