Latest / The BioHub - by Avetix / Episode 84 - Tord Labuda - CEO of Alzinova

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Episode 84 - Tord Labuda - CEO of Alzinova · The BioHub - by Avetix

• 0:04
  Unless this occurred, it's a Biovo podcast.
• 0:06
  We were joined by Todd, the boda of Alzanova.
• 0:10
  Alzanova are a Swedish based biotech actually in Gothenburg
• 0:15
  on the verge of entering Phase 2 with their lead assets which is
• 0:19
  an Alzheimer's vaccine. Todd joined us to talk through
• 0:23
  busy 2026 challenges in neurology, drug development and
• 0:28
  a bit of background on his journey from big pharma to start
• 0:32
  up biotech. Thanks a lot, Callum.
• 0:35
  Really happy to be here. Awesome.
• 0:38
  Just to start with thought, I guess always useful to give a
• 0:42
  little bit of background as to yeah, the story, the history of
• 0:46
  of Arsenova, the inception of the company, including how, how
• 0:50
  you getting to be with them and and when you joined as well.
• 0:54
  Right, so, so I similar first of all is a is a spin out, you
• 0:58
  could say from the University of Gothenburg in on the West Coast
• 1:02
  of Sweden. It was founded in in 2011 by the
• 1:07
  Sundberg, The Who Laith herds who Laith was professor at
• 1:12
  university. And I mean, this was HD student
• 1:15
  work on the projects at the beginning, but that's how they
• 1:18
  all start. And, and so it's been around for
• 1:21
  quite a while. And that recently took us quite
• 1:24
  some time to get, get to the clinic was that it's very
• 1:29
  difficult chemistry we're working with on peptide.
• 1:32
  So it's taken us a while to get to the clinic.
• 1:35
  But now as you mentioned, we're, we're going towards based.
• 1:39
  So we'll talk more about that later.
• 1:40
  I guess my background, I come from a long career in, in, in
• 1:44
  far in the pharma industry and at some point here in around
• 1:49
  2022, I decided that I wanted to do something else and the end of
• 1:54
  that journey with big Pharma and moved on to start.
• 1:58
  Working starting. Start work started working you
• 2:01
  could get in general and then on this journey I found us in OMA
• 2:06
  and thought it was a very interesting company on on the
• 2:10
  great trajectory and at the very interesting stage.
• 2:13
  So I, I actually contacted the board and, and yeah, that was
• 2:19
  the start of it and we had, you know, long process and, and, and
• 2:22
  there I was so been with the company for a year now and then
• 2:26
  it's an exciting time to join for sure.
• 2:29
  Yeah, absolutely awesome. I mean, yes, in the space you
• 2:35
  mentioned, it's taken a while to to get to where you guys are at
• 2:38
  now. I think that's a a familiar
• 2:40
  challenge for for many companies pursuing Alzheimer's, right, But
• 2:45
  are incredibly important. I think I read on your website
• 2:49
  30 million people currently diagnosed globally, that's
• 2:51
  expected to triple by 2050. But it's always been, I mean,
• 2:56
  I've done some work in the space before.
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  It's always been a tricky area to develop products in with
• 3:04
  falls in over. You're making some real positive
• 3:05
  steps. Firstly, why do you think it is
• 3:09
  the case that it is historically difficult?
• 3:11
  And secondly, sort of what gives you the confidence that you guys
• 3:15
  might be able to bring in? Yeah.
• 3:17
  And a new option for patients, which is much needed, obviously.
• 3:22
  Yeah, you're right. I mean it, it notoriously has
• 3:25
  been a graveyard for a lot of companies obviously and a lot of
• 3:27
  compounds that's gone down that road.
• 3:29
  I think that the struggle has, I mean, there's a few things.
• 3:34
  I mean, one of them is of course, the lack of of translate
• 3:38
  translatable models, right? It's really, really difficult to
• 3:42
  to have an animal model that is predictive for Alzheimer's
• 3:45
  disease. There's there is of course you,
• 3:47
  but we don't really know how predictable they are until we
• 3:51
  actually have a treatment where we can follow it all the way
• 3:54
  through, right? So that has been one of the
• 3:57
  challenges and then I think, you know, general struggle to figure
• 4:01
  out what what actually is thriving with the seas has been
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  has been been a hurdle. And and I think we're starting
• 4:08
  to at least know square surface here now with the with the two
• 4:12
  disease modifying treatments that we actually have on the
• 4:15
  market at this point. So we know that damily data pass
• 4:20
  boy is involved. And and then what part of that
• 4:23
  is involved there is is still up for for the for the jury.
