Latest / The BioHub - by Avetix / Episode 155 - Lu Han - CEO & Co-Founder

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Episode 155 - Lu Han - CEO & Co-Founder · The BioHub - by Avetix

• 0:06
  So welcome back to another episode of the Biohub and Avetix
• 0:09
  podcast. Today, I'm joined by Luham,
• 0:12
  founder and CEO of Enviva Biotech.
• 0:15
  Lu founded the company in China and is now building it into a
• 0:18
  truly global biotech focused on allogenetic off the shelf CAR T
• 0:22
  cell therapies. Enviva is developing allogenetic
• 0:25
  CAR T platforms designed to improve access, cost and
• 0:29
  scalability in cell therapy with active clinical programs in the
• 0:33
  US. In this conversation, we talk
• 0:35
  about building biotech across borders, the role Chinese
• 0:39
  innovation can play globally, navigating US China dynamics,
• 0:43
  and why in Viva recently rebranded.
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  So let's get into it. Lou, how are you?
• 0:49
  Very good. How are you, Max?
• 0:51
  Nice to see you again, Morgan. Yeah, absolutely.
• 0:54
  It's a pleasure to have you on. Like really is a privilege.
• 0:57
  Let's let's start about the start with the founding of
• 1:01
  Nviva. You, you founded a company in
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  China and now you're building what is what a truly global
• 1:08
  footprint. How did the original scientific
• 1:11
  idea come about and what problem were you trying to solve from
• 1:15
  day one? Yeah.
• 1:16
  Thank you for asking that. Like the company actually we
• 1:19
  found this company 8 years ago in the beginning of like 2018.
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  I think the IP and the science actually came from my Co founder
• 1:31
  Doctor John Tower and who actually was a postdoc in in
• 1:37
  cartoons lab for a couple of years while like the at the
• 1:40
  Haiti of autos Carty approval during like 2013 to 2017, you
• 1:46
  know, in cartoons like they've already started working on
• 1:49
  allergenic Carty. So he was there and then I met
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  with him around like end of 20/17/2018.
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  So we, we decided, you know, to move this really exciting
• 2:00
  technology into real life because as maybe some of our,
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  our our audience knows that, you know, our thoughts car T is, you
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  know, transforming, you know, patient T cells into a kind of
• 2:15
  targeting after genetic modification have the targeting
• 2:19
  effect so that I can kill specific leukemia cells or
• 2:23
  diploma cells for the patients. And because it has to use the
• 2:28
  same cells that the patient that derived and then the phrases.
• 2:32
  So like every batch of every dose that the patient receive is
• 2:37
  actually a kind of like custom made, really high cost form of
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  drug. And then, and then in, in, in
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  order to solve this cost issue, accessibility issue, you know,
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  the, the group of scientists in, in Europe and they've been
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  thinking that can we actually just use a kind of healthy donor
• 3:02
  anyone, you know, to be the source of the T cells.
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  And then after the genetic modification, we can actually
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  eradicate some of the immune identity of that cells so we can
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  have the hypo immunity features so that can be reinfused to any
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  patient. So we're like, you know, making
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  this organ or this tissue or this cell in into a kind of
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  universal cells that can be refused back to any patient and
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  not really hugely going to change the cost structure of
• 3:36
  this kind of drug. You know, in the US approved CAR
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  T cells are, you know, we're going to cost around let's say
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  200,000 US or even more to manufacture and then it sells at
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  maybe like say 500,000. And I think, you know,
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  definitely if you use allergenic cars, you can bring the cost
• 3:57
  into 110th and definitely you don't.
• 3:59
  And then if you have to manufacture the car to you,
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  right, you the patient has to be around the manufacturing
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  facility, right? It can only be admitted into
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  certain sites that that they have this car T manufacturing
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  qualifications, but with the allergenic RT approach, you can
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  definitely just manufacture the cells in one place and ship that
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  to the to the to the global scale and benefit every patient
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  that who really needs this. So I think really that's that's
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  a great idea at the very first beginning.
