Latest / The BioHub - by Avetix / Episode 81 - Clarke Attwell - CEO Claris Biotherapeutics

Transcript

Episode 81 - Clarke Attwell - CEO Claris Biotherapeutics · The BioHub - by Avetix

• 0:05
  So, well, thanks so much for coming on.
• 0:07
  How are you? Very good.
• 0:08
  Thank you, Tom. Glad to be done and thank you
• 0:11
  for the invitation. Yeah, that's it.
• 0:15
  Yeah. Look, it's an absolute pleasure.
• 0:18
  So let's just start off with a little bit about you then.
• 0:20
  So can you talk us through your journey to get to where you are
• 0:23
  today and what inspired you to pursue a career in the biotech
• 0:27
  industry? So I was, I was, I was born in
• 0:32
  Africa. That's important because I, I
• 0:36
  wanted to become a, a physician. And many, many of my family
• 0:38
  members are physicians and they have a long history of that,
• 0:41
  both on my, on, on my father's and my mother's side.
• 0:46
  And very much planned to be a physician.
• 0:49
  And as I went through school in Africa, decided I, my parents
• 0:53
  are Americans, wanted to come back to the US.
• 0:56
  And in my pre Med courses, I had a lot of interactions with the
• 1:01
  medical community And it was very different.
• 1:04
  The, the, the being a physician in Africa, I think was, was
• 1:08
  lagging what it was being in America.
• 1:11
  And so in America you had Hmos telling you how much time you
• 1:13
  had to spend with patients and it became very much a sort of a
• 1:17
  business. And that was not kind of what I
• 1:20
  wanted to do. And so I pivoted into
• 1:23
  biotechnology. My parents both, both both my
• 1:26
  parents were entrepreneurs as well as my grandfather.
• 1:29
  And so it made sense to move into biotechnology or or
• 1:34
  pharmaceuticals. And pharmaceuticals for me are
• 1:37
  strategically very rich area when you think about strategy
• 1:40
  for developing drugs, bringing them to the market.
• 1:44
  And then also the, the lever that you have to, to actually
• 1:48
  help people and actually do good and have some positive outcome
• 1:52
  out of your efforts is also a very positive.
• 1:55
  So that's why I moved into into biotech.
• 1:59
  Very good. So your career has been deeply
• 2:02
  rooted in ophthalmology. Why?
• 2:05
  What sparked your interest in the field and how has it
• 2:08
  influenced your entrepreneurial ventures as well?
• 2:12
  I think for me, ophthalmology is I, I started out my career in,
• 2:17
  in, in cardiovascular and then moved into specialty, which was,
• 2:21
  I was on the launch team for Crick Savann at Merck.
• 2:24
  And that was the first time I, I, I got introduced to just sort
• 2:28
  of specialty pharmaceuticals. And, and that is, I, I thought
• 2:31
  it was more biotech like is you have small sales forces, small
• 2:34
  companies can, can go in and, and, and, and develop and market
• 2:38
  drugs. So that was the first sort of
• 2:41
  inkling that I wanted to be in that kind of market.
• 2:45
  I think when I was, I had, I had the great benefit of working
• 2:51
  with Doctor David Guyer as a consultant at Itech.
• 2:54
  And that's what was my first introduction into ophthalmology.
• 2:57
  And I think it's a very neat area because for a long time
• 3:01
  it's a very sleepy area and all the of the sort of established
• 3:06
  companies in those areas, Alcon, Allergan, great companies, but
• 3:10
  they, they very much did not bring a lot of innovation to
• 3:14
  those areas. And the innovation came from
• 3:16
  companies like Genentech, Merck at the time with Tom Optic.
• 3:21
  So there's a lot of innovation, but it was coming from the
• 3:23
  outside. I also went to my first AAO and
• 3:27
  I noticed that normally when you go to these conventions, if you
• 3:30
  go to the American Society of Hypertension, the booths were
• 3:33
  all pharmaceutical and they take up the floor.
• 3:36
  And my first AAO, the pharmaceutical companies were in
• 3:39
  the back and the device companies were in the front.
• 3:43
  And that to me seems like a great opportunity.
• 3:46
  I think the other thing I like about ophthalmology is you can
• 3:48
  visualize the anatomy of the organ you're trying to affect.
