Celniker Gets Eleven Bio Ready For OIS and Conference Season

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Eleven Biotherapeutics last spring issued some disappointing news when its leading project, EBI-005, didn’t fare well in a Phase III trial for Dry Eye. However, the company’s AMP-Rx platform is chugging along and its EBI-005 is making progress against other conditions including allergic conjunctivitis. CEO and President Abbie C. Celniker, PhD, updates OIS Podcast listeners on the pipeline and shares how the company is preparing for the oncoming conference season, which starts with OIS.

Podcast Guest

Podcast Transcript
Tom Salemi: Hi, welcome back to the OIS Podcast. Hard to believe it is time for OIS@AAO. On Thursday we will see you at Planet Hollywood in Las Vegas for what will be our largest OIS ever. If you haven’t been before, this would be a good time to go. If you haven’t registered before and you’ve been before, you might want to show up. So we’ll see you on Thursday morning starting at 7:30 at the Planet Hollywood in Las Vegas. But today we’re going to, in honor of the start of our main event, we’re going to meet with Abbie Celniker of Eleven Biotherapeutics. She is the president and the CEO, and Abbie and I had a conversation about big meetings like OIS and JP Morgan and others. It is meeting season, conference season for ophthalmology. Abbie is warming up to present at OIS. She’ll also be presenting at JP Morgan and other major ophthalmology events going forward. So Abbie talks a bit about the conference season and also brings us up to date on Eleven Biotherapeutics’ pipeline. Last visited with Abbie earlier this year when there were some hopeful thoughts for EBI-005 in dry eye, but unfortunately that did not pan out. But Eleven still has a robust pipeline and is moving forward. So please listen in. See if Abbie will reveal her favorite secret meeting spot at JP Morgan in San Francisco, and if she doesn’t, then at the end of the Podcast I may share mine. So thanks for listening, and again, we’ll see you on Thursday morning at the Planet Hollywood Hotel in Las Vegas for OIS@AAO.

TS: Abbie Celniker, welcome back to the OIS Podcast.

Abbie Celniker: Thanks, Tom. Great to be here.

TS: You’ve joined an elite group of return guests to the Podcasts, so I hope that makes your day.

AC: Oh, absolutely. Looking for running a hat trick maybe here.

TS: I would love to have you back. So it’s hard to believe that OIS and AAO are upon us. How has your life been as an ophthalmology company the last couple weeks, and how does it change once the conference season, the meeting season starts?

AC: Well, I think that one of the things that’s really great about being in ophthalmology is we continue to see a lot of interest in the therapeutic area. Still see a lot of unmet need, and all of the companies are making great progress in moving their programs forward in the clinic. So it’s a real exciting time to be in ophthalmology right now. And I think the way that we get ready to move into the meeting season is really refining the points that we want to make sure people understand about our products and our pipelines, and really making sure that the stories are crystal clear, and it’s really clear that we’re working in areas of high unmet need. And so I think that that’s really what we’ve been focused on, will be presenting at OIS, and certainly be talking to a lot of people at the AAO meetings. And as you move forward into the year, they’re always looking forward to the data readouts that you have coming up that will allow you to continue to present and communicate your story.

TS: Who is your primary audience at an AAO? Are you exclusively focused on reaching out to the clinicians because they’re there with you in that big building? Or is this really just a show for Wall Street because you’re a publicly traded company?

AC: Well, no, no, it’s definitely not the show for Wall Street. I think that’s JP Morgan.

TS: That’s a good point.

AC: So I think that the AAO for us hits maybe 3 main objectives. One objective is that we’re always doing clinical development, and AAO is really just the great opportunity to get together with the key opinion leaders and your investigators to both give them updates about the programs that they’re currently working on, thinking about programs that you’re actually planning, and getting their ideas for what are some interesting opportunities for the future. So that’s one of our objectives at AAO. Also at AAO, it’s very important for us to be able to communicate with other companies. And there’s always opportunities for companies to collaborate with each other, so AAO is a great opportunity for us to meet our colleagues from other companies and who are thinking about maybe even complimentary types of collaborations that we could put together. And then finally, I think that OIS is a unique opportunity at AAO because it does bring together entrepreneurs who have new ideas, things that eventually could make a difference in how we’re thinking about developing things. It brings together the investment community, and more recently, some focus on publicly traded companies and public investors makes that a really interesting and useful destination for us. But also, you know, at OIS you see and hear a lot about trends and how different things can be considered as far as how the FDA is thinking about things, how people are thinking about things outside of the US. So AAO and OIS tend to be a really productive time for us.

