Ep. 361 - Kelonia, Kailera, pyschedelics and T cell engagers

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<v Voice Talent>BioCentury This Week is brought to you by IQVIA Biotech.

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<v Voice Talent>A full-service CRO right sized for biotech.

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<v Voice Talent>Dedicated to helping biotech leaders close unproductive gaps in clinical development so they can protect timelines, preserve capital and stay ahead of risk.

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<v Jeff Cranmer>Welcome to the latest edition of the BioCentury This Week podcast.

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<v Jeff Cranmer>Lilly is continuing to be active in the dealmaking space, announcing its fifth major deal of the year, a$3.25 billion upfront payment for an in vivo CAR T company named Kelonia, we'll take a look at why Lilly is buying this company, and how it's differentiated from another deal it recently did.

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<v Jeff Cranmer>And speaking of deals last month gave T-cell engagers new credibility as a potential modality for B cell depletion in autoimmune diseases.

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<v Jeff Cranmer>And from Washington, an executive order seeks to smooth the glide path toward approvals for psychedelic therapies.

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<v Jeff Cranmer>Meanwhile, in finance, Kailera and obesity play with China roots upsized.

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<v Jeff Cranmer>Its IPO late last week, which vaulted it to rare air, potentially one of the biggest ever biotech IPOs.

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<v Jeff Cranmer>And we'll, remember Denis Lucquin, the father of French biotech.

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<v Jeff Cranmer>I'm Jeff Cranmer, host of the BioCentury This week podcast, and joining me to discuss all of this, our editor in Chief, Simone Fishburn, Executive Editor Selina Koch, Washington Editor Steve Usdin, and the illustrious Lauren Martz, Executive Director of Biopharma Intelligence.

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<v Jeff Cranmer>But first, right around the corner Simone and Steve and a few of our other colleagues will be flying off to Prague to enjoy a beautiful city and the premier biotech CEO and Investor conference, which is now in its 26th year.

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<v Jeff Cranmer>Speaking of Denis uh Denis and his partner Antoine at Sofinnova, helped BioCentury by being the inaugural sponsor of this event.

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<v Jeff Cranmer>They always championed this event and well uh it's one of the reasons why Bio€quity is what it is today.

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<v Jeff Cranmer>Simone, are you getting excited?

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<v Jeff Cranmer>You uh got your uh scene setter stuff already baked?

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<v Simone Fishburn>Am I ever excited.

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<v Simone Fishburn>First of all, I want you to know that I'm, I'm now deeply immersed in reading loads of books set in Prague.

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<v Simone Fishburn>You know, Milan Kundera comes to uh

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<v Jeff Cranmer>yeah

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<v Simone Fishburn>to the fore.

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<v Simone Fishburn>Yeah.

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<v Simone Fishburn>Having a good time with that.

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<v Simone Fishburn>But uh

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<v Jeff Cranmer>What's your favorite Milan Kundera?

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<v Simone Fishburn>What is my favorite?

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<v Jeff Cranmer>Yeah.

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<v Simone Fishburn>Ask me in a couple of weeks when I've read a few more

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<v Jeff Cranmer>All right.

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<v Simone Fishburn>right now I'm on Lightness of Being.

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<v Jeff Cranmer>Keep it unbearably light, Simone.

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<v Simone Fishburn>yeah Um anyway, yes, the, I'm also extremely excited about the scene set analysis that I'm doing, which I will talk a little bit more about when I've just done a little bit more work on it.

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<v Simone Fishburn>But broadly, we are looking at clinical trials in particular Phase I, globally and within Europe.

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<v Simone Fishburn>Where they're being done and who's doing them and in what disease areas and where the different hotspots and strengths are.

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<v Simone Fishburn>So it's really, you know, shaping up to be very interesting.

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<v Simone Fishburn>And as I said, we'll talk more about that.

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<v Jeff Cranmer>The need for speed.

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<v Jeff Cranmer>It's gonna be a great event.

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<v Jeff Cranmer>We have a great lineup of a hundred presenting companies from across Europe.

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<v Jeff Cranmer>a few slots left.

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<v Jeff Cranmer>So if you're interested, reach out to me or my colleague, Tim Tulloch, and if you're interested in attending jump right in, there are pre-event excursion still available and there will be lots of networking, networking, networking, networking.

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<v Jeff Cranmer>If you're looking to get in front of investors in Europe, this is the conference to do it.

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<v Jeff Cranmer>Alright, Eli Lilly deal number five.

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<v Jeff Cranmer>It, it seems like it's a race between Eli, Lilly and Gilead this year to see who can have the most.

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<v Jeff Cranmer>Big time deals.

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<v Jeff Cranmer>Lauren has been following most of them for us, along with our colleague Paul Bonanos.

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<v Jeff Cranmer>In this deal, well, it's once again putting its obesity earnings to work, building out its pipeline.

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<v Jeff Cranmer>Not quite as big as the Centessa deal that we recently talked about, that was 6.3 billion.

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<v Jeff Cranmer>This again, as I said, is, is 3.25 billion uh potential to get up to 7 billion, that's the bio buck number.

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<v Jeff Cranmer>Um, Lauren, what set this company apart from the others and then inspired Lilly to pull the trigger?

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<v Lauren Martz>So if I, if I had to guess, I think it would probably be the fact that Kelonia has some of the longest durability data for any in vivo Car Ts that we've seen so far.

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<v Lauren Martz>And we haven't seen a lot of clinical data and it's not a lot of durability data.

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<v Lauren Martz>But at ASH at the end of last year, we saw data from four patients.

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<v Lauren Martz>I think one of them had about five months of follow up.

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<v Lauren Martz>And efficacy still looks strong at that point.

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<v Lauren Martz>And so, that's kind of the most that we're getting right now.

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<v Lauren Martz>And I think when it comes to what people wanna see for these in vivo CAR T platforms durability is kind of everything, safety and durability.

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<v Lauren Martz>But Um that's kind of the, the yet unknown out there right now, especially when you're talking about applying these to cancer.

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<v Lauren Martz>so you mentioned that this was Lilly's second deal, I think for an in vivo CAR T company this year, just about two months after they announced the acquisition of Orna.

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<v Lauren Martz>What's different here is that that was an RNA based technology to create in vivo CAR T. This is a lentivirus based technology.

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<v Lauren Martz>I think we're still also waiting to see how these two different, and, and there are others, how these different mechanisms for creating these in vivo CAR T cell therapies really plays out in the clinic.

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<v Lauren Martz>I think there's some speculation that maybe the lentivirus will be more durable and something that can be applied to cancer.

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<v Lauren Martz>Maybe the mRNA will be something that you know, is faster acting and uh can be applied to autoimmune diseases.

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<v Lauren Martz>I don't think we know that yet, but this does give Lilly two different shots uh at the in vivo CAR T mechanism.

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<v Simone Fishburn>Lauren, this space is obviously just getting hotter and hotter.

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<v Simone Fishburn>I know the.

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<v Simone Fishburn>been a few sort of setbacks on the way here and there, patient death and also some, you know, what you've pointed to in durability.

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<v Simone Fishburn>I'm just sort of wondering, we've seen a few deals in this   is this becoming something that pharmas need to have in their stable, they need to have an in vivo CAR T, or is it not reached that kind of point yet?

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<v Lauren Martz>I think it's reaching that point.

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<v Lauren Martz>I think the data speak for themselves.