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  We're going to tell tell you a little bit like those challenges
• 4:34
  that we face in the future, but but at that bright future, that
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  bright kind of idea as you can either like the the early birth
• 4:42
  of this company. So me and my Co founder, we met
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  in we met actually in in Children's Hospital of
• 4:49
  Philadelphia. And then that chop is really
• 4:53
  like the birth place of of of hos Karti Kim Reya.
• 4:56
  Nobody's Kim Reya. We met there.
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  Like we got really excited in in into the bright future of
• 5:01
  Algerian Karti. We decided to move back to China
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  and then and started this company 8 years ago and now
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  we're here. And then we have around right
• 5:10
  now operations in both US and China.
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  We did our some of this, our early discoveries in China,
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  early clinical POC in China, but also we do kind of full scale
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  manufacturing in the US and we do clinical trials globally
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  especially you know launching from US as a starting point and
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  then moving gradually to Europe and then other places.
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  Yeah. See, that's an interesting
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  point. You know, you obviously have
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  early discovery in China and then CMC ING clinical progress
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  in the US. So how do you think about using
• 5:44
  different global ecosystems to build a stronger biotech as a
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  big part of you know, how you thought about the business?
• 5:51
  Yeah. That, that's actually a very
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  interesting question because I think it's, it's beyond like our
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  company a lot. I, I think we've witnessed a, a
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  recent kind of dynamic change in, in the biotech ecosystem
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  these years. Definitely Chinese biotechs are,
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  are kind of catching up on, on a lot of like innovations and
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  providing like early stage molecules to, to global biotech
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  systems. But what we've seen is in China,
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  there are a couple of unique features that really gives the
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  Chinese biotechs some kind of unique competitive advantage,
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  right? So in this part of the world,
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  right? So you, you got a lot of CIOs,
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  right, you know, Wuxi, you know, like Famura.
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  And then those traditionally like China companies are, are
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  really like the best at really being the CIO providing separate
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  like tasks for, for the, you know, file tax.
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  But I think gradually Chinese about early biotechs emerge and
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  they, they act as a kind of like project manager, managing all
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  these CI OS, levering their resources, leveraging the talent
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  pool, you know, huge talent pool that here that works really hard
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  relentlessly to to to really deliver in a very time efficient
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  manner. So I think China's really good
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  at the early discovery to get in the molecules tested and
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  formulated in in the wet lab, wet lab.
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  But actually I think that's kind of like the first wave of a
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  Chinese biotechs advantage. But recently we've seen
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  something else. We were seeing that the clinical
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  trials has been kind of really boomed in the past like 5 years.
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  I think traditionally, like the patients here, I have not really
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  heard about this clinical trial idea in before right until I
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  think in 2017 that there's a huge reform and then that the
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  trials has been kind of starting booming.
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  And then the patient has a lot of confidence in the new trials
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  being launched in China. And then the participation in
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  the clinical trials has been, has been kind of skyrocketing
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  these days. And I think that really gives a
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  lot of like clinical resources that we can leverage.
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  So you have really fast side launch, you had really fast
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  patient enrollment. And then that has been
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  demonstrated in, in, in the recent boom of like the ADC
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  companies, biotech booming in China and then and subsequently
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  with a lot of like licensing out of these ADC molecules.
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  And we are one of them. Like we, we just leveraged all
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  these not only like the chemists, but the biologists
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  huge talent pool to really have high throughput kind of molecule
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  screening to get the best early molecules and then to get the
• 8:59
  drug candidates. But also I think the speed that
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  we we test in, in, in clinical setting is, is really one of
• 9:08
  the, the fastest in the world. I can give you an example,
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  right, especially in in cell therapy field, we have this IT
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  policy where cell therapy companies can get into the
• 9:20
  clinical settings without the China FDA approval, right?
