Ep. 370 - Calmer waters for FDA; Servier, Lilly deals

FDA’s new leadership is sailing the agency into calmer waters amid a search for a permanent commissioner and permanent center directors. On the latest BioCentury This Week podcast, BioCentury Washington Editor Steve Usdin discusses how FDA’s new, interim leaders have changed the tone at the agency and why they are putting medicines derailed under former FDA Commissioner Marty Makary back on track. Usdin also highlights FDA’s new real-time clinical trials initiative.
BioCentury’s analysts then turn to deals, including an analysis of the 20 deals Eli Lilly has done this year; Servier’s move to expand in neurology via BD; and Monday’s billion-dollar deals by Incyte, which will acquire Vega Therapeutics, and Johnson & Johnson, which is buying Firefly Bio.
The team also discusses Grand Rounds U.S., held last week in Seattle, including the conference’s Rising Star prize winner Sylvain Simon of Fred Hutchinson Cancer Center.

View full story: https://www.biocentury.com/article/659699

#FDA #BiopharmaDeals #ClinicalTrials #BiotechMA #GrandRoundsUS

01:23 - Grand Rounds Seattle Takeaways
04:43 - FDA's New Leaders
11:48 - FDA's Real Time Trials Pilot
20:40 - Servier Bets on Neuro
25:33 - Lilly's Deal Spree
30:21 - Dealmaking Roundup

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

Transcript

0:00

[Autogenerated Transcript]

Jeff Cranmer: 0:01

FDA's new leadership is rowing the agency into calmer waters as it seeks a permanent commissioner and permanent center directors. We'll check in with Washington Editor Steve Usdin on the latest as FDA enters a new phase. Also on the BioCentury This Week podcast, FDA's real-time clinical trials initiative may have real but unexpected benefits. Meanwhile, in deal land, Servier continues its M&A build-out. It's acquiring Edgewise's neuro programs as it seeks to add a new pillar to its pipeline. That was one of several billion-dollar-plus deals in biopharma over the past few days. We'll have a look at the latest in biopharma dealmaking and check in with the 900-pound gorilla in biotech deals, Eli Lilly. I'm Jeff Cranmer, Executive Editor at BioCentury and host of the BioCentury This Week podcast. Joining me, our Editor in Chief, Simone Fishburn, our man in the UK, Stephen Hansen, and of course, Steve Usdin. welcome to the show, guys. Gonna start off with Simone, back from Seattle. Simone how was your time up in the PNW?

Simone Fishburn: 1:31

So actually, Jeff, would you like to hear my new theory about Seattle, which I got about, I told about 10 people this, and they all agreed with me. So Seattle really wants to be part of Canada. It doesn't really wanna be part of the US. I'm just saying because everybody in Seattle doesn't really live there. They live in these little islands around, and they all take little boats or planes to get into Seattle. I don't think they like Americans so much. I think they like Canadians, and they're all kinda like Canadian nice in July. I'm just saying that great place, but

Jeff Cranmer: 2:03

soggy

Simone Fishburn: 2:03

also… Yeah, I also wanna say that your um your Cascadia idea, got a lot of momentum there,

Jeff Cranmer: 2:11

it's true. Uh, I uh continue to be a proponent of Cascadia bringing together Alaska, British Columbia, Washington State, Oregon, California, and we'll even throw on uh Baja because, you know, who doesn't like those beaches down near Cabo?

Stephen Hansen: 2:29

That's a lot of coast.

Jeff Cranmer: 2:30

I like it.

Simone Fishburn: 2:30

Right. the uh when the AI bots take over or some other event. But yeah, no, I mean, Grand Rounds was a huge success, and now we're very excited about Amsterdam in the fall. But you know, we have a podcast coming out later this week. there were a few highlight sessions, you know, for me. I, I get the pleasure of a fireside chat with Chris Arendt, who's the CSO of Takeda, really talking about how that company is imbuing it, like really working with AI throughout, and that was a very interesting take he had. And another panel is a topic we're gonna talk a lot about, which is first-in-human trials. And one of the issues, comes up between if you want to expedite them, how much the universities themselves can do, like, improving the IRB process and reducing certain amount of back and forth, a lot of issues around protocol amendments. And there's a certain amount that requires sort of FDA or, or regulatory change. One of the interesting things is, you know, there's all this talk about AI, and it feels like there has been for a long while, but actually the AI conversation is changing massively and so fast. Even within six months, I mean, if we all think where we were six months ago, I don't think we're all using Claude and really integrating it, in our daily work. And so the AI fluency is just growing up so fast, and staying ahead of that is pretty interesting.