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<v Lauren Martz>We've seen quite a few acquisitions and, and just broad partnership deals around these, these technologies.

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<v Lauren Martz>It's still early, there's still limited clinical data, and I think this is the time when people wanna get in and not have to invest a ton.

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<v Lauren Martz>Although the steel, obviously is a big investment.

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<v Lauren Martz>But if this technology works as people are hoping it will work, then yes, these pharmas wanna be in, in here.

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<v Lauren Martz>CAR T cell therapies, ex vivo Car Ts are incredibly effective.

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<v Lauren Martz>And, and that limiting factor is the delivery and the manufacturing and all of that.

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<v Lauren Martz>This takes away so much of that complexity.

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<v Lauren Martz>if this is as effective and as an ex vivo CAR T. It's something that  could be more effective than a T-cell engager, for example.

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<v Lauren Martz>You know, it, it just, it if the efficacy and the durability and the safety, which there could be safety advantages here over the ex vivo too.

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<v Lauren Martz>If they play out, then this could be a huge game changer in cancer, but also in autoimmune diseases as well.

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<v Lauren Martz>So it's still early, but I think it's the time that companies wanna get in.

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<v Selina Koch>Lauren.

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<v Selina Koch>Um, on the durability front and people do say this durability is sort of everything, right?

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<v Selina Koch>But if these are off the shelf and if they're say, a bit safer.

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<v Selina Koch>Couldn't you just redose?

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<v Selina Koch>Is it so absolute as durability has to be as long?

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<v Lauren Martz>That's a really good question.

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<v Lauren Martz>I think that certainly with an mRNA based approach, you have the opportunity to re-dose and that's something that the companies are looking into.

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<v Lauren Martz>I think it's kind of an open-ended question when you come to the viral vector based strategies because there's always the risk for an immune response.

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<v Lauren Martz>You know, like we've seen with AAV gene therapies.

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<v Lauren Martz>re-dosing is, is a challenge.

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<v Lauren Martz>So I'm not exactly sure how that will play out in the future.

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<v Simone Fishburn>I have another question, Lauren.

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<v Simone Fishburn>most of what we've seen so far is in the same cancers as Car Ts, so multiple myeloma, the other blood cancers.

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<v Simone Fishburn>Just wondering if you think that this will have more chance of expanding into other indications and, you know, what the timeframe might be.

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<v Simone Fishburn>Have, have people talked about that?

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<v Lauren Martz>I haven't heard too much about that.

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<v Lauren Martz>I think there's so much technology risk here that going after CD19 And BCMA and uh maybe CD20, that's the obvious place to go.

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<v Lauren Martz>Um, the, so we mentioned the differentiation on manufacturing.

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<v Lauren Martz>There's potentially a safety advantage here too, because you take out the, you know, the lymphodepletion aspect, which adds a huge amount of toxicity to the ex vivo CAR T cell process, so.

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<v Lauren Martz>I don't know how that can help translate to other tumor types, like the solid tumor challenges are the solid tumor challenges, it's an antigen problem and I don't know exactly how, how an in vivo CAR T cell therapy could address that, but uh, I'm sure people are thinking about it.

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<v Jeff Cranmer>Okay.

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<v Jeff Cranmer>And uh this deal according to BioCentury's BCIQ database is the largest ever takeout for a private venture-backed biopharma.

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<v Jeff Cranmer>And it tops the Tubulis deal that we talked about literally just last week.

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<v Jeff Cranmer>And that was Gilead, as I teased at the top.

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<v Jeff Cranmer>3.15 billion buying the antibody drug conjugate company outta Germany.

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<v Jeff Cranmer>Tubu let's head over to T-Cell engagers.

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<v Jeff Cranmer>Now, there's been quite a few deals lately.

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<v Jeff Cranmer>This is bumping up the credibility of TCEs in autoimmune diseases, and Lauren did one of her classic deep dive analysis decks and well, what did you learn?

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<v Jeff Cranmer>What, what really jumped out at you?

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<v Jeff Cranmer>Uh, Lauren.

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<v Lauren Martz>As background as you said, the reason that we were looking into this is because we saw a couple of deals for T-cell engagers for autoimmune diseases recently.

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<v Lauren Martz>And I think it just kind of, this field is at a tipping point.

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<v Lauren Martz>And the question that those deals raised for me was we have T-Cell engagers for cancer.

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<v Lauren Martz>These are a well established, or for heme cancers.

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<v Lauren Martz>This is a well established modality.

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<v Lauren Martz>they're effective.

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<v Lauren Martz>The same therapies can be applied to autoimmune diseases, but do we want the same therapies for cancer and for autoimmune diseases?

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<v Lauren Martz>And what are the different properties that may make something safer and more effective if you're applying it in a different setting?

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<v Lauren Martz>What I've found in looking through the data, the pipelines and the deals, is that it's pretty split between programs that companies are repurposing or pivoting from cancer, you know T-cell engagers that were developed specifically for cancer and now are being used in autoimmune applications and those that are uh or develops specifically to treat autoimmune diseases.

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<v Lauren Martz>The main difference when you're looking at these two different disease areas is safety and durability maybe, but mostly safety.

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<v Lauren Martz>So if you're treating a cancer where Um survival times are relatively short, there's a lot of flexibility on the adverse events that may be tolerated in a, in a therapy that gets approved.

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<v Lauren Martz>If you're treating a chronic autoimmune disease the bar for safety just goes way up.

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<v Lauren Martz>And so what's been happening in the cancer space is companies are already trying to make the T-cell engagers safer.

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<v Lauren Martz>They found that if you change the arm of the antibody that binds CD3 and binds the T-cell, activates the T-cell and lower its affinity for that CD3.

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<v Lauren Martz>The safety profile is better, the efficacy is comparable, so the whole field has been moving in this direction of making safer T-cell engagers for cancer.

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<v Lauren Martz>And the thought is that we probably can repurpose this and have this be something that's safe enough to treat an autoimmune disease, especially if there's some tweaking of the dosing and the dose schedule.

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<v Lauren Martz>The hope is that when you have a T-cell engager for autoimmunity, you may be able to dose once or just do one cycle of treatment to knock down the B cells that are causing a problem, the autoreactive B cells, and reset the immune system.

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<v Lauren Martz>That was the first finding that that's, it's really split Um between, trying to take the safer T-cell engagers that are being developed for cancer, not, maybe not the first generation ones, and apply those to Um this new setting and then developing sort of fit for purpose antibodies.

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<v Selina Koch>Okay.

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<v Selina Koch>So that's the safety side.

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<v Selina Koch>Let's talk a little bit about the efficacy side.

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<v Selina Koch>You have this nice uh diagram in there that kind of shows that even though these are the, some cases, the same therapies or therapies against the same targets, like the tissue environment in the B cell driven cancer versus the autoreactive B cell tissue is, is just different.

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<v Selina Koch>And that can also influence the drug properties that you're seeking.

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<v Selina Koch>can you talk a little bit about, for instance, proliferation rates are really high in cancer, right?

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<v Selina Koch>So maybe the absolute number of disease B cells are a lot higher in that setting.

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<v Selina Koch>You wanna talk a little bit about that?

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<v Lauren Martz>Sure.

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<v Lauren Martz>So we mentioned that safety was, was really important when you're taking these into autoimmune diseases.

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<v Lauren Martz>I think like naturally.