• 3:53
  You can visualize the pathology, and then you can also visualize
• 3:55
  the effect you're having on that.
• 3:57
  So unlike, you know, say, say renal, renal or cardiac, you
• 4:02
  really can only go in and see what's happening to the tissues,
• 4:04
  to biopsies and scans and things like that.
• 4:07
  But you're the anatomy of the eyes readily invisible.
• 4:11
  I think the other thing that's very exciting about
• 4:14
  ophthalmology is that ophthalmologists themselves, if
• 4:18
  you think about the innovation curve, they're all the early
• 4:21
  adopters and innovators. They were always the top of
• 4:24
  their class. And so they're, they're very
• 4:27
  smart people and very well educated and they love
• 4:29
  innovation. So your your uptake for
• 4:32
  innovative products is is very quick.
• 4:36
  Very good. So Clarisse emerged from stealth
• 4:39
  mode in 2024. Can you share the story behind
• 4:43
  its inception, the vision that drives the company as well as a
• 4:48
  little bit on the pipeline as well?
• 4:50
  So the the technology itself comes from Scape and Zai
• 4:53
  Institute from the labs of Doctor Reza Dana and Doctor
• 4:57
  Sunil Chauhan. And they are have long been
• 5:00
  leaders in developing therapeutics and for the corneum
• 5:03
  for the front of the eye. I had known Doctor Dana through
• 5:08
  earlier work at Lux Biosciences, and they had called me in
• 5:12
  because they had isolated what they thought was going to be a
• 5:14
  very interesting molecule. So they've been taking
• 5:17
  mesenchymal stem cells and placing them on the on the
• 5:20
  surface of the eye. And they saw a salubrious
• 5:22
  effect. But the problem was you can't
• 5:24
  place the holes on the eye. It's not a, it's not a, there's
• 5:27
  no regulatory development path forward for that, at least one
• 5:30
  that's not easy. So what they did is they went in
• 5:33
  and silenced the elements in the secret home.
• 5:36
  And when they silenced HGF, that's when they saw the
• 5:39
  beneficial effects go away. And so they knew they had an
• 5:43
  active moiety there that could be very potent in healing,
• 5:47
  prevention of fibrosis and, and acceleration of the, the, the,
• 5:56
  the cells that were there. So they're in healing, but also
• 5:59
  for us more more important than liberal stem cell.
• 6:01
  So it actually because it promotes the promotion of the
• 6:05
  growth of those cells, but also stops the apoptosis of those
• 6:07
  cells. That was kind of this Swiss Army
• 6:10
  knife. And then the question was what
• 6:12
  indication do we first go into? And so we started the company
• 6:16
  based off of the idea of going to the surface of the eye and
• 6:20
  and bringing HGF to those complex diseases in the front of
• 6:23
  the eye. Good.
• 6:26
  And then biotech has so many highs and lows.
• 6:29
  I guess Claris earlier in its in its journey faced negative
• 6:34
  clinical data that could have easily marked the end for such a
• 6:38
  young company. Yet under your leadership, the
• 6:41
  company pivoted and was able to find a new direction.
• 6:44
  Can you walk us through that moment, what the data revealed,
• 6:49
  how you processed it as a leader and what ultimately LED you to
• 6:54
  steer the company towards a different and successful part?
• 6:59
  Yeah. So biotech is, is, is is not
• 7:03
  unknown to failure and that does happen.
• 7:05
  I think we had a rationale for why we went into NK and felt
• 7:10
  that we were, we were going to see positive results.
• 7:13
  Often in, in biotechnology, the worst thing you can get is Gray
• 7:16
  results. And because then you don't know
• 7:19
  what, whether you can go forward or backward or what, what the
• 7:22
  problem is. We, we got definitive results.
• 7:24
  The drug did not work. And when we looked at every
• 7:26
  subset, we could not find a difference between vehicle and,
• 7:31
  and the drug. The first thing you do is that
• 7:35
  you, you sort of have to absorb that you've spent, you know, two
• 7:38
  years working 3 for me, 4 years working on it, the team two
• 7:41
  years and, and it's, it's a big emotional blow.