Jeff Cranmer: 4:00

Just don't tell Ronnie Chieng. He gave his fabulous Harvard commencement address and called upon uh Harvard's recent graduates to uh destroy AI

Simone Fishburn: 4:11

they may need to go to Claude and ask how to do that

Jeff Cranmer: 4:15

Excellent. And we also had the Rising Star winner at Grand Rounds Sylvain Simon out of Fred Hutch with a synthetic chimeric T cell receptor. you can read about that. our brilliant colleague Dr. Danielle Golovin wrote about it. It's in front of the paywall. I'll drop a link into the show notes so you can read about this new tech out of Fred Hutch. All right. Steve, another busy week for you in Washington. quite a few interesting meetings went down including one with the new FDA commissioner doing his first official meeting uh and it was with the rare disease community. What went down?

Steve Usdin: 5:01

Acting FDA commissioner.

Jeff Cranmer: 5:03

Oh, I shouldn't get ahead of myself.

Steve Usdin: 5:05

yeah, yeah. Uh uh and that's interesting actually. There, you know, there's some momentum, some people are saying, "Well, why not make him the commissioner?" I, I don't think that he will. Um, I don't think that that's gonna happen for a variety of reasons. Look, there, there's a sense at FDA that with Makary's exit, kind of a fever is broken, right? It started that with the, the DOGE destruction, and it kind of peaked with a memo that Vinay Prasad sent to sta- f- outlining his intention to substitute ideology for science in the regulation of vaccines and other products along with the resignation of Rick Pazdur as CDER director and appointment of Tracy Beth Høeg to succeed him on an acting basis. So now it feels like all of that's kind of a long time ago, even though it really wasn't. And acting FDA Commissioner Kyle Diamantas i- is really trying to row the agency back into calmer waters. And one of his most public steps was this June 3 meeting with rare disease patient advocates. It was a closed-door meeting but there were representatives from 15 groups there. Um, they, they all came out of it talking to me and uh and other reporters. The acting CDER director was there, the acting CBER director was there, other agency leaders were there. The discussion was facilitated by Amy Rick, who's head of the Rare Disease hub. And the people who I spoke with who attended the meeting came away with the sense that FDA really wants, one, to mend its relationship with the rare disease community, and two, to rebuild trust. A big part of that is gonna be going back to more regular ways of doing things which is really based on supporting the work of career scientists and abandoning the top-down approach um that Makary and Prasad applied to FDA. The thing about that is that, you know, FDA wasn't perfect before the DOGE and Makary started whacking it with a two-by-four. And so much leadership, so much institutional memory and talent has walked out the door It isn't gonna be possible to revert to where it was in twenty twenty-four. So part of the agency's leadership job now is, is sorting through the initiatives that Makary announced or started, many of which were well-intentioned, and figuring out how to implement them in ways that advance the agency's mission without causing inadvertent harm.

Simone Fishburn: 7:29

Steve, so, you know, there's, there's two parts of this and, you know, you're right. There's no going back. There's no point in trying to reinstate the FDA that was before Makary's time. So I guess it's, you know, one thing is, redesigning it going forward. You of course wrote most of back to school last year that actually addressed what it should look like. But there are some things that need to be done, and it looks like they are, some things are being undone. So you had a piece on CRLs, right? That had sort of thrown a lot of companies or a few companies into disarray, and are they getting back into array, shall we say? Can you talk a little bit about the CRLs?

