Latest / The BioHub - by Avetix / Episode 91 - Sten Sörensen - Cereno Scientific

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Episode 91 - Sten Sörensen - Cereno Scientific · The BioHub - by Avetix

• 0:05
  Welcome back to another episode of the Bio Podcast.
• 0:07
  Today I'm for to be joined by STEM, who is the CEO of Cerritos
• 0:11
  Scientific. They are a clinical stage
• 0:14
  biotechnology company looking to extend the lives of patients
• 0:17
  with cardiovascular and pulmonary diseases.
• 0:20
  STEM, thank you for coming on. Great to be here, yeah.
• 0:23
  Fantastic. Well, just to start with, can
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  you give us an overview into your career and ultimately how
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  you ended up joining? So yeah.
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  Yeah, I, well, I'm a curious person and that took me to
• 0:35
  chemistry and and university and I was actually curious about how
• 0:42
  you become sick and what you can do about it.
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  So, you know, that's maybe why I'm not here now.
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  But yeah, so that brought me to a decision, Should I go into
• 0:52
  Meadows Medical School or should I do a PhD or should I go to the
• 0:57
  pharma industry? And the person gave me the
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  advice, go to the industry, you know a fair bit about chemistry
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  and the microbiology and biochemistry.
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  So you can speak to the other world.
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  And then eventually you'll be sitting in between the
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  scientific part and the other part, the market or financing.
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  So. So that was the start.
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  And so I fairly briefed education and I think my
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  education actually has been when I've been working with various
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  projects and in organizations through my life and especially
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  the key opinion leaders or scientists or colleagues around
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  the world in various diseases. Yeah, trying to drive, identify
• 1:44
  vision, drive it implemented and hopefully succeed with that.
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  Yeah, that's been the real learning code of I think for me,
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  rather than academic education. Yeah.
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  And then the path to join Sereno.
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  Talk us through that in a little bit more detail.
• 2:00
  Sure. I so I joined Astra.
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  Astra yeah, at that time, a long time ago and as a safe threat in
• 2:10
  cardiology. And I was a serious word for the
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  beta blocker metopro, metoprolol.
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  And And I was recruited over to a family company, GD Searle,
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  owned by a Monsanto, you might know, a big company.
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  And they eventually recruited me over to a head office in
• 2:28
  Chicago. And I got the telephone and a
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  product and, you know, let's see what you can do with this.
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  I was 29 years old then, and then and I, a year later,
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  together with the college, identified a great opportunity.
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  We thought, yeah, at that time with this old drug that was
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  launched in 1964. And, you know, Fast forward, we
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  actually pursued a survival trial.
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  And today's used in 9095% of these heart failure patients.
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  Yeah. And they're saving lives and
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  including lives every day. And what struck me then was that
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  you think that everything is already discovered when you're
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  young. And we, we thought we are either
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  stupid or perish because we have something here that we think can
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  do really well for these patients.
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  Yeah. And it turned out to work.
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  Yeah. And so that was my period for a
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  Monsanto Titisola in Chicago globally.
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  I became head of marketing globally and then was recruited
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  back to Astra Zeneca in 95 where now it's a long time ago and
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  became head of marketing again for cardiovascular products.
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  And Astra was sitting with an old product and that there was
• 3:53
  the beta blocker metoprolol that I was sales right for.
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  So within my first job and, and having spent five years in in
• 4:03
  heart failure and initiating the move from more pump and plumbing
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  towards more hormonal control and Astor had a beta blocker.
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  And this time we pursued then survival trial with the beta
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  blocker and it's called Merit Day, Jeff.
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  And first one Ross. And they both were successful
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  and were published in New England Journal of Medicine.
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  And actually the first one ended up in Wall Street Journal
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  because it was founded out of my marketing budget.
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  So yeah. So 2 early experiences of
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  repurposing with old drugs into a different use in heart failure
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  is saving lives and improving lives.
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  And so then I was asked to meet a company in Gothenburg by a
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  colleague who had recommended me to maybe I could look at this
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  and other companies to join the board.
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  And I was struck by the technology that Sereno
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  Scientific had, and it reminded me about the two other
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  experiences. It was a, a, a vision to utilize
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  technology and mode of action that actually had been on the
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  market for long, not time, decades.
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  Yeah, 20 years at least. And that was epigenetic
• 5:28
  modulation through HTAC inhibition.
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  And I couldn't resist joining the company.
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  And, you know, this is 11 years late, so.
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  Yeah. Yeah.
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  That's how I you know, yesterday.
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  And Fast forward to now, we're we're here at Jeffrey's, Yeah,
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  in London. You've had some fantastic
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  progress over the last year. You received fast track
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  designation for your lead asset at CS1.