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  Actually get regulated under the Ministry of Health and then thus
• 9:29
  the hospitals, certain hospitals have decentralized IRB approval
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  system without the centralized approval, the Irbs of each, each
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  hospitals can just approve this CGT trials.
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  So that we might be able to get into the clinical settings with
• 9:47
  a very early stage, let's say CMC process that reduce up maybe
• 9:52
  a 24 month of, you know, concept to, to 1st patient in duration
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  to let's say 12 month. And that really gives the the
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  South therapy companies in China a lot of advantage.
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  We've been, we've been, you know, iterated in Congo settings
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  for almost like 12 generations of allogeneic CAR T, while maybe
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  our competitors in the US have and in Europe have maybe let's
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  say 3 generations of iterations. And then with that kind of like
• 10:23
  you know, clinical resource and the clinical capabilities, we
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  actually held a couple of US biotechs also bring them to, to,
• 10:32
  to have Chinese IIT settings to make them access, get access to
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  the Chinese IIT trials. We so far we have already helped
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  three US biotechs launched IIT trials in China.
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  Save them a lot of time, save them a lot of money.
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  And then I think there are more and more US biotechs and global
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  biotechs actually considering getting trials launched in
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  China. But I think that that should be
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  like the future of the world, right?
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  Like, you know, biotech, one of my UMass actually always told me
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  that biotech is there's no US biotech, there's no China
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  biotech. It should be biotech is biotech.
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  Biotech should be competing at the global scale.
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  So I think that that is the something that will really
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  invasion what's going to happen in the next, you know, decade.
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  We we can combine like the best of each world together.
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  You know, like we can use maybe China's early discovery and
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  early clinical resources combined with, you know, Uus and
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  Europe golden standard of like regulatory credibility and and
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  clinical development expertise and market access so that we can
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  actually build global biotech with more efficient approach.
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  I think that's so true. And you articulated it really
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  well there. But like it, it was a constant
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  discussion across JP Morgan, right?
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  Like this innovation coming from China shouldn't be seen as
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  competition. It should be seen as, you know,
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  there's, there's a way to combine the 2 and then there's
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  also this aspect that we spoke about a little bit as well,
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  which this US China relations, which in some ways going to have
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  some kind of impact on the industry.
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  How is that dynamic affected in Viva's growth and strategy?
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  And how do you navigate as ACEO as well?
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  That's a great question. I think we we cannot really
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  comment on like, you know, the grander scheme of like the
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  geopolitics of, of, you know, like the global tensions and all
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  the things that I think that's actually everyone is observing
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  that rate right now. But but I think to be
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  specifically in in in Baltic world, I think there are a
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  couple of things what we can do to to at least make this global
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  tension less kind of impact for, for, for, for biotech like us.
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  So first, I think, I think, you know, we, we actually not only
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  just do everything in China, right?
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  Like if you, if you just, you know, produce everything and
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  then then do everything and make every penny just by yourself,
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  like, you know, definitely this is not a sustainable model,
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  right? So what we did is, is actually
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  not only, but not only that's not going to be a sustainable
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  model, but also I think, you know, it's not possible if you
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  only want to just use one part of the world resources to
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  achieve global competitive biotechs concept, right?
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  That's we just said you need to combine the advantage of
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  different parts of the world. Right now we have around 20% of
• 13:46
  our employees in the US actually because all those, all those
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  employees in the US actually manage a couple of CR OS and CDM
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  OS in, in the US. So I think directly or
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  indirectly we we actually have engaged more headcounts that in
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  the US helping the company development of our products,
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  right. So I think China's advantage is,
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  is more on the early discovery and early clinical, but for the
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  full scale manufacturing, for the near commercial
• 14:19
  manufacturing, we're doing that in the US, right.
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  We're doing that through a USCDMO.
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  And then also I think for the clinical trial, our U.S. team in
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  the US has been able to to launch our Phase 1B/2 trials in
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  the US And also I think this year we're going to launch the
• 14:42
  trial in Europe and in Japan as well.