• 4:27
  But but but at least you know what, what we're doing now is a
• 4:31
  great step on the right the track, I think.
• 4:34
  Sure. I guess a lot of the modalities
• 4:38
  that I've looked on, certainly even in the analytic beta space
• 4:42
  have been, yeah, there's been a struggle, I guess maybe to
• 4:47
  understand what's, yeah, treating the, the symptoms or,
• 4:52
  or what's treating the cause in Alzheimer's.
• 4:55
  And that's probably still a true struggle.
• 4:56
  That's that's in place today. All right, That's, that's not
• 4:59
  gone anywhere. Your programs obviously a
• 5:04
  vaccine, right, which is it's an active approach to it.
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  And do you feel like you're more targeting that the 'cause I
• 5:12
  guess rather than the the, the, the symptoms downstream?
• 5:17
  Well, I think first of all, I, I, I guess you know, with both
• 5:20
  Kisuma and Lekembe now on the market, I think they are
• 5:23
  targeting something that is disease modifying.
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  We did we see a small improvement right in the
• 5:28
  patients over time. And you know there was some
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  other studies showing that over a longer period of time more
• 5:34
  patients number in that study. But with Lekembe, but but still
• 5:37
  interesting data shows that that we had we had some delay in the
• 5:42
  progression of the disease, right, which which is the
• 5:45
  significant. So, so not that's important.
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  But but we also see that despite the fact that the drugs are
• 5:52
  basically removing the plaques from the pain, we still have the
• 5:57
  challenge of it's not complete translating into great
• 6:02
  clinically thick. So, so there we're probably
• 6:06
  targeting a part of the pathway that is involved, but maybe not
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  the full story there. From our perspective, we are not
• 6:12
  targeting the blacks, white, not Ibrius, not the monomers.
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  We are targeting exclusively these toxic polygamyre.
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  And we believe that that's what's actually dropped into
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  this piece. And I think also there's a lot
• 6:26
  of science indicating that that might be the case over the last,
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  I would say decade or so that there's publications around
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  that. So, you know, we, we did a small
• 6:37
  study of Phase 1B32 patients. Our data, I think indicate that
• 6:42
  we are on the right track that we are with that in, in, in, in
• 6:49
  our language. Now we're taking the 2 to
• 6:51
  actually prove in the in the bigger population that that is
• 6:54
  the case, right? And you mentioned the phase one
• 6:58
  study and, and obviously usually there's some indicators as to
• 7:03
  the proof concept a little bit, but it's normally done, yeah,
• 7:07
  for different reasons. But what results have you seen
• 7:10
  in phase one that really point to potential efficacy?
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  Because I know when we spoke last time you said that there
• 7:16
  was some really positive data out of that.
• 7:19
  Right. So we had a few things.
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  I mean, obviously it's a phase one study, right.
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  So we we say phase 1B, we did it in patients, we had 32 of them.
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  I think that first and foremost, of course, we look at safety and
• 7:33
  tolerability, right. We saw that we have a based bug.
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  We don't have a lump area then not more than what we see at
• 7:42
  background levels. We would say that includes all
• 7:45
  the patients with that background of AP4, right.
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  So, so overall a very safe, tolerable treatment.
• 7:53
  And then as you mentioned, it's an active approach, right.
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  So we, it's a vaccine. So we are injecting the actual
• 8:00
  oligomyre together with an adjuvant and, and, and, and, and
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  of course it's important then that we actually generate the a
• 8:08
  good immune response here. And, and that we see we have a
• 8:12
  very, very robust immune response in the majority of the
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  patients. Actually up to 95% of the
• 8:18
  patients mount a very good immune response.
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  This is long lasting, which is also important.
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  And then we see that it's recurrent when we give the
• 8:27
  booster doses, right? So a quick, quick return of A,
• 8:30
  of a strong immune response indicating that we have a memory
• 8:34
  B cell response here, which of course also is important for a
• 8:37
  vaccine, right. So judged by this, we will be
• 8:41
  able to give this at 3:00 to 4:00 doses per year, which is
• 8:45
  quite compared to where we are other treatments now, regardless
• 8:49
  if it's IV infusions bi weekly or as we see with the new, with
• 8:54
  the new paradigms here where they do in subcutaneous
• 8:59
  injections, which is actually weekly and that's only after the
• 9:03
  IV infusions for 18 months. So I think that, you know, we
• 9:06
  have a very good opportunity coming up with a much more
• 9:10
  convenient treatment here for patients.