• 7:44
  But once you get over that, if you have the right team, then
• 7:48
  you start getting down and, and breaking up the data and trying
• 7:51
  to find out what went wrong. And I think from a mass
• 7:53
  mechanistic perspective, we have a very good understanding of
• 7:56
  what went wrong. And basically we were looking in
• 7:59
  our models at healthy eyes and we were treating unhealthy eyes.
• 8:02
  So some of the signals, some of the, the, the, the, the neuropex
• 8:06
  types that we needed were not present in those eyes.
• 8:09
  So we, we didn't see an effect. So then, then really after that
• 8:14
  you said, well, what do we do next?
• 8:16
  I think that's too late. If that's where, if, if, if
• 8:19
  after you've gotten the negative, negative data, you're
• 8:21
  thinking about where you're going to go next.
• 8:23
  You, you, it's, it's too late. So I think we always in, in
• 8:27
  biotechnology, I believe in preparing for calamity, calamity
• 8:31
  at a company scale. And then also in all the various
• 8:33
  disciplines, be it CMC or preclinical, you're always
• 8:36
  thinking what could go wrong? What's our Plan B?
• 8:38
  What's our plan C, what's our plan D?
• 8:41
  So the basis of any surviving any of these things is having a
• 8:45
  good team. And you have people who you
• 8:48
  trust each other, you have lots of experience, you've seen these
• 8:51
  things before and you're dedicated to what you're doing,
• 8:55
  the molecule, the people, the company, your investors.
• 8:58
  And so that's the first thing. The second thing is you have to
• 9:02
  plan for that failure. So we did have extra money in
• 9:05
  the bank. We had a formulated drug so that
• 9:08
  we could continue doing, doing studies and other indications.
• 9:12
  We had listened to our investigators.
• 9:14
  So during the conduct of the NK trial, we had physicians who
• 9:18
  were saying they were seeing potentially a benefit in NK, but
• 9:22
  they were also seeing a benefit in the patients who had
• 9:25
  concomitant limbo stem cell deficiency and NK.
• 9:28
  And when we picked, when we heard that and we heard it from
• 9:31
  enough physicians in the study, we decided to start another
• 9:36
  proof of concept trial. And so as we got the negative NK
• 9:40
  data, we'd already been enrolling and we're seeing
• 9:42
  positive data from that. We also from our preclinical
• 9:46
  work knew that we could prevent scarring and reverse scarring.
• 9:49
  So we had another POC. So we had two PO CS going in, in
• 9:53
  parallel at the same time. So we had money, we had drug, we
• 9:57
  can continue doing our PO CS. We had developed a good rapport
• 10:01
  with our, with our investors and they wanted to support us as we
• 10:05
  move forward and see what that data would be and, and, and, and
• 10:10
  allow that data to, to mature. And they did.
• 10:13
  And that's, that's why we're, we're where we are right now and
• 10:16
  very, very happy with the data we're seeing in both, both, both
• 10:20
  POC trials. Yeah, for sure some, some
• 10:25
  journey the company's been through, right.
• 10:26
  The, you know, you talk about highs and lows in biotech that
• 10:29
  probably summarise it in a nutshell.
• 10:35
  Yeah, good. And so raising capital in
• 10:39
  today's biotech market is is notoriously challenging.
• 10:43
  I know Clara's bio are working towards a series B round after
• 10:47
  an impressive A round. How are you navigating these
• 10:51
  difficult conditions? What's been your strategy in
• 10:54
  communicating value to investors?
• 10:56
  The story and what gives you confidence that now is the right
• 11:00
  time to go out and scale? To answer the last question, the
• 11:06
  the right time to to go out and raise money as always.
• 11:09
  Now there's no, there's no, there's no better time.
• 11:15
  So I think I think that that that's the answer to that
• 11:18
  question. I think when it comes to
• 11:20
  conveying the value, I think what we do have is even in the
• 11:24
  in in trial with NK, what we were able to de risk in that
• 11:28
  trial was our safety profile. Our safety profile is, is is is
• 11:32
  is is is outstanding. We actually saw in the patients
• 11:40
  who had any sort of AE that was related to inflammation.
• 11:46
  We actually saw much lower numbers in the active group.
• 11:49
  And that that fits with our with our mechanism of action where it
• 11:52
  we're an immunomodulatory agent. So we have an excellent safety
• 11:57
  profile. We saw a hint of our activity
• 12:00
  and in that pay in in the safety data we've derisked the
• 12:04
  formulation. The formulation is safe.