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  But getting back to your question, I, I think what do we
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  actually proceed from, you know, in the news, you heard a lot of
• 14:54
  like really tensions and then and, and a lot of like, you
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  know, really negative kind of news, right?
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  But in our daily life, we, we didn't really face that much
• 15:07
  challenge. I think every, a, every
• 15:10
  stakeholder, every agency, every, even every people that
• 15:13
  we've met has been really helping us to, to achieve this
• 15:17
  global biotech and dream, right? So I can give you some example,
• 15:21
  right, FDA, you know, people are always saying that FDA is, you
• 15:24
  know, you know, they're going to be having a, you know, a, a, a
• 15:28
  maybe a bias view in the evening looking to the Chinese data.
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  But actually it's not like we would provide them with our IT
• 15:35
  data that we generate in China. And the FDA actually give us a
• 15:38
  very good feedback and they allow us to get into phase 1B
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  directly with, with the RP2D that we'll propose, right?
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  You know, and they're a federal agency, but they are also very
• 15:49
  scientific driven party, right? So they're pretty nice to us.
• 15:55
  I think the P is if you have really have a drug that can
• 15:58
  solve patient's problem, right? I think Pi will definitely help
• 16:02
  you a lot, right? Pi want to have this kind of the
• 16:05
  best technology around the world to help the patient because
• 16:08
  that's their ultimate goal, right?
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  You know, ignoring the nationality and all the things,
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  you know, helping the patient that getting them the best
• 16:16
  treatment available is the P is kind of ultimate task.
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  So if we can help them, they really, you know, respect us and
• 16:25
  then help give us a really quick access and expedite our trial
• 16:30
  process in in those sites. And also like, I think
• 16:33
  recruitment as well, like we've we've, you know, build a team in
• 16:40
  the USI think we've we've build a team culture that really
• 16:44
  reached a different a part of the world's like resources and
• 16:47
  then the work, you know, kind of around the clock.
• 16:49
  You know, I think we we face more help than challenges even
• 16:54
  in this really kind of intense political kind of background.
• 17:02
  That's awesome. And like you say, like from from
• 17:04
  an outsider's standpoint, you know, you hear all this negative
• 17:07
  thing in the news, but really you just don't see that, which
• 17:11
  is great and. Well, they're news, right?
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  Like, yeah, true, the daily life you what what we've seen is a
• 17:18
  lot of like nice people love like nice deeds, right?
• 17:20
  Like really things are working smoothly.
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  But once these kind of really negative things happen, then
• 17:26
  they become news. So I, I, I do think, you know,
• 17:29
  the trend is if you were willing doing a great job on, on bring
• 17:33
  the best talent together, like developing the best drug for
• 17:36
  the, for the global skilled patient.
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  I think these kind of things should be rewarded by the
• 17:41
  society as as a whole, right. And then that's exactly what
• 17:45
  we've been we've been through these days.
• 17:48
  Yeah, yeah. And then you guys have recently
• 17:51
  had a rebrand from Biohang to now Enviva.
• 17:55
  Why was that the right move, and what does the new name represent
• 17:59
  for the company's future? Yeah, like when you just
• 18:04
  introduce like the biohop and I think, oh, that sounds like
• 18:07
  Biohon, our previous name. But yeah, like Biohun is
• 18:11
  actually like the the previous Chinese direct translation of
• 18:15
  our our, our Chinese name before, right.
• 18:17
  I think during the early days of of the company development, we
• 18:21
  were still working on early discovery and trying to get a
• 18:25
  molecule that we were very happy with.
• 18:28
  But I think once we got a really great candidate and that we have
• 18:34
  tested and proved that to be very powerful in the conco
• 18:38
  setting, I think it's time to bring this drug to a global
• 18:42
  scale. And then at this point, I think,
• 18:45
  you know, Baohung is very difficult to pronounce right for
• 18:49
  a lot of people. And then people don't really
• 18:51
  know like what's the what's the meaning behind that?