• 9:12
  Now you mentioned, oh, what, what, what is also interesting
• 9:16
  is to look at what happened with the explore the endpoints we had
• 9:19
  here in at the end. And so we had this through two
• 9:21
  different things. First of all, of course, we we
• 9:23
  looked at at different scales, right?
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  And the one we used was the one that a side developed for the
• 9:30
  treatment called ADCOMS, which actually is a composite score of
• 9:34
  of three of the other main scores that are widely used in
• 9:37
  the clinic and also proved by the authorities, right.
• 9:40
  And, and, and on this scale, we, our data indicates that the
• 9:45
  patients do not progress in their disease over the two years
• 9:49
  we have them on active treatment.
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  So, so you know, if we can show that this is the case when we
• 9:55
  move this into a bigger patient population, it's going to be
• 9:58
  revolutionary data, I would say so.
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  So that the main, main point that we're looking at.
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  The other thing we saw was we looked at, of course a lot of
• 10:08
  biomarkers. For us, the most interesting to
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  look at here is neurofilament light or NFL, which just as you
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  know is a, is, is a biomarker of a neurodegeneration in general,
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  right? So, and none of the other
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  treatments has actually been able to move this biomarker and,
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  and we do see a good trend here as well and supporting our data.
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  So, so that was really, really cool to see that I think and,
• 10:38
  and, and strong. And the third thing that I think
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  was quite interesting was that we found that when we looked at
• 10:48
  healthy elderly people, they, they have naturally occurring
• 10:52
  antibodies towards this toxic oligomyre.
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  And, and, and, and this was surprising at first, of course.
• 10:59
  And, and then we decidedly, OK, So what does it look like in,
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  in, in the Alzheimer's patients before we give them the vaccine,
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  right. And turns out they have very low
• 11:09
  levels, which again was interesting.
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  And we decided, OK, let's look in young people.
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  What does it look there before you know any signs of elder or
• 11:19
  age? And, and in those we have 0.
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  So there's nothing in that, which was an interesting finding
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  in per SE, right. And then of course we look what
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  happens in these Alzheimer's patient when we actually give
• 11:31
  them the the vaccine. And it turns out that these
• 11:34
  patients that we give the vaccine, they came up come up to
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  exactly the same levels as the healthy elderly.
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  So age matched, which is a really interesting finding and
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  something that that further supports that this mechanism
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  might be involved in the disease, right.
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  So this is something we are going to dig that deeper into
• 11:53
  now and try to figure out, you know, how this develops over
• 11:56
  time and and obviously also be be part of a diagnostic
• 12:01
  approach. Yeah.
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  Then of course, it's tempting here to speculate that this also
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  might be a immune deficiency that we see in Alzheimer's
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  patients that that we don't see in the healthy LLB, right.
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  So there's all. Nice.
• 12:18
  And and you mentioned digging deeper, I guess that's what
• 12:20
  you're going to be doing in. Spreading.
• 12:23
  Get that? The last part.
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  Now you mentioned you're going to be digging deeper into to
• 12:28
  that, into the data and whatnot and obviously exploring more
• 12:32
  longer term, but will come with the phase two trial.
• 12:35
  Do you want to update? I think win the phase two trial
• 12:39
  for sure, but that's going to be more focused on efficacy, right.
• 12:42
  If you're going to look through that's going to be the primary
• 12:45
  endpoint there. We will have ad comps there as
• 12:47
  the memory readout. And then of course also that the
• 12:50
  safety holds up in a bigger population important.
• 12:53
  So, so we will do that. And when it comes to these
• 12:57
  background levels or naturally occurring antibody levels, that
• 13:01
  is something we will we'll do on the side I think and that that
• 13:05
  will be more of an more of a scientific study just just to
• 13:09
  figure out what this actually means.
• 13:11
  And hopefully we're in the part in collaboration with somebody.
• 13:14
  Sure, sure. Because you guys are also not,
• 13:18
  you obviously had the lead drug in that's going into phase two,
• 13:20
  but you also have an earlier asset which is essentially an
• 13:24
  antibody, right? Is that?
• 13:26
  Yeah. We have an antibody terms the
• 13:28
  exact and target, right. And and this antibody is, is, is
• 13:33
  in preclinical development now. So we have a few stages here
• 13:36
  before we can move that into the clinic and obviously all of this
• 13:41
  is being fine I think for the future.