• 12:06
  Unlike most biologics, we have a very stable protein and so our
• 12:11
  formulation can be in the patient's hands at room
• 12:14
  temperature. So that's another benefit for
• 12:16
  biologic, especially for something that might be used
• 12:18
  chronically. We've developed our CMC.
• 12:21
  So we have a a new process. So we've we've taken a lot of
• 12:24
  risk out of of the system. We are late stage and so they're
• 12:28
  not a lot of late stage assets out there.
• 12:31
  And we could see top line data in 2027, we could have an
• 12:35
  approval in 2028. So there is, there is the
• 12:38
  ability to to launch this or or see the data at least pretty
• 12:42
  soon. We're also unique in the sense
• 12:45
  that there, there are there there are not a lot of areas
• 12:49
  where a biotech can go forward and be successful in, in, in,
• 12:53
  in, in launching a drug. There's a lot of risk around
• 12:55
  that. But we've seen a lot of
• 12:56
  companies that Tarsus Dante, we've seen a lot of these
• 12:59
  companies be very successful in launching products.
• 13:02
  And so I think that that that is also a path that's amenable to
• 13:05
  us. So de risk us from, you know, do
• 13:07
  we have to do an IPO? Do we have to do an M and a no,
• 13:09
  there's there's a third viable third path for us.
• 13:12
  So I think all of that sort of de risks it ultimately I think
• 13:16
  it comes to the data and we're seeing a very robust signal
• 13:20
  especially in limbo stem cell deficiency.
• 13:23
  We're seeing you know 50% of our patients have a 15 letter gain,
• 13:29
  at least a 15 letter gain and the rest that are are behind
• 13:34
  them are, are are very close. So that even though those that
• 13:37
  we have some people we describe as partial responders and
• 13:41
  they're seeing 10/12/11 letter gains.
• 13:44
  So if you compare that to AMD, what you would expect in an AMD
• 13:48
  trial would be, you know, maybe 30% of patients would reach that
• 13:51
  level. So we're we're seeing a robust
• 13:54
  signal there. So I think that helps a lot with
• 13:56
  the data and all of the elements of our data sort of line up
• 14:00
  together. When we take the patient off the
• 14:02
  drug, their visual acuity comes down.
• 14:04
  When we put them back on the drug, their, their visual acuity
• 14:06
  goes back up. So we're seeing that dose effect
• 14:09
  and the patients continue to get better the longer they're on the
• 14:12
  drug. So I think all of those elements
• 14:16
  really, really help. Yeah, in regional.
• 14:20
  Yeah, for sure, absolutely. There's a famous saying culture
• 14:24
  eat strategy for breakfast especially.
• 14:27
  I guess that's more so true in early stage biotechs where
• 14:30
  uncertainty is high and seems a much smaller.
• 14:34
  How have you approached building a strong culture at Claris, and
• 14:39
  how has that culture helped the company stay focused and
• 14:41
  resilient through scientific and difficult market conditions at
• 14:46
  the moment? Yeah.
• 14:50
  So I completely agree with that statement that that that the
• 14:53
  cultural strategy for launch, I completely agree.
• 14:56
  I think and and you kind of pointed to it, one of the
• 14:59
  benefits of biotech is especially a start up is you get
• 15:01
  to build your team from the ground up.
• 15:03
  So the people you bring in, I've had the great fortune of working
• 15:07
  with Susan, I've had the great fortune of working with Piotr.
• 15:09
  I've had the great fortune of working now recently with Tommy
• 15:12
  and, and with Henry, our, our, our chief business officer.
• 15:16
  So you can bring in people that are like minded people who
• 15:18
  behave the same way often say you don't want to bring any
• 15:22
  cannibals into the canoe because you're going to be out in the
• 15:24
  ocean for, for maybe five years and people get hungry.
• 15:27
  So I think it always starts with the people, people who are
• 15:31
  thoughtful, people who have a lot of integrity, people who are
• 15:34
  dedicated to the, to the mission or, or to, to the objective.
• 15:37
  And I think it's also important to set that objective.
• 15:40
  And I think always I learned this from Merck and I've carried
• 15:44
  this through my career. If you put the patient first, it
• 15:47
  makes all the other decisions easier, or at least maybe not
• 15:50
  easier, but it gives you a, a, a Direct Line to what you're, what
• 15:54
  you're targeting and what you're aiming for.