TS: And what do you try to accomplish on the floor with your booth at AAO? Give me some insights on that. You don’t have any products to sell yet, but someday soon. What message are you trying to get out to folks?

AC: I think the message is that we’re getting out when we’re really just out and about talking to folks at AAO is that we’re really committed to the idea that there is a need for innovation in ophthalmology. There is an increasing incidence of ophthalmic diseases with the aging population. There are co-incident ophthalmic diseases with diseases such as diabetes and other chronic inflammatory diseases. And we’re seeing it on the rise. And we don’t want to just be putting the same molecules to work in different indications, when they all possibly associated with either less efficacy than you’d like or greater safety issues than you’d like. And so we want to send the message that innovation is really important, and that we have a proprietary platform that we can apply towards developing innovating protein therapeutics which have been very well validated as potentially the most transformative approach towards treating ophthalmic diseases, even when we think about the approach that people are taking with gene therapy. Gene therapy is a way of delivering proteins, and it’s really telling you how key and central protein therapy is towards treating the unmet needs in ophthalmology. So that’s really the message that we’re getting out there, and we need clinicians to understand that because we need their support in thinking about the best way to get these developed, and understanding the patients who have the highest unmet need.

TS: Great point. And you mentioned the show of shows, JP Morgan. What are your objectives when you go there? I mean that is just obviously gotten so massive that it’s for me at least, it’s almost – obviously no one goes to the show anymore, but it’s almost so busy that it’s even hard to get meetings with people, or the right people. You’re a CEO of a dynamic young company, so I’m sure you have a far easier time. But what will you be doing at JP Morgan, and have you reserved your table at Starbucks yet for $50 or whatever the company charges?

AC: Yeah. What’s interesting is that the circumference of the area of meetings at JP Morgan has grown tremendously.

TS: That’s true.

AC: And thank goodness San Francisco has kept up with renovating their different neighborhoods to accommodate that. No, I think for us, JP Morgan – I agree with what you’re saying Tom, is that JP Morgan has become so big and so diverse that it’s not essentially a clear objective for any single company on why they’re there, other than you’ve gotta be there. So I do think you have the opportunity to speak to investors. I think that there is a great opportunity to really network and get to know the people who are trying to maybe get into ophthalmology because sometimes there’s companies that are not yet in ophthalmology, bigger companies, and they are often somebody who we look to collaborate with. So there’s great business development opportunities at JP Morgan. Yes, we certainly set space aside to make sure that we have meeting places that we can meet with investors that are our current investors or investors in the future. But also, interestingly enough, what we’ve really found over the last several years is that there’s more and more people that are in the general sort of service areas as well, so you can even meet several who might be a great partner in manufacturing sometimes, or a really good commercial partner at some point in time. So it’s a very productive 5 or 6 days because everybody is in one place. So even just walking up and down the streets, you can have that right meeting. So you just gotta be there.

TS: absolutely right. Do you have the secret coffee spot that you know you can get a table at, but you won’t tell anyone else about it? I have one.

AC: Well, as long as you’re early, and I lived in San Francisco for a while, so I have some insights. I’m not sharing that with you, though.

TS: No, of course not, no. I’m not telling you mine, either.

TS: We’re going to take just a quick, quick break from this conversation with Abbie to remind you it’s this Thursday. Come to OIS@AAO at Planet Hollywood. Go to OIS.net for all the information you’ll need. Now back to the conversation with Abbie.

TS: Let’s talk about Eleven. Since the last time we spoke, last time we spoke, EBI-005 was still moving forward in dry eye. Obviously in the spring, after OIS, you reported the disappointing news in the phase 3 trials. Bring us up to date on that, and what has that news meant for your company? What changes have you undergone since then?

