# Episode 183 - May 15, 2026

An episode of [Biotech Hangout](https://invisiblenetwork.ai/podcast/1568911820), 15 May 2026, 1 h 01 min.

Audio: https://anchor.fm/s/55bdff38/podcast/play/120056790/https%3A%2F%2Fd3ctxlq1ktw2nl.cloudfront.net%2Fstaging%2F2026-4-15%2F424243063-44100-2-1b773696e49f4.m4a

On this week’s episode, Sam Fazeli, Josh Schimmer, Eric Schmidt, and Tess Cameron kickoff with deals, highlighting the up to $15.2B Hengrui–BMS partnership and the broader trend of outsourcing early-stage drug development to China. The discussion continues with the co-hosts noting China’s edge in speed, quality, and cost-efficiency, while underscoring that the strength of U.S. capital markets remains a key advantage. This week also saw a significant raise, with Isomorphic Labs announcing a $2.1B Series B. In regulatory news, the group described the departure of FDA Commissioner Dr. Marty Makary as creating fresh uncertainty around FDA leadership and direction as they speculated on his exit and who will replace him. On the data front, Regenxbio met the primary endpoint inits Phase 3 trial for Duchenne, though the hosts flagged potential investor skepticism around the side effects, limited data, and FDA uncertainty. Next, they discuss that Biogen and Ionis are advancing their Alzheimer’s tau program despite mixed results. The co-hosts also mention Inhibrx’s Phase 2 data in head and neck squamous cell carcinoma, as well as Moderna’s Hantavirus vaccine research following the recent cruise ship outbreak. The episode concludes with a look ahead to upcoming conferences, including ASCO, ADA, and ATS. *This episode aired on May 15, 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
[0:07] a group of biotech leaders and experts.
[0:11] I'm Sam Fazeli and my Co hosts today are my friends Josh
[0:14] Shimmer, Eric Schmidt and Tess Cameron.
[0:17] And Tess is on her way. She's not quite here yet.
[0:20] For more information about our hosts and guest speakers or to
[0:24] listen to the most recent episodes, which I encourage you
[0:27] to do because they're always great for a catch up, please go
[0:30] to biotechhangout.com. Now looking at this week, we've
[0:37] had some not necessarily the busiest week in terms of news
[0:43] etcetera, but we've got some events that took place that
[0:50] we're we definitely are going to talk about, which is of course
[0:54] related to the FDA. But we're going to start with
[0:57] deals and financing. We've had another big deal that
[1:04] involves a China biotech company, this one is
[1:08] Bristol-Myers with Henry. I'm going to call it the massive
[1:12] deal, but it's not the most massive because we've had bigger
[1:17] ones recently and continues to show the trend of outsourcing
[1:21] some early drug development to what I would call potentially
[1:25] still a cheaper and faster country for early stage drug
[1:28] development. So the agreement includes 4
[1:32] drugs, oncology drugs and hematology drugs from Hangry, 4
[1:37] immunology assets from Bristol-Myers and five
[1:40] innovative assets to be jointly developed and, and and
[1:44] discovered and developed by both companies.
[1:46] And and it uses clearly the Hangry technology platforms
[1:52] etcetera. And of course some of the assets
[1:54] that are coming from Bristol-Myers have been
[1:55] discovered at Bristol. So, so they're going to agree
[1:59] has an option. This is an interesting aspect in
[2:01] this deal because I haven't seen this necessarily in other deals,
[2:05] although I have to say I can't remember every single detail of
[2:08] every single deal to Co develop select assets and the potential
[2:12] to conduct certain commercialization activities
[2:15] globally with Bristol-Myers. That's the interesting part that
[2:19] I've not seen before. I've seen these deals where the
[2:22] farmer partner often US or European farmer partner is
[2:27] working with the company, but they the the, the local company
[2:30] keeps the region Macau, Hong Kong, China and usually leaves
[2:34] the global commercialization rights to others.
[2:38] So this is interesting to see. And of course part of the reason
[2:43] that these deals are happening aside from the good science that
[2:46] that that takes place in China is because early clinical
[2:49] development is still a little faster in in China or some
[2:53] meaningfully faster in China than it is in the rest of the
[2:56] world. And of course this comes back to
[2:58] our conversations that we will have later on about the FDA and
[3:01] the changes in leadership etcetera.
[3:04] And and the term deal terms are the Ms. pays about 900 or or up
[3:10] to $950 million to angry in a tranched investment or or
[3:17] payment $600 million upfront, 175 on the 1st anniversary and
[3:23] another 175 on the 2nd anniversary.
[3:25] This reminds me of their deal with Biontech which is
[3:28] interesting spread out over two years or three years.
[3:31] In terms of the Biontech deal was for permit to make which is
[3:34] the PDL 1 VEGF that Bristol licensed about a year ago now.
[3:39] So the total potential value of course is a big number $15.2
[3:42] billion with all those milestones etcetera thrown in.
[3:47] This is not the biggest China deal this year.
[3:50] The Astra CSPC deal was larger that was in earlier this year,
[3:56] but also in 2026. So with all these details in
[4:01] hand, I want to pass it on to the rest of the team, starting
[4:04] with Josh, because Josh is relatively fresh from China.
[4:09] And just to get your perspective, and I'll have a
[4:11] couple of queries for you as well.
[4:14] Josh. Yeah, thanks Sam.
[4:17] So our our colleague Lee Watson does an annual bus tour to to
[4:22] China. So I joined this year to, to get
[4:24] a sense of what all the hullabaloo has been about it.
[4:28] It really is impressive seeing it kind of first hand and
[4:32] including that and Gray and understanding that, you know,
[4:35] the, the pace, speed, quality, caliber, affordability of
[4:39] innovation there. You know, it, it really brought
[4:43] to life, you know, a lot of the discussions that I've been
[4:46] hearing about, you know, China being a, a, a competitive risk
[4:51] to the US, which it is and is going to increasingly be for,
[4:56] for all those aforementioned reasons.
[4:57] Like in the moment, though, China still seems to be a source
[5:02] for high quality validated assets, often kind of me better
[5:07] versions of of what some of the local innovators have come up
[5:12] with. And and then that creates its
[5:13] own disruptive dynamic. But, but, you know, often is a
[5:21] kind of a wealth transfer right from, from China innovation and,
[5:25] and, and US domicile companies or investors who can get these
[5:28] cheap assets from China and then bring them to the US where they
[5:32] can be very lucrative. And, and so you know, that
[5:36] that's its own separate dynamic and, and that creates kind of a
[5:40] different type of risk for the sector where, you know, you just
[5:44] kind of worry. Is there something better that
[5:46] may be licensed out of China into a pharma company into a
[5:51] local biotech company? But what we also heard on the
[5:54] bus tour was that these companies do have plans to
[5:58] ultimately become global commercial entities that, you
[6:01] know, kind of kind of agree. They indicated that that their
[6:05] time frame may be like three to five years to to be
[6:08] accomplishing that. So this deal very much aligns
[6:11] with that strategy, right? Like they're going to partner
[6:13] with Bristol, but going to find, you know, lessons and, and and
[6:17] develop their own capabilities of commercializing globally,
[6:20] including in the US market. And that's where it now it
[6:23] becomes particularly tricky, right?
[6:26] Because now you know, that the the value capture of the
[6:31] innovation may be increasingly shifting to China based
[6:35] companies. At the same time, China is
[6:37] gonna, it sounds like China's gonna open up its own markets
[6:40] for innovation and pay more for new innovative drugs.