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<v Lauren Martz>You may, you know, you could use the same therapy and there may be just a better safety profile if you're treating an autoimmune disease because the whole idea here is that you're, it's like we should have said this at the beginning.

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<v Lauren Martz>You're using a a t-cell engager to direct T cells to kill B cells, whether those are cancerous B cells in a heme cancer, or B cells that are autoreactive in an autoimmune disease patient.

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<v Lauren Martz>And so cancerous patients, as you me mentioned, they have, you know, a huge proliferation of B cells.

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<v Lauren Martz>So you're having a ton of T-cell activity and inflammation, and that leads to some of the inflammatory side effects that that happen Um in those settings.

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<v Lauren Martz>For autoimmune diseases, the B cells are, are targeting the wrong thing, but they, they're not proliferating like they're on cancer.

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<v Lauren Martz>You have a relatively normal number of B cells.

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<v Lauren Martz>So from the start that you won't have the same level of inflammatory toxicities or at least that that's what's expected.

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<v Selina Koch>Would it also make it easier to achieve the efficacy that you want, 'cause you don't have to eliminate as many of the B cells.

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<v Lauren Martz>Well, that's the hope.

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<v Lauren Martz>And the other hope is that, you know, the expectation is that there's a threshold of how  how much of the B-cell population you need to eliminate to have the therapeutic effect that you wanna have in an autoimmune disease.

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<v Lauren Martz>And cancer.

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<v Lauren Martz>You can't leave any cancerous cells behind because they'll just, you know, grow again and the patient will replapse.

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<v Lauren Martz>In autoimmune disease,  the hope is that if you can get rid of enough of the autoreactive B cells, you're actually able to reset the immune system and, bring it back to a naive B cell state and, and those, those cells will then not react to whatever the auto antigen was that they were reacting to.

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<v Lauren Martz>So there is this thought that maybe we don't need to be as effective.

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<v Lauren Martz>We probably don't have to be as durable.

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<v Lauren Martz>You don't need something like sitting around and being surveillance for any cells that snuck by.

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<v Selina Koch>so like you said in the, in the, in the slide deck there's a whole lot of promise.

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<v Selina Koch>I think you just listed at least three really big reasons why it makes sense to reposition over here.

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<v Selina Koch>To autoimmunity.

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<v Selina Koch>I think you also said this bolus of activity recently is more on the promise than on the data.

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<v Selina Koch>Like what's, what's the state of the field?

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<v Selina Koch>Are we expecting milestones?

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<v Lauren Martz>The state of the field is that there's relatively little clinical data supporting the use of T-cell engagers in autoimmune diseases.

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<v Lauren Martz>We do have clinical data supporting CAR T cells against these same targets in autoimmune diseases, we've seen that CAR T cells can reset the immune system.

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<v Lauren Martz>And the whole idea is that a T cell versus an antibody like rituximab can get into the tissues and, and find those B cells that antibodies can't reach, which you sort of stay in the circulation more.

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<v Lauren Martz>The hope here is that a T-cell engager can draw the T cells to the tissues and the T cells can then penetrate the tissue better and have a CAR T like effect.

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<v Lauren Martz>But we've only seen data from like a limited number of patients.

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<v Lauren Martz>There's been some Blincyto results that have looked really promising.

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<v Lauren Martz>I think it's like six patients with rheumatoid arthritis who have, indications that you may be seeing some sort of an immune reset.

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<v Lauren Martz>And we've heard from a couple other companies that they do have positive data.

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<v Lauren Martz>We just have seen some top line results.

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<v Lauren Martz>What we will see this year is a few programs that are scheduled to read out in multiple indications.

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<v Lauren Martz>We, we have, I think three different indications from Cullinan for CLN-978.

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<v Lauren Martz>That's gonna be in lupus, rheumatoid arthritis, and Sjogren's disease.

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<v Lauren Martz>And they'll have a second Um therapy that also reads out soon.

00:17:49.300 --> 00:17:51.537
<v Lauren Martz>And I think we'll see data from others as well.

00:17:51.537 --> 00:17:54.539
<v Lauren Martz>We just haven't necessarily been told exactly when that will be this year.

00:17:55.540 --> 00:17:56.741
<v Simone Fishburn>Lauren, two things.

00:17:56.741 --> 00:18:00.645
<v Simone Fishburn>So first of all, I really recommend subscribers see this deck.

00:18:00.645 --> 00:18:01.680
<v Simone Fishburn>It is an amazing deck.

00:18:01.680 --> 00:18:02.847
<v Simone Fishburn>It's really interesting.

00:18:02.847 --> 00:18:04.650
<v Simone Fishburn>I kind of got deep into it.

00:18:05.017 --> 00:18:08.953
<v Simone Fishburn>I just wanted to call out one thing that surprised me and one thing that didn't.

00:18:09.153 --> 00:18:09.688
<v Simone Fishburn>Okay.

00:18:10.122 --> 00:18:12.324
<v Simone Fishburn>And the on the surprise me front.

00:18:12.990 --> 00:18:28.906
<v Simone Fishburn>You talked a little bit about what data we have, but on the early preclinical part of the spectrum, there's really so much innovation, not just so you know, there's a certain number of targets and combinations of targets that people are going for, but then there's also a lot of different structures.

00:18:28.906 --> 00:18:50.295
<v Simone Fishburn>So you've got co-stimulatory receptors, you've got bispecifics, co-stimulatory receptors, you've got tri specifics, and so it feels like there's a lot of modularity in here, and I understand that there's a lot of indications you could go for, but I've tended to think about this as fairly restricted number of targets that you could go for for B-cell depletion, but it seems that people are going different ways about it.

00:18:50.561 --> 00:18:52.564
<v Simone Fishburn>So that's Um I dunno if you've got a comment about that.

00:18:52.564 --> 00:18:54.500
<v Simone Fishburn>That's my, on the, I was surprised.

00:18:54.967 --> 00:18:58.936
<v Simone Fishburn>And the not so surprised was the amount of activity in China.

00:18:59.270 --> 00:19:02.273
<v Simone Fishburn>So Um why, why wouldn't I be surprised?

00:19:02.273 --> 00:19:04.442
<v Simone Fishburn>Because we, that's just this recurring theme, right?

00:19:04.675 --> 00:19:05.711
<v Simone Fishburn>Especially in this space.

00:19:05.711 --> 00:19:13.484
<v Simone Fishburn>And so a fair number of deals, I think uh are cropping up in this space with a fair number of uh innovators from China.

00:19:13.519 --> 00:19:14.419
<v Simone Fishburn>Any thoughts about those?

00:19:14.419 --> 00:19:14.819
<v Simone Fishburn>Lauren?

00:19:15.420 --> 00:19:19.625
<v Jeff Cranmer>Well, I wanted to quickly jump in and just say like, it, it's very fitting with the trend.

00:19:19.625 --> 00:19:25.497
<v Jeff Cranmer>We're seeing that a lot of the low hanging fruit, late stage assets in China are now gone.

00:19:25.830 --> 00:19:27.932
<v Jeff Cranmer>Companies are moving way upstream.

00:19:28.200 --> 00:19:38.609
<v Jeff Cranmer>So just looking quickly at this brilliant table that Lauren put together of about, I don't know, nine deals most of which are in China uh almost all are preclinical.

00:19:39.076 --> 00:19:41.212
<v Jeff Cranmer>That about right, Lauren, did you wanna jump in there too?

