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Business as Usual: Knopp Biosciences CEO

Today's Business as Usual, will feature one of Pittsburgh's top life sciences companies -- Knopp Biosciences. President and CEO Michael Bozik will detail how the vision of Knopp is to change the course of human health. It targets diseases imposing high costs on the healthcare system, with patient populations clearly identifiable using validated biomarkers or genetic testing. Knopp is also committed to expanding the drug discovery and development industry in western Pennsylvania. The Pittsburgh area is home to some of the nation's most significant and well-funded research institutions, creating a favorable environment for the biopharma industry. Bozik will explain how Knopp plays an important role in expanding the region’s capabilities and reputation as a premier location for bioscience commercialization.

 

 

 

Transcription: 

Good afternoon, everyone. This is Audrey Russo, President and CEO of the Pittsburgh Technology Council welcoming everyone to today's business. As usual, I'm also joined by Jonathan kersting. He's vice president of all things media, and marketing and on the team in the tech Council. And by the way, he's just celebrated 23 years with the tech Council. So he knows a lot about what's been happening in the ecosystem. And thrilled to have all of you here, I would like to just give a shout out to Huntington bank for their long standing partnership and belief in our work. If you don't know anything about them, go to their website, and you'll find out all the things that they do and how they support both small and large businesses, as well as their civic mindedness in our community. So today's are 100 and 31st session business as usual, which we launched at the beginning of the pandemic, to help keep the community connected and informed and to showcase some of the world changing innovation that is occurring right here in Pittsburgh. So it's been fun, it's exciting. And I actually thought that we would only do this for two weeks. Little did I know that we're now entering our third season, we just started fall. So it's pretty, it's pretty crazy. And we're trying to provide as much relevance as possible and keep the community tethered. So we've muted your microphones just to make sure that there's no sound in the background to interrupt our guests. And then we also have the chat session enabled, Jonathan's gonna keep his eyes peeled on that to make sure that we have some time to talk with our guest and answer some questions. So today's program, and I'd like to welcome Michael bozak. He is the President and CEO of canape bio sciences. And we just realized that we've known Mike for about a dozen years. And I'm very excited to do a deep dive with him because I think you're going to be really proud to hear about the work that they have been, you know, just diligently working on. It's pretty amazing. So welcome, Mike, welcome to be a you and before we talk about cannot let's just sort of set the stage and talk about who is Mike a little bit about your background, because it's really interesting. And I think it will be inspiring for others to hear about your own professional journey.

Oh, thanks, Audrey. And thanks to Pittsburgh Technology Council for the invitation is a great opportunity to be so happy to give you the sort of the thumbnail sketch. I am a physician by training actually was trained in neurology and neuro oncology at the University of Pittsburgh and the Cancer Institute here and was a academic physician scientist, paddle lab, director of the brain tumor Center at the Cancer Institute, and it's sort of always been oriented toward trying to develop treatments that are difference makers. That led me to, to leave the university in 1998 to head up the CNS, the neuroscience clinical development group at Bristol Myers Squibb where I spent the next seven years in in various roles and made my way back to Pittsburgh. When I met the founders of canape Tom pettinger. And Greg, he bring can up was, I don't know, company number four or five hours of Tom's launch site. Group. And it was a natural fit for me because the focus was on developing a solution initially for a really important medical disease where there's a high unmet need, which is which is Lou Gehrig's disease. So, I'm delighted to have made my way back to Pittsburgh, my wife was from Pittsburgh was even more delighted, made her way back to Pittsburgh, so I happen to be here.

So how did how did you sort of make this kind of pivot like to become an entrepreneur?

Yeah, so interestingly, when I was at Bristol Myers Squibb, my initial role, heading up the neuroscience clinical development group, more often and in a, in a in a larger in a different role, heading up aren t at our specialty form of business. And during that transition, they actually decided to shelve a lot of the neuroscience programs, including one that is akin to what we're working on today. It's not and the head of CNS marketing and the head of CNS science but then I got together we said, we should try to spin out a company and do this So so we had an internal plan at Bristol Myers Squibb had some funding, the short version is that we got close. But it was decided it wasn't a good corporate move. And, and but that that sort of gave me an exposure to, you know, what it would be like to take the really the, the lessons learned that you get really great institutions like the University of Pittsburgh, or Bristol Myers Squibb and apply you know, your lessons, learn your best practices in an environment where you don't have the encumbrances that also come from, you know, large institutions.