[6:43] Of course, this comes at a time that who is better positioned to
[6:47] to benefit from that other than China's own biotech companies,
[6:51] right. So, so I think in the in, in the
[6:54] moment, China remains a very attractive source for low cost,
[6:58] high speed, affordable, validated, you know, top tier
[7:01] type innovation. And, and in the race to come up
[7:04] with the, the best of whatever, the Best Buy specific, the best,
[7:08] you know, monoclonal antibody, the best ADC, the best dual
[7:11] warhead ADC, China has a clear advantage, but but still remains
[7:16] an affordable low cost source of innovation.
[7:18] But over time, over the five to 10 year period, that's where
[7:23] kind of the global trade issues, I think are going to be
[7:26] particularly problematic. And the US is going to have to
[7:30] figure out what strategy and ultimately deploys to protect
[7:35] its markets to enable local innovators in, in a race.
[7:42] And that that's not really a fair race at all, just given
[7:47] where China is and and is headed with their their speed of
[7:50] innovation. Tess, you wanted to come in
[7:54] here, right? Yeah, yeah, yeah.
[7:56] No, maybe just maybe just like extrapolating, extrapolating
[8:00] what Josh shared, like, you know, roll forward 5 to 10 years
[8:05] and let's say that, you know, Hangrui and, and Hansel and and
[8:09] CSPC and a number of these other, you know, China
[8:13] innovators like really have gone global, right?
[8:15] Like, I think there's a question of, well, what would still like
[8:18] be in the US and what would like need to be in the US from a
[8:22] security standpoint? I think 1 would be
[8:25] manufacturing, right? Because security of supply is
[8:29] really important and you know, in, you know, critical to kind
[8:34] of have a certain amount of, you know, onshore or like very
[8:39] closely allied, you know, country manufacturing and like
[8:43] sales reps, right? Like you're still going to need
[8:46] like U.S. sales reps, aren't you?
[8:48] So you know, like there's this kind of five to 10 year like, is
[8:53] that what like US biotech will be?
[8:56] It will basically be like manufacturing and like sales
[8:59] reps. I think that's kind of a bleak
[9:02] view. Like, I like to think that US
[9:06] biotechs are really competitive and want to win and want to make
[9:11] great drugs. And, you know, we'll figure out
[9:14] ways to do that. And maybe that means that like,
[9:17] they're going to have to do more in China in order to be
[9:19] competitive. And maybe it means that they're
[9:21] going to have to do more in India to be competitive.
[9:24] And hopefully, you know, I think the big hope is that it means
[9:29] that the US is actually going to have to do more things like, you
[9:33] know, the CTN pathway legislation that's being, you
[9:38] know, that's being proposed. You know, there's a lot of work
[9:41] and a lot of, you know, a lot of changes at the IRB and other
[9:45] level that would have to go in to actually make a non Ind pass,
[9:52] you know, clinical early clinical development feasible in
[9:55] the United States. But let's hope, let's hope it
[9:58] gets there and that the US can be more than, you know,
[10:02] manufacturing and and sales reps Josh, I'm, I'm interested in
[10:07] that vision of the future and how you think US biotechs can,
[10:12] you know, can really compete in this new, you know, kind of new,
[10:18] new order. Well, it's, it's ever evolving,
[10:21] right? And, and China's focus right now
[10:23] is in certain therapeutic categories and, and certain
[10:27] modalities. And so, yeah, there are still
[10:30] areas where US bio innovation is relatively insulated.
[10:34] Of course. The question is how long is it
[10:35] going to remain insulated? You know what, one of the
[10:38] challenging, to me, one of the most challenging dynamics is
[10:41] that, you know, the US innovation, right?
[10:45] Just these new ideas, new concepts is, is, I think, you
[10:51] know, far superior to anywhere else in the world where China's
[10:54] really excelling is, is building on those innovations to take
[10:58] them to the next level, right? And that actually is where,
[11:02] right. So innovation is where the risk
[11:04] is, optimizing is where the value is.
[11:07] And that's kind of that's where random Tesla kind of probably
[11:10] where what you're seeing is as you're kind of painting that
[11:13] picture and, and how do we find ways for the US to not just be
[11:17] the innovator, but also continue to optimize?
[11:21] And then part of it'll come from AIA great efforts in, in AI that
[11:24] that'll help level the playing field.
[11:27] Part of it may come from, you know, more U.S. companies going
[11:30] to engage in in China for development so that they can
[11:34] move quickly as well to proof of concept.
[11:37] While we're kind of waiting for the US ecosystem to hopefully
[11:41] speed up as much as it can, China's always going to have a
[11:45] cost and scale and speed advantage.
[11:48] I, I don't think that's anything that the US will ever be able
[11:51] to, to match. And that's where it probably
[11:54] gets most tricky as well. It, you know, the idea that we
[12:00] want access to the best innovation, right at, at some
[12:04] point there may be tough decisions to be made in the US
[12:07] market, whether that also includes innovation in China,
[12:13] because again, balance of trade issues are going to be very
[12:15] important. And this is an very important
[12:17] sector now for, for both countries to defend.
[12:21] So it's so hard to predict what the future is going to look like
[12:25] when it's moving so fast. And you know, there, there are
[12:29] there are legislative considerations down the road
[12:32] that that may change the landscape and the dynamic.
[12:37] Maybe maybe just building on that like one layer more, right?
[12:40] Like if, if now optimizing is, you know, the ways that that
[12:46] investors, you know, investors get paid, like is that something
[12:51] that becomes more commoditized, right?
[12:55] Is that something that becomes more commoditized and, you know,
[13:00] zero to 1 innovators, right, which are kind of scarce?
[13:04] Like can they kind of have their choice of optimizers because
[13:09] it's something that's more commoditized and, you know, can
[13:12] be done very efficiently, You know, with the current patent
[13:16] system, that's, that's probably hard, right?
[13:19] But that's just another, you know, kind of big picture
[13:24] thought to throw out there about how things could evolve.
[13:28] Yeah, when when I got back from China, I emailed all, all my
[13:31] companies that that I cover and our work with and and basically
[13:35] said like you need to have a, a China strategy even if there's
[13:40] no strategy to be had in the moment.
[13:42] But part of the strategy may be, you know, if if you are the zero
[13:46] to 1, if you are the original innovator, you need to think
[13:49] about more so than in the past, cannibalizing yourself with with
[13:53] me better type innovation. And you can go to China.
[13:58] This is there's still a window, right, where China itself is
[14:02] split between the haves and the have nots and they're very
[14:04] dependent on external capital and funding and validation.
[14:08] And so you know, there there is that like they are commoditizing
[14:11] innovation. Absolutely.
[14:13] And and potentially to the advantage of the US where it
[14:17] does, as I said, become challenging is when China now
[14:20] wants to commercialize into the US market at the high drug
[14:23] prices that we spend after having basically shut their
[14:26] market from high drug prices, you know, up until you know
[14:31] what, what may be the next coming years.
[14:34] You know, you guys are both touching I think on a really,
[14:36] really important topic, which is the strength of the US capital
[14:40] markets, right? That may actually be our best
[14:42] defense in terms of protecting the the US biotech ecosystem.
[14:47] There's no capital market in the world like that in the US test.