Steve Usdin: 8:07

Yeah. So basically what I did is I looked at the really some of the unexpected setbacks that have happened, most of them have been CRLs. Um, there also been some that have been at earlier stages, but the CRLs are the most obvious ones. so I looked at them and I, and I looked and see which ones of those have been rolled back or seem to be getting back on track, right? And identified seven um CRLs that were issued under Makary that have either been reversed or the companies have had meetings with FDA and have come out of them saying that they think that they're gonna be back on track, that's pretty interesting. And then there's another about seven of them that are pending. They're, you know, that it's unclear exactly what's gonna happen with them, but I think that they're probably also being reevaluated. I know that all of the companies are engaged in discussions with FDA. and I wouldn't be surprised to see some of those roll back as well

Stephen Hansen: 9:07

Steve, I, just thinking about this now, I mean, we've seen numerous instances, right, in the past, say, 18 months or 16 months or however long it's been that Makary's been there, where companies were talking about how, you know, they had gotten advice from FDA or had discussions with FDA about trial design, about product, and sort of a way forward for, for a program that then changed drastically on them at the time. and it was, you know, all this, all this upset and, and, and issues came from that. Should companies now be thinking that if they had gotten advice, say, in 2024 or sort of pre-Makary advice, is that-- can you rely on that advice now again, do you think? Uh, is that something they can feel confident moving forward in? Or is there still concern there?

Steve Usdin: 9:52

No, there's still got to be concern, and I think that the fact that some of the things that were-- some of the CRLs are being reconsidered is definitely good for the patients who are- depending on those products. You know, of course, not all of them it's not necessarily the case that all of them were uh were inappropriate. But for those that were inappropriate, for those that were big uh diversions from FDA's path that, that it had been on, I, I think that the company's concerned, and certainly the patients who are gonna hope to benefit from those products feel like things are getting on a better path. it's not as clear what's happening with things that have less visibility, things that are earlier in the pipeline, and I think that that's where the problems stemming from FDA is losing a lot of institutional memory, from losing a lot of its leadership, from losing even the connective tissue that it needs to be able to evaluate submissions. But that's gonna be an ongoing overhang. It's gonna be an ongoing problem. I think that we'll have a lot better idea, everyone will, when we know who's the next FDA commissioner, and especially when we know uh what's happening with the center directors. You know, there's, there's a possibility that the acting center directors uh who are in place now, either one of, of them will be asked to stay on uh on a, in a permanent capacity, or it, it, it's also possible that there'll be new center directors appointed. The logical way to do that would be to do it after a commissioner has been nominated and confirmed so that so that they'll play a part in selecting the new center directors, but that isn't necessarily the way it's gonna happen. But in any case, I think we'll have a better answer to the question after we know who the next commissioner is, after we know who the next center directors are, and um kind of what the Trump administration's posture to FDA is gonna be for the remainder of the administration.

Jeff Cranmer: 11:47

All right, Steve. Well uh let's head over to the Real-Time Clinical Trials Initiative. Now, here's something that came up in the Makary regime, and it's sticking around. They're not getting rid of this one. It's making some big promises. you wrote that uh the initiative is looking to sweep away 60 years of tradition. What, what exactly did you mean by that?

Steve Usdin: 12:12

Well, no, what, what I said is what I meant to say, I think is what I said, is that when then Commissioner Makary announced it, he announced it like he did with a lot of things with these sweeping claims and, and assertions and saying that he was doing away with, you know, 60 years of tradition and everything was starting over new again You know, I don't think that that's really what's going to happen. And what, what is interesting about it is that I think that the parts that, you know, what I wrote, I call it the unglamorous data plumbing, you know, that, that part of the initiative probably is gonna be the clearest win from it, right? So it's essentially a multivariate experiment. One variable involves process improvements, and the other one changes the relationship between regulators and sponsors by turning trials into continuously supervised events. So the first part, the process improvements, which at least in the pilot stage lean heavily on work from Paradigm Health to automate clinical trials data are unambiguously beneficial. And I, and I think that they're beneficial for two reasons. One reason is that um Paradigm's got systems for for extracting data from routine clinical care and using it to, to create data for clinical trials that obviates the need for a tremendous amount of manual data input now. And the people who I spoke with said you really can't exaggerate how much benefit that's gonna be. it's gonna save tremendous amounts of time. It's gonna improve quality. But the other thing that's really interesting about this to me is, and the main thing I think, is that um for this real-time initiative, what FDA did was they said, "Well, instead of having companies submit massive amounts of data, raw data to FDA," which in some cases amounts to millions of pages by the time an NDA or BLA is submitted they're gonna submit signals. And in order to determine what those signals are, the companies, the sponsors and FDA are-- they're gonna meet in advance, and they're gonna define what would be actionable data, what would be actionable safety data, what would be actionable efficacy data from trials. and then we're gonna-- they're gonna report that in something like real time, and then FDA reviewers, if they want, will be able to ask for additional information. Well, the step of doing that is really, critical. It could be transformative because you're saying in advance, "Here's-- Here are the things that matter." And by the way, when you're saying that, you're also saying everything else, unless there's something, you know, completely, earth shaking that you hadn't anticipated, everything else probably doesn't matter. So you're making it possible to separate the signal from the noise at, at an early stage, and that's gonna have downstream effects for the whole the whole review. And I think that, that may be the most important aspect of this whole thing that's been underappreciated.