Well, good. I mean, not a lot of people make that kind of transition so successfully. So, you know, just wanted a peek inside to understand usually, you know, scientists following a methodology, and then sort of the craziness in the iteration of entrepreneurship that doesn't necessarily follow the same path. So thank you for that. And tell us about the history of canonical, you know, what about some of the pivots that you've made along the way, you know, sort of take us through the journey?

Sure. So as I mentioned, Konami was founded in 2004. And it was initially an als comparison diagnostics company. And Tom and Gregg named the company cannot neurosciences at the time because the pit the founder or the patient who actually supported the initial research was a man in a local Pittsburgh entrepreneur named Walter canape. They, they named the company that after Walter because his gift, supported the the initiating technology that was licensed around this diagnostic technique that led to a conversation with an investigator at the University of Virginia, Jim Bennett, who had a drug that potentially could be used to treat dexpot and Paxil, that's when I got involved. I did the diligence on the drug, it seemed to be promising, you know, the brass ring that any that I have always been looking for, personally, professionally. It is, is a drug that's a difference maker. And this had the potential to do that we thought we could sort of that was sort of the first major shift in sort of business strategy. And we moved from a diagnostics company to a therapeutics company. We raised between 2006 and 2009, in in two series of fundraises $10 million in series a $30 million in a Series B. That's London, the development of decks crema Paxil, as an als therapeutic through phase one in 2007, to phase two in 2008, and 2009, and to a large license with Biogen Idec in 2010, who took over responsibility for the phase three study. We that was an important point in the company history because we used the proceeds from that to fund a second program that I'll I'll talk about today that is sort of reaching finally the maturity stage which is our our neuroscience, ion channels focused, epilepsy focused program. Unfortunately, in Biden's hands between 2010 and 2013, they didn't replicate the the ALS result we recovered the rights to dex brown packs on and and then this produced the next major focus one. We we had to endure a you know, what, in many instances is a catastrophic phase three failure. We have some loyal investors who supported our ability to pivot the company to an observation resolve, which is the experiment Paxil turns out to be a drug that lowers a depletes a cell called the ESN. Bill. And anybody that's watching TVs these days might have noticed commercials and do you know what your your Senate Bill is? And it's an it's a white blood cell that contributes to inflammation and in particular asthma exacerbations. So when that knowledge sort of emerged between 2007 and 2013, when we were developing Textron, Paxil, we pivoted the company and had been exploring Textron and Paxos potential as a treatment for innocent afflicted sore. So that's

the that's this announcement about the completion of the enrollment in phase two. Is that what that?

Exactly? Yeah, so the way Last week, we announced that we completed enrollment in a in a phase two asthma study. When we finished, when we got the rights to get Paxil back from Biogen Idec, we needed to demonstrate the east end of the law. And we had seen in ALS patients who have normal levels of obese animals, it actually is relevant in patients who have high levels of vehicles. So we have done two proof of concept studies. Between the before we started this, this asthma study, and the proof of concept studies were in a condition called hypereosinophilic syndrome, which is sort of a non malignant, isn't about leukemia, it's a proliferation of cells. It's a bad disease. It's an orphan disease, with very high levels of use in adults and only corticosteroids as a treatment. And the other one was, sinusitis with Nasal Polyps, these are sort of these, this, these polyps below your nose, you can't breathe, feel congested, and they're filled with the US Senate bills. And what we showed in both of those studies is that we the profound ESN of belonging, we saw an als actually occurs in these patients as well. And these, we published the results of these studies and and in HGS, this hypereosinophilic syndrome, we actually had some patients that went into complete disease remission. So we know it's an app to drug loading, isn't it pills, we've seen some clinical evidence of early evidence of clinical benefit. And that led us to start a this asthma study a year ago, we've completed enrollment, and we expect to have the top line results early in 2008. So

what what I always find fascinating is, first of all, what is the target population? I mean, what's the what's the number, you know, give us an example of, of how many people are affected by these conditions?

