# Episode 184 - May 29, 2026

An episode of [Biotech Hangout](https://invisiblenetwork.ai/podcast/1568911820), 29 May 2026, 58 min.

Audio: https://anchor.fm/s/55bdff38/podcast/play/120740600/https%3A%2F%2Fd3ctxlq1ktw2nl.cloudfront.net%2Fstaging%2F2026-4-29%2F425155483-44100-2-72648194007b8.m4a

On this week’s episode, Chris Garabedian, Brian Skorney, Graig Suvannavejh, and special guest Ginkgo Bioworks CEO, Jason Kelly, kick off with a market update, highlighting a continued positive sentiment, citing Endpoints’ recent Biopharma Sentiment Index survey results, which showed improvements in biopharma conditions. The co-hosts also note the continued IPO activity, including Kardigan’s recent filing. The conversation shifts to China, with Jason suggesting that genetic engineering is a strategic technology extending beyond therapeutics, warning that the U.S. is offshoring critical innovation to China. This sparks a debate with others noting that global collaboration is embedded in drug development and questioning whether restricting partnerships would ultimately harm U.S. competitiveness. In deals, the group highlights Lilly’s acquisition of three vaccine companies for up to $3.8 billion and Apogee’s $1.3 billion strategic collaboration with Blackstone to advance their eczema drug. The conversation shifts to data, with GSK’s Phase 3 data for chronic hepatitis B drug, and an overview of datasets at ASCO 2026, including Revolution Medicines Phase 3 trial results for pancreatic cancer, which are expected to be the headline of the conference. The episode concludes with an overview of Biohaven’s R&D Day, BMS in multiple myeloma, Dyne’s DMD, and updates on the FDA following the recent leadership changes. after the departure of Dr. Marty Makary. *This episode aired on May 29, 2026.

## Transcript

[0:00] You're listening to Biotech Hangout, a live and unedited
[0:03] weekly discussion of all the latest news in our industry with
[0:06] a group of biotech leaders and experts.
[0:08] I'm Chris Garabedian and my Co host today are Brian Scorney,
[0:12] Greg Swanoway and our special guests, the Co founder and CEO
[0:17] of Ginkgo Bioworks, Jason Kelly. And really glad to have you.
[0:21] For more information about our hosts and guest speakers or to
[0:24] listen to the most recent episode, please go to
[0:26] biotechhangout.com. So first that we always like to
[0:30] touch on kind of market overview.
[0:32] I'll just mention we saw another IPO filing cardigan.
[0:38] This was following last week's Parabolas.
[0:43] You know, IPO and Cardigan is the latest filing.
[0:46] It's about the 11th biotech filing this year, already
[0:50] beating or matching the total number that we saw in 2025.
[0:54] Cardigan is led by the former CEO and management team of
[0:58] Myocardia. So task host Gianakakos is the
[1:02] CEO. He brought on his former CMO and
[1:05] CSO from Myocardia which was acquired by BMS for 13 billion.
[1:10] So they've assembled, acquired several clinical stage products.
[1:15] They have three unique products with different mechanisms in
[1:18] phase 2B studies going after genetic cardiomyopathy and
[1:23] severe hypertension and aortic valve atherosclerosis etcetera.
[1:32] So they've got, you know, late stage pipeline and again,
[1:36] they've raised more than half a billion in their Series A and
[1:40] Series B just in less than the last 18 months.
[1:43] And so going public, this will be a, you know, one of those
[1:47] record setting amounts raised for in track to IPO, you know,
[1:52] within 18 months that we've seen.
[1:54] So you know, again, I think we're all watching so far the IP
[1:59] OS have held pretty well. And just wanted to, you know,
[2:03] ask Greg and Brian, you know, as we sit here about to enter June,
[2:08] the six months of the year 11 IP OS.
[2:12] How are you guys reading this in terms of we were all looking at
[2:14] the beginning of the year with an eye toward IP OS as a marker
[2:18] of how healthy the the current states of biotech are.
[2:22] How do you guys see it where we are today at the end of May?
[2:29] I'll jump in first and, and Greg, feel free to correct me
[2:32] with your thoughts. Welcome in.
[2:34] I, I think it's, I think it's good.
[2:37] You know, certainly capital markets is a is a big driver at
[2:40] these companies all consume a lot of cash.
[2:41] So you know, being able to raise a decent valuations, raise a lot
[2:45] of money, have an IPO window open it.
[2:49] You know that that kind of makes everyone happy, right.
[2:51] I think, you know, IP OS and as, as things move earlier and
[2:55] earlier, right, that's also somewhat of a signal of, you
[2:59] know, moving to bubble territory.
[3:00] I don't really think it's there yet, but you know, there's
[3:03] certainly been an acceleration. I think earlier in the year,
[3:06] maybe January, we we talked about this a lot.
[3:10] I think on one of these with Matisse and Shimmer and I, I
[3:14] think Shimmer said he was looking at like 50 plus IPOs.
[3:17] I think that I don't remember exactly what Matisse number was.
[3:21] I think it was maybe like 13. I said I was sort of in the
[3:23] middle. It was 15 I remember.
[3:26] Being on that 15 All right, so, so so you know unless things go
[3:29] really South, Paul is going to wind up undershooting that
[3:32] number so so we'll have to see you know, I think I think it's
[3:35] healthy. I think the follow ONS have
[3:37] looked really healthy, right. I mean strong companies with
[3:40] strong data have have done really well and been able to
[3:42] trade up So you know I think capital markets overall looks
[3:46] healthy for biotech. You know I, I get the question
[3:49] of like is it past healthy? Are we getting past the point
[3:52] where too many companies are raising too much money?
[3:54] And, you know, we, we all remember, I mean, everyone's
[3:57] been in this game long enough to kind of remember 2000 and the
[4:02] peaks of COVID and, you know, the, the kind of dearth of IP OS
[4:06] that followed as the market kind of cratered after that.
[4:09] But I, I don't think we're anywhere near that, right?
[4:11] I mean, you know, this is not a frothy biotech market to any
[4:17] extent. I'll just say, Brian, my comment
[4:19] is I, I think this this collection of IP OS a little bit
[4:22] different later stage clinical. We see companies that have had
[4:26] clinical data, you know, like Evelyn that have gone out.
[4:29] And so, you know, if this was a preclinical right, we have ideas
[4:34] to have a bunch of drugs that are moving into the clinic with
[4:37] a great management team that has a proven track record like
[4:39] Cardigan does. I'd be much more worried than
[4:41] having three Phase 2B, you know, shots on goal makes it a little,
[4:47] I, I guess less frothy in, in my opinion.
[4:52] Let let me just continue with endpoints.
[4:55] Does these quarterly biopharma sentiment indexes and it's kind
[5:00] of a nice way to just track where things are going with
[5:03] different stakeholders. And they just released one this
[5:06] past week. And the the overall index, so
[5:09] 100 kind of being the, the, the standard average, the overall
[5:13] index moved from 78 across all stakeholders in fourth quarter
[5:18] of 25 to 90 in first quarter of 26 to 96 in second quarter of 26
[5:25] this latest survey. But again, that is an average
[5:28] among various stakeholders. And so when they cut it by
[5:31] investors and the finance group, they have a finance investment
[5:35] and then they have different levels within that, but they
[5:40] basically moved pretty considerably from Q1 to Q2.
[5:44] The business conditions currently moved 50 points to 100
[5:49] over the index. The overall average among
[5:52] finance investment went to 120, even though the overall average
[5:56] was 96. So it seems that the investment
[5:58] community and the finance are definitely more feeling more
[6:02] bullish in this second quarter. They rate subcategories like
[6:07] business conditions I mentioned move 50 points, funding climate
[6:10] move 54 points. They also look at the 12 month
[6:14] outlook and that move 26 points and so and regulatory
[6:20] environment over the next 12 months.