Simone Fishburn: 15:13

So Steve, from a bean counter point of view how are we gonna, like, not necessarily measure that impact, 'cause I, as a bean counter, I don't necessarily need to measure it precisely, but how's it gonna be evident? Will it be just faster reviews? What is the way that companies are gonna start kind of palpably feeling this?

Steve Usdin: 15:32

For one thing, it's important to note that the two proof of concept trials from um AbbVie and, and Amgen that are using this process are very small early stage trials. FDA is planning to expand it into a pilot phase with more, more companies conducting more trials, but they're also initially going to be early stage trials. So the, so the kinds of things when you say s- to speed up decision-making, the kinds of decisions that are gonna be accelerated It's not gonna be the final approvals at this point. What's gonna be accelerated are gonna be things like um dose escalation decisions or go, no-go decisions on going from one um from a Phase IIA or Phase IIB, for example. I think and personally, and this is kind of what I was trying to get at in my story, I think that the time savings there are not as important as the benefits to kind of clarity of thinking around changing from a mindset where companies are submitting massive amounts of raw data to one where they're identifying actionable signals and then communicating back and forth with FDA about those actionable signals. I think that's what's gonna be really important. So I think that the quality is gonna be more important than the quantity, than the speed.

Simone Fishburn: 16:52

I'm gonna argue on behalf of the companies, that is time, that's really important time-saving. Like, if you are getting that better information sooner and more reliably and so on, I think that's very palpably relevant to companies. I understand it's, you know, not necessarily… I think there are a lot of parts, this is, like, also the first inhuman conversation that we're gonna keep having. There's a lot of parts along the continuum that just, that aren't just around how fast did I get my approval after I got all the data there, right? And I think breaking down these bits, so I, I think that's really interesting

Steve Usdin: 17:24

Well, and part of it though, it remains to be seen whether it really will speed those decisions. But I think again, I think that the process improvements along the way are gonna have been worth it even if it doesn't speed those decisions. So that's really the really important thing here to, to, to take a look at. And I think it's a good example of what we're gonna see, getting back to the earlier conversation about what acting Commissioner Kyle Diamantas is trying to do and what I think other FDA leaders are trying to do, which is trying to take these ideas that have come up over the last year and a half, these initiatives that were announced, which honestly, we've talked about this on the podcast in the past, many of them were half-baked and were really announced more for their PR value than for their practical effects. It-- So now it's the time to kind of try to dig in and make these things work, and make these things work in ways that benefit patients, that benefit the companies that are developing drugs and advance FDA's mission. And I think this real-time clinical trial project or, or pilot is an example of how FDA is going to have to dig into these things and, and kind of pull out the parts that are really gonna benefit patients. And I think there's a similar reevaluation that's going on about what was formerly called the Commissioner's National Priority Voucher Program, which is um now the commissioner's n- uh, name has been stricken from it. But there's still an evaluation to see, well, what's really valuable there, if anything, and should it be re-retained? There's a similar discussion that's, that's ongoing in effort at FDA and in the rare disease community over the plausible mechanism framework and trying to figure out how to make that live up to the promise that advocates and FDA and biotech companies um really hope to achieve with it

Jeff Cranmer: 19:13

All right. Thanks for that update, Steve. Uh, we're gonna take a quick break, and we're gonna come back and talk deals.