[14:51] I know, you know, RA might feel comfortable going over to China
[14:54] and, and investing in private companies, but for the great
[14:57] majority of funds that are willing to put literally
[15:01] hundreds of billions of dollars into biotech each year, they're
[15:05] not going to go invest in Chinese markets, right?
[15:07] So maybe in addition, terms of your view of the future addition
[15:12] having manufacturing capabilities and, and, and
[15:15] capabilities in sales and distribution, the future of US
[15:19] biotech is to have investor relations and, and, and, and
[15:23] analysts responsibility, things like that.
[15:25] I know for all of our vocations we'd probably enjoy that.
[15:28] But but I just wonder whether it is possible for China companies
[15:32] to truly penetrate the US from a capital market standpoint and
[15:36] whether you guys see that as evolving or changing.
[15:39] Whether that hurdle, that bar is going to become so low in terms
[15:43] of fund flows from Chinese listings in the US, or whether
[15:47] US investors will always want the management teams to be here
[15:51] to speak English to, to press the flesh, you know, to reside
[15:55] in the US. But I just say that that's
[15:59] probably that's why I look at this like a 5 to 10 year
[16:01] consideration, right? Like, like the, the companies
[16:04] are, are certain ones are really starting to thrive in China,
[16:09] right? And as, as China pays more for,
[16:12] for drug spend, their, you know, their revenue and profitability
[16:15] is going to improve. The resources are going to
[16:16] improve. They're going to be learning
[16:18] along the way, you know, from partners like Bristol, you know,
[16:21] how to commercialize. It's not, it's not rocket
[16:23] science, right? It there, there are many
[16:26] different ways to approach that. And, and that is what they're
[16:28] gearing up to do, but they're not there yet, right?
[16:32] And and that's what creates this window where there's more,
[16:35] there's probably right now more opportunity than than risk to,
[16:39] to license assets out of out of China and bring them into the US
[16:43] market or even globally and capture all that, all that value
[16:47] in the process. But but over over 10 years that
[16:51] that's where it it becomes hard to hard to anticipate because
[16:54] China will have more and more capital to to enable their
[16:57] commercial efforts and their expertise as they partner with
[17:00] companies like Bristol. Yeah.
[17:03] So just to summarize this, I'm going to take the other side of
[17:07] the conversation and assume that I'm sitting in China right now
[17:11] and I am either in the government or or running one of
[17:15] these companies. I think what I would want to
[17:16] watch is to make sure that my current competitive advantage,
[17:21] which I would classify as brute force, right?
[17:25] Which is, you know, you can call it whatever you want, OK, It's
[17:28] cheaper, but also the, the number of companies that can
[17:32] iterate on the same idea of APD 1 Veja for PDL, 1 Veja for PD1,
[17:37] CDLA for whatever you want it to be, right?
[17:41] It is so high that that by, by sheer mathematics or arithmetic,
[17:47] they'll end up with one of the assets being one of the best
[17:49] potentially out there. So that's what I, if I was
[17:52] looking at that of, of the at the region, I would worry that
[17:55] that sheer force capability will eventually erode, partly because
[18:00] the US catches up with the idea of having to be able to do
[18:03] science faster. You mentioned AI, Josh, and then
[18:08] the fact that that, that we, we eventually will wake up.
[18:11] And, and I think that process started with Marty Mccarry's
[18:15] trying to streamline clinical developments so that drugs can
[18:18] get into early trials faster so that we can catch up at least on
[18:22] that front as well. The question I have is whether
[18:26] there's these risk appetite and maybe some of these companies
[18:29] are not getting so well funded that they, their risk appetite
[18:32] goes up to do that hardcore innovation.
[18:35] No question they can do it. I mean, you know, human brains
[18:38] over there are as good as the human brains over in the US
[18:41] Access to capital is the issue, which is what Eric brought up.
[18:43] So will they be able to get onto the absolute early innovation
[18:48] stage? I we know as a fact for a fact
[18:51] that they've been able to do that in the material sciences
[18:54] world and the Chemistry World. So there's nothing stopping
[18:57] them. It's just this needs, this needs
[19:00] a different level of risk appetite.
[19:02] And that's where I think the needs to, to evolve over there
[19:06] in China. So great conversation here,
[19:09] guys. Thank you.
[19:11] I think maybe on that particular front and talking about AI and
[19:14] how it can make it a change to the world, I want to just talk
[19:18] about one of the largest fundraisers that I've come
[19:20] across, which is the isomorphic. Remember, this is the biotech, I
[19:27] would call it AI biotech company that's run by Demi Sasabis as
[19:32] CEO and who's also the CEO of DeepMind, which is Google's AI
[19:38] business segment. And they just raised just over
[19:42] $2 billion from investors. Now this is after this series B,
[19:48] right? And test you tell me how many
[19:50] series BS you come across that are this big.
[19:52] They, they had only just raised $579 million just March last
[19:58] year. So this is 2 point $2.58 billion
[20:02] of cash going in here. And I'm, I'm assuming they're
[20:06] seeing development or evolution in their, in their assets, which
[20:08] is what they're talking about in the press release they put out.
[20:10] But these are huge numbers. The one little thing that
[20:13] worries me? Somewhat is that there are I
[20:16] don't see any biotech type investors in there maybe because
[20:22] they were excluded, maybe because they couldn't put up
[20:26] with the valuation that was going in here or what makes of
[20:30] it was both of these things. So, but that is where, you know,
[20:33] I know that Zerah, they had a billion dollars that came from
[20:36] Arch Ventures and one other whose name I forget.
[20:41] I, of course, I, I'm, I'm pretty close to in silico.
[20:44] They're doing relatively well in the world of AI and there's a
[20:47] whole host of other companies, right.
[20:48] So, and this is where we're going to see whether they're
[20:52] going to be able to really genuinely get, get the speed
[20:55] going. Now Isomorphic has proven part
[20:58] of its efforts, which is Alpha Fold and the Alpha genome,
[21:03] etcetera, etcetera, that are openly available and are
[21:06] everywhere. And pretty much every chemist
[21:09] that I've come across is using them.
[21:10] So I just wondered if Tess wanted to comment on that.
[21:16] The, the, the, the number, the $2.1 billion I was raised.
[21:20] I'm sorry, I don't know why I'm laughing, but it's a huge amount
[21:23] of money for a series B. It absolutely is.
[21:26] It absolutely is a huge amount of money.
[21:28] And I think, you know, look for biotech specialists, you know,
[21:34] we're going to be focused more on assets, right?
[21:37] And what is the, you know, what is the value of the assets that
[21:41] are being developed? You know, I think too many
[21:44] biotech investors, you know, including us have, you know,
[21:48] being in situations where we put a lot of value on a platform and
[21:53] technology and you know, it, it ends up not necessarily
[21:56] translating into, you know, into into assets that can be
[21:59] commercialized. So I think, you know, kudos to
[22:04] the isomorphic team for, you know, attracting that capital.
[22:07] But you know, I do think that is, you know, much more of a, a
[22:10] tech mindset on, you know, getting a technology that is,
[22:15] you know, scalable and can help make drug discovery and
[22:18] development more efficient, which let's hope, let's hope
[22:21] that technology works and can help, you know, and can help,
[22:25] you know, our, our companies, our companies compete better,
[22:28] but very different, you know, very certainly very different
[22:32] type of deal and type of underwriting.
[22:34] Then you know your your biotech, your biotech specialist.