00:19:41.846 --> 00:19:42.580
<v Lauren Martz>That looks right.

00:19:42.580 --> 00:19:44.682
<v Lauren Martz>And yes, this is a trend that we're seeing a lot of.

00:19:44.750 --> 00:19:46.684
<v Lauren Martz>and Simone, back to your first point.

00:19:46.951 --> 00:19:59.664
<v Lauren Martz>Something I noticed about a lot of these preclinical stage programs and the ones that look more innovative that are, you know, the tri specifics, the ones that are targeting two antigens or the ones that have a co-stimulatory receptor.

00:20:00.031 --> 00:20:04.469
<v Lauren Martz>Those are often designed specifically for autoimmune diseases, which I thought was interesting.

00:20:04.702 --> 00:20:08.339
<v Lauren Martz>And those are, a lot of those are, are coming from biotechs in China as well.

00:20:08.640 --> 00:20:16.080
<v Lauren Martz>Yeah, it, it's all in the deck and it's, it's really interesting to get into how companies are picking the indications for these.

00:20:16.114 --> 00:20:17.682
<v Lauren Martz>Uh, you know, the target list is limited.

00:20:17.682 --> 00:20:19.017
<v Lauren Martz>There's just three main targets.

00:20:19.017 --> 00:20:26.825
<v Lauren Martz>But they each have their own place and there isn't a lot of proof of concept yet, but we have ideas of where they'll work and what will be enough in each indication.

00:20:26.825 --> 00:20:34.465
<v Lauren Martz>And it's all a really interesting strategy and, and I've, I've spoken with some companies about how they're going about it and that will be in a future story.

00:20:34.799 --> 00:20:38.336
<v Lauren Martz>But I'm looking forward to seeing how that, that works out in the clinic.

00:20:39.003 --> 00:20:41.740
<v Jeff Cranmer>And the buyers uh some interesting names.

00:20:42.074 --> 00:20:43.307
<v Jeff Cranmer>So no surprise.

00:20:43.375 --> 00:20:54.685
<v Jeff Cranmer>Uh, Gilead was in on the biggest deal with Ouro uh the upfront is by far and away the largest among these 1.7  billion that was in March.

00:20:55.053 --> 00:21:01.292
<v Jeff Cranmer>And then Sanofi, UCB, Boehringer, Otsuka, Cullinan, as Lauren mentioned.

00:21:01.393 --> 00:21:19.076
<v Jeff Cranmer>Prolium, and then Ken Song's Candid connected with Rallybio, to uh get a BCMA CD3 TCE. That I think is the most advanced Lauren or sort of neck and neck with the Gilead program that it's getting.

00:21:19.611 --> 00:21:25.284
<v Lauren Martz>I think so uh Candid has some clinical data, but we've only seen the, the top line results so far.

00:21:26.018 --> 00:21:26.384
<v Jeff Cranmer>All right.

00:21:27.051 --> 00:21:29.954
<v Jeff Cranmer>Well great piece, obviously from Lauren.

00:21:30.021 --> 00:21:34.192
<v Jeff Cranmer>Uh, if you're not a subscriber this one might tip the scales for you.

00:21:34.492 --> 00:21:44.269
<v Jeff Cranmer>Okay, we're gonna take a quick break and then we're gonna come back and talk about the latest executive order affecting development and regulation.

00:21:44.736 --> 00:21:50.008
<v Voice Talent>BioCentury This Week is brought to you by the 26th Bio€quity Europe in Prague, Czech Republic.

00:21:51.942 --> 00:21:57.015
<v Voice Talent>Innovators everywhere are seeing speed as the driver of investment, partnering in success.

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<v Voice Talent>In its 26th edition, Bio€quity Europe travels to central and Eastern Europe for the first time — to explore emerging opportunities in the region and debate how European biotech can accelerate to compete — and lead — in today's world.

00:22:37.888 --> 00:22:43.494
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00:22:44.061 --> 00:22:47.965
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00:22:48.700 --> 00:22:50.301
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00:22:52.837 --> 00:22:53.771
<v Jeff Cranmer>Okay.

00:22:53.771 --> 00:22:59.443
<v Jeff Cranmer>And, well, you heard it from that fine young man there, go to Bio€quity Europe in Prague.

00:22:59.678 --> 00:23:06.183
<v Jeff Cranmer>we've already sold you on the beer and the history and the literature, and now we're ready to sell you on the biotech.

00:23:06.317 --> 00:23:07.318
<v Jeff Cranmer>Shouldn't be too hard.

00:23:07.519 --> 00:23:12.557
<v Jeff Cranmer>Okay, Steve executive order out either last night or today.

00:23:12.758 --> 00:23:13.357
<v Jeff Cranmer>What's in it?

00:23:13.991 --> 00:23:16.127
<v Steve Usdin>First I have to say I like the idea uh you know, go.

00:23:16.394 --> 00:23:17.895
<v Steve Usdin>For the beer stay, for the biotech.

00:23:18.296 --> 00:23:18.829
<v Steve Usdin>What's in it?

00:23:18.829 --> 00:23:21.900
<v Steve Usdin>It accelerates the development of Um psychedelic therapies.

00:23:22.467 --> 00:23:35.846
<v Steve Usdin>It instructs the FDA commissioner to grant commissioners national priority vouchers to appropriate psychedelic drugs that have received a breakthrough designation and comply with criteria of the voucher program.

00:23:36.681 --> 00:23:39.183
<v Steve Usdin>This is notable, it's prescriptive language.

00:23:39.183 --> 00:23:43.422
<v Steve Usdin>It doesn't merely permit FDA to issue CNPVs to psychedelics.

00:23:43.488 --> 00:23:44.855
<v Steve Usdin>It directs them to do that.

00:23:45.423 --> 00:23:52.596
<v Steve Usdin>It allocates $50 million in federal funds to ARPA-H for state level psychedelic research investments.

00:23:52.931 --> 00:24:02.840
<v Steve Usdin>This is basically intended to provide matching funds that will enable a program in Texas for studying ibogaine if that's how you pronounce it, I'm sorry if I'm mis mispronouncing it.

00:24:03.107 --> 00:24:10.248
<v Steve Usdin>and separately it instructs HHS FDA and VA to increase clinical trial participation and data sharing.

00:24:10.582 --> 00:24:18.222
<v Steve Usdin>Here's the key thing, another key thing also is it creates a right to try pathway for psychedelics.

00:24:18.222 --> 00:24:19.958
<v Steve Usdin>Again, specifically also for, for.

00:24:19.958 --> 00:24:21.625
<v Steve Usdin>ibogaine or ibogaine.

00:24:21.926 --> 00:24:22.693
<v Steve Usdin>This is new.

00:24:22.727 --> 00:24:23.961
<v Steve Usdin>It's never worked before.

00:24:23.961 --> 00:24:41.880
<v Steve Usdin>There's never been a, possibility really of using Right to Try for psychedelics that was tried in the past and it was legally blocked by the Ninth Circuit in 2025, which said that the Right to Try Act didn't create an exemption from DEA's Controlled Substances Act, that's another big change in this order.

00:24:42.614 --> 00:24:47.486
<v Simone Fishburn>Steve, it's almost as if somebody in the administration has a particular interest in this area.

00:24:48.487 --> 00:24:48.953
<v Simone Fishburn>Um,

00:24:49.153 --> 00:24:49.453
<v Jeff Cranmer>Yeah.