Yeah, what two comments and the short answer your question about how many people are affected? About half the people with asthma, which is 25 million in the US 25 26 million have an ear Sena philic type of asthma? And the your question actually is a really important one as we think about drug development in 2020. Versus, you know, 1995, when I was at the Cancer Institute, where we really had not fully unlocked the power of one the human genome and an understanding the genetics of medicine, and understanding sort of the the fact that when we say something like asthma, as it is that we think of it as one disease, it's actually many diseases. And the ESN. endo type is one subset of that. of the patients that have that about a million patients have severe asthma, meaning they're at high risk for these asthma exacerbations. They're on inhaled corticosteroids and a long acting beta agonist. And that's along with patients with moderate disease, which is another 2 million. So they're about 3 million patients that that really need a solution to this. This is cynical a component.

And so would it have applicability to people who don't have that, and but they have asthma.

We, we don't know. But it's less likely. The drug that we're developing text problem, Paxil is an oral drug in contrast to every other approved treatment for the phenotype of the disease, but none of those drugs directly, relaxed, smooth muscle. So you know, the inhaler that you take relaxes and smooth muscle, the airways dilate, and you can breathe more easily. They have an indirect effect by reducing inflammation and have a modest effect on relaxing the airway, but they make it less predisposed to, to sort of tightening up and giving an asthma attack. So if you don't have that driver of inflammation, that's the Senate Bill. We don't have any reason to believe that it would be beneficial and non

okay. And anything, anything that's happening with COVID in terms of the impact of people who are in this condition, because I would think that

Yeah, yeah, great, great question. So, you know, like the PTC has doubt is in their third season, a business as usual, as, you know, it was anything but businesses as usual for us, in the pandemic, and so on. We actually, the study would started in September of 2019, we suspended enrollment in the middle of March and resumed at the, at the end of May, early June. So it did slow us down. Fortunately, the patients that were in the study, we were able to, to keep in the study, and, and, you know, there's patients with certain pre existing conditions are more vulnerable to covid. And certainly asthma or any respiratory disease is one of those. So, you know, we'd like to think that by if we actually are improving lung function and and reducing the risk of these asthma attacks, that that the being on the drug may have, may have conferred some benefit. We're able to resume the study very. So along with a lot of other assumption activities in June, and we completed enrollment, as we announced last week.

Wow. It's, it's, it's good. I'm glad to hear that they're continuing that that didn't hamper your journey for because for many it has. So that's great. So beyond the work in asthma, cough has been pursuing novel drug treatments to multiple other immunological and neurological diseases. So can you describe some of that? Can you talk about any of that?

Sure. So on the immunology side dextra backs is a unique drug, but it's really a plat we call a platform in a product so its potential to be directed to inflammatory disorders is not limited to asthma. So yes, clinical plays a role in in a wide variety of diseases like this hypereosinophilic syndrome there's there's a condition that's become very prevalent called Eastern up look at Safa gyrus, which is very troublesome, there may be there may be some people on the on the broadcast today that that are affected by it, but it's it's it's a condition where you have pain, swelling and swallowing and it's a very debilitating condition. There are other gi conditions there. Another condition A atopic dermatitis or eczema is associated with isn't about infiltration of the skin. So we will be exploring after this asthma study. Our plan is to broaden out the potential use of techmount Paxil in a host of of these immunologic disorders at our heart and in terms of our The, the sort of expertise of the company, we really are the neuroscience company. We were founded as a neuroscience company around Lou Gehrig's disease. Our Chief Scientific Officer headed up the ion channels program at Bristol Myers Squibb. And that's why in 2013, we introduced this this second plank of our of our business and which is our what's called it's called kV seven k for potassium V for voltage gated seven for the seventh type of passing channel, that is this voltage gated channel. And we actually recruited a chemists from around the country, we recruited biologists from around the country, and we have our own sort of homegrown Discovery Program that now has yielded a, a drug candidate that we hope to be in, in clinical development with the second half of next year for a rare genetic pediatric epilepsy.

Well, we're gonna get to some of your people in a minute. But But I want to just talk about I just want everyone to understand that that the obviously this work is sophisticated, it takes a lot of high skills. You have a variety of people that work on your team, and how many people are working, like give us like a profile of what your team consists of?

Yeah, so we have 21 people working at canape. Now. About 12 of them are in the lab. So we have five, full time. Five full time medicinal chemists, we have five full time biologists plus our Chief Scientific Officer and a sort of a, an informatics person, the data that you need to be able to collect, analyze and interpret you know, is very sophisticated and the the sort of multiplexing of the of the tools that we use. It requires a lot of technology implementation, Are you hiring

at all?