[22:40] Right. I mean, just to put more of a, a
[22:42] skeptical hat on it. Tess, it's such a nice,
[22:44] wonderful person. She's, she's probably a little
[22:46] bit less snarky than I am, but but Sam and Tess and Josh, you
[22:50] all know this is the first time we've seen big tech kind of
[22:54] weighed into healthcare waters, right?
[22:56] Whether it's IBM or Amazon and other initiatives in the past,
[23:00] they've all kind of ended well. They've started with a bang like
[23:03] this seems to be doing and ended with a bit of a whimper.
[23:06] And it's just the divide between tech and healthcare.
[23:09] I think it's still very great. I think it takes a certain
[23:12] mindset to develop drugs. And this test mentioned that is
[23:15] where the value is coming from. It's not coming from platforms
[23:18] and somewhere between an interesting platform which
[23:21] isomorphic has a technology certainly valuable as you noted
[23:24] Sam between that and and turning it into a a drug development
[23:28] discovery business is a huge, huge gap that just hasn't been
[23:31] breached by anyone else before. I mean, the only thing I would
[23:34] say to, to finish on this is Davis Sabis is actually a
[23:39] neuroscientist and he has surrounded himself by some who
[23:43] biotech type of biology, at least knowledgeable folks.
[23:47] So I mean, let's hope it works out because they are good
[23:50] people. They're one of the, what's the
[23:54] right phrase here? More concerned people as it
[23:59] comes to AI, right? A little bit like anthropic in
[24:02] terms of their, their attitudes to the safety risks of AI,
[24:06] etcetera. So let's hope that it works out
[24:09] for them. But I completely hear you.
[24:11] And you always worry about that when this volume of money goes
[24:13] into a company. So with that in mind, let's talk
[24:16] about the other key subject of this week, which is Marty
[24:20] Mccarry's resignation. Now, I had a conversation with a
[24:25] good friend early in the week who said to me, I've met with
[24:29] Marty recently and there's no way he's leaving.
[24:32] So all these folks are are are, you know, or at least not
[24:34] getting fired. And then of course, and now, and
[24:37] that's what happened, right? The issue isn't that anyone's
[24:41] misinformed etcetera. I think it's probably still part
[24:44] of the ongoing difficulty of being able to judge where the
[24:51] administration will land on something here or there.
[24:53] And and you know, Marty was it's I'm going to ask, obviously all
[25:00] of you to comment did some great things, did perhaps a little too
[25:06] many podcasts and presentations and and the videos.
[25:09] I don't know. I mean value judgement.
[25:11] That perhaps isn't my place to do.
[25:15] There were issues with vaccines and how they were being handled
[25:19] that were allowed to happen, although maybe that's because
[25:22] his ultimate boss was in charge of all those areas.
[25:26] The story with Vinay Prasad was was in the end, whether you like
[25:32] him or not as a scientist etcetera.
[25:33] And Josh have heard you several times talking about this.
[25:38] In the end it wasn't necessarily a positive.
[25:40] Rare diseases were supposed to be a great focus, but nothing
[25:43] really ever came of it. If a pristone is something that
[25:46] probably was a major factor in in what happened in the end in
[25:51] terms of his decision to resign and this flavoured vapes thing.
[25:54] I just can't can't believe as a father of four that that it was
[25:58] ever in the course. But he did say great, some great
[26:00] things streamlining at least the idea of streamlining clinical
[26:03] trials, the rare diseases, but I spoke to it reducing animal
[26:07] testing, bringing in some, you know, the plausible mechanism
[26:12] idea for one arm or single arm trials and faster trials.
[26:16] And of course, this new streamlining of trials, which
[26:19] was quite important. So I'd love to hear from you all
[26:23] with regards to how you think this is going to play out,
[26:25] because it just increases. It's a little bit like the
[26:27] leadership contest in the UK government.
[26:30] It just creates uncertainty. Now who's going to be in charge?
[26:33] We do have somebody, Kyle Diamantes, who's in charge, and
[26:37] apparently he's a reasonably straight person in terms of how
[26:44] he's been engaging with folks at the FDA.
[26:48] So Josh, you're unmuted. So I'm going to pass it on to
[26:52] you. That's the selection criteria.
[26:56] I'll take it. It's interesting, right, Because
[27:01] what you read in in the press is a little hard to interpret,
[27:06] right? Like was this him not following
[27:09] all of RFK Junior's, you know, whims and and and and and
[27:15] beliefs and and views? And in which case, you know, why
[27:18] would we expect anyone better than Mccary to come in to to
[27:23] lead the agency if they still have to report and kowtow to RFK
[27:26] Junior? Which, you know, is, is probably
[27:30] where, where all of the problems for the most part, start, start
[27:33] and finish. And even there, the frustrating
[27:35] part is that some of his some of his ideas are, are actually very
[27:39] thoughtful, good ideas. Others are seem to be more whims
[27:43] and, and, and paranoia than actual scientific merit.
[27:47] And then you almost have to go through on a case by case basis
[27:49] and figure out which is which. So on the other hand, there's
[27:53] also reports that maybe the White House is playing a more
[27:57] heavy-handed role in choosing FDA leadership, recognizing that
[28:02] with the midterms coming up, some of the healthcare policy
[28:05] may actually be be working against them.
[28:08] So they kind of have to marginalized RFK junior to stay
[28:12] in control the House right. So so depending on which one of
[28:15] those you you're going to follow that it either points to really
[28:19] starting to stabilize the agency with new credentialed leadership
[28:23] tests to saw that I think we all saw that no patient left behind
[28:27] advocacy for to bring back pastors as head of Cedar ahead
[28:33] of the FDA. I should say, you know, and if
[28:35] we can start to, you know, regroup and re re able the FDA
[28:42] with the right people in the right seats, then that should be
[28:45] a very good thing. But if we go down this path of
[28:47] of more enablement of of, you know, anti scientific winds
[28:52] etcetera, that's not a good thing.
[28:56] We, we've kind of also debated like what, what was it that
[29:00] Mccary did wrong that got him in such hot water?
[29:05] Like like even the same with Vinay Prasad.
[29:08] Like their decision making process for many of these drug
[29:12] approvals were relatively sound, right?
[29:15] And so do we want someone who's just going to come in and
[29:19] approve everything no matter what?
[29:21] Do we want to go back to that framework that we had that we
[29:24] used to all complain about? How do you get the balance
[29:26] right? Or is it not even about any of
[29:28] this and it's really just about agency morale, which is
[29:31] obviously eroded substantially. So there's still a lot that we
[29:35] we don't know and, and we're just going to have to wait and
[29:38] see how it all plays out. How does this feed into your
[29:44] current? Or does it into your decision
[29:47] making whether how much you worry about this when you're
[29:51] making investments or not? I mean, I don't know if these
[29:53] short term issues impact your your processes at all.
[29:59] Well, for the most part, drugs are black and white, right?
[30:03] They they work and they should be approved.
[30:06] They don't work and they shouldn't be approved.
[30:07] But there are in in particular probably the drugs that go
[30:10] through C Burr more than C Durr because the just smaller patient
[30:15] populations, it's harder to generate the same amount of
[30:18] substantial evidence of efficacy and and safety that you do wind
[30:22] up in, in much more of a Gray zone, right.
[30:25] And and we have to align that Gray with the policy and the
[30:29] decision makers. And when when those policy and
[30:33] decision makers are changing, so does that Gray zone and its
[30:36] alignment with those, those drugs that haven't been
[30:39] definitively proven to work, that are often considered for
[30:43] accelerated approval, that are often judgement calls as to
[30:47] whether, you know, the data that a company's generated really
[30:50] does portend A meaningful clinical benefit.