[6:21] And now it's not clear if this was surveyed before and or after
[6:26] Mccarry's departure. I think the survey might have
[6:29] gone out before Mccarry's departure and they might have
[6:32] collected more after, but that moved 53 points in terms of
[6:35] expectations of the regulatory policy environment.
[6:38] So whether that would have gone down knowing that the
[6:42] commissioner left or if it went up maybe because he did leave, I
[6:46] don't know. But anyway, the overall
[6:48] sentiment is shifting across all stakeholders, including CE OS,
[6:52] biotech, CE OS, CR OS and CDM OS.
[6:55] They they pull those are still tracking below the 100 index,
[6:59] but are all moving in the right direction.
[7:01] So overall things are looking pretty positive.
[7:04] And again on the venture side, we're still seeing good deal
[7:07] flow on the on the private side. So we wanted to move to our
[7:13] special guest. So Jason Kelly, who I mentioned
[7:17] at the top of the hour, Co founder and CEO of Ginkgo
[7:21] Bioworks and we he's been speaking about the China issue.
[7:26] China's been a main topic for our industry now, you know, at
[7:30] least for the last year to two years in terms of the reliance
[7:34] of pharma and biotech increasingly to access drugs in
[7:41] China. And this has sparked quite a
[7:44] debate on social media. Peter Kolchinsky test Cameron
[7:47] from RA Capital put a kind of a white paper out in kind of an
[7:51] anti protection in a stance. And Jason, I, you know, wanted
[7:56] to thank you for for coming on and kind of speaking about your
[7:59] position. I I will mention and I just want
[8:01] to ask about this. So be besides being Co founder
[8:05] and CEO of Ginkgo Bioworks. Your own profile on the website
[8:09] says you served as chair of the US National Security Commission
[8:13] on Emerging Biotechnology, which overseas how advancements in
[8:16] emerging biotechnology will shape current and future
[8:19] activities of the US Department of Defense.
[8:22] And so, you know, just trying to understand how much that has
[8:26] colored your lens. Maybe there's if there are
[8:28] things that you have insight on about China and the threat of
[8:33] biotech working with China, would love to understand that
[8:37] better because you have a unique vantage point having served in
[8:41] that role. But but also, I want to kind of
[8:44] challenge the idea that, you know, we've been quote,
[8:46] outsourcing for a long time now. I mean, you know, you know,
[8:50] chemistry to India and China and, and so many of us view this
[8:55] as just a, a natural extension of what has gone on for decades
[9:00] in terms of outsourcing, you know, globally, even going to
[9:03] Australia for a Phase 1. You know, there's many different
[9:06] ways that we access other. But anyway, I wanted to set that
[9:09] up for our audience. But yeah.
[9:11] What's your perspective on it all?
[9:14] Yeah. And, and I think like all that
[9:16] complexity just in sort of the supply chain that goes into both
[9:19] the discovery of a drug, the clinical trials associated with
[9:23] the drug, the ultimate then manufacturing and
[9:25] commercialization of the drug. It's very complicated, right?
[9:28] Which is why it makes this like a pretty tricky topic to talk
[9:31] about. So I will try to like drill down
[9:32] on what I'm specifically worried about and it, it is informed by
[9:35] my experience with the NSCDB, right.
[9:38] So I chaired that for two years. And then now Senator Young is
[9:40] the the chair of that Commission.
[9:42] And like just to give like a little bit of background, the
[9:45] these, there's a Commission like this now, I guess six or seven
[9:48] years ago that Eric Schmidt was the chair of that was focused on
[9:52] AI. And then one before that like
[9:55] way back in the day on like cyber, right?
[9:57] And so the idea is, hey, there are these strategic technologies
[10:02] that matter ultimately to national security.
[10:05] And we want to make sure that the US is like the leader in
[10:09] those technologies, right? We don't have to be the only
[10:11] place that does them, but but we want to make sure the frontier
[10:14] is happening here, right? And, and you can kind of feel
[10:16] this viscerally like if anthropic and open AI and all
[10:20] that energy was happening in China right now.
[10:22] And we were sort of here in the US deciding if we wanted to use
[10:25] a Chinese model, you know, like that.
[10:28] Like to me like the power of that technology regardless, like
[10:32] we know that one is going to be deployed for military purposes,
[10:35] both for economic and national security, military reasons.
[10:38] I certainly feel a lot better that that technology is centered
[10:41] here in the United States. OK.
[10:43] And so, so I think we have this question, which is how do we
[10:47] feel about biotechnology, right? And what's weird about biotech?
[10:52] And, and again, this is a this is a call very much focused on
[10:55] the therapeutics industry. But I think part of the reason I
[10:58] was asked invited to be the chair of that Commission was we
[11:01] had actually done a lot of work I think over the years in
[11:03] industrial biotechnology. So this is, you know, the
[11:05] development of enzymes and things like that for production
[11:09] of chemicals also in agricultural biotechnology.
[11:13] And we did work in therapeutics. And so we kind of cross cut and
[11:17] what I would say is I believe we're very much at the infancy
[11:21] of biotech, right. It's sort of like if you were
[11:24] round the clock on computers, you know, yeah, we look at
[11:27] computers today, but they were really invented sort of in like
[11:30] the 40s and 50s. And then IBM kind of got them
[11:33] off the ground in the 60s and 70s in a big way with
[11:35] mainframes. And then we all noticed them as
[11:38] consumers in the 1980s and 90s when they were like fully 60
[11:42] years into sort of like, computation moving to machines.
[11:46] Sure, Right. And, you know, engineering
[11:48] really began in 1978 and Genentech in the early 80s,
[11:51] Masanto in the 90s, you know, so here we are kind of like 40
[11:55] years into our journey. All right, So it's still early
[11:59] and we're still seeing what are the first uses of this
[12:02] technology. But to me, the engineering of a
[12:05] cell, the designing of DNA, this is our other sort of
[12:08] programmable substrate alongside computers.
[12:10] And we should not assume the only use of this technology is
[12:14] to make protein therapeutics. Sure.
[12:16] Yeah, OK. Like, that feels really short
[12:19] sighted. Yeah, about genetic engineering
[12:21] and I, considering all of our food is made with genetic
[12:24] engineering. The atmosphere, sorry, is made
[12:27] with biology. The atmosphere is produced by
[12:28] biology. Our human bodies are made out of
[12:30] biology. Like the idea that genetic
[12:33] engineering and biotechnology is just therapeutics in terms of
[12:38] what it could be used for is, is to me is naive or people are
[12:42] just saying that because they have other motivations to, to me
[12:46] ultimately, it is very clearly a technology that has dual use.
[12:48] It's very clearly a strategic technology we experienced with
[12:52] COVID that, you know, a single RNA virus can shut whole
[12:56] countries down, right? Like, like we, we cannot be.
[12:59] I think it's time for the biotic industry to grow up a little bit
[13:02] and under and appreciate that this technology has great
[13:05] potential and great power and and thus it is strategic and and
[13:09] countries will treat it that way.
[13:10] And so my experience with the NFCB was just looking and
[13:13] noticing quite how strategic China was being about it.
[13:17] And so. But I'll pause there for a
[13:18] second. Yeah.
[13:19] Well, before I dive into drugs like like, what has got me on
[13:23] about this is I watch the, the one like the, you know, the
[13:28] weird thing about genetic engineering today is that 90% of
[13:31] the market for cell engineering is basically therapeutics.