Voice Talent: 19:20

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Jeff Cranmer: 20:31

We are back on the BioCentury This Week podcast. I'm Jeff Cranmer, Executive Editor here at BioCentury, and we've got Stephen Hansen with us to talk about the latest in billion-dollar biotech deals. we had a lot to kick off the year it felt like and into spring, and uh felt a little light lately, but uh good to see Servier ramping back up. they're paying uh north of a billion to accelerate its build-out in neuro. and it's buying a key asset from Edgewise actually well north of a billion, right, Stephen? Uh, one- 1.5 billion.

Stephen Hansen: 21:16

1.55

Jeff Cranmer: 21:18

Five, five. All right, cool. Well tell us about what they're getting and what they're trying to do?

Stephen Hansen: 21:23

Yeah, sure. Thanks, Jeff. Servier has uh the point I kind of want to make here is that they're, they're kind of taking and repeating a playbook that they've sort of already used. So Servier, this French sort of what I guess you might describe as a mid-sized private pharma company really wanted to get into cancer uh about six uh well, now eight years ago. So first thing they did is they went to Shire and they bought Shire's oncology business, which gave them one marketed product and a few to add to their pipeline. that was twenty eighteen. they then did a similar thing in twenty twenty. They bought uh Agios' cancer business for a couple billion dollars, which added some more products. And then most recently, earlier this year, they bought uh Day One Pharmaceuticals for even more, which gave them another marketed product. But that was the thing. In each case, they were adding both marketed products and some pipeline assets to add to that. And basically, they were able to go from having no presence in oncology and very little presence in the US to basically now having a pretty large commercial presence in the US. Uh, they've built out R&D there, along with this sort of big cancer pipeline that is now basically one of their biggest growth drivers. And so effectively, that's sort of like a second pillar for Servier on top of their more legacy cardiovascular programs. Now they're looking to neuro and hoping to do the same thing again, essentially. And so Edgewise is basically the first big deal in neurology for Servier to try and accelerate and build out a pipeline there. So what they're getting here, as you mentioned, they're getting a program called sevasemten, which I'm going to shorten to seva because I don't want to have to say sevasemten lots of times uh because it'll mess me up. Uh, so they, so they acquire seva, which is in a pivotal Phase II trial to treat uh Becker's muscular dystrophy. And the thing they see here is you're familiar with uh muscular dystrophies, obviously DMD, Duchenne muscular dystrophy is the big one that affects boys pediatric age children. But then Becker's dystrophy is essentially a similar set of, of symptoms, but the onset is much later. It usually happens in the teens or early twenties, and it's slower progressing, but it can have the same outcome potentially as, as DMD. And the difference is, is that there's no treatments approved for Becker's muscular dystrophy. So they see an opening here uh to potentially come in with a sort of first in disease therapy for Becker's. The difference though between what Servier did previously and what they're doing now though is previously, as I mentioned, all of those deals came with a commercial asset, so they were already It wasn't a lot of risk. There was some risk in the sense that, you know, if some of the pipeline stuff didn't play out, then maybe you don't get as much as you'd hoped for, but everything was already approved. Big difference here is this asset is in, as I said, in this pivotal study. It reads out that at the end of the year, and if it doesn't work here, it's probably not gonna work in the follow-up indication of DMD. And so it's, it's a much more binary risk event for, for Servier. And so I found that quite interesting as well, is that they were sort of willing to up the risk factor in this first big attempt to build out their neural pipeline

Jeff Cranmer: 24:34

What else do they have?

Stephen Hansen: 24:36

Uh, yeah. So they've got While this was their biggest deal in neuro, it wasn't uh it wasn't the first one. They actually did a deal uh last year with Caris Bioscience Limited for, I think it was up to four hundred and fifty million total. That brought them a program uh that's in phase one for fragile X syndrome. they've also got a f- an in-house sort of ASO oligo platform that they're using to generate some candidates. So they've got one that's in Phase I development for developmental epileptic encephalopathies. and, you know, in talking to David Lee, who's head of their US affiliate, that's kind of the area that they're thinking about. Movement disorders uh encephalopathies, seizures, th-that's kind of the area that they, you know, these rare n-neurological uh disorders is kind of where

Jeff Cranmer: 25:23

so not Alzheimer's or Parkinson's,

Stephen Hansen: 25:26

Alzheimer's, not Parkinson's. Yeah, they're trying to avoid those big ones and try and stick to stuff where they think they can, you know, they can move the needle

Jeff Cranmer: 25:33

Well, very active, but not quite as active as Eli Lilly, Stephen. You took a look at their pipeline. how many deals have they done so far this year?