[30:53] And so and you've seen it, you know, the sector has been
[30:56] incredibly volatile based on, you know, commentary and and
[31:00] leadership, particularly with Vinay Prasad as we're all trying
[31:03] to guess, you know, how is he going to look at, we're
[31:07] guessing, how is it going to look at the next data set?
[31:10] And then whoever comes in, we're going to have to go through the
[31:13] same process of aligning the Gray with the data and the unmet
[31:18] need. Right, right.
[31:20] Test Eric. I would say the change really
[31:25] impacts our, you know, investing not at all right.
[31:30] I think if, if anything, you know, the extent to which, you
[31:34] know, Macri was kind of in the news and, you know, being loud
[31:39] about what the FDA is doing probably worked, you know,
[31:43] against him more than for him. And I, I'd be, you know, kind of
[31:48] similar to to what Josh shared. Like, I think a lot of the
[31:52] approval decisions, like they ended up being decisions that
[31:54] like, hey, maybe they were, you know, they were hard.
[31:58] And I'm sure like not everyone agrees with, you know, all of
[32:01] the decisions he made, but they're also like
[32:03] understandable, right? Like the things that, you know,
[32:06] weren't approved are things that were, you know, where there was,
[32:11] you know, where there, where there really was, you know,
[32:14] debate about whether there's not the right, as, you know,
[32:17] evidentiary standard. I I would just highlight like
[32:20] another, you know, really important thing, which is like
[32:23] in February, you know, Kennedy announced like several
[32:29] appointments to his team that included Chris Clump, that
[32:34] included, you know, Kyle Diamantis, that included Grace
[32:37] Graham, John Brooks. These are like very, you know,
[32:44] these are credible people, right?
[32:46] And they're, you know, having a really important role in
[32:50] managing the FDA and, you know, managing succession.
[32:55] And I think that is that is really important and has, you
[32:59] know, I think contributed to, you know, some greater level of,
[33:05] of stability within the organization.
[33:07] That's that's really important. Despite, you know, despite the
[33:10] change with with Mccarry, you know, question will be like
[33:15] last. I think I, I don't think that
[33:19] the administration wants to turn this into a, you know, Senate
[33:24] confirmation hearing process that could, you know, distract
[33:28] from the midterms, right. So I, I think it'll be very
[33:32] interesting to see how that plays out.
[33:34] And you know, good news. There's some excellent
[33:37] candidates, you know, Rick Pastor certainly as, as NPLP
[33:41] headed highlighted in the letter, but there's, there's
[33:43] others as well. And, you know, I think the
[33:48] prospect of a, you know, very contentious, you know,
[33:53] confirmation hearing, you know, it's probably it's probably not
[33:56] one that the administration really wants to pick right now.
[34:00] I may regret saying that, but at least maybe that is, you know,
[34:06] maybe that is my hope, you know, which would suggest like a
[34:10] candidate who is, you know, not going to be not going to be
[34:14] extremely controversial. Right.
[34:16] Eric, do you want to add anything before we move on?
[34:18] Well, just quickly, thank you. Look, I think nobody's going to
[34:23] miss Doctor Makari. That's pretty clear.
[34:24] And maybe Josh is right. Maybe it's a higher level issue
[34:27] with HHS that, you know, we're we're all bemoaning here.
[34:31] But but let's be clear, he didn't do anything as
[34:34] commissioner that he was supposed to be doing.
[34:36] And when we're talking about, you know, an NFA commissioner
[34:39] making decisions about different drugs or raising or lowering the
[34:43] bar to approvals, that's not what we should be talking about.
[34:46] We shouldn't have a guy go on CNBC and talk about Unicure or
[34:50] Replymune or any of that stuff. The job of the commissioner is
[34:54] to support the review staff, to protect the agency from
[34:57] political intervention, and to advocate for a stronger FDA and
[35:02] be a leader. And he did none of that, as far
[35:05] as I can tell. So I just hope whoever comes to
[35:09] lead this agency going forward kind of reverts back to what
[35:13] traditionally has been the job of the FDA commissioner, which
[35:16] is to run the organization, not to decide FDA review decisions.
[35:21] I love the fact that you guys are literally offices next to
[35:24] each other and you have so interestingly not massively
[35:28] different but quite different views on on all this sort of
[35:31] stuff, especially when it comes to the.
[35:33] Regular. Well, that's just because I'm
[35:34] always right. So actually test, given that
[35:39] we're talking about this, we just had some data now moving on
[35:42] to the company news and data conversations we're going to
[35:45] have from Regenix bio what seemed like at least, you know,
[35:50] a phase three trial that worked out.
[35:51] They, they talked about the percentage of muscle fibers that
[35:54] had expression of micro dystrophin, etcetera, etcetera.
[35:57] But we're not going to file because we don't know who's
[36:01] going to be looking at our file, which is a direct result now or
[36:05] potentially of what's going on at the FDA.
[36:07] Do you want to take that? Tell us about the data?
[36:09] And is that something, I mean, the share price was down.
[36:12] Was it because of this or was it because of the, I don't know,
[36:16] the news folks seem to have latched onto 2 side effects,
[36:19] which the company appears to say was manageable.
[36:22] Over to you, Tess. Thank you.
[36:26] This was a very, this was a very interesting 1.
[36:29] So indeed, they came out with data where they met their
[36:33] primary endpoint, right. And you know, they said they
[36:36] were preparing for potential for accelerated approval in 2027.
[36:42] And what they showed is they showed a correlation in nine
[36:47] patients between, you know, you know, between essentially 2
[36:55] scores. So they were showing, you know,
[36:57] correlation between microdistophrine expression and
[37:01] then NSAA, which is the functional, you know, functional
[37:05] endpoint in DMD. And their argument is that, hey,
[37:10] these can serve as strong evidence for accelerated
[37:14] approval. Now they do have more patients,
[37:18] right? So this is, you know, this is 9
[37:20] patients. I think they have, you know, I
[37:22] think they, they will have 30 or so in the PR.
[37:25] And so I think there was some questions about, well, how about
[37:28] everyone else? And you know, what's what's
[37:31] going on with them and, and what would the full, you know, what
[37:34] would the full data package, you know, what would the full data
[37:37] package look like? And then I think there was, you
[37:41] know, a lot of, you know, just discussing about, you know,
[37:45] well, how is the FDA going to be thinking about this?
[37:48] You know, how you know, how about these side effects, you
[37:52] know, what does what does this mean?
[37:54] But you know, I think also just questions about what the, you
[37:58] know, what the complete, you know, what the complete data set
[38:01] would be. They also shared, like when
[38:03] talking about messaging for the FDA, you know, 1.1 key point was
[38:09] on this correlation with clinical outcomes, right?
[38:11] And so they said, OK, well, we've shown that, right?
[38:14] We've shown that with the 9 patients.