[13:36] You know, it's proteins, it's cell therapies, it's gene
[13:38] therapies, it's RNA, right? But that, that whole like line
[13:41] of like designing nucleic acids and, and having the talent and
[13:44] the technology base, it all sits downstream a basically one app
[13:49] area at the moment. And so whoever controls that
[13:52] application area, that ultimately controls genetic
[13:55] engineering, it's a little bit like controlling computers in
[13:58] the 60s and 70s. And, and what's woken me up as
[14:01] I'm watching us offshore that to China and I'm watching us
[14:05] actively, US investors, US particular companies supporting
[14:09] the out, the offshoring of what I consider to be a strategic
[14:13] technology that will ultimately be more important than
[14:15] computers. Yeah.
[14:16] So let me I'm just not. Going to plan to watch it happen
[14:20] so I'll yeah. Let me just provide a different
[14:22] counter. So look, I think it's a healthy
[14:24] debate, especially as you look at longer term, I'll call more
[14:29] existential kind of, you know, meta narratives around
[14:32] technology and you know, who will kind of control that and
[14:36] own that. But you know, the, the, the real
[14:40] issue is and the reason this was elevated recently was the idea
[14:42] of the COINS Act, which, you know, depending on your
[14:45] interpretation and the reading of it.
[14:47] And I'm not an expert in the, in the legislation, but it's, you
[14:50] know, really going to be curtailing this activity of, you
[14:53] know, licensing drugs and really finding opportunities to advance
[14:58] and accelerate human therapeutics for real disease
[15:01] applications. When I was a public company CEO,
[15:03] I was partnering with the Department of Defense.
[15:04] This was what became Surrepta called Avi Biopharma.
[15:08] And, you know, we were definitely working on medical
[15:10] countermeasures and, you know, bioterror threats and all of
[15:13] that. So, you know, definitely there's
[15:14] a place for that to understand how to protect our country from
[15:17] misuse or, you know, using those technologies against us and the
[15:21] the people United States. But in in the cases that I think
[15:24] are being brought up, it really is about why curtail our ability
[15:30] where we, you know, most would argue the US is best practice in
[15:35] terms of drug development and the ability to take something
[15:38] that, you know, might be found preclinically, you know,
[15:41] wherever it may come from. Or, you know, designing a drug
[15:45] de Novo and working with an India supplier or China supplier
[15:50] taking the next step of all right, let's see a well
[15:52] characterized asset, or even one that has even entered the clinic
[15:56] in China is even more well characterized before it's
[16:00] brought over, right? And, and, you know, having had
[16:03] have to do the, the clinical trials, the pivotal studies, you
[16:06] know, that makes it a real therapeutic.
[16:09] And so the, the idea is that aren't we really just arguing
[16:13] over the next incremental step of outsourcing that the
[16:17] industry's come to rely upon? And then I'll just add that that
[16:20] I didn't read the, the entire detailed white paper, but you
[16:24] know, RA came up with this idea of your washing, which is the,
[16:27] the idea that you're, you're incorporating unintended
[16:31] circumstances where just like when we were offshoring to
[16:34] Ireland and domiciling there for tax benefits.
[16:37] And you know, are you going to see the same thing happening
[16:40] because, you know, we can have European or multinationals and
[16:44] we already see this with deals with China, with, you know,
[16:47] GSKAUK based company, but BMS and even, you know, today
[16:50] Pfizer, right, another announcement of China.
[16:53] So I, I don't think we're going to be able to put, you know, the
[16:56] toothpaste back in the tube. And aren't we just hurting the
[16:59] US by trying to restrict us from being able to have that that
[17:02] free market capacity? Yeah.
[17:04] So, so there are two questions embedded in there and I'll I'll,
[17:08] I'll get to both. So, so the and maybe I'll, I'll
[17:11] go quickly through the first one, we can circle back on get
[17:13] to to your to the second point. You just brought up the, the, so
[17:19] on the first one, I think the from my perspective again sort
[17:23] of what I just said, the I, I think it is a bit simplistic to
[17:27] to say that whoever that this is just about the therapeutic uses
[17:34] of this technology. I think it is about a industrial
[17:37] capability in the area of biotechnology and it's fine if
[17:42] it's, hey, other places are going to have it.
[17:44] All I insist is that the US is the frontier, and I don't agree
[17:48] with you that we are assured that.
[17:50] I think we are in the process of offshoring the innovation engine
[17:56] of biotechnology right now. And you see this reflecting, I'm
[17:59] here in Massachusetts, right? We for the first time since Mass
[18:02] Bio has tracked it, we saw a decrease of 1100 R&D jobs in
[18:07] 2024, right? These are like US scientists who
[18:11] cannot get work anymore in the biopharma industry because that
[18:14] work is now happening in China. These are discovery scientists.
[18:17] These are the people who lead the frontier, OK, we have 1/3 of
[18:20] our lab space here in the Massachusetts area empty right
[18:23] now. And so I and you know, this is
[18:26] not cyclical in my opinion, this is a consequence of an
[18:29] offshoring. OK, so, so, so that's where and
[18:31] we can we can talk more about that.
[18:32] But that my point number one is I do think what we're starting
[18:35] to lose here is not I'm handing off to a chemist to make a
[18:38] molecule that was designed here, you know, in the United States,
[18:42] but rather I'm actually just moving the science of genetic
[18:46] engineering offshore. OK.
[18:49] And then to your second point, yes, Peter, I think thinks that
[18:52] the article is long enough, it's convincing, but the but you know
[18:56] that you're watching thing I don't think makes any sense.
[18:58] And the and the basic reason is that if you look at the market
[19:03] for drugs, it is not a free market, OK?
[19:06] And you can tell because 70% of the profits for therapeutics
[19:12] originate with US consumers, who make up 4% of the world's
[19:16] population. Right.
[19:19] So are are, you know, operating? In a, in a free market
[19:23] environment here at all. And so then the question is just
[19:27] what do we want to do about that?
[19:28] We could go to a a scenario where, you know, we spread the
[19:33] cost of R&D across a wider set of countries or we could say,
[19:40] hey, the cost, you know, if you want to have the national
[19:43] security and strategic value of a biotechnology industry with
[19:48] high quality scientist jobs and moving the frontier of
[19:51] technology, if you want that. And by the way, I think it's
[19:52] real valuable to have that, as I already said at the beginning,
[19:55] well, then you better have a domestic therapeutics industry
[19:58] to support it. Yeah, I'm sorry, Jason.
[20:00] No, but but why is it you don't? Get the industry.
[20:02] But what we're doing right now is we are paying for all the R&D
[20:07] that is going to be creating a capability in China, even though
[20:11] the US voter and the US consumer is the one paying for everything
[20:14] and that there is no euro washing.
[20:17] That's like a nonsense term that just got made-up. the US can
[20:20] obviously block whatever it wants.
[20:21] We can control our market and we are in this case uniquely.
[20:26] So like unlike say cars or electronics or software where
[20:30] there's a large ex U.S. market, quite simply, we are the market
[20:34] for drugs. So the rules we set, I do not
[20:36] believe that you'll see some magical merger of like Europe
[20:40] and China, because who will they sell to?
[20:42] Yeah, yeah. But Jason, I'm sorry, it seems
[20:43] sounds like your argument of the US being the beneficiary of the
[20:47] profits, right, which Peter's talked largely no?
[20:51] No, no, you're not the beneficiary of the profits or
[20:53] or. Go ahead, finish your comment.
[20:55] Yeah, no, but you. You just said 75% of the profit
[20:58] that's made is is in the US. I'm saying it, it is no, no, it
[21:02] the the buying like who is buying the drugs like like
[21:07] there's a certain amount of. I know.