AC: Yeah. So I think that whenever you go into a big pivotal program, you understand that the company is facing a pretty significant business impact if things aren’t as you anticipated them to be. So once we understood that the data from the first phase 3 trial was not moving in the direction that we had hoped it would, we just immediately changed our focus to allergic conjunctivitis, which was clearly an indication we had started to invest in and studied prior to the readout. We’d always known that we were going to be studying both allergic conjunctivitis and dry eye. As a matter of fact, we like to always remind people that the first data that was really generated to demonstrate that IL-1 was a key component to ocular surface inflammation were studies that were done in animal models of allergic conjunctivitis. So we probably knew that that was an important indication even sooner than we thought about dry eye. So I think that obviously it’s very important for a company to be flexible and resilient, and I would say that my team is incredibly flexible and resilient, and immediately folks changed gears and really got themselves focused on the AC trials. We got those trials up and running in what I would say is about record time, and complete enrollment, which is what we announced just recently. So we’ll be reading out the first allergic conjunctivitis phase 3 trial in the first quarter of 2016. So we’re pretty excited about how fast we were able to move with that. We did truncate our safety study that was initiated in general support of our ocular surface inflammation program. It had been designed more specifically to the dry eye program, but based on conversations we had had with the FDA, we were optimistic that the same trial would be very supportive of our clinical development program in allergic conjunctivitis. And so we did truncate that study so that we weren’t necessarily taking it forward at the full spin that it would have been executed against with the dry eye program. And we will have a readout from that program in the first quarter of 2016 as well. So we’re very excited about AC. We like the fact that in allergic conjunctivitis there is a single stimulus that initiates the IL-1 mediated inflammatory response. It’s an allergen binding to an ITE molecule and stimulating mast cell T granulation and the activation and recruitment of other cells. That’s something that is very predictable. And with dry eye, I think we all know that it’s a very heterogeneous disease and it’s a disease that’s initiated by many different stimuli and has underlying etiologies of different diseases. So AC in a lot of ways is a lot more straightforward disease to be developing in. So we’re anxious to see the readout from that trial. And if that data is favorable, we’d be moving into our second phase 3 trial in 2016 with a targeted BLA filing in 2017. So we’re just really excited about how that program is moving forward. We’re also continue to be very focused on the development of EVI-031. So that is our novel IL-6 antibody, so an antibody that blocks the binding of IL-6. And it blocks it differently than the other commercially available antibodies against IL-6 in that it’s very potent and very comprehensive blocker. But additionally, we’ve engineered it so that when it is injected in the back of the eye, between the potency and how we’ve engineered the antibody, it has a longer vitreal retention. And that should translate into fewer intravitreal injections compared to standard of care for other intravitreally injected therapeutics like anti-VEGF. So we’re very excited about the pharmacokinetics properties of this molecule. But very importantly, we’re excited about recent validation of the role that IL-6 plays as a target in diseases such as uveitis and the cystoid macular edema that accompanies uveitis. So there were some studies done with an anti-IL-6 receptor antibody by Roche and by others, and it demonstrated blocking IL-6 systemically with that antibody, demonstrated some very favorable and pretty unique efficacy in reducing cystoid macular edema. And so from our perspective, that’s validating a target that we have been working on for a number of years and have really been committed to, and now we’re very excited to move that molecule forward into clinical trials for both uveitis as well as diabetic macular edema. And so again, from our perspective, it’s all about keeping focused on moving forward with these very innovative protein therapies. So you’re question about how did the company change in response to sort of at least our lead indication changing from dry eye to allergic conjunctivitis, and the answer is really it didn’t change much. We’d always run a very lean team. We’d always brought in extremely experienced senior drug developers who are experts in both ophthalmology and biologics, and that allowed us to just switch gears very quickly and continue developing. We did have one senior person leave the company, and he just was moving on, I think, to take on an opportunity in a different therapeutic area in a company that has already established a commercial infrastructure. So that really didn’t have anything to do with the readout, per se. So like I said, the company really hasn’t changed. Moving forward, very aggressively with our AC and 031 trials, and our research group continues to work on our AMP-Rx platform and leverage our understanding of what impacts sort of an antibody or a protein’s ability to be an optimal therapeutic for the back of the eye, and that’s where we’re really focused now. And we’re even considering some pretty well validated targets like VEGF in how we might be able to create differentiated molecules with our platform.