[38:16] But it's like, yeah, but like what about the other, like, you
[38:19] know, 20, right? Are you going to show it with
[38:21] the other 20? So like that's one kind of key
[38:24] point of uncertainty. And then, you know, there's this
[38:29] question of like, well, is the FDA going to recommend a
[38:32] randomized controlled, you know, trial or are external controls
[38:37] going to be sufficient? And together with some, you
[38:41] know, FDA uncertainty, you know, I think that, you know, they're,
[38:46] they're probably a lot of investors that are not maybe not
[38:49] willing to give the benefit of the doubt and want to have more
[38:53] certainty on the path forward. And probably, you know, want to
[38:56] want to see a more complete data set, you know, before they
[39:00] really start giving a lot of credit for accelerated approval
[39:04] here. Very, you know, interested in
[39:07] any other interpretations, interpretations of the, of the
[39:10] data. I think, you know, certainly,
[39:13] you know, strong on the correlation, you know, point
[39:16] strong data with the nine so far.
[39:17] But you know, I think many investors are, are simply
[39:20] interpreting that as you know, hey, you know, strong data on
[39:24] the 9 patients. Maybe need to see a bit more.
[39:27] Maybe need to understand the side effects in a bit more
[39:29] context. Understand the regulatory path
[39:32] you know before you know, before giving credit for accelerated
[39:36] approval. And I guess what makes this so
[39:39] tricky is that Levitus is approved.
[39:43] So how do you not approve this too?
[39:47] And should, well, should Levitus ever have been approved in the
[39:50] 1st place? And back when the FDA was really
[39:53] like really functional, we heard them talk and opine a lot about
[39:56] setting precedent, right? Concern about setting precedent
[40:00] because if you approve one thing, then all of a sudden.
[40:02] You're almost locked into, into approving, you know, things like
[40:06] it that still may or may not work.
[40:08] And so, you know, it looks relative to Levitus like a
[40:12] promising drug. But does that mean it's a
[40:14] promising drug for, for Duchesne's?
[40:16] But we're, we, we got boxed in from a drug approval that
[40:20] probably shouldn't have happened in the 1st place.
[40:22] And you know, again, now here we are criticizing the FDA for not
[40:25] approving everything while we're literally dealing with the
[40:28] consequences of what happens when you do.
[40:32] You know, there's another point here which is solid bio is, is
[40:35] coming solid bio, at least according to our analyst Kristen
[40:38] Kluska that follows a space may have an even superior construct
[40:42] with superior data. I know, I know that the solid
[40:45] bio drug has shown some reductions in CK, which I find
[40:48] to be a very important objective biomarker.
[40:50] I don't, I don't think we've seen that from Virgin X bio yet,
[40:52] but you know, they're they're probably going to be there too
[40:56] with maybe even somewhat better data.
[40:58] So where do you draw that that line?
[41:00] It's almost like we're we're getting boxed in from not just
[41:02] one side, but maybe multiple angles here.
[41:05] So it just makes you wonder whether that original, on the
[41:08] one hand, the elevators approval obviously enticed people to
[41:12] continue to invest and and continue to develop drugs.
[41:15] That's one of the arguments the regulators, at least at the time
[41:18] made, on the other hand, is created this now in with
[41:23] hindsight, this, I don't know what you want to call it a
[41:26] vacuum or a difficulty or a hurdle or a bar for people to
[41:29] try and get over. So pity.
[41:33] I hope that at some point the best drug for these young, often
[41:37] very young patients, boys, gets over the line because they need
[41:43] it right. So I think in the middle of all
[41:46] this, we mustn't forget that there are these patients that
[41:51] are that are potentially losing out if there is a good drug out
[41:55] there that's not making it through.
[41:57] So and actually, Eric, you were the last one to have the MIC.
[42:01] So I'm going to pass it back on to you Talk about Biogen's Tau
[42:04] data, which has been a favorite of mine instead of amyloid in
[42:08] the in the Alzheimer's space. But maybe set the scene a little
[42:12] bit about what's the difference between town and amyloid time
[42:15] wise impact or disease and then tell us what happened and what
[42:18] your view on the data is. Please over.
[42:21] Well, I'll be really quick on the background here, Sam,
[42:23] because I think this is a juicy topic, certainly one that was
[42:26] debated to great degree on Wall Street this week.
[42:29] And I'd love to hear your view, Tessa's view, Josh's view on
[42:32] whether Biogen's making the right decision here.
[42:34] But in essence, they've got an anti an anti censolago ASO
[42:37] called Bib 80. It's now shown in both the phase
[42:41] one study and, and just this week in a phase two study that
[42:44] has the ability to reduce Tau not just in the CFS, but in PET
[42:49] imaging as well. So the drug is working as it's
[42:51] designed. And for the first time ever,
[42:54] they're starting to show at least in smaller phase two
[42:56] studies. And to the extent that you can
[42:58] show anything in a small phase two Alzheimer's study, they're
[43:01] starting to show some potential improvements in terms of slowing
[43:07] of disease progression, improved cognition relative to controls.
[43:12] I say potentially showing that because again, we've all been
[43:15] misled by early stage Alzheimer's drugs in the past
[43:18] and there's so much PTSD around this whole situation that I, I
[43:22] know we're going to talk about in a moment.
[43:25] Despite missing the prospectively identified primary
[43:28] endpoint, which was having to do with those responsiveness.
[43:31] So I agents made the decision to move into a phase 3 and that's
[43:35] kind of where the funds started yesterday.
[43:37] And, and a lot of the debate and discussion arose from.
[43:41] And this company has been telling us for three or four
[43:44] years now post at Canamab that it's not going to take big
[43:48] aggressive risky bets in their gender disease.
[43:50] That's moving into I and I that there's a better return on
[43:54] invested capital in, in moving to more easy to de risk, yet
[43:59] still high value programs. And at the first sign that
[44:03] they've got maybe something interesting from a phase two
[44:06] study on a novel endpoint, we're back to, you know, potentially
[44:11] something that's that's, that's much, much different in terms of
[44:15] the risk quotient. So I, I've had a tough time
[44:18] honestly trying to swallow that and, and come to grips with
[44:22] that. And of course, we haven't seen
[44:24] any data yet that will be presented next month at the the
[44:27] Alzheimer's conference. But you know, it's, it's a big,
[44:31] it's a big shift or a big veering to the right for this
[44:34] company. And I don't know, not everyone
[44:37] is is comfortable with it. Was to take that next test or if
[44:43] there's anything. Yeah, I think, I think we'll, I
[44:46] mean, the, the drug is, is clearly having an impact on Tau.
[44:49] Whether Tau reduction will have an impact on the disease is
[44:53] still unknown. So I think we'll we'll know in
[44:57] maybe four years, right, or, or something like that.
[45:01] I think there were a lot of groups hoping that this was
[45:04] going to unlock a lot more work in this space, right.
[45:09] We've seen incredible progress on blood brain barrier shuttles
[45:14] and, you know, kind of shuttle efficiency and how much drug you
[45:18] can get into the brain. And like, oh, like, wouldn't
[45:20] this be another great target to, you know, be able to, you know,
[45:25] apply that technology to. And I think we're just, I think
[45:29] we're just not going to know until you know a, a face, you
[45:32] know, the, the, the, the Phase 3 results.
[45:36] Yeah, Eric, Eric's note on this was one of my favorite notes
[45:39] I've I've read in a long time. Just so, so blunt and to the
[45:42] point. Biogen's seems to be a moth to a
[45:45] flame when it comes to Alzheimer's, despite getting
[45:48] burned multiple times by that same flame, which is
[45:50] interesting. The only other thing I'd add is
[45:52] that, you know, at the end of the day, biotech companies that
[45:56] are lucky enough to get drugs approved and become profitable
[45:59] are, are now businesses. And as such, what at least in my
[46:04] view, the the right strategy for these companies is for the risk
[46:09] tolerance in terms of innovation and capital allocation to fall
[46:13] substantially and act more like businesses really thinking about
[46:17] driving top and bottom line growth without excessive risk,
[46:21] without wasting excessive capital.