[21:09] But how did China benefit from that when when we're talking
[21:12] about multinationals who sell these drugs or even US biotechs
[21:16] that are able to, even if they license the drug from China, if
[21:19] they commercialize that and are hugely successful, yeah, China
[21:24] might have a small equity position that gets diluted over
[21:27] time. But I'm not clear on how that's
[21:30] benefiting China. If we license a drug from China,
[21:35] successfully commercialize it, right, pay the R&D, but become
[21:39] the beneficiary of the revenues and profits disproportionately
[21:43] right, to the rest of the world. Yeah.
[21:47] And. Again, I will, I will.
[21:48] I'll focus back on what I said at the beginning.
[21:50] The the thing I consider to be national security relevant is
[21:55] who has the capability to do the frontier of biotechnology.
[22:02] But you're are you talking like new tools and new technologies
[22:05] that are emerging, let's call it like as when CRISPR and bass
[22:09] editing evolved? Because absolutely.
[22:12] Right, Yeah, 100%. All those types of things, DNA
[22:15] synthesis, whatever it might be, there's new technologies all the
[22:18] time and. I just think that's a narrow
[22:20] view and part of the controversy around here is the COINS Act
[22:23] seems to be wanting to overreach and make it very overly
[22:27] restrictive because I would argue that, you know, drug
[22:30] discovery, like we know already that 99 plus percent of drugs
[22:35] that look good in a rodent model never make it to approval.
[22:39] OK. So this is a a industry that
[22:42] lives with failure and 90% plus the latest data when Atlas did
[22:47] their annual review was 97% don't make it to FDA approval
[22:51] for products that are entering into the clinic.
[22:54] So this is not a game that's going to be easy.
[22:56] And I think the argument is that like we need to figure out and
[23:01] access wherever those technologies might be coming
[23:04] from. I understand your idea about
[23:06] like biodefense and existential threats over that.
[23:09] But if we're talking about trying to just develop a
[23:11] technology for a unmet need disease and that's why I brought
[23:16] up the human therapeutics, I don't see how having it overly
[23:20] restrictive of being able to license an antibody from a China
[23:24] company, right is a problem. I'll, I'll be honest, I've
[23:27] spoken about this. I think the bigger risk is that
[23:30] pharma bypasses US biotech and goes straight to China to do the
[23:35] deals that GS, KS done with Hengro and BMS has done and
[23:38] Pfizer's doing within event like that is a bigger threat where
[23:42] they don't need US biotech, they don't need the financing behind
[23:46] that. They'll just go direct that.
[23:48] That's exactly what I'm talking about, yes.
[23:50] Yeah, Well. All right.
[23:51] But that's different than the biotech industry, right?
[23:54] And the idea that, you know, biotech can thrive.
[23:58] And, and actually, I mean, I would argue that Ginkgo, again,
[24:01] just reading your website, I don't know your business model
[24:03] like you know, fully, but like autonomous labs, I mean, you
[24:07] speak about like testing jobs with robots.
[24:10] That's the easiest, yeah, yeah. But but but still.
[24:12] I mean are are if you're worried about U.S. jobs.
[24:15] Isn't ginkgo contributing to eliminating jobs?
[24:19] Which I don't think is bad. I think we need to get more
[24:21] efficient, no? We're not actually.
[24:23] Yeah, it's a good question. Yeah.
[24:24] So, so I'll speak to a couple things, but but let me.
[24:28] OK, so autonomous labs is not gonna eliminate jobs, human
[24:31] jobs. Yeah, so.
[24:32] Like for example, the as a great ad, I'll post it on Twitter
[24:36] after this from 1952 IBM ad and it's it talks about the the IBM
[24:42] mechanical calculator. And there's this great picture
[24:45] of this like refrigerator sized electronics device and it says
[24:48] does the work of 150 extra engineers and it shows 150.
[24:54] Oh man, of course, holding slide rules.
[24:57] OK, 150 of these engineers. And you might have imagined that
[25:01] the IBM electronic calculator would be bad for engineer jobs,
[25:05] considering they'd be out of work moving the slide rules.
[25:10] Now, of course, that's the opposite of what happens.
[25:12] Yeah, no. I, I as we.
[25:13] As we made as we made the ROI on the what was in the heads of
[25:20] those engineers more valuable because we made the work no
[25:23] longer manual. Yeah, I.
[25:25] I understand the debate that AI will create more jobs.
[25:28] Jobs for engineers. And so I think the only way in
[25:32] the long run that we are able to 'cause I do agree like no one
[25:36] fights about that we should make US R&D more efficient.
[25:39] No one fights that we should make our clinical trials more
[25:42] efficient. Everyone just getting upset when
[25:44] I talk about things we should do to slow down China.
[25:47] So this is a thing in the bucket of making us more efficient.
[25:50] And I know, I think it would expand the number of jobs just
[25:53] like it did in the in the, yeah. I look I generally and I think
[25:56] that we can move. To yeah, yeah.
[25:57] No, no, and Jason, no, I appreciate it 'cause I think the
[26:00] reason we wanted to have you on was to allow you to articulate
[26:03] your view. You know more, you know
[26:04] precisely right. And there's Nicholas Tillman's
[26:08] was also representing more of that the the view you're
[26:11] describing online. So people can check that out his
[26:14] ex threads and posts and read Peter call chances to have a
[26:18] better nuance of this. I I think at the end of the day,
[26:20] the the argument as I see it is that when you start to put
[26:24] impose specific controls and incentives and disincentives, it
[26:30] does invite unintended consequences.
[26:32] And often times those are actually worse than the original
[26:36] intent. And so, yeah.
[26:38] And I. Got I just, I really think it's
[26:39] it's not appreciating how unique it is that we and this is the
[26:43] thing I want to not lose here. The reason I'm bringing 70% of
[26:46] the profits is not about that the US companies make that
[26:50] money. It's that the US consumer pays
[26:54] them. the US voter pays for the profits of the drug industry,
[26:59] period. And so if the US voter wants to
[27:03] have this industry operate in a certain way because it's in our
[27:06] national security interest in the country or it's good for
[27:08] jobs for the US voter or whatever it might be, boy, can
[27:12] they decide that. And there isn't some weaselly
[27:14] way to get around that. When you are 70% of the market,
[27:17] you can set the rules. Yeah, I understand what you're
[27:20] saying about Medicaid, Medicare and, you know, the payment
[27:23] there, you've got a lot of private pay.
[27:25] You've got like the investors are the ones putting the capital
[27:28] at risk to try to, you know, benefit.
[27:30] And look, we're all, you know, agreeing that we need Europe and
[27:35] other countries to pay their fair share and that we've been
[27:38] carrying the brunt of the profitability of this industry.
[27:40] Otherwise it's going to go away completely.
[27:42] And I think it hurts the entire, you know, industry.
[27:44] But but but this has been helpful.
[27:45] Let me let me just invite our other Co host if there's any
[27:47] other questions or comments for Jason, Greg or Brian or anything
[27:52] that I missed in terms of a commentary on on this this
[27:55] topic. No, that was great.
[27:58] I'm just listening with fascination myself.
[28:02] Same. Great, great.
[28:04] Well, look, look, Jason, I think, well, I appreciate.
[28:06] Here's many. Of the time yeah yeah, it was
[28:07] fun to chat yeah. And I.
[28:08] Know we we had to go and and that's why we we we covered this
[28:11] topic first Jason appreciate your time I know you've got to
[28:15] run at the half hour and we've got a lot more to cover here so
[28:18] thanks and. By the way, I appreciate you
[28:20] guys doing this. Like in general, the biotech
[28:21] hang out, like I'll put in a plug that more people should be.