TS: Terrific. Greg Perry left as CFO and Chief Business Officer, was it, and you sort of split those roles into two people now?

AC: That’s correct. So when Greg left, so Gary Sternberg, who joined us from Genentech a couple of years ago, Gary was actually running the medical affairs group for Lucentis while he was at Genentech, so he is an ophthalmologist and a drug developer. But he’s also done business development over the years. So he had joined us and had been working for Greg. And when Greg moved along, Gary just stepped into the Chief Business Officer role, and already established amazing connections with a variety of strategic partners in the ophthalmology area. And then John McCabe, who had always been sort of our principle financial officer, has just taken on the financial roles that Greg had overseen.

TS: Sounds great. Final question. Going into AAO, take off your CEO cap for a second. What are you anxious to see? What booth might you walk over to to see what’s going on?

AC: Well, I think that right now one of the things that we’re very interested in are technologies and therapy approaches, therapeutic approaches that deal with things like patient compliance. As we get into sort of this, again, we’ve talked about the aging population, more patients who are developing glaucoma, more patients who need to be compliant with their administration of or having their anti-VEGF therapies administered in order to get the maximum impact, were really excited to see what people are doing to achieve better delivery and more consistent exposure, so that they enhance patient compliance. That’s something that I think we’ll be interested in looking around and hearing and seeing more about. I think that we’re all interested to see how the gene therapy companies are going. I think it’s an interesting niche that is going to be important for some diseases, but I don’t think it’s the panacea that maybe Wall Street thought it might be. And so it’ll be interesting to see the progress that the gene therapy companies are making. And I think that it’s going to be extremely interesting to see what clinical data is coming out, really thinking about what the missing link is in more effective therapies for diabetic macular edema and uveitis. So we’re very excited to see more of the data looking at the role that IL-6 plays in uveitis.

TS: And I should also ask about OIS. Anything interesting – it’s all interesting, but does anything interest you the most as to what we’ll be bringing up that day?

AC: Yeah. You know, I’m really interested to see sort of where the private investors are thinking versus public investors. I think that that’s one of the things that’s really interesting when you look at how companies grow up in this business. We all know sort of how that works in some different therapeutic areas, but it’s been a long, long time since ophthalmology companies working in the therapeutic space as opposed to the device space have really been able to transition from private to public companies. And there’s been quite a few of them in the past couple of years. So it’ll be really interesting to see if that’s changed the way private investors think. It’s going to be interesting to see if the public investors have a difference of opinion than maybe they did a couple years ago when they started investing in this area. So I think that’s what’s really going to be interesting at OIS, is now that there’s a good distribution of both public and private companies, it’s going to be interesting to see what’s happening there. I think it’s also going to be interesting just to hear about healthcare in general. And when we think about ophthalmology and chronic diseases, where does that sort of hit on the radar screen of healthcare costs and how payers think about things. It’s really important for us to understand that as we think about developing the target product profiles of our drugs. And so hopefully, we’ll get some insights about that as well.

TS: Terrific. Well, I look forward to seeing you there, and think you for joining us on the Podcast.

AC: Great. Thanks, Tom. Appreciate it.

TS: Thank you, Abbie Celniker for joining us on the OIS Podcast and for giving us some insights on how CEOs deal with this busy conference season. And also, although you weren’t willing to share your secret spot, I’m willing to reveal mine at JP Morgan. On Post Street, I’ve never had trouble finding a table at Café Lataza. LATAZA. Very good coffee, very good food, and usually a table. Probably not any more. But anyway, we’ll see Abbie Celniker and Eleven Biotherapeutics, and I hope you at OIS@AAO coming up on Thursday. Again, this will be our largest OIS ever. I’m not quite sure why you wouldn’t be there. So we’ll see you in Las Vegas.