[46:24] And and that many of these companies are just kind of stuck
[46:27] in the we're, we're biotech companies, we spend a lot, we
[46:30] take risk, We're not, we're not thinking like a real business.
[46:33] And then they do so at not only their own peril, but the peril
[46:36] of the industry in general. Yeah.
[46:39] I mean, look, the thing I would add here is that this is not the
[46:43] same management team that made the initial decision with
[46:48] regards to add to help, right? So what I'm, and I hear you
[46:53] saying that or your point about the fact that they were talking
[46:57] about INI etcetera. I mean, I could be flippant to
[46:59] say that Alzheimer's disease is, is potentially an immune
[47:02] disease, but that's not that, that that put that aside.
[47:06] It is a novel mechanism. It is one that has probably, in
[47:11] my view at least, more scientific rigor behind it as a
[47:15] causative agent in the disease process.
[47:18] The timing is a tougher 1 here with regards to when Tau comes
[47:21] on because it's very proximal to to the start of symptoms.
[47:24] But we'll see what the data shows.
[47:26] And you know, I don't cover Biogen, One of my other
[47:29] colleagues does Still, again, it's a disease.
[47:33] Perhaps that's why this the, this moth keeps going back to
[47:37] that flame, Josh, the fact that there's such a massive demand
[47:41] for it at the end of the day, right?
[47:44] So if you get it right, you're going to be in the remember
[47:49] possibly in the same ballpark as an obesity product potentially.
[47:53] I don't know. I mean just just a commentary
[47:55] there right now. Back to Eric again, perhaps yes,
[48:00] to talk about Inhibrx, we had some data, some machinations
[48:04] there. This is a company who who have,
[48:07] I love these stories, as I've said several times before, in in
[48:10] the world of biotech where stock that was trading at $10.84 at
[48:14] one point in the past month or so was 14X higher.
[48:20] So it's like a, a Lazarus, a, a phoenix rising from the ashes.
[48:25] But tell us how much of A phoenix it is, Eric, in terms of
[48:29] the dates that we saw in head and neck?
[48:34] Yeah. Let's see.
[48:36] So where do we start? They've got an OX40 agonist and
[48:40] we've had some experience with OX40 drugs before in the past.
[48:43] We've had a lot of experience with novel IO drugs in the past
[48:46] and they haven't really transpired into much tangible
[48:52] benefits. There's a good phase to study
[48:55] here. So give give the folks in the
[48:57] networks credit. They've done a a randomized
[48:59] controlled phase to study and head neck cancer randomized to
[49:03] Keytruda and they doubled the response rate.
[49:06] So that's not bad. The numbers are still, you know
[49:10] a little small responses in head neck cancer are a little
[49:15] ephemeral and that they don't always correlate with stronger
[49:19] endpoints like PFS and Nos. So we still have a ways to go
[49:22] here. And maybe you know, from my
[49:24] standpoint, most importantly, we we've now gotten to a, a next
[49:28] level of drug development and head neck where we have
[49:30] companies like Maris, which was acquired by Genmab and their
[49:34] drug Pitacentamab and also by Cara which is developing a drug
[49:38] called Fycerafas that are more than doubling response rates
[49:42] relative to Keytruda. So the bar is going up
[49:44] substantially and head and neck and, and it's nice to see yet
[49:48] another mechanism and yet another positive phase two
[49:50] study. But relative to some of those
[49:53] other candidates, they're even much more advanced now.
[49:56] Both American and by car drugs are in deep into phase threes.
[50:01] I just don't know what to do with the inhiberex.
[50:04] So you're right, Sam, it's had a nice little rise.
[50:07] Phoenix from the ashes. That's always nice and wonderful
[50:09] to see. I don't know what the next steps
[50:11] are to be honest. Yeah.
[50:13] I mean, look, so the sort of things that we want to look at
[50:16] is follow up. We don't know how long the
[50:18] follow up was. So maybe with further follow up,
[50:22] the responses could deepen. We'll see.
[50:26] I would be interested to see the HPV stratification too because
[50:29] there could be an edge there. But at the minute to our eyes,
[50:34] it looks potentially from a time perspective, but also from a
[50:39] from a data perspective. So far, as I said, there's a lot
[50:42] more to be known less competitive than the GFR drugs
[50:46] at this stage. So let's wait and see how that
[50:47] comes out, but. Just on the topic of.
[50:51] Go, go ahead, Josh. Yeah, Just going to say, just
[50:54] just to give them credit, they're a San Diego biotech
[50:57] company and really wonderful people there, you know, for
[51:00] their DR5 agonist and chondrosarcoma, which showed a
[51:03] very dramatic PFS benefit in a full proper random, large
[51:07] randomized control trial leveraging their kind of protein
[51:10] engineering expertise. So you know, Dr. 5 is a very
[51:14] challenging target that they were able to crack.
[51:17] So as we think about the the aux 40 data, it's a hex valence very
[51:22] different approach, a little number of the other aux 40
[51:24] agonists out there. I think just having a little bit
[51:27] of that perspective and acknowledgement that at least
[51:30] with one hard target, you know they were really able to get it
[51:33] to work. And by the way on the DR5 data,
[51:37] fairly low response rate, but turned out to have a very
[51:41] meaningful PFS benefit. So there is a little bit of
[51:43] context I think relevant to interpret the aux 40 data.
[51:46] Absolutely right. That's the PFS data that we're,
[51:49] I think they indicated it's coming at ESMO, which of course
[51:51] I will be there. And of course San Diego, one of
[51:54] my favorite cities in the United States.
[51:56] So that that's that's an additional positive.
[51:59] And I just wanted to quickly touch on Moderna story.
[52:04] This week we had A and the hantavirus.
[52:07] I just want to hark back to the days when I couldn't talk about
[52:11] anything but COVID, which of course is gone and are my, are
[52:14] my colleagues in Bloomberg media and news always call on me when
[52:17] there's pain and misery in the world, which is this was the
[52:20] hantavirus outbreak of this cruise ship.
[52:25] And the company, they said what was going on, which is that they
[52:31] are working with in collaboration with somebody on a
[52:33] hantavirus vaccine share price popped.
[52:37] I even had some professional investors asking me, you know,
[52:41] what is it do? Do we need a vaccine?
[52:43] When can we get a vaccine? When is the vaccine about?
[52:45] And I'm thinking, wow, this thing is so far from being
[52:49] eligible for causing a pandemic. But of course, it's a virus.
[52:53] It does mutate. It does cause issues if you get
[52:55] into enough people allow it to jump from person to person, but
[52:59] it's very hard for it to jump from person to person.
[53:02] So it was interesting to see that.
[53:04] And now I think Moderna has kind of given up some of those gains
[53:08] and we're back to the story of when we're going to get the data
[53:11] for the Melanoma vaccine that they're developing or or
[53:16] individualized new antigen therapy that that we're going to
[53:20] get and that's sometime potentially next this year.
[53:22] And that is what the driving story here is.
[53:25] So what was also interesting was and none of the other mRNA
[53:30] companies, which of course are, is the technology to deal with
[53:33] when it comes to wanting to be prepared for a next pandemic or
[53:40] another awful virus to hit this. The, the, the, which is the last
[53:44] thing we need in the middle of everything else we're dealing
[53:46] with. And that never goes away.