Stephen Hansen: 25:42

Yeah. So they've done-- So I, so I looked at both partnerships and acquisitions. So they've done 20 deals overall so far this year, and looking at a total deal value basis, basically what they've committed to, obviously a lot of this is milestones and these types of commitments, but they've committed to forty-five billion so far in their deal making uh up to this point. It's a big number, and it's been really active. And um so here's, here's the little trivia question I can ask related to Lilly's deals. So out of these 20 deals, Simone, Jeff, how many do you think were obesity related?

Jeff Cranmer: 26:17

I did so bad on your

Simone Fishburn: 26:18

Oh, to 20? Oh.

Stephen Hansen: 26:20

Out of 20.

Simone Fishburn: 26:21

I'm gonna say not that many. I'm gonna go with… You're going with two, Jeff? You gotta say it out loud. You're going two.

Jeff Cranmer: 26:31

you know, I wanted to be polite and let you go first

Stephen Hansen: 26:34

You think five,

Simone Fishburn: 26:35

you went with two. You went, I'm going with five. And Jeff he went with two. He can't roll back now.

Stephen Hansen: 26:39

Jeff went with two. Yeah, okay. Yeah, so the answer is-- And this is overtly. Obviously, there are a couple ones where the targets aren't disclosed, but overtly, only one of those deals is an obesity deal. so I found that quite interesting.

Jeff Cranmer: 26:51

Oh, I win.

Simone Fishburn: 26:51

Yeah, but covertly, covertly I'm going. I'm dealing with, I'm leaning on the covert here.

Stephen Hansen: 26:58

think the point is, I think the point is, though, that it's less than you would expect um that you would have expected at least, you know, a couple of those deals to have been obesity-focused, which is obviously, that's their current and near-term sort of bread and butter, right? I mean, they pulled in thirty-six billion

Simone Fishburn: 27:13

right, I'm gonna go back at you here, Stephen. Not trivia, right? But I've been, I've been talking to people, all right? I, I've been talking. Now, I will stipulate very clearly this is not my view. I think Lilly should go and do whatever deals Lilly wants to do. Got a load of money and it can do whatever it wants, okay? But some of its peer pharmas are like,"What the is Lilly doing? What are they doing? What are they, a vaccine company now?" So there's that, right? And do they even have the people who can, you know, make these uh deals actually go somewhere? That's a thing. Although on the vaccine front, you know, there's talk that this was a Peter Marks related hooray for them. Like, he's, he's there. He can do that. But m- you can address that, but there's, there's nothing wrong with a new kid on the block uh struttin' their stuff. But I do think there's one thing that we're also hearing, which is, are Lilly's deals actually gonna skew the market? Like, 'cause they can pay and they are paying what they want, and are they actually enough of a factor now that they're gonna start skewing it, which is a question. So

Stephen Hansen: 28:25

Possibly. So, yeah. So, so here's what I think. I think Lilly is a very different buyer than most of the other pharmas out there in the sense that most other pharmas are still looking to plug LOE holes coming up, right? They're still looking for later stage stuff, I mean, I know some of it's pushing a bit earlier, but I think by and large, what everyone wants still are the late stage assets to fill in. That's not what Lilly's doing. Lilly's late stage pipeline and, you know, near launch commercial are covered. You know, like a- as I was saying, their tirzepatide franchise last year had thirty-six and a half billion in sales, and the combined growth of those two products was like one hundred and eighteen percent. So I I don't think they're hurting in the late stage asset. They're, they're not in that same position. And so all of these deals were Phase II or earlier. The majority of them were research or preclinical. So I think this is Lilly looking long-term, how do we build out, how do we diversify our, our, our opportunity set for that early stage part of our pipeline? And so when you t- mention like the infectious you know, they're moving into other areas of neurology that they haven't really been in before, you know, I think this is them sort of using that, th- these strong cash flows to be able to, take risks and, and, and try and push the boat out on things that, you know, maybe you wouldn't otherwise do if, if you had very near term issues. And so I, I think this is them actually being pretty smart and saying, "Hey, w- we have these opportunities. Let's try and maximize and see how much we can expand out and build out." whereas to be honest, I think some other pharmas just aren't in a position necessarily to be able to take those risks because they have bigger problems that are much more near term is the way I guess I would