[28:25] I listen to it frequently. So I just think we need more
[28:28] people talking about our industry on social media and
[28:31] things like this. So I'm glad you got it.
[28:32] All right, Jason, thanks so much for joining.
[28:35] OK, so, so let, let, let's move again.
[28:39] Hopefully the audience enjoyed that because it has been a kind
[28:42] of a raging back and forth on, on, on social media.
[28:46] But you know, again, I, I mentioned the, the, the Pfizer
[28:50] deal again, this is just another continuation of China.
[28:54] I'll also mention that Wuxi announced a deal with Veridian,
[28:57] A biotech company for, you know, a manufacturing deal.
[29:02] Wuchi also announced that they they grew in 2025.
[29:06] Their numbers grew despite concerns about the Bio Secure
[29:09] Act. So there's still a lot of
[29:11] biotechs that are outsourcing to China.
[29:13] That doesn't seem to be going away.
[29:15] And I think, you know, we'll have to see what ultimately
[29:18] happens with the Coins Act and the final, you know, provisions
[29:20] or anything around that. But anyway, it's something.
[29:23] But anyway, Greg or Brian, do you want to cover just the the
[29:26] Pfizer any any further comments on that?
[29:29] Again, follows the BMS deal with Hengro.
[29:32] These are bio dollar deals deals.
[29:34] So this was only 650 million upfront, But I don't know, do
[29:37] you guys have any different perspectives on the whole, you
[29:40] know, licensing from China, whether it's pharma or or
[29:43] biotech or not? All right, let let's move to a
[29:55] Lily deal. Again Lily has been bolstering
[29:58] the M and A numbers for 2026 very active in this case.
[30:02] They bought 3 vaccine companies announced in one day for up to
[30:07] and again these are bio dollar with milestones but up to 3.8
[30:10] billion. And very specifically, they
[30:13] bought Curevo for up to 101.5 billion for a shingles vaccine.
[30:19] They bought the vaccine company, it's called vaccine company for
[30:23] an Epstein Barr vaccine for another 1.55 billion.
[30:27] And they also bought Limitech for a staph aureus vaccine that
[30:30] is really used to prevent kind of hospital based infections
[30:33] associated with surgery for 780 million.
[30:36] Notably, Lily hired Peter Marks who was the FDA official in
[30:40] charge of vaccine approvals. You know, we talk a lot about
[30:44] migration from CA-2 industry, but you know, presumably he
[30:49] shared his expertise about vaccines and vaccine approval.
[30:53] So it seems like Lily's solidly in the vaccine business with
[30:56] these 33 acquisitions. Let's see, Brian, why don't we,
[31:02] why don't we go to some of the antiviral stuff?
[31:07] I know you've, you've covered Gilead for a long time.
[31:09] Do you want to cover the the HPV data that came out that, you
[31:12] know, kind of had some of the best, you know, functional cure
[31:16] rates that we've seen and and then in bio heaven R&D Day, are
[31:21] you good to start with that? Yeah, yeah.
[31:22] Of. Course, yeah.
[31:23] So, so hepatitis B has been funny, funny, funny disease
[31:26] area. You know, I covered all the Hep
[31:28] C companies and it was like it was big change and standard of
[31:32] care that Pharmacet first Vertex, then Pharmacet, then
[31:36] ultimately Gilead wound up being the big winner alongside of
[31:40] ABBI. And and you know, for years on
[31:43] the peak of that, people were looking to HPV as sort of like
[31:46] the next, the next place to go from, you know, chronic or very
[31:51] low rates of cure to, you know, sort of a shorter oral therapy
[31:55] cure eventually. And that's sort of like always
[31:58] been the goal to get patients. Right now, patients with Hep B
[32:01] will be on antiviral therapy that just chronically suppresses
[32:05] them and, and as long as they're on the therapy, don't have the
[32:08] virus really inflaming the liver, causing liver damage.
[32:11] But ultimately, like in Hep C, we want people to just be cured,
[32:14] you know, some short, easy to take regimen and, and the virus
[32:16] goes away. And it has been a long, long,
[32:20] slow development path. And, you know, a number of
[32:24] companies have come and gone trying to do this.
[32:26] And Glaxo just the other day announced data from two phase
[32:32] three studies of their treatment, Beppy Beppy Roberson,
[32:38] which is actually one of my onus is old drugs, I believe, and
[32:43] it's an injectable targeted agent.
[32:46] They show not fantastic functional cure rates, but
[32:50] functional cure rates. In these studies, they got about
[32:52] a 19% functional cure rate. And a functional cure is when
[32:56] you both have undetectable levels of DNA and surface
[32:59] antigen in the blood for at least six months after all
[33:01] therapy has stopped, right? So this is actually a very, very
[33:05] long treatment for so patients will will stop all treatment
[33:10] after 48 weeks if they meet a specific secondary endpoint.
[33:14] And of those patients, about 19% were able to maintain those
[33:19] markers without seeing a relapse.
[33:22] Now this is, you know, arguably better than than what we've seen
[33:25] there are, is data in publications to kind of indicate
[33:29] that like pegylated interferon combination therapy with the
[33:31] Viryad can can, you know, maybe drive 510% functional cure
[33:36] after, you know, very, very long time.
[33:38] So, you know, I, I don't, I haven't heard people
[33:40] particularly enthusiastic about this, but you know, I wonder if
[33:43] it brings back interest into the heavy realm once again, knowing
[33:48] and seeing that, you know, we can maybe push the functional
[33:51] cure rates up higher. And as we evolved
[33:53] scientifically, you know, maybe we'll get to that point that we
[33:57] were hoping for 10 years ago on the peak of Hep C to, to be
[34:00] replicated shortly thereafter with Hep B.
[34:03] It's not the case. But science, you know, often
[34:05] moves a lot slower than than we anticipate.
[34:10] Well, and. I'm dating myself, but I
[34:11] remember like CCCDNA, was there really hard, like, you know,
[34:15] hard to crack that code And like have they just figured out
[34:18] mechanistically how to generate that more sustained right S
[34:24] antigen, right? Like, you know, clearance and
[34:29] like like just, I don't know because I know it was very, very
[34:32] hard, much harder than in HCV. And so is that kind of what
[34:36] we're seeing? Obviously, it creates the unmet
[34:38] need. And then maybe just speak a
[34:40] little bit, the HDV approval that Gilead got, this was a
[34:43] subset. You have to have HBV in order to
[34:46] have the HDV, which is the more severe phenotype.
[34:49] Maybe you want to speak to that at all.
[34:52] Yeah. Sure.
[34:52] So, so, yeah, I mean, this isn't specifically targeted to CCCDNA,
[34:56] but you know, the presence of CCDNA and sort of its latency
[35:01] within hepatocytes is, is, you know, thought to be one of the,
[35:04] you know, the primary reasons why you see relapse of, of
[35:06] hepatitis B and, and you never quite get a cure rate that it
[35:09] just kind of sitting around in those hepatocytes and, and not
[35:12] subject to viral inhibition or clearance, viral clearance.
[35:18] So you get rid of the HPV, but eventually the CCC DNA can
[35:23] produce HPV virus and, and you wind up with with a rebound.
[35:27] So this isn't targeted to CCC DNA directly.
[35:30] That's been a very, very hard nut to crack.
[35:33] This is this is targeted to inhibiting a a number of the RNA
[35:38] components of the hepatitis B virus.