• 13:43
  Yeah, of course, of course. Do you want to update us briefly
• 13:47
  on where you're at with the phase to kick off toward?
• 13:49
  You obviously had the the Ind recently cleared by by the FDA.
• 13:54
  Fight so, so that so, so we had that sent in on the 8th of
• 13:58
  August and and we just cleared it now.
• 14:00
  So a little bit ahead of time the 30 days.
• 14:03
  So actually very smooth process and and super happy of course
• 14:07
  about that. We have released the drug
• 14:10
  substance previously and that we are working on the drug, drug
• 14:13
  product release. We we have selected the CRO.
• 14:18
  So we have, we have actually selected worldwide clinical
• 14:22
  trials very experienced CRO had more than 9000 patients through
• 14:27
  in, in, in the area over the last couple of years.
• 14:31
  And and I think that if anybody can do it to take this all the
• 14:36
  way, I think I think they will be a very good partner for us.
• 14:40
  So, yeah, that, that that's where we're standing right now.
• 14:43
  We haven't, you know, started with the details when it comes
• 14:47
  to selecting sites and all that yet that, but it's between the
• 14:50
  plans. Of course the protocol is ready.
• 14:55
  Yeah. What else?
• 14:57
  I think that's where we're standing right now.
• 14:59
  So that there's of course a lot of work to do.
• 15:01
  And I think, you know, the biggest hurdle right now is of
• 15:05
  course we're doing a study in 240 patients.
• 15:07
  It's it's a bigger study of course, but also I think
• 15:11
  essential, essential for for us to be able to have had a readout
• 15:16
  that they can rely on. And we're also planning to do an
• 15:19
  interim readout basically have a through that we give us a good
• 15:23
  indication on if we're on the right side, right, right.
• 15:26
  So, so that's something we're working on as well.
• 15:28
  Sure. I mean, trials in on time, is
• 15:30
  that notoriously quite long as well, right?
• 15:34
  What's that so of? Course, I mean, we're, we're
• 15:37
  counting on, on three years here, about 12 months
• 15:39
  recruitment and then, then and then then of course the actual
• 15:44
  treatment time we will be around 2 year.
• 15:46
  So yeah. Yeah, OK.
• 15:48
  Understood. You mentioned worldwide and,
• 15:51
  and, and obviously you work with polypeptide right as well for
• 15:54
  manufacturing. So you've so you've got a really
• 15:58
  like quite lean team right throughout the journey.
• 16:01
  Is that, is that something that you've done on on purpose or
• 16:05
  like managed costs or yeah, how? Yes.
• 16:09
  I think, you know, for us to be able to be flexible and, and
• 16:12
  cost aware is crucial at the stage we're at.
• 16:16
  I, I, I think, you know, we have to be able to, to, to speed up
• 16:20
  and slow down as, as, as we see, as we see the world around us
• 16:24
  and, and, and, and our situation.
• 16:26
  So, so that, that is certainly on purpose.
• 16:28
  And I think, you know, once we are funded good enough to take
• 16:32
  this, this through the phase two, we will of course do some
• 16:36
  ramping up on, on, on, on on the staff side as well.
• 16:39
  But right now, you know, we're, we're 8 to 9 people in the team
• 16:44
  and 9:00, but not everybody is full time.
• 16:46
  We have, we have patent and and admin on on a little bit less
• 16:50
  than full time. So, so overall a very, very lean
• 16:52
  team for now. Yeah, makes sense, right.
• 16:56
  I mean those, those Charles are costly Charles to to run as
• 16:59
  well. And and you mentioned the
• 17:00
  financing part and in the short and and mid term, I guess long
• 17:06
  term as well looking ahead of you keeping like a bit of a
• 17:10
  balancing app between maybe looking partnering long term,
• 17:14
  what you looking to know? We have ongoing discussions with
• 17:20
  a number of players in Big Pharma and I think that
• 17:23
  everybody is the CNS space and Alzheimer's are of course
• 17:26
  interested in discussing and, and, and talking to us about
• 17:31
  this. And, and, and that's what we're
• 17:32
  doing, updating people on the data and, and trying to extend
• 17:35
  those conversation into something more meaningful for,
• 17:38
  for both parties. And, and, and this, this will
• 17:41
  continue until, you know, until we're successful with that.
• 17:44
  And so, yeah, hopefully that will happen sooner than later.