• 15:55
  And so it does require many times when you put the patient
• 16:00
  first, it's not something you want to do.
• 16:02
  It's not the easy thing to do. Sometimes you have to make some
• 16:04
  difficult decisions. Sometimes you have to to, to, to
• 16:07
  change, change course a little bit.
• 16:09
  And I think that brings out the sort of honesty, honesty,
• 16:13
  integrity, courage in those people.
• 16:16
  So I think that people who who are action oriented, I think
• 16:19
  those are the kind of people you're looking for.
• 16:21
  And I think then you the other thing I think is really
• 16:24
  important in the culture is transparency and the allowing
• 16:27
  everybody to contribute. And I think that's super
• 16:30
  important in biotech and pharmaceuticals because
• 16:34
  everybody's there for a reason, right?
• 16:35
  These are multi disciplinary teams.
• 16:37
  There's preclinical, there's talks, there's, there's safety,
• 16:40
  there's clinical, there's CMC. You have all these different
• 16:43
  pieces. And if, if, if you don't allow
• 16:46
  and provide for a space for everybody to speak openly and
• 16:50
  freely, then you, you, you lose that.
• 16:53
  And that's, that's where the culture will kill any strategy.
• 16:57
  And I think the other important thing is in that environment
• 17:00
  that you give credit for everybody's idea there.
• 17:03
  I think there's a lot of cultures where, you know,
• 17:06
  somebody takes credit for everything that goes on that's
• 17:08
  beneficial. And that's, I think attribution
• 17:10
  is very, very important. We, we do it in referencing
• 17:13
  documents and and scientific articles.
• 17:15
  We should do it for ideas as well.
• 17:17
  And then the last piece is, is I think this CEO needs to get out
• 17:22
  of the way. I think often, often I find I,
• 17:26
  I'm a recovering micromanager. I think Zoom meetings have been
• 17:30
  zoom meetings and not being in an office have been very
• 17:33
  helpful. We're a team that, you know, has
• 17:35
  a lot of experience, so we don't need to be micromanaged.
• 17:38
  And I think the the less you you sort of nudge and poke on the
• 17:42
  team and only come in if there's a problem and if you're invited,
• 17:45
  I think is is is helpful. Yeah, I think whenever I ask
• 17:50
  that question to people, he could have the great best tech,
• 17:54
  the best science, the best team, whatever, but it's always it's
• 17:58
  always people that it comes down to at the end of the day.
• 18:00
  And yeah, completely know where you're coming from with that.
• 18:04
  And this is a question we always finish with on the bio hub.
• 18:08
  I know I wanted to give you a bit of a heads up on on this
• 18:10
  question, but if you were to have dinner with three people,
• 18:14
  past or present, who would they be and why?
• 18:16
  Don't necessarily need to be biotech innovators, although
• 18:20
  they can be if you like. But yeah, it's three people
• 18:22
  within it. I think so.
• 18:26
  I did think about this. Thank you for letting me giving
• 18:29
  me a heads up that you can ask this question.
• 18:32
  I think for me, I, I, I, I would just love to see my father and
• 18:36
  grandfather again. And I think that they were such
• 18:41
  interesting men. They were also very
• 18:44
  intellectually curious, loved history, loved science.
• 18:48
  So I think putting them together and then inviting somebody that,
• 18:51
  you know, we don't know, but would be interesting for the
• 18:53
  conversation, you know, a Mark Twain, Jules Fern, somebody
• 18:58
  famous in history on a Napoleon. We didn't need, we need a
• 19:01
  translator. But something like that I think
• 19:03
  would be, would be kind of keen. But mostly just to see my father
• 19:07
  and my grandfather again. Yeah, good.
• 19:10
  Well, I love those answers. And yeah, I think thanks so much
• 19:15
  for helping us out with this. I think you've given a really
• 19:17
  unique perspective on ophthalmology like Clarice's
• 19:21
  progress as well, and certainly a company I'm going to be
• 19:23
  following a lot more for sure. So sounds exciting what you're
• 19:27
  building and thanks again for helping us out with this.
• 19:31
  Thank you for your time and thank you for the for the
• 19:33
  invitation.