[35:40] It's an antisense oligonucleotide and you know, I
[35:44] think the, the, the mechanism of how exactly, you know, very,
[35:48] very long suppressive inhibition of parts of the virus,
[35:54] components of the virus ultimately leads to functional
[35:57] care. People believe, you know, maybe
[35:58] there's an immunomodulatory approach, maybe if you just keep
[36:01] it sustained sustainably down long enough, the hepatocytes
[36:07] with CCCDNA ultimately turn over and, and the CCDNA is not there
[36:12] to source virus anymore. You know, whatever it is, you
[36:16] know, it seems like you really throw the kitchen sink at this
[36:18] virus for a long time. You know, some patients will
[36:22] wind up with with with functional cures.
[36:26] But yeah, I think we have a long way to go and a lot more to
[36:28] understand about sort of bleed and see the virus and how to
[36:30] really kind of turn that over. So HDV, so so Gilead got
[36:35] accelerated approval of hep Cluedex.
[36:38] And this is a, this is a product that they bought in an
[36:41] acquisition a number of years ago.
[36:43] They, they wound up getting approval in, in Europe and is
[36:46] approved in Europe. And, and hefty is I think, also
[36:49] a very, very interesting virus. It, it, it basically lives off
[36:54] of S antigen. So it's, it's a, it's a
[36:56] prerequisite to have hepatitis B to effectively have infection
[37:02] with hep Delta. And it is, you know, these
[37:05] patients are, are very severe. It's a, it's a, you know, hep B,
[37:09] the virus is kind of slow. It can take, you know, a decade,
[37:13] even untreated to really lead to liver impairment, liver failure.
[37:19] You know, patients with, with backhoe infection of Hep B, Hep
[37:23] D progress very rapidly. So there's a, there's definitely
[37:27] a significant need for, for hep Delta treatments.
[37:31] This is the first treatment for chronic HDV infection.
[37:36] It does the data's OK. You know, I think there's a
[37:39] number of companies that have been working on products to, to
[37:41] substantially improve upon. That's why I actually follow one
[37:43] of these companies in Miriam Pharmaceuticals where they're
[37:47] targeting S antigen specifically to basically prevent HDV some
[37:51] from from utilizing and binding to S antigen to to ultimately
[37:58] see viral replication. This has been a long time coming
[38:01] in the approval. You know, it doesn't Gilead
[38:04] doesn't break out hepatitic cells in in Europe right now.
[38:06] So, so it's not a very big drug. You know, I don't think there's
[38:10] high expectations that Cludex is going to be a big driver for a
[38:13] Gilead. But you know, I think it's a
[38:15] it's a very severe disease. And I think, you know, even
[38:18] though it's, it's mostly in third world countries, you know,
[38:21] I think you see a lot of pricing power here.
[38:23] Yeah. Yeah.
[38:24] And continue to just, you know, create their their strong
[38:27] foothold on the antiviral space and hepatitis.
[38:31] So Greg, are you, are you back with us?
[38:33] Can you want to make sure we test out your voice?
[38:37] Yeah. Can you hear me?
[38:38] Yeah, you. Sound great?
[38:39] Great. So sorry about that.
[38:41] No worries. Now you were going to touch on
[38:42] the Apogee Blackstone and then you've got a lot of cancer
[38:45] update to cover. We might have to go a little
[38:47] more rapid fire, but I wanted to go ahead and start.
[38:51] Yeah. So again, apologies to the
[38:53] audience for my technical issues.
[38:54] But yeah, Apogee reported some very positive top line phase two
[38:59] data earlier this week for its lead asset which is called
[39:02] Zemilo Kaibart. If I'm saying that correctly,
[39:05] it's a it's an antibody for atopic dermatitis.
[39:09] The data were were positive, although there was some debate
[39:13] as to what they saw with the dose response where the high
[39:17] dose did not work as well as the middle dose.
[39:20] But in any case, they are moving forward and that program into
[39:24] phase three. And what's really interesting
[39:27] here is that while most of us assume that, you know, the
[39:30] standard playbook for a biotech is that you raise capital via,
[39:34] you know, post good data via a follow on equity based
[39:38] financing. Instead, concurrent with the
[39:40] data released, Apogee announced a financing with the folks at
[39:44] Blackstone Life Sciences and what looks to be a pretty
[39:46] creative deal structure. Deal structure.
[39:49] So there's up to 1.3 billion available in a non dilutive deal
[39:56] with 800 million available in what's being called a synthetic
[39:59] royalty financing and another 500 million available as a more
[40:04] traditional senior debt offering that can be, you know, elected
[40:10] to be used at a time in the future when the when both
[40:13] parties agree. So very interesting structure.
[40:16] We've seen Blackstone, you know, become more active in the space.
[40:21] Certainly we've seen royalty pharma get involved, but I think
[40:24] most of us thought that, you know, on good data there'd be a
[40:27] big capital raise and all the, you know, the, the banks would
[40:30] be jockeying for, for seeing who could get on the deal.
[40:33] But instead, I guess no banks got paid and Blackstone came in
[40:38] and provided the financing. So very creative structure
[40:40] there. Great.
[40:42] And just a new player, I guess if they got comfortable around
[40:44] another royalty buy out, maybe we'll see more coming out of
[40:47] Blackstone on that because they just did close at large fund
[40:50] again this year. So they've got a lot of fresh,
[40:52] fresh powder. Yeah.
[40:55] And then with that, maybe I'll go into, you know, a, a, a bit
[41:00] of an ASCO preview. So part of my technical issues
[41:05] is I just landed in Chicago about two hours ago and, and
[41:08] lifted over to my hotel to be able to do this podcast.
[41:11] And so again, apologies for my my technical issues, but let's
[41:15] talk about, you know, ASCO. So, you know, as most of we all
[41:19] know, ASCO, the annual ASCO Cancer Conference, which takes
[41:23] place in Chicago, officially kicks off today.
[41:27] And ASCO is the largest cancer conference in the world.
[41:30] An estimated, you know, 35 to 45,000 people from all over the
[41:34] world attending. You know, there are doctors,
[41:37] cancer care providers and cancer caregivers, researchers and of
[41:41] course pharma and biotech that are here to present their latest
[41:46] data here, the latest and greatest that's happening in the
[41:50] oncology space. And there's also a small army of
[41:52] folks from the investment community like myself who will
[41:55] be attending as well. So with that said, I think as we
[41:59] think about ASCO this year from an investment community
[42:04] perspective, I think it's relatively light this year in
[42:08] terms of the major data sets that we think could, could
[42:12] really move stocks. But that being said, I still
[42:14] think there's still so much to be excited about at ASCO this
[42:18] year. I decided to make the trip,
[42:20] obviously with some really great advances in the field and
[42:23] innovations that will be presented.
[42:25] You know, with so much going on over the next 5 days, it's
[42:29] really hard to capture all that will take place.
[42:32] But with that said, I think, you know, some of the key
[42:34] technologies and asset classes that have been really gaining
[42:38] traction and the attention of investors would be things like
[42:43] bispecific antibodies, antibody drug conjugates, cell therapies
[42:47] like, you know, CAR T, which have had great success in the
[42:51] hematology oncology space, but, you know, trying to make, you
[42:54] know, make their way into solid tumors.
[42:58] And then there's this class of drugs that's called the Ras
[43:01] inhibitors. And you know, we've probably
[43:03] spoke spoken about the Ras inhibitors a lot of these past
[43:06] several podcasts, but the plenary sessions take place on
[43:11] Sunday. And there are a couple of
[43:14] presentations that I think a lot of people will want to, you
[43:19] know, listen and hear and speaking about the Ras
[43:23] inhibitors Revolution Medicines, which has a drug for pancreatic
[43:28] cancer called Diracs on Rasib. You know, they will be
[43:32] presenting the results of their phase three Resolute 3O2 study.