We're not hiring currently. But, you know, we certainly, you know, had the plan going gone, according to script. Back in, in 2013, you know, we had hoped actually to, of course, most importantly, for the patients have a drug that worked in Gehrig's disease. But sort of looping back to the beginning of the conversation. One of the reasons I left Pittsburgh in 1998, to pursue a career in the biotech pharmaceutical industry was not because I wanted to leave Pittsburgh with you know, we have incredible healthcare and, and life sciences capabilities. But there really was not a, an ecosystem, a biotech ecosystem. And so part of the goal for us is, is to meet with success. And to keep the company in Pittsburgh, I mean, Tom has lots of experiences here. But we were told very early in 2005, when we were licensing a drug by a local expert in this area, it's like, why would you want to do a life sciences company in Pittsburgh, you know, you should take it to Boston, and we have a different point of view. And the goal would be to see six, you really have to get a drug, either, you really have to get a drug approved, and you have to have, obviously, in business revenue. That's our goal. You know, we, we we aspire to, you know, become a company that can anchor itself grow, and sort of be that, you know, if we could be the, you know, the that for Pittsburgh, you know, the jet as Genzyme was to Cambridge, which, you know, if you went to Cambridge, right, in the late 80s, early 90s, it looks like the Southside of Pittsburgh, and today, it's just, it's, it's, you know, biotech center.

Hmm. That really back in the 80s or 90s.

Yeah, yeah. I mean, you know, when when Genzyme and Biogen which are really the two anchor company there, um, you know, when Copaxone knuckles maximum, I'm blanking on the name right now of Biogen sort of their beta interferon beta, Sarah, um, you know, it did, it was just a bunch of empty warehouse. And in today's

main lobby now

what, what I think everyone needs to understand if they don't know already, is that if you can hear from Mike about the tenacity that it takes to do this kind of work. And, you know, you're really in this for the long haul, and raising money is, you know, a really integral part of the work that you do, obviously, you can find grants here and there, you know, obviously, there are certainly, you know, initiatives but revenue generation doesn't come, you know, quickly in this process. So, can you sort of just tell us about, you know, what, what's the climate like? I mean, even now, what's the climate like in terms of, you know, raising money being in life sciences being in, you know, pharma, etc?

Yeah, I mean, I think they're, you know, there's the climate in Pittsburgh, versus the climate in in Boston, or the Bay Area.

ls Yeah. Your your, your view?

Yeah. So I mean, the, the climate in Pittsburgh is a challenge. Now. Now, we have been fortunate over the years to our paid in capital, at this point is over 100 million dollars. So you know, that that's a reflection of the, you know, the magnitude of the capital that's required to, to try to accomplish what, what we are trying to accomplish. You know, the, our investment has come from outside of Pittsburgh, largely, we started out, of course, with some Angel funding, but it's largely been outside of Pittsburgh, the environment for biotech. If you look at the amount of money that's going into biotech, it's unprecedented amounts of money, and it's, it's large amounts of money. So there is capital that is out there. And at the end of the day, what we learned with the biogenetic transactions if you have a compelling story and a compelling product, You will get investment from that. And so we that occurred for us when we had the the phase two als results. The, you know, again, went back to what was announced at the time, you know, the license that we signed with Biogen Idec included a $90 million upfront and that that could have we elected to do that license instead of raising the capital to do the phase three, study ourselves. But if you have a product, either a strategic investor, or you know, some of these, you know, the Orban meds and the RA capitals and the Wellington's they will invest when there's when there's a compelling story. And what we hope that post the asthma study is that we will have a compelling story to tell,

well, let's you're being a little too modest. It's not just a compelling story. It's the the amassing of a team that people bet on. And they bet on leaders and they bet so it's a twofold bet. So I mean, I just I know you weren't gonna brag about that. But that decision, that's a very important piece of, of investment, right, people.