Jeff Cranmer: 30:06

The LO- LOE, which uh for those scoring at home, loss of exclusivity. Good old-fashioned Patton cliff, so. Uh, well, that's, that's interesting, Steven. I know that's in my inbox for editing. I look forward to checking that out. Um, we woke up to a couple of other deals that were sizable today. J&J getting into the degrader antibody conjugate space, which got off to a bit of a rocky start, but is starting to gain a bit of momentum. I count roughly eight deals since 2021. Um, our colleague uh Danielle did a nice little analysis of this space. So what we have here is J&J paying uh let's see

Stephen Hansen: 30:55

One billion upfront, I think, in for Firefly

Jeff Cranmer: 30:58

Cold hard cash Firefly uh built by Versant. the company launched couple of years ago. Lilly was one of the investors, NPM, Decheng Capital, $94 million Series A. Versant, as I said was the founding investor, I believe. And it really hasn't said much about what it's doing, right, Stephen? We

Stephen Hansen: 31:22

Not a lot. I think it's, you know, but it's, but, but it is this, this sort of interesting concept of, of essentially you're replacing, you know, for, for a DAC or, you know, short form, form for the degrader antibody conjugate. You know, essentially you're replacing the cytotoxic with a degrader and I think the point is, is you get greater specificity. So you have the specificity of the antibody and the specificity of the target of the degrader and, you know, you can potentially get better effect, you know, especially depending on what that degrader is hitting. So I think we've seen some pretty interesting early data, from some of these companies and uh so yeah, no, it looks like uh it looks like a really interesting opportunity for J&J

Jeff Cranmer: 32:00

But yeah, this deal is by, by far the biggest of the ones we, we've seen. Nice play by J&J. Uh, hats off to Firefly and, its backers. Other big deal out early this week, Incyte. What do you know about that one, Stephen?

Stephen Hansen: 32:16

Yeah. So this is Incyte acquiring uh Vega Therapeutics, which was a subsidiary of uh this company Star Therapeutics. Essentially, they've got a um I they've got a Phase III asset for Von Willebrand disease. And, you know, that seems to be a good fit I think for Incyte. Incyte, you know, a lot of their, their focus has been in hematology. Um, you know, a lot of their commercial assets and, and their pipeline, frankly, is focused around hematology. So it seems to be a really good fit there, and they're paying one point two five billion upfront for that. And then there's, I think, seven hundred and fifty million in potential milestones there. So I can see that fit uh you know, being, being pretty, pretty good for them. I, I, I did want to mention also just on, on the degrader thing, you know, when we were talking about the DACs, there was another degrader deal as well today uh that we saw which was Roche paying seven hundred million upfront for a access to a BTK degrader from… from Nyrix, right, Jeff?

Jeff Cranmer: 33:15

Yeah. Yep, that's right. it's a pivotal compound for CLL, and I believe there's plans for some other indications, including MS. Uh, 2.3 billion biobucks. Couple of other interesting deals today. Everest a China company that we follow closely here at BioCentury in a deal with CORXEL for China rights to an ophthalmology program. And then GSK and Engitix They're going to collaborate on liver fibrosis reversal target discovery 44 million pounds upfront. So quite a few deals are gonna make it into our deals report on Monday

Stephen Hansen: 34:00

Deals, Deals Monday is back, it seems like

Jeff Cranmer: 34:02

Deals Monday is back. It's good to see for the industry. so hats off to our biotech and pharma BD teams out there. Keep giving us stuff to talk about and think about. All right. Um, well, Stephen, Steve, Simone, thanks for joining today to talk biopharma on the BioCentury This Week podcast. If you're listening and you like what you hear subscribe to our podcast. Check out our other podcast uh The BioCentury Show, where Stephen uh Selina, Simone, Steve, myself, we uh we sit down with a mover and shaker in the industry to, to get their thoughts. Richard Pops was just on with Steve. and we have some other good shows coming up for you. Thanks for tuning in, and thanks to Kendall Square Orchestra for providing the music for our podcast.