00:24:49.488 --> 00:24:51.288
<v Jeff Cranmer>So what's, what's the background here, Steve?

00:24:51.288 --> 00:24:51.556
<v Jeff Cranmer>Why?

00:24:51.556 --> 00:24:51.756
<v Jeff Cranmer>Why now?

00:24:52.423 --> 00:24:53.791
<v Simone Fishburn>But let's just go to precedent.

00:24:53.791 --> 00:24:57.394
<v Simone Fishburn>I mean, obviously  you know, this kind of thing has been done in cancer.

00:24:57.628 --> 00:25:04.435
<v Simone Fishburn>I assume you know, picking out a specific area for favor and I think that, Selina might talk to this in a minute.

00:25:04.469 --> 00:25:07.471
<v Simone Fishburn>There's no question about the unmet need in this particular area.

00:25:07.905 --> 00:25:18.383
<v Simone Fishburn>But do either of you see any, you know, potential risks associated with this kind of a policy from the White House in this way?

00:25:18.583 --> 00:25:19.217
<v Steve Usdin>Yeah, I see.

00:25:19.284 --> 00:25:23.188
<v Steve Usdin>I, I see a lot of 'em, but first I want to correct one thing, this is unprecedented.

00:25:23.221 --> 00:25:27.925
<v Steve Usdin>There's never been an executive order before that has done anything like this.

00:25:27.925 --> 00:25:38.068
<v Steve Usdin>There have been executive orders that in a general way have said, you know, accelerate cancer drugs or accelerate research into treatments for opioid abuse or something like that.

00:25:38.336 --> 00:25:42.440
<v Steve Usdin>But there's never been one that's been this prescriptive in this specific right.

00:25:42.840 --> 00:25:47.412
<v Steve Usdin>And the other thing is, is that the process, the backstory behind this is extraordinary.

00:25:47.811 --> 00:25:57.689
<v Steve Usdin>So there's the podcaster, Joe Rogan, he said that he sent a text to the president touting um, 80% cure rates for opioid addiction from ibogaine treatments.

00:25:57.721 --> 00:26:02.861
<v Steve Usdin>And he said that the president texted him right back and said, oh, this is a great idea, you know, FDA is gonna do it.

00:26:03.161 --> 00:26:11.135
<v Steve Usdin>And then a day or two later, they have this ceremony at the White House to which Joe Rogan is invited which lends credence to his comments on this.

00:26:11.135 --> 00:26:14.538
<v Steve Usdin>The administration hasn't pushed back and said that what he said wasn't true.

00:26:14.838 --> 00:26:24.316
<v Steve Usdin>That creates an appearance of political motivation, including the possibility that the White House is attempting to offset Rogan's criticism of the Iran War.

00:26:24.648 --> 00:26:26.651
<v Steve Usdin>At the uh white House ceremony.

00:26:26.951 --> 00:26:41.967
<v Steve Usdin>Marty Makary, the FDA Commissioner, kind of gave a little bit more credence or weight to some concerns that maybe that the administration and FDA has already decided what it's going to do and it's going to put pressure explicit or implicitly on FDA reviewers.

00:26:42.232 --> 00:26:48.772
<v Steve Usdin>One of the things that Makary said, he said, the stories of individuals who have taken these drugs are dramatic.

00:26:48.940 --> 00:26:52.376
<v Steve Usdin>He said, this is a quote, the stories of those individuals with dramatic results.

00:26:52.376 --> 00:26:56.647
<v Steve Usdin>That is data, that is scientific data, even from a single individual.

00:26:56.914 --> 00:27:00.250
<v Steve Usdin>Well, that's not really the traditional definition of data, right?

00:27:00.384 --> 00:27:01.051
<v Steve Usdin>in fact, you

00:27:01.286 --> 00:27:02.686
<v Simone Fishburn>It's absolutely not data.

00:27:03.587 --> 00:27:05.624
<v Steve Usdin>they, they, they, the, the, the,

00:27:06.625 --> 00:27:08.393
<v Simone Fishburn>Its at best datum, its certainly data..

00:27:08.559 --> 00:27:09.493
<v Selina Koch>possibly an anecdote.

00:27:10.028 --> 00:27:10.628
<v Steve Usdin>Yes, exactly.

00:27:10.628 --> 00:27:16.401
<v Steve Usdin>The idea that the the plural of anecdotes is, is data, is is not one that's usually taught in medical school.

00:27:16.734 --> 00:27:20.704
<v Steve Usdin>Um, then he also talked about, which is interesting also, then Makary also talked.

00:27:20.704 --> 00:27:23.273
<v Steve Usdin>He said, well, we have randomized controlled trials.

00:27:23.474 --> 00:27:25.676
<v Steve Usdin>We have to do those because you know, they're a good idea.

00:27:26.076 --> 00:27:31.915
<v Steve Usdin>And if you look at those trials, there's a 30 to 40% remission rate for conditions like PTSD.

00:27:32.317 --> 00:27:49.867
<v Steve Usdin>Well, the interesting thing there is that if you look at the numbers and you look at what he said, it seems to be that he's talking about Lykos' MDMA trials, which interestingly enough in 2024, an FDA advisory committee voted 10 to one against approving, and then FDA subsequently issued a complete response letter for.

00:27:50.300 --> 00:28:04.382
<v Steve Usdin>all of this strikes me as, being kind of seat of the pants, and trying to push things through which is problematic, both because these are really serious conditions and they're really serious drugs, which actually may have promise.

00:28:04.749 --> 00:28:07.117
<v Steve Usdin>But they need to be developed in a careful way.

00:28:07.484 --> 00:28:15.693
<v Steve Usdin>We've talked on this podcast before and Selina has a lot of knowledge about all of the complexities of doing clinical trials with psychoactive drugs.

00:28:16.060 --> 00:28:32.277
<v Steve Usdin>But then there's the bigger issue also, which this kind of reinforces the narrative that I've heard from biopharma CEOs and lobbyists in Washington increasingly over the last couple of months, which is that if companies want to maximize their chances of getting their drugs to market.

00:28:32.644 --> 00:28:38.583
<v Steve Usdin>They have to have not only a clinical strategy, not only a regulatory strategy, but they need a political strategy.

00:28:38.782 --> 00:28:48.926
<v Steve Usdin>They need to be able to have some kind of political influence in the White House or in FDA or with Secretary Kennedy to make their drug approval go smoothly.

00:28:49.294 --> 00:29:05.710
<v Steve Usdin>The Commissioner's national Priority voucher program reinforces this idea because the commissioner or the, in this case it seems the president can pick things out and say, well, these are the things that we're going to give a big push to, and by the way, create a competitive advantage against other company.

00:29:06.443 --> 00:29:25.063
<v Simone Fishburn>And just to remind the listeners who may not have thought about it at the moment, but obviously 2024 was a different person's FDA I think that just adds to this feeling of what FDA said and ruled previously not hold now and just contributes to the continued uncertainty.

00:29:25.063 --> 00:29:27.898
<v Simone Fishburn>That's just at a broader level, you know, was

00:29:27.932 --> 00:29:28.465
<v Jeff Cranmer>And

00:29:28.500 --> 00:29:28.700
<v Simone Fishburn>now.

00:29:29.400 --> 00:29:30.734
<v Jeff Cranmer>and more changes coming.