And just maybe a follow on to that, you know, we have been fortunate to be able to recruit some very experienced pharma talent, and that that's very possible in Pittsburgh there. You know, look, when I talk to my colleagues in Boston, who are paying, you know, $120 per square foot for their lab space. We're paying. Yeah, they're they're certainly that we can we can do this in Pittsburgh, we can accomplish it in Pittsburgh. And, But to your point, we don't, I got, we've got a great team. In addition to Tom and Greg, our Chief Scientific Officer Steven Turetsky spent the first 17 years of his career at Bristol Myers Squibb, in the last 13. He's been here. And Bristol Myers Squibb has mentioned, not only did he head up the ion channels Discovery Program, but he was actually the discoverer of the gene that is responsible mutations to this gene are responsible for the pediatric epilepsy that we're pursuing. So that's sort of the was the level of scientific expertise that we've been able to recruit to, and also a nice sort of full story or full circle story. And then our chief Commercial Officer, Mark Preston spent 30 years in Big Pharma. He launched a drug called redsea Bristol Myers Squibb. He headed up global immunology, at j&j. And his last five years he actually was that cell before he came to us was at Celgene, heading up their, their i&i franchise, and he watched a drug called otezla, which you may people may have seen commercials for. It's the only oral drug in psoriasis market. And we actually hope to replay that story in asthma, if you will. So be in there, our drug would be the only oral drug that would treat us like asthma. And, you know, we've been fortunate, as I said, to be able to convince, you know, people with large pharma experience that this is this is a good team to join, and why somewhere important,

and that's what's important in terms of fundraising, as well. Jonathan, there's a question. You're not involved in the covid 19 related research at UPMC. Correct? We are not. Right. That's what I thought. So Jonathan, Dirk has a question. And I just think it's about clarity. So if you could just do that before we wrap up? I think that'd be great.

You're on mute. Okay, Jonathan, you're on. Sorry about that.

Yes. Dirk kalp has a question here says Could you explain a bit about the Aminu illogical disease? autoimmune diseases like rheumatoid arthritis basically, are when the immune system goes crazy and attacks the body. So inflammation becomes chronic as opposed to short term healing process. How does this differ in the types of asthma that you've mentioned?

Yeah. So it's unclear at this point, whether he is going to be asthma. What sort of triggers it as opposed to ruin rheumatoid arthritis or, or psoriasis and although you know, the, the, the pathophysiology, those are still being uncovered. I think one thing that is a distinction is that with rheumatoid arthritis and psoriasis, there is a a Maybe a broader inclusion of the immune system. So there are lots of inflammation that's mediated not just by in those samples play a modest role in a modest role in psoriasis, less than one. rheumatoid arthritis. But those are those are really sort of lymphocytic proven inflammations, and sort of a broader repertoire of cells. So different cell type one, and of course, in rheumatoid arthritis, and in psoriasis to get a lot of tissue damage and destruction. And in asthma, there's less of sort of a five block component to the disease that you would see maybe in COPD, or by analogy to rheumatoid arthritis.

So we have we have run at the end of our show. And I like to thank you, is there anything else that you think that we should cover? Or you should mention, we've given the website out, you can follow what's happening with them via their website? And you could probably find a way to reach out to Michael, if you're interested. But is there anything else, Michael, that you think is really important for us to know? And you've been a leader in the community as well, so?

Well, I think that one by supporting each other, and just, you know, the tip of the cap to you, Audrey and the team at PTC, because, you know, this is important to Pittsburgh's future, I think that we're not alone in our efforts. And And certainly, you know, the, the University of Pittsburgh is making a big commitment to translational medicine, it's important that we succeed. So I think these types of forums and, you know, staying integrated and working with each other sharing knowledge sharing best practices, you know, I think that's really important work so that we can, you know, get, get the first big win across the finish line, and then celebrate Well, first of all,

thank you so much for taking the time. I know you're absolutely busy, that my hat's off to you and canape for all the work that you've done, the people that you've attracted here. And as I mentioned earlier tenacity in terms of solving really hard problems for people. And we'll stay connected with you. So I want to thank you for joining us today. Thanks, Jonathan. Thanks to the team at the PTC and thank all of you for joining us really learned a lot today and tomorrow we're going to be talking about neighborhood 91 neighborhood. 91 is the additional neighborhood that is now erupting near the airport and Moon Township. So we're going to be talking about what's happening there. So thanks, everyone, stay safe, and keep connected with us and we will try to do the same with you. Awesome

thanks

Transcribed by https://otter.ai