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  You recently announced you submitted your Phase 2B pro
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  school to the FDA. Can you just give us no view
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  over how the last sort of few years have been transitioning
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  from like an early stage complete through said some more
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  late stage? When when we when I joined the
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  company, there was no business plan.
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  It was no money. So that first thing I was a
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  fantastic vision. Yeah, so and which you know hit
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  me well through my early days, yeah, the curiosity.
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  So and I raised my hand after one year wanted to be the CEO
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  and to put a businessman proper together finance the company.
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  And at that time VCs were not venture capital wasn't that
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  present in in Sweden. So but the stock market was open
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  for the early companies. So we less than a year, eight
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  months later we had a list of the company at the spotlight and
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  then we have later two years ago up list to NASDAQ first north
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  in. But yeah, so the original idea
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  of Professor Shakur Yan and his Co founders was to utilize this
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  technology for preventing thrombosis, the biggest killer
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  on the planet, by utilizing epigenetic modulation and H DAC
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  inhibition and in so doing in strengthening the endogenic
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  defense mechanism that we have against thrombosis.
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  And that has been proven in our work.
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  Yeah. But when I rejoined my previous
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  colleagues coping kioping leaders and and met doctor
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  Professor Pitt, professor emeritus at University of
• 7:40
  Michigan in 2018, he asked what I was doing and I said this and
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  do this. And he said this is fantastic.
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  Let's put the scientific Advisory Board together.
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  Yeah, we must meet now and and we did he he advised us to do a
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  complete review of all the science.
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  Yeah. And we found 600 articles around
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  this technology of a published proof of concept materials and
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  other. Yeah.
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  And and having done that complete review of the
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  literature and then all possible indications we could pursue with
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  this technology, we pivoted over to rare diseases.
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  Yeah. And so now we have two programs
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  and with this technology, HTAC inhibition and for genetic
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  modulation. One for the rare disease
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  pulmonary teal hypertension, mostly affecting women.
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  The other one for an idiopathic pulmonary fibrosis and mostly
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  affecting men. The oath, deadly diseases.
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  Yeah. Devastating diseases and a
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  common denominator here is that they have a pathological
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  progress, a remodeling progress that is destroying their lives.
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  And so far the drugs that have been deployed to help these
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  patients are more symptomatic oriented.
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  And we believe we have a drug and and a mode of action that
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  can impact, so slow down, halt and even reverse that those
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  pathological processes in the cardiovascular tree such as DH
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  pulmonary artery or in the lung tissue.
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  Yeah, yeah. So, so we have two acids like
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  that and the first acid CS 1 is a repurposed old drug, previous
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  experiences and we have brought that through a Phase 2A program.
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  Yeah, We got some very intriguing data, exciting for
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  us, where we impacted both prognostic values, the function
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  of the heart, functional class, so quality of life for these
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  patients and even the contractility of the heart, of
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  the right heart, which is actually why you die eventually.
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  So that gives us a lot of hope. Yeah.
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  And also the patients, the physicians asked us to apply for
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  extended access program which we got by FDA.
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  So we have patients running now for a year from that study.
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  And and we took this data out of this trial Phase 2A, which was
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  rather small, rather short trial.
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  Yeah. And had a discussion with the
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  FDA and they were fully aligned and then submitted a fast track
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  application, got that a couple of 2-3 weeks ago of it.
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  And now we just submitted our protocol to FDA the 7th of
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  November. So we hope we can get that
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  protocol approved. Yeah.
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  And now before the end of the year and then get going with the
• 10:44
  recruitment next year, yeah. And in terms of the movie also
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  that trial when you is also spring to middle of next year.
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  Well, you know, so when you do these tries, so we signed up
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  with, we believe the best CRO to run the program was, you know, a
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  big force in many diseases, including H, and we've been
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  working with them since the summer.
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  Yeah. So rotocol definition,
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  regulatory pathways, documentation, all of that.
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  And when you then get the acceptance by the FDA and
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  eventually will, you know, apply to Iman and other markets, you
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  have then to get local ethical approvals, you need to sign up.
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  Yeah, it defined which sites a contract decides.
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  Yeah. And then get going, Right.
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  So we expect to have our first recruitment before the summer,
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  as I said, yeah. So this is a study that's going
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  to be run globally. Yeah, probably around 40 sites,
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  125 patients or or so. Yeah.
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  And yeah, we hope to conclude that sometime in during 2028,
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  yeah. And then what's the plan with
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  your other? Assets it's.
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  Obviously IPIPF. Yeah.