• 18:54
  But I think in Viva is actually reflecting our global expansion,
• 18:59
  reflecting our it's it's much easier to read name for global
• 19:04
  audience, right? It's actually we we've we've had
• 19:09
  like a couple of selections candidates of the names.
• 19:13
  But me and my Co founder will love will love in Viva not only
• 19:16
  because it's like immunology plus Viva like the life, right,
• 19:19
  But also it sounds like in vivo studying vitro, say like in vivo
• 19:23
  like so I think it has some kind of biologic kind of like nerd
• 19:28
  kind of taste to to to sounds like a very biological jargon
• 19:32
  that we that we love that we we toast that as well.
• 19:37
  Yeah. Nice.
• 19:39
  Yeah. And and just to go a little bit
• 19:41
  more into into the focus, you know, I was generating off the
• 19:45
  shelf car T therapies. How do you see the current car T
• 19:49
  landscape? And then also, where do you
• 19:51
  think our genetic approaches can really change the game,
• 19:55
  especially what you guys are doing?
• 19:57
  I think if you look at the, you know, the current car T sales
• 20:03
  globally like in last year, it's around like 5 billion market,
• 20:10
  right. But I think among that 5
• 20:12
  billion, maybe 4 billion happened in the US and.
• 20:19
  And in my only benefited only let's say 5 billion divided by
• 20:23
  let's say 500,000 and maybe like only, you know, like 10,000
• 20:29
  patients, right? That kind of skill.
• 20:32
  But I think this is really a powerful form of drug.
• 20:36
  And then he has a really amazing kind of efficacy in hematology
• 20:42
  oncology patients, right? It can hates the CR rate as high
• 20:46
  as 80%, right, really provide a potential cure kind of hold for
• 20:52
  these group of patients. And now it is expanding to
• 20:56
  immunology which can which are even bigger than the hematology
• 20:59
  oncology, maybe like 10 * 40 * 50 times bigger.
• 21:03
  And then that definitely needs this drug to be able to be
• 21:06
  accessed and afford by a much wider group, group of patients
• 21:12
  globally, right? So automatically everyone knows
• 21:17
  we need to shift from autos car T to a newer form, right?
• 21:21
  Whether it's, you know, allergenic, whether it's another
• 21:25
  kind of like allergenic car T or or IPSCNK, you know, any
• 21:29
  approach that can make this drop off the shelf, which is, you
• 21:34
  know, not customized made would definitely bring down the cost.
• 21:38
  But also, you know, I think the vein to vein time for
• 21:43
  manufacturing product also actually takes 40 days in the of
• 21:46
  Hoscarti settings, right? And the patient has to be near
• 21:50
  the manufacturing center. So if you're thinking like a
• 21:52
  patient who lives really a long way from from let's say US
• 21:56
  continental Europe, it's just impossible for them to get this
• 22:00
  treatment. So I think both from cost
• 22:02
  perspective and access perspective, you need to have an
• 22:05
  innovative solution for this. So that's why allergenic is
• 22:12
  automatic choice. And then there are actually a
• 22:15
  couple of other options as well like such as in vivo car T.
• 22:19
  But you know, I think each approach actually not only a
• 22:25
  kind of direct replacement of the other, but somehow may be
• 22:29
  complementary to each other, right.
• 22:31
  So I'll give you a really good example, right.