[43:38] And recall back in April, the company announced second line
[43:45] data where patients who received darracs on rasib, again in a
[43:50] second line setting, they were able to achieve a median overall
[43:55] survival of 13 .2 months and that compares with 6.7 months
[44:02] for standard chemotherapy. So you're talking about
[44:04] practically a doubling of the survival benefit.
[44:09] But that was just top lined. So on Sunday here at ASCO, we'll
[44:12] get more details from that phase three resolute 3O2 study.
[44:19] You know, importantly we'll all be looking at the overall
[44:22] survival data on a patient by patient basis, progression free
[44:26] survival, duration of response, duration of treatment and
[44:30] notably safety, tolerability and adverse events.
[44:33] I'm sure some of you on the podcast may have seen the New
[44:37] York Times video based interview with former Senator Ben Sasse
[44:40] who unfortunately has late stage pancreatic cancer.
[44:43] He very brave and in coming out and and to show everyone how
[44:48] he's living with his disease. But he's being treated with
[44:52] Derrox on RASIB and and doing relatively well.
[44:57] But that being said rash that some of you may have seen
[45:00] particularly on his face is something that's undesirable.
[45:04] So with that said, we are going to, you know, try to get more of
[45:08] a view on the overall safety tolerability of Derax on RASIB.
[45:13] They are going to, you know, be sharing data at some point this
[45:16] year, I think in a first line setting.
[45:19] But these Ras inhibitors are, are really exciting.
[45:21] There's several companies right behind Revolution Medicine that
[45:27] are working on other flavors of Ras inhibitors and some of these
[45:31] companies and it's not meant to be an exclusive list or an
[45:33] exhaustive list, but this includes A RASCA that at Mizzou
[45:38] how we cover and also Vera Stem, which is a company that I cover.
[45:41] These are earlier stage, but clearly Revolution Medicines
[45:45] with their pan Ras inhibitor is set an impressive efficacy bar.
[45:50] That said, we've also I think right after that we're going to
[45:54] have data from Summit Therapeutics, Summit in licensed
[45:59] PD1 VEGF by specific from a Chinese company.
[46:03] And so you know very topical, you know they are presenting
[46:07] study data from a Chinese study that's late stage, it's called
[46:12] the Harmony six study. I've got that correctly, but
[46:18] very we'll be very interested in seeing like how that data
[46:22] evolve. And I think a lot of excitement
[46:25] amongst investors has been about the potential of this PD1 VEGF
[46:31] by specific being perhaps a better Keytruda like drug and
[46:35] and remember last year Keytruda generated some 32 1/2 billion
[46:39] dollars in sales. So that all eyes will be
[46:43] certainly on that plenary session in my own coverage
[46:46] universe. So we've got three companies in
[46:49] particular that will have interesting data.
[46:51] One that I'll mention is called Corbis Pharmaceuticals.
[46:54] They're advancing A Nectin 4 targeting antibody drug
[46:58] conjugate for several cancers in particular treatment with their
[47:03] CRB seven O 1 drug was shown and the company announced announced
[47:09] this data last week and I'll talk about that in a little bit.
[47:12] But that led to a 43 percent response rate in patients with a
[47:17] certain type of head and neck cancer called oropharyngeal
[47:19] cancer. And that compares with like
[47:21] teens response rates that you see with current standard of
[47:25] care. So that's one company will be
[47:27] paying close attention to another smaller cap company is
[47:32] called immuneering. They have a novel neck pathway
[47:35] inhibitor and with what we consider to be very tantalizing
[47:39] data in a first line pancreatic cancer setting, they just
[47:44] announced 17 months of median overall survival in patients and
[47:49] depending on which chemotherapy based standard of care that is a
[47:54] more than doubling of what patients usually see.
[47:58] And then lastly, a company that I'll I'll briefly mentioned,
[48:01] that company is called a Maddox. A Maddox has a presence in
[48:05] Germany, but they're Houston based and they are tackling
[48:10] praying which is an antigen that is expressed in over 50 cancers.
[48:16] And Maddox has a a broad portfolio of therapeutics to
[48:22] hopefully attack PRAME which is highly expressed in Melanoma.
[48:26] But I think ASCO is going to be very important for this company
[48:29] because not only will they show the power of their platform, but
[48:34] they have both cell therapies and by specifics that can go
[48:39] after praying. And I think the key here at this
[48:41] conference is it all is to also show that they can go beyond
[48:45] Melanoma. So those are some of the
[48:47] companies that we're paying close attention to, but there is
[48:50] so much happening at ASCO and hopefully that's just some some
[48:54] high level snippets there. Well.
[48:56] It sounds like you got a busy week ahead, as many companies
[48:59] are. Covered.
[49:00] And I'm glad we got you back online, otherwise we might have
[49:02] had to end biotech hand early this this week.
[49:05] I'll also just mention that there was a phase three data
[49:07] with mesigdomide in multiple myeloma.
[49:10] This is from BMS. This is extending their strong multiple
[49:15] myeloma franchise that they acquired from Celgene just
[49:18] briefly in a phase three trial. Adding mesigdomide help keep
[49:25] cancer at Bay for roughly 10 months longer than the standard
[49:27] treatment of carfilzomib and dexamethasone alone.
[49:31] The study was conducted in relapse or refractory multiple
[49:34] myeloma patients and in addition, the treatment led to a
[49:36] higher response rate of 80.2% compared to 53.4% with the
[49:41] standard treatment alone. So again kind of a follow on to
[49:44] REVLIMID and POMALYST for the BMS multiple myeloma franchise.
[49:49] Brian, let's go to you. You, I think you had a Bio Haven
[49:54] R&D Day you covered and then you can then speak to Dine as well.
[50:00] Yeah, that sounds great. Yeah.
[50:01] I mean, I just wanted to comment on the mezzoamide side of things
[50:06] to a covered Celgene back in that I actually have the protein
[50:09] structure and a little deal toy that they gave out probably a
[50:13] decade ago. So, you know, I think it's
[50:15] notable they didn't have another image in that they were
[50:18] comparing it to. So I just, I just wonder, right,
[50:20] I mean something like a Lenalidomide or a pomalidomide
[50:22] plus caroflosomide index would really be sort of the second
[50:26] line standard of care. So I'd wonder how that would
[50:28] fare versus mezidomide, because, you know, like Pomalyst and
[50:33] Revlimid have, I believe, shown good results as well in the
[50:37] indication. And maybe moving on Bio Haven,
[50:39] yeah, there's like a highly debated name, one of the most
[50:42] highly related names that I cover on the street.
[50:46] You know, it's a company with a very, very big pipeline.
[50:47] Sometimes that is a bit of their downfall because they do spend a
[50:51] lot of capital. So one of the things that hear
[50:52] criticism from investors is the dilution, but they have a number
[50:56] of things that they updated on. You know, I thought were were
[50:59] all interesting. You know, people really focus on
[51:01] sort of their KV Senate 7 channel mod channel opener,
[51:05] which is phase three for focal onset seizure.
[51:08] They they've provided some interesting update from the open
[51:10] label extensions from their phase three studies.
[51:13] We're going to see the full phase three data later this
[51:15] year. Everyone's really looking to
[51:17] compare it to as of Kolner, which is a, a, a program also
[51:24] KD7 that is from Xenon and they had really great phase three
[51:28] data earlier this year. So, you know, there's really
[51:30] kind of like this head to head competition show who could put
[51:32] up the, the better data sets here.