00:29:30.934 --> 00:29:31.635
<v Jeff Cranmer>Oh, go ahead, Selina's.

00:29:32.036 --> 00:29:33.570
<v Selina Koch>So I can't speak to the ibogaine data.

00:29:33.570 --> 00:29:35.339
<v Selina Koch>I haven't followed that as closely.

00:29:35.339 --> 00:29:39.911
<v Selina Koch>I'm not sure if there's large, well done randomized controlled trials there.

00:29:40.044 --> 00:29:41.412
<v Selina Koch>Um, but certainly.

00:29:41.645 --> 00:29:50.320
<v Steve Usdin>the, just quickly, so FDA announced in conjunction with this White House meeting that they were clearing the first IND for ibogaine.

00:29:50.355 --> 00:29:58.930
<v Steve Usdin>So here you have the president and you have Um the FDA commissioner, asserting that we have a, a product that actually could have tremendous therapeutic potential.

00:29:59.196 --> 00:30:02.232
<v Steve Usdin>And there hasn't even been a Phase I trial conducted in the United States of it..

00:30:02.432 --> 00:30:07.872
<v Selina Koch>This is when you need really strong scientific and regulatory institutions, then you need to let them do their job.

00:30:08.873 --> 00:30:14.679
<v Selina Koch>But anyway, what I can speak to like the companies who are most advanced with psychedelics, who this might advantage, right.

00:30:14.679 --> 00:30:23.387
<v Selina Koch>So we have, Compass Pathways has two positive Phase III trials with a psilocybin analog in depression.

00:30:23.755 --> 00:30:25.890
<v Selina Koch>And does that drug have potential?

00:30:25.890 --> 00:30:30.627
<v Selina Koch>I mean, both trials were positive, so it has, it's a replicable result.

00:30:30.828 --> 00:30:35.400
<v Selina Koch>But when the first Phase III read out, it lost 49% of its stock value that day.

00:30:35.633 --> 00:30:42.773
<v Selina Koch>Because the magnitude of the benefit was basically right at that minimum bar for clinical meaningfulness.

00:30:42.773 --> 00:30:51.082
<v Selina Koch>So the, the ma, the normal, the standard rating scale, excuse me, for depression trials, right, the Montgomery Asberg Depression Rating Scale.

00:30:51.281 --> 00:30:52.450
<v Selina Koch>It's a 60 point scale.

00:30:52.983 --> 00:30:59.590
<v Selina Koch>it moved, it 3.6 points versus placebo, so around 3, 3, 4 points.

00:30:59.590 --> 00:31:04.394
<v Selina Koch>That's kind of generally accepted as you're just meeting the threshold for having a real effect there.

00:31:04.796 --> 00:31:08.499
<v Selina Koch>So you know, the stock tanked, then they had a second Phase III read out this year.

00:31:08.900 --> 00:31:20.545
<v Selina Koch>Um, and in that case they did something that's really good because it's so hard to keep these trials actually blinded because these are powerfully psychoactive and people generally know if they got the treatment or placebo, right.

00:31:20.878 --> 00:31:36.527
<v Selina Koch>So the way that reputable companies like Compass are trying to navigate that difficult road is by testing a, a dose that is perceptible, barely perceptible, but far below what's thought to be therapeutic instead of placebo.

00:31:36.594 --> 00:31:44.501
<v Selina Koch>So you can also have that comparison'cause it makes it, some people in the placebo group or the control group think that they're probably getting treatment right.

00:31:44.935 --> 00:31:49.207
<v Selina Koch>And so that phase reread out and it was also positive.

00:31:49.374 --> 00:31:51.808
<v Selina Koch>And the good news was that the result didn't get any smaller.

00:31:52.442 --> 00:31:54.278
<v Selina Koch>So it was also about a three point something.

00:31:54.278 --> 00:31:56.614
<v Selina Koch>I think that one was 3.8 change.

00:31:56.748 --> 00:31:57.015
<v Selina Koch>Okay.

00:31:57.015 --> 00:31:57.949
<v Selina Koch>So that was good.

00:31:58.016 --> 00:32:00.285
<v Selina Koch>regained some of its share value, it's moving forward.

00:32:00.285 --> 00:32:02.420
<v Selina Koch>It plans, its NDA this year.

00:32:02.720 --> 00:32:06.156
<v Selina Koch>I mean, that just goes to show you like there probably is some benefit with this class.

00:32:07.057 --> 00:32:10.193
<v Selina Koch>We definitely need new treatments in these disease areas.

00:32:10.193 --> 00:32:12.262
<v Selina Koch>There's no doubt about that.

00:32:12.462 --> 00:32:19.836
<v Selina Koch>But the hype around it, the language around the transformative potential and just gonna be more effective than anything that's come before.

00:32:19.836 --> 00:32:24.675
<v Selina Koch>It is like, I don't know, I think we should just let the regulators do their job right.

00:32:24.675 --> 00:32:24.909
<v Selina Koch>And.

00:32:25.643 --> 00:32:29.579
<v Simone Fishburn>I think, I think it's just a really important point 'cause I just wanna make it very clear.

00:32:29.579 --> 00:32:32.383
<v Simone Fishburn>It's not that we at BioCentury have a position.

00:32:32.817 --> 00:32:35.086
<v Simone Fishburn>Against this class of drugs, right.

00:32:35.086 --> 00:32:38.623
<v Simone Fishburn>The skepticism is not from the potential of the drugs.

00:32:38.923 --> 00:32:42.226
<v Simone Fishburn>I think it's really more looking at the process.

00:32:42.226 --> 00:32:47.030
<v Simone Fishburn>And this, you know, Selina, you've talked, and you've just said some nice things about Compass.

00:32:47.332 --> 00:33:08.152
<v Simone Fishburn>It puts so much responsibility on the companies pushing these drugs forward to do the trials the right way to, you know, you talk about the regulators doing their jobs, the companies have to be adhering responsibly, creating data that investors, that most of all physicians and patients can rely on.

00:33:08.752 --> 00:33:15.792
<v Simone Fishburn>Rather than looking at a glide path that might have been created for them in and of itself, they should not be short circuiting.

00:33:15.960 --> 00:33:21.465
<v Steve Usdin>and, and, and that's precisely short circuiting and creating glide path is precisely what this executive order is intended to do.

00:33:22.133 --> 00:33:38.048
<v Steve Usdin>And it's precisely what the, the language around the White House, what Marty Makary was talking about, and creating this Right to Try Pathway, which is going to create a lot of, well, the most positive way to look at it would be it's gonna create a lot of real world data.

00:33:39.083 --> 00:33:43.820
<v Steve Usdin>I think the most likely thing is, is it's gonna create a lot of selective.

00:33:44.221 --> 00:33:51.762
<v Steve Usdin>Anecdotal data, you know, everybody who thinks that they benefited from it and maybe people really did benefit from it is gonna come forward.

00:33:51.996 --> 00:33:57.434
<v Steve Usdin>Um, whether we're gonna hear from the people who didn't benefit from it is less likely.

00:33:57.634 --> 00:33:58.702
<v Simone Fishburn>So Steve, quick question here for you.

00:33:58.769 --> 00:33:59.037
<v Steve Usdin>Yeah.

00:33:59.871 --> 00:34:02.272
<v Simone Fishburn>Do pay payers have a role here?