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  So what happened to us was that other smart researchers that
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  were reciting neighbors to us in our bio hub where we were rich
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  originally, they were actually the developers of the follow up
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  compound to once the biggest seller in the world, low sick
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  omeprazole for gastric ulcers. They developed the follow up
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  compound to that drug for Astra and they came to us saying we
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  know what you're doing with this drug.
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  Yes, molecule BPA, we think you should do a second generation.
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  Here's our idea. We thought that idea was
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  excellent. We bought it, and that's our
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  second compound. And so we have decided
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  strategically to pursue this HTAC inhibition in these two
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  tissues, cardiovascular remodeling and lung tissue
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  remodeling. So the second asset is for
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  pulmonary, idiopathic pulmonary fibrosis.
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  By that, we get 2 attempts to prove the impact of this
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  technology in pathological processes.
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  And so, so that drug is called CSO 14.
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  Yeah. So it's a new chemical entity
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  and we got our first patent in the UK and we completed our
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  Phase one program and reported that communicated that in July,
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  I think this year. So we're pursuing that program
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  for phase two also. Now it's a little behind the
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  first program. So we aim to get the definition
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  discussions with regulatory authorities and then get that
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  program accepted by protocol. So we can start recruit by the
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  end of next year or early 26. Yeah, 27, I should say, but
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  maybe the end of of next year already.
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  I, I give him a hair at Jefferies and you know, I guess
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  within the biotech world there's always talk around partnering
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  and business development. What are your thoughts as you're
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  moving towards a later stage company?
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  What are your thoughts towards partnering?
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  Well, you know, we kept our head down for a few years until we
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  had we believe substance to talk about.
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  Yeah. And in the very early day when
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  we just had a vision, we were out a bit and you know, we had.
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  So it was interesting, but not so interesting to talk it too
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  early. Yeah.
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  And now we get fully booked basically at these pardoning
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  events. So it's very interesting for us.
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  I get to tell what is what we are speaking about it now.
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  But really we think we have something for the patients and
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  every the stakeholders here and we believe that we will you
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  know, probably end up with a partner for this for either
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  local, regional or the global development and that's probably
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  the fastest way to get this to market.
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  Yeah, and but rare diseases you can pursue yourself, right as a
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  biotech cop. So we'll see.
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  Yeah. But we're very active on the
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  partnering front, so. Yeah, and I guess off the back
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  of all of this and a really successful few years, you know,
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  this evening you've been nominated at the European
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  Lifestyles. Awards for C of the Year.
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  How well, how does that make? You feel well, it's a bit, I
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  don't know it it makes me happy. Yeah.
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  You know, so I think it's a reflection on on our progress
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  with the company. And if you spent eleven years
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  with the company and you get recognition for the progress of
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  the company and that you have been leading the company over
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  those years, it's nice, you know, and I'm surrounded by
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  other nominations the whole evening.
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  So it's a it's a nice recognition.
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  Yeah. And you know, I tell my team
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  that you, you created this for for us and for.
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  Yeah. So.
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  Yeah. Good.
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  It's it's become a little bit uncommon as such for someone to
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  remain at a company for such a long period of time in biotech,
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  especially at the moment, you know, average tenure has dropped
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  massively. So the fact that you stayed
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  there and built the whole mission is is credit to you
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  really. Thank you.
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  And, you know, I got the same comment when I was at the
• 16:14
  Monsanto. Yeah.
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  And. And because people were leaving
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  after a couple of years. Yeah.
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  And I stayed six years. But, you know, we got the
• 16:22
  survival trial. Yeah.
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  You're done. So.
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  So if you want to be a visionary or change paradigms, Yeah.
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  It's not a quick fix. Well, so.
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  So. Yeah, I love it.
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  Yeah. And.
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  And. Then looking ahead 6 the next
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  sort of 6 to 18 months, what is it that you're really looking
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  forward to most of the three-year?
• 16:41
  Well, I, I, you know, really to get the first patient recruited
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  into the next phase 2B trial. And as you know in this
• 16:49
  business, when you have a Phase 2B trial, it's the, if you know,
• 16:56
  more exposure safety tolerance. But we know this drug has been a
• 17:00
  man for almost 60 years in much higher dosages.
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  So we're not that concerned about safety intolerance,
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  worried about the the outcome. What we really want to see is
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  efficacy. Yeah.
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  And we think that's the, the, the, the very significant
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  inflection point for the company.
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  Yeah. So getting that study started,
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  get the patients in again and working globally with this
• 17:24
  concept. Yeah, very much looking forward
• 17:27
  to that. Yeah, fantastic.
• 17:28
  Well, look, thank you so much for for coming in today.
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  All right, the. Issue.
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  Best of lucks this evening. Yeah, but it was over.
• 17:34
  For the next. Few years at Surya as well, so
• 17:36
  yeah, thank you. Thank you, super.