[51:35] I would say, you know, we felt like it it, it was a little bit
[51:38] of a positive incremental update just in terms of producing some
[51:41] data that that people haven't seen before in terms of some of
[51:44] the, the, the reductions in seizure frequency, the obesity
[51:48] side of the story. They have a drug called
[51:49] Teledaphropop alpha, which is a myostatin antibody.
[51:52] You know, kind of one of the big debates in the obesity spaces is
[51:56] because you lose so much weight, a lot of that weight on GLP ones
[52:00] is actually muscle mass. Myostatin targeted therapies
[52:06] have been shown to, in, in the case of an Atlas Venture company
[52:10] that got bought by Lilly, their drug benagrimab, they've shown,
[52:14] you know, about 10% weight loss as a monotherapy.
[52:18] And what it really does in combinations with some Agglotide
[52:21] versus data they presented last year is it is it changes sort of
[52:24] the, the body composition. So patients are losing weight,
[52:27] but they're primarily losing just fat weight and they're
[52:29] maintaining or even increasing muscle mass.
[52:31] There's this big concern if everyone's going to lose, you
[52:33] know, 40% of their weight and it's all, you know, half muscle,
[52:36] half fat, particularly for patients who wind up getting in
[52:39] that way back, they usually gain at all weight.
[52:41] And, and there's concerns that are going to lead lead to
[52:44] significant problems as people will take much longer to rebuild
[52:49] muscle. Bioaven is going to have phase
[52:51] two data and, and you know, one of the knocks on, but Benagra
[52:54] mabs had a had a pretty hairy tolerability profile in that
[52:58] Lily data and doesn't seem like it's moving forward.
[53:00] So they could kind of replicate the Benagra mab data in
[53:03] combination with some agglotoid. Ultimately, I think that, you
[53:07] know, becomes a really important piece of the puzzle for for
[53:10] treatment obesity. But the thing that I care the
[53:13] most about at bio Haven is they, I think they have this molecular
[53:15] degrader and and trap program that utilizes or suffering
[53:22] hepatocytes to really turn over extracellular proteins really
[53:25] quickly. They showed some very
[53:26] interesting Igan data. IGA nephropathy, which is a a
[53:34] pathogenic antibodies, auto antibodies targeting the kidney
[53:38] leads to very significant morbidity and mortality.
[53:42] There's a lot of patients out there who will ultimately go on
[53:46] to progressive kidney failure as a result of Igan.
[53:50] This really targets the underlying, the exact underlying
[53:53] pathogen which is GDIG A1. They showed very good pro nuria
[53:56] reduction data, very good hematuria resolution data.
[54:01] And I think you know, there's a number of companies that are
[54:03] involved in this space targeting broad B cells and lowering sort
[54:06] of all immunoglobulins. And we have a launch and I game
[54:10] from Matsuka and Vertex and Vera are have submitted applications
[54:15] for more B cell targeted therapies as a number of B cell
[54:17] targeted therapies. But I think this is really like
[54:19] a very, very targeted specific therapy that doesn't really
[54:23] suppress the immune system. I think it's really interesting
[54:25] and they're planning to start a pivotal program in the next
[54:28] couple of weeks here. So I thought that was an
[54:30] interesting update. Maybe we're not to well mention
[54:32] the dying thing, but I think I think there's a broad, you know,
[54:36] I've gotten a lot of questions on FDA, right, all the all the
[54:40] time, really. And I think, you know, one of
[54:42] the bio haven has a piece of this dime has a piece of this,
[54:45] but there's a number of things. But you know, with the with the
[54:47] turnover of sort of this most recent guard at FDA of Marty
[54:50] Macri and I Prasad, Tracy, Beth Hogue, sort of all of these
[54:54] people who were viewed by industry as, you know, maybe
[54:58] kind of talking out of both sides of their mouths in terms
[55:01] of having like the flexibility that the GOP wants.
[55:03] But maybe this level of rigor that is more characteristic of
[55:09] Maha certainly in sort of pharmaceutical products.
[55:13] And, you know, there's been a lot of like CRLS, you know,
[55:16] whether they're fair or not, we should debate those.
[55:18] But you know, there are a lot of places where, you know, sort of
[55:21] Macri was saying, oh, we're going to be super flexible and
[55:23] like we're going to prove anything even on like
[55:25] theoretical mechanism. But the reality was that, you
[55:28] know, there were a number of CRLS and, you know, with him
[55:31] gone, the the interim FDA commissioner is is actually he's
[55:38] been at the agency for a little bit.
[55:40] Kyle D Amontas he was actually under Scott Gollyb, I think
[55:45] previously. He's evidently good friends with
[55:48] with Trump. You know, we're hearing kind of
[55:51] nicest things about him, I think very reserved.
[55:53] I mean, I think it's it's, it's that he faces a you know, this
[55:55] is a really tough job, right? There's a lot of conflicts
[55:58] between GOP and Maha in sort of the, you know, what they want
[56:03] the FDA to do and he's going to have to work in that dynamic.
[56:05] But what we're really seeing is that there's been a lot of turn
[56:08] around in terms of these companies that were sort of
[56:10] pushed aside, you know, at least getting a second chance.
[56:13] So right, just this morning we have roughly Munoff
[56:14] substantially on announcing an agreement to resubmit the BLA
[56:17] for their Melanoma therapy. Earlier this week, Outlook
[56:21] announced that they are resubmitting their application
[56:23] for bevacizumab in ophthalmology.
[56:26] This is interesting because in their press release they're
[56:28] basically like the FDA agreed that we have demonstrated
[56:31] substantial evidence of effectiveness.
[56:32] It's going to be a Class 1 suppression, Class 1 submission.
[56:36] So, you know, if all of that's true, you know, it's almost like
[56:38] the FDA is guaranteeing an approval if manufacturing is
[56:41] okay. You know, Dine has announced
[56:44] that they submitted their BLA. This is on time.
[56:46] This is not necessarily a surprise, but covering Dine,
[56:49] there's a lot of debate and you know, Chris, you kind of know
[56:51] this. There's a lot of debate as to
[56:53] what the FDA is going to do with sort of next generation Exxon
[56:56] skippers. Because you sort of have this
[56:57] precedent that was started with a Templar Sun that if you show
[56:59] dystrophin expression with with an Exxon skipper, then that's an
[57:03] approvable drug. Dine's drug certainly does more.
[57:06] I think in every measure it shows more production of
[57:09] dystrophin than any of sort of the the naked PM OS have.
[57:13] So it has better data there. So just on precedent, you would
[57:15] think this would be a layup, but obviously it's been super
[57:18] controversial. You know, I'm sure like if Vinay
[57:21] Prasad was still there. I mean, you know, he's he's kind
[57:23] of said some pretty mean things about your ex company.
[57:25] Yeah, so. And and the risk profile would
[57:27] have gone up if he was still there for sure, for sure.
[57:30] For. Approval.
[57:31] So yeah, that's crazy. Yeah, Brian, that's a great
[57:34] overview. And I, you know, look, it's the
[57:36] hard part is, is that I don't know that we really we're we if
[57:41] we were seeing the full potential fruits of the reforms
[57:45] of Mccary and there was this kind of schizophrenic kind of
[57:48] perspective. But let's hope that this is a
[57:50] harbinger of more positive right and predictability, most
[57:54] importantly of the FDA. So, but that's great rap.
[57:58] So we're at the hour. Just want to say thanks to our
[58:01] Co hosts Brian and Greg. Thanks for and for Jason, who
[58:05] signed off earlier as a special guest.
[58:07] And thank you all for tuning into this episode of Biotech
[58:10] Hangout.

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