00:34:02.272 --> 00:34:08.713
<v Simone Fishburn>Might they be the ones to require a higher standard of data, or do you think Not for these drugs.

00:34:08.713 --> 00:34:09.480
<v Simone Fishburn>How, how do you look at that?

00:34:09.947 --> 00:34:12.016
<v Steve Usdin>Well, of course payers are gonna have a point of view.

00:34:12.215 --> 00:34:17.387
<v Steve Usdin>It's notable that Mehmet Oz, the Administrator of CMS was at that White House meeting.

00:34:17.855 --> 00:34:22.994
<v Steve Usdin>the Order directs the Veterans Administration to work closely with these companies.

00:34:23.360 --> 00:34:36.807
<v Steve Usdin>So I think that the implication is that at least on the, the VA side and on the CMS side, and they're gonna be big payers for these kinds of products, they're aligned with the push to, to, you know, to get them through and to get them reimbursed.

00:34:36.807 --> 00:34:47.318
<v Steve Usdin>So they're, they do seem to be looking at this both from the, You know, smoothing the, the path uh the regulatory path to get approval and the reimbursement side.

00:34:47.717 --> 00:35:04.902
<v Steve Usdin>And again, I think that, you know, the two issues that I would bring up, I think that are the most, maybe most salient beyond Um psychedelics is the level of concern around having political influence or podcaster influences on regulatory decisions.

00:35:05.103 --> 00:35:08.905
<v Steve Usdin>And the influence that that might have on  FDA reviewers.

00:35:09.507 --> 00:35:12.409
<v Simone Fishburn>Not all podcasts, Steve, they should be listening to this one, right?

00:35:14.811 --> 00:35:24.222
<v Jeff Cranmer>So Steve, uh, staying with FDA we now have a candidate to replace Vinay Prasad as CBER Director, can you give us a quick take?

00:35:24.454 --> 00:35:27.257
<v Steve Usdin>Yeah, so there, there are multiple candidates who are in play.

00:35:27.257 --> 00:35:28.192
<v Steve Usdin>That's what I've heard.

00:35:28.793 --> 00:35:38.702
<v Steve Usdin>I've also heard from some individuals who've said that they've been approached, to take the job and that they either declined themselves or that they were informed later by the administration that they were no longer under consideration.

00:35:39.036 --> 00:35:46.077
<v Steve Usdin>But the leading candidate seems to be Houman Hemmati, a nd again, I, I apologize if I've mispronounced the name.

00:35:46.309 --> 00:35:51.449
<v Steve Usdin>He seems to be clearly to be uh Marty Makary's top choice for the job.

00:35:52.048 --> 00:36:01.525
<v Steve Usdin>What I'm hearing is that the actual final sign off on this is gonna rest with Chris Klomp HHS Chief counselor who's overseeing day-to-day operations at HHS.

00:36:02.293 --> 00:36:05.429
<v Steve Usdin>Hemmati doesn't have any experience at FDA or in government.

00:36:05.630 --> 00:36:08.900
<v Steve Usdin>He does have a lot of experience as a scientist and in drug development.

00:36:09.199 --> 00:36:11.101
<v Steve Usdin>He worked on clinical programs at Allergan.

00:36:11.802 --> 00:36:16.974
<v Steve Usdin>He was VP of Medical and Clinical Development for new therapies at Capricor Therapeutics.

00:36:17.340 --> 00:36:27.117
<v Steve Usdin>And in parallel with these roles, he's been a biotech entrepreneur and holds part-time positions at several companies that are developing ophthalmic drugs.

00:36:27.485 --> 00:36:41.565
<v Steve Usdin>His appointment would, if he gets a job, would mark a, continued break from decades of precedent in which center directors have always been nonpartisan, scientific leaders with deep agency experience, and honestly, very low profiles, right.

00:36:42.400 --> 00:36:49.005
<v Steve Usdin>Prior to the second Trump administration, FDA, center directors really consider themselves to be civil servants.

00:36:49.005 --> 00:36:52.309
<v Steve Usdin>They avoided making public statements about controversial or political issues.

00:36:52.543 --> 00:36:54.378
<v Steve Usdin>Hemmati is very politically active.

00:36:54.378 --> 00:36:58.583
<v Steve Usdin>He's got a profile that's unlike any other previous center director.

00:36:58.682 --> 00:37:05.289
<v Steve Usdin>He's frequently on Fox News, another conservative media most recently talking in support of President Trump's actions in Iran.

00:37:06.090 --> 00:37:10.661
<v Steve Usdin>He's leader of an organization that's seeking the recall of California Governor Gavin Newsom.

00:37:11.128 --> 00:37:20.036
<v Steve Usdin>So to me the relevant point really isn't what his political positions are, it's the fact that he has them and he is so politically active and vocal.

00:37:20.036 --> 00:37:27.644
<v Steve Usdin>And then to think that somebody who's, who's been so politically active and vocal would go into what's essentially a civil service job is unusual.

00:37:27.844 --> 00:37:32.516
<v Steve Usdin>Over the last few days, he's posted on X stating that politics and health should be kept separate.

00:37:32.849 --> 00:37:36.119
<v Steve Usdin>So it seems to be an effort to address these concerns.

00:37:36.387 --> 00:37:37.588
<v Jeff Cranmer>Steve, I'm gonna have to stop you there.

00:37:37.588 --> 00:37:49.065
<v Jeff Cranmer>We want to save some time to talk about what could be one of the largest or the largest biotech IPO ever after Kailera upsized its IPO.

00:37:49.065 --> 00:37:52.402
<v Jeff Cranmer>I'm, I'm still waiting to see if they close the greenshoe.

00:37:53.304 --> 00:37:57.875
<v Jeff Cranmer>They raised 625 million late Thursday.

00:37:58.376 --> 00:38:05.750
<v Jeff Cranmer>The stock then traded up 63% to lift its market cap above 3.3 billion.

00:38:05.882 --> 00:38:18.028
<v Jeff Cranmer>Now if the underwriters exercise their over allotment that'll bump them up to nearly 720 million, which knocks Sana out of the top spot.

00:38:18.262 --> 00:38:20.297
<v Jeff Cranmer>What do you think about these guys here, Simone?

00:38:20.297 --> 00:38:22.166
<v Jeff Cranmer>That's, that's quite, quite an achievement,

00:38:22.632 --> 00:38:24.601
<v Simone Fishburn>Yes, it's quite in achievement.

00:38:24.601 --> 00:38:29.507
<v Simone Fishburn>The first thing I think Jeff, as I said to you the other day, is, wow, they grow up so fast, it

00:38:29.907 --> 00:38:30.106
<v Jeff Cranmer>Yeah

00:38:31.007 --> 00:38:38.416
<v Simone Fishburn>Only yesterday that Kailera was on uh NewCos being spun out of China you know, to create new companies in the West.

00:38:38.416 --> 00:38:40.650
<v Simone Fishburn>And here they are with the biggest IPO.

00:38:40.684 --> 00:38:44.121
<v Simone Fishburn>But let, let's just put a couple of things in context.

00:38:44.422 --> 00:38:54.731
<v Simone Fishburn>We are talking about the field of obesity and we are talking about a company that is now looking, it's got Phase II data and it's now looking to start Phase III.

00:38:55.065 --> 00:39:05.409
<v Simone Fishburn>That's a very different color of company than the, you know, crazy IPOs of a few years ago on preclinical data and so on.