• 22:34
  So for the allergenic car T, our first product will be targeting
• 22:38
  on T cell leukemia. So if the patient T cells are
• 22:42
  actually leukemia cells, you cannot really use that T cell to
• 22:45
  manufacture autoscar T because the patient T cells are are just
• 22:49
  leukemia cells, right. You cannot extract the T
• 22:52
  leukemia T cells from the patient and manufacture into the
• 22:54
  drug itself. So, and you cannot really using
• 22:57
  vivocar T, right, because because if you just inject like
• 23:01
  virus or or LMP to transduce that T cells, it just doesn't
• 23:05
  really make any sense because the T cells are leukemia cells,
• 23:07
  right? Automatically like allergenic
• 23:09
  might be the best approach to to tackle the indicate this
• 23:13
  indication. So I think that's kind of like
• 23:16
  how we how we perceive this, you know, like the future of of this
• 23:21
  field allergenic car T in Viva car T and TC ES, right?
• 23:26
  Every one of them will be having their unique biologic kind of
• 23:31
  characteristics and then you need to match this product
• 23:35
  biology with specific disease biology, right.
• 23:38
  There are some of them will match better than the others and
• 23:41
  in that indication with that specific call MI need will be
• 23:46
  best suited for that kind of indicator for that modality.
• 23:50
  So we're seeing advantages for allergen CAR T in T cell
• 23:55
  malignancies and T cell related diseases also T cell chronic
• 23:58
  diseases, but also like I think in autoimmune setting, right.
• 24:03
  So because the autoimmune patient have the the potency and
• 24:09
  then the expansion and the persistence required by CAR T's
• 24:14
  definitely lower than in the oncology setting.
• 24:18
  So that's why I think autoimmune would also be a very good field
• 24:21
  for for the allergenic CAR T. So that's exactly the two areas
• 24:24
  where we've been firstly working on these days.
• 24:30
  Yeah, it's so good to see you guys on this journey, like you
• 24:32
  say, 8 years from start to where you are now.
• 24:35
  It's good to see you at JP Morgan.
• 24:37
  And then we're we're coming on to my final question, which is
• 24:39
  the question I ask every one of our guests, which if you could
• 24:43
  have dinner with any scientist or innovator, past or present,
• 24:47
  who would it be and why? Oh yeah, Like I, I think, you
• 24:50
  know, this question that I, I, I would have different answers in
• 24:54
  different time, but right now I think definitely I would, I
• 24:57
  would say Geoffrey Hinton, like the AI professor in from
• 25:04
  Toronto. I I think if you're doing any
• 25:08
  industry right now, you're, you're, you're really or not
• 25:12
  only any industry, but everyone in the world right now are
• 25:14
  facing a really a radical kind of changes or revolutions in, in
• 25:21
  their specific field in each field, because AI, right.
• 25:25
  So I'm really like, you know, kind of wondering like what's
• 25:29
  the really like the future of the human world?
• 25:33
  Like after the impact is Asia is really going to come in, in the
• 25:37
  next decade? And then if so, like are they
• 25:40
  going to develop drugs faster than we do?
• 25:42
  Right? No.
• 25:44
  So like, you know, if so, then how can we actually help to make
• 25:47
  that happen, right. So that, you know, we can help
• 25:50
  them to develop, help the AIAGIS to develop drugs faster so that
• 25:53
  we, we might be able to solve all the disease that, that, but
• 25:57
  if not like we can also leverage these tools to, to expedite like
• 26:01
  the drug development process, right.
• 26:04
  So I think AI is definitely like the the biggest things for me in
• 26:09
  the next kind of couple of years and to see how that would
• 26:12
  benefit our company and, and and then the field as a whole.
• 26:17
  I agree. Yeah.
• 26:18
  I mean, everyone, whether you're in biotech or not, you've got to
• 26:20
  jump on it now before anyone else put it before you, right?
• 26:23
  Like everyone has a great answer.
• 26:26
  And look, thank you so much for coming on, Lou.
• 26:28
  It's been an absolute pleasure. And congratulations to all the
• 26:33
  success so far and best of luck going forward.
• 26:35
  Right. Thank you, Mike, so much.
• 26:37
  Thank you for holding me. Yeah, and please everyone like
• 26:39
  and subscribe to the bio hub and and thank you so much again,
• 26:42
  Lou.