• 17:48
  And that's something we are, we are, you know, focusing on every
• 17:51
  day. And Sebastian, our, our BD guy
• 17:54
  here, he's he, he's spending his yeah, full time on this,
• 17:58
  obviously, right. So, so then there's a lot to do
• 18:01
  and we have by Japan coming up by Europe also here in, in
• 18:05
  Vienna in, in beginning of November.
• 18:08
  So there's a few events here that requires a lot of focus and
• 18:13
  and work. Yeah, sure.
• 18:16
  I mean, I, I know it's something that you wanted to touch on
• 18:18
  previously when we, when we discussed before the podcast,
• 18:21
  but the upcoming value drivers or at least in the next 12
• 18:24
  months really partners or investors are looking at for
• 18:28
  your business. Do you want to talk about them
• 18:30
  briefly? I think you know we will have, I
• 18:33
  think you know the Ind cleared was one thing that that we were
• 18:36
  looking for. We have fast track application
• 18:39
  and and prime for Europe coming up hopefully in the in the near
• 18:43
  time future after that you know, we will look at of course
• 18:49
  initiating the trial first patient first visit.
• 18:52
  I think it's it's a major milestone obviously.
• 18:55
  And then, and then then of course I think you know we will
• 18:59
  have a few milestones during that part as well in terms of
• 19:03
  50% of patients recruited. I think at that time we were
• 19:06
  labeled when we have them in, in the year we will be able to have
• 19:09
  the interim readouts. I think that's the, you know the
• 19:12
  the two year plan basically. So before end of 27, I'm hoping
• 19:17
  we can have the interim readout. Nice.
• 19:20
  Understood. And the fast track designation,
• 19:22
  is that something that's been granted already or is that?
• 19:25
  Oh no, it's, it's, it's something that will happen here
• 19:28
  in the near future, I hope. Fingers crossed.
• 19:31
  Yeah, Yeah. I think that's for sure.
• 19:33
  It's, I mean for a small biotech, it's important.
• 19:35
  I mean it's an open door to the to the FDA and and you know,
• 19:40
  supporting conversation and and also of course and down the road
• 19:46
  it will be important for us with respect to speed to market.
• 19:48
  So so there. There's a lot there.
• 19:51
  Absolutely, for sure. You mentioned a few of the
• 19:53
  conferences you'll be in attendance by Japan, by Europe
• 19:57
  is a, will we be at Jeffrey's as well.
• 19:59
  Is there anywhere else potentially interested party?
• 20:01
  Yeah. Yeah, you're looking at that as
• 20:03
  well. So we haven't decided yet, but
• 20:05
  but it's it's in the in the past.
• 20:07
  So hopefully, yeah, nice. Very good.
• 20:10
  Well, it looks like sounds like a very busy end to the year and
• 20:14
  and a really exciting 2026 tour. Looking forward to keeping a
• 20:19
  track of progress. Yeah, I think been great to hear
• 20:22
  the back story and a little bit about what you guys are hoping
• 20:25
  to achieve for sure and much needed as well.
• 20:29
  So yeah, best of luck with everything.
• 20:31
  And I guess we'll we'll wrap up with the sort of typical Biohub
• 20:35
  question which I told you about when we initially spoke.
• 20:38
  And that was if you if you could have dinner with one scientist
• 20:42
  or entrepreneur, anyone, who would it be and and why?
• 20:47
  Yeah, I think, I think I'm going to pick a scientist.
• 20:50
  I I mean, you know, at first I was first thinking it would be
• 20:55
  really nice to, to actually have been there with Alzheimer.
• 21:00
  He's long dead, right? But, but, but it would still be
• 21:04
  an interesting thing. But then I thought, OK, so I'm
• 21:06
  an immunologist. Maybe I want to talk to somebody
• 21:08
  that that's in the field. And of course I talked to a lot
• 21:11
  of people already. But but there's, there's one guy
• 21:14
  I never met and I spent seven years working in Japan.
• 21:18
  So I would really like to meet Susumu Tonigawa.
• 21:22
  I mean, he got the no Nobel Prize, you know, in 87 for for
• 21:29
  the diversity of antibodies. But he had made an interesting
• 21:32
  career shift also and are currently in the CNS field at
• 21:36
  older age. So I think, you know, to have a
• 21:39
  conversation with him around the vaccine in Alzheimer's disease.
• 21:43
  He's super fun and it's possible he's in California, so.
• 21:47
  Who knows, he who knows, Maybe one day.
• 21:52
  Very good. Well, Todd, pleasure to have you
• 21:54
  on. Thanks for that.
• 21:55
  And yeah, best of luck for everything.
• 22:00
  Thank you. Take care.