[53:49] That is the right technology to be going to be using and it's
[53:52] the easiest and most rapid to to scale up and do so.
[53:55] I'm assuming it's not unfair to say there has to be some value
[53:59] ascribed to that as as long as the regulators and and
[54:04] healthcare bodies don't keep trashing the technology.
[54:08] So time will tell. So that was that story.
[54:11] Now for the rest of the call. If everybody's OK, we just want
[54:15] to, we've only got about 5 minutes left.
[54:17] Ask was coming up, we're going to be enjoying the abstracts
[54:22] released on the 21st. So does anybody want to pick one
[54:27] thing that they're super excited by and they're looking for
[54:30] excited by not necessarily if the data would be superb, but
[54:33] that you really excited to see the data.
[54:36] I'm going to go to Josh 1st and you can you can do a hospital
[54:40] pass to Eric if you want. Oh, I pride myself on spending
[54:45] fairly little time in oncology because it is so hard to get
[54:49] ahead of anything and and invest around.
[54:52] So I don't really have much exposure to ask about Eric.
[54:54] So, Eric? Yeah, well, those of us who are
[54:58] a little bit more intellectually inclined, we like looking at
[55:01] data and trying to parse out the competitive landscapes.
[55:06] So I don't know, Sam, I guess we're all keen to see the the
[55:09] some of Harmony 6 results, right?
[55:12] This will be the survival data from a frontline study.
[55:15] It's being done in China and it's certainly not going to be
[55:18] the the ultimate arbitrator where the drug works.
[55:21] We still need to wait for Harmony 3 and the global readout
[55:24] later this year for that. But certainly there'll be a lot
[55:28] of interest in in whether in addition to the very strong PFS
[55:31] benefit we saw for ivanescamab and frontline lung cancer, we
[55:35] may also see a strong survival benefit.
[55:39] Yeah, yeah. And then of course, we've got
[55:41] the pancreatic data from Evolution Medicines coming.
[55:44] There are a whole bunch of companies snapping at their
[55:47] heels, but you know, they have a good drug from an efficacy
[55:51] perspective. People can raise issues with the
[55:54] side effect profile, but this is this is an awful cancer and you
[55:57] have to keep keep the remembering that, which is
[56:00] something that comes up in other mechanisms of action like PRMT 5
[56:04] seems to be one that keep people keep going on about that.
[56:07] It causes infections, but you know, a lot of the drugs cause a
[56:10] neutropenia, which is not as a lymphopenia and all sorts of
[56:14] issues. So and we've also got some data
[56:16] coming for re prevent in head and neck cancer OS data.
[56:22] So that's what we're looking forward.
[56:23] And maybe if that OS data looks really competitive with the bar
[56:27] that's set by Gen. maps Pito, then maybe people will start
[56:32] thinking a little bit more about perhaps the first line could
[56:36] also be good, although the data didn't look that great that we
[56:38] saw in the phase 2:00-ish arena. And there's a bunch of myeloma
[56:43] data coming out, which of course, again, and remember,
[56:46] myeloma is one of those diseases that keeps going through
[56:50] revolutions, right? We had the image and then we had
[56:54] the Darzalex City 38 and then we have Carvick T and the and then
[56:59] by specifics. And so here we've got some
[57:03] combination data that's coming out that we're looking for
[57:05] forward to which of course will also be at E ha, there's more
[57:09] there. So monumental 3 from Johnson and
[57:11] Johnson who seems to be leading and owning this space.
[57:17] And then we have ADA quickly, is it just should it not be called
[57:23] ADBA or ADOA? So associate, I can't remember
[57:28] now American Diabetes and Obesity Association, right,
[57:32] We've got a bunch of data coming out there.
[57:34] My colleague Mike Shaw is really keen to see the data for
[57:39] especially the for the first view of Astrazeneca's oral GOP 1
[57:44] is coming out there. Let's see what that looks like
[57:47] and retracted side, which of course the detailed date is
[57:49] going to be there. That's going to be fun to see.
[57:53] And lastly, we have ATS coming now.
[57:57] Does anyone want to highlight one or two things that they're
[58:00] excited about at ATS? American Thoracic used to be a
[58:04] conference where I used to go and then after a while I think I
[58:07] started thinking why am I going? Because it was all about llamas
[58:10] and lavas and, and, and any was combinations and, and now of
[58:15] course, the world's changed. We have all these biologics.
[58:18] So tests, you want to take a stab at that or Eric or Josh
[58:22] given that it's not oncology well?
[58:28] I guess I'm just going to pick up for the, the the less
[58:33] intellectual of us Eric, the non oncology space.
[58:40] I wasn't putting you in Josh's fucking test, just to be clear,
[58:43] Josh. Has his own special place.
[58:48] So, yeah, so I think, you know, they'll be there should be some
[58:51] interesting, you know, data coming in IPF that we'll be that
[58:56] we'll be looking at that will give an understanding of some
[58:59] different, you know some different combinations.
[59:03] And we have data from AstraZeneca, you know, a drug
[59:09] that AstraZeneca has been developing, which is an Illinois
[59:12] 33 where the abstracts looked pretty interesting.
[59:17] So this is a drug called tozurakamab and this is an IL
[59:21] 33. You know, I think everyone
[59:25] probably recalls it a pekamab that Santa Fe had been
[59:28] developing that, you know, disappointed, you know,
[59:31] disappointed a year ago or so. And, you know, Santa Fe had
[59:37] shared that COVID was a big part of that.
[59:40] And, you know, I think there was, there's still some, some
[59:45] debate about it, but it was certainly very encouraging to
[59:47] see the, the, some of the TOZO data in the abstract.
[59:50] So a lot happening now in COPD and asthma and other respiratory
[59:56] diseases. And it's great to be following,
[1:00:00] you know, some of these, you know, some of these new targets
[1:00:04] and, and target combinations as they get unearthed.
[1:00:07] Yeah, that tested feels like it's going down the same Rd. as
[1:00:11] as psoriasis and and and RA and and and some of these other
[1:00:18] ionized spaces. So maybe I'll start going back
[1:00:22] to ATS again and and have some intellectual stimulation.
[1:00:26] I'll just, I'll just test quickly.
[1:00:28] Defend yourself a bit and. Then you'll just have to have
[1:00:30] Eric do it. Oh, no, no, I I'm not defending
[1:00:33] myself. Eric is the intellectual.
[1:00:34] I just focus more on generating strong returns for a portfolio.
[1:00:38] So when it comes to to IPF, one thing I would flag there's
[1:00:42] again, San Diego company Endeavour, John Hood, one of the
[1:00:46] legends of bio innovation. Here's the CEO.
[1:00:48] They're showing some really incredible data.
[1:00:50] And if you're looking at IPF at all, you have to look at fluid a
[1:00:53] scans because it is probably the, the, the best signal of of
[1:00:58] a real anti fibrotic effect is with the fluid of scans.
[1:01:01] Then there's also some interesting drug delivery
[1:01:04] technology that's, that's come along as well.
[1:01:06] That's quite interesting. So there are there are other
[1:01:08] things happening in the rest, but I think you're quite
[1:01:10] fascinated. Right, so we need to end here.
[1:01:14] All three of the Co hosts are absolutely brilliant.
[1:01:17] They're all super intelligent, which is why they're on here.

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