00:39:05.809 --> 00:39:10.547
<v Simone Fishburn>What I'm really trying to say is there's very good reason for this amount of money.

00:39:10.914 --> 00:39:24.461
<v Simone Fishburn>They have good clinical data, they have good clinical differentiation, and they are in a therapeutic area with very, very significant market size where there's room for a lot of players kind of thing.

00:39:24.461 --> 00:39:32.235
<v Simone Fishburn>So I do think that  if you were actually gonna paint a picture of a company that would have the biggest IPO, this is probably the one that you pick.

00:39:32.235 --> 00:39:33.903
<v Jeff Cranmer>Yeah, I, I agree with you there.

00:39:33.903 --> 00:39:35.672
<v Jeff Cranmer>And then the timing worked.

00:39:35.706 --> 00:39:49.186
<v Jeff Cranmer>Um, we heard from Guggenheim's James Lee who said that they kind of got out right when sentiment greatly improved last week after the initial ceasefire, maybe that was two weeks ago.

00:39:49.387 --> 00:39:54.992
<v Jeff Cranmer>But that ceasefire's fragile uh nerves are, well, it's, it's.

00:39:55.425 --> 00:39:57.027
<v Simone Fishburn>Don't get me started on the ceasefire.

00:39:57.193 --> 00:39:59.797
<v Jeff Cranmer>Yeah, I, I, I, yeah, I got you Simone.

00:39:59.797 --> 00:40:08.438
<v Jeff Cranmer>I, it's Um in the context of the IPO market, it's making an already tricky situation trickier uh leave it at that.

00:40:08.438 --> 00:40:20.451
<v Jeff Cranmer>I do wanna give a hat tip to Jiangsu Hengrui, one of the bigger players in the NewCo model that we've been following, that is where this asset has come from.

00:40:20.717 --> 00:40:34.898
<v Jeff Cranmer>And Hengrui is, and I'm probably butchering that I'm gonna have to double down on my Chinese lessons,  they still own a uh fairly sizable amount in Kailera.

00:40:34.898 --> 00:40:42.039
<v Jeff Cranmer>I think they're still around, let's see, they're at 14% going into the offering.

00:40:42.206 --> 00:40:52.349
<v Simone Fishburn>Jeff, can I just give another little shout out here because we got the big splashy Kailera one, but there was another IPO last week for Alamar, right?

00:40:52.349 --> 00:40:55.085
<v Simone Fishburn>And that's a post money of over a billion.

00:40:55.085 --> 00:40:55.820
<v Simone Fishburn>Thank you very much.

00:40:56.619 --> 00:41:02.525
<v Simone Fishburn>And I don't really wanna call it little Alamar 'cause that's really only next to uh Kailera.

00:41:02.860 --> 00:41:03.092
<v Jeff Cranmer>Yeah

00:41:03.360 --> 00:41:08.199
<v Simone Fishburn>that is a developer of proteomics tools for biomarker profiling and analysis.

00:41:08.431 --> 00:41:09.800
<v Simone Fishburn>So what does that tell you?

00:41:10.000 --> 00:41:14.472
<v Simone Fishburn>Not only that, maybe the IPO window is opening, but look at where money is going.

00:41:14.472 --> 00:41:24.981
<v Simone Fishburn>Biomarker profiling, proteomics, these are maybe the terms of this next era somebody thinks that they can make money with, with that technology.

00:41:24.981 --> 00:41:31.856
<v Simone Fishburn>And you know, that had some good underwriters, J.P. Morgan, BofA Securities, Cowen, Leerink, Stifel.

00:41:31.856 --> 00:41:43.701
<v Simone Fishburn>So, you know, I, I really think that, we are looking at the IPO Q, Seaport's in there, Hemab Therapeutics in there, we'll probably talk a little bit more about that on future pods I expect.

00:41:43.800 --> 00:41:46.836
<v Jeff Cranmer>don't, don't Sleep on Odyssey, led by Gary Glick.

00:41:47.403 --> 00:41:52.476
<v Jeff Cranmer>that company file it under, they grow up so fast a as well, Simone.

00:41:52.576 --> 00:42:03.686
<v Jeff Cranmer>And uh I think we, we would be remiss if we didn't  give a shout out to Revolution Medicines, pricing the second largest follow on ever for a NASDAQ traded biotech.

00:42:04.788 --> 00:42:07.391
<v Simone Fishburn>Well deserved on some incredible data.

00:42:07.925 --> 00:42:08.125
<v Jeff Cranmer>Yeah.

00:42:08.259 --> 00:42:09.592
<v Jeff Cranmer>pancreatic cancer.

00:42:09.726 --> 00:42:10.661
<v Simone Fishburn>right, for KRAS.

00:42:11.161 --> 00:42:11.362
<v Jeff Cranmer>yeah.

00:42:11.561 --> 00:42:13.731
<v Jeff Cranmer>So 1.75 billion.

00:42:14.063 --> 00:42:21.739
<v Jeff Cranmer>Uh, I wanted to take a quick minute before we go to  pay tribute to one of biotech's all time greats Denis Lucquin.

00:42:22.672 --> 00:42:34.318
<v Jeff Cranmer>He was an architect of Sofinnova Partners, a founding father of French biotech, and one of the most important figures in the growth of Europe's biotech ecosystem.

00:42:34.518 --> 00:42:36.920
<v Jeff Cranmer>He passed away early this month.

00:42:37.221 --> 00:42:45.996
<v Jeff Cranmer>He was a trusted advisor to his CEOs, a mentor to his colleagues, and a champion of his companies in and out of the boardroom.

00:42:46.429 --> 00:42:52.835
<v Jeff Cranmer>His presence was critical to the development of a generation of biotechs throughout Europe.

00:42:53.103 --> 00:43:02.713
<v Jeff Cranmer>BioCentury's remembrance of Denis can be found in the show notes or on BioCentury.com, and that is open access.

00:43:03.146 --> 00:43:05.516
<v Jeff Cranmer>well, thanks for uh hanging with us.

00:43:05.548 --> 00:43:07.016
<v Jeff Cranmer>Uh, we went a little longer today.

00:43:07.016 --> 00:43:08.117
<v Jeff Cranmer>We had a lot to discuss.

00:43:08.585 --> 00:43:15.626
<v Jeff Cranmer>Which if you're in biotech, you know, that's a good thing, lots of news, lots of deals, financings, data.

00:43:15.893 --> 00:43:24.400
<v Jeff Cranmer>You can go to our website to check out our AACR data, including a great story on dual load ADCs by Lauren.

00:43:24.635 --> 00:43:27.972
<v Jeff Cranmer>Uh, and we'll have more coverage this week.

00:43:28.204 --> 00:43:34.945
<v Jeff Cranmer>A thank you to Kendall Square Orchestra as ever for providing the music for BioCentury this week.

00:43:35.278 --> 00:43:46.657
<v Jeff Cranmer>And we'll have a special podcast later this week with Kyle Bryan CMO from our sponsor, IQVIA Biotech, and we'll be talking a bit of AACR on that.

00:43:48.559 --> 00:43:53.998
<v Voice Talent>BioCentury would like to thank IQVIA Biotech for supporting the BioCentury This Week podcast.

00:43:54.498 --> 00:44:01.371
<v Voice Talent>To learn more about how IQVIA Biotech’s dedicated teams deliver support from innovation to impact, visit IQVIABiotech.com