Ep. 365 - Thin ice for Makary, redosing AAVs

Marty Makary’s hold on the top job at FDA is slipping, with White House leaks about President Donald Trump’s displeasure with the FDA commissioner shifting the question from whether he will be fired to when. On the latest BioCentury This Week podcast, Washington Editor Steve Usdin discusses the pressures on Makary, how long he will hold onto his post, and the leading candidates to succeed him.
BioCentury’s analysts then discuss solutions to AAV’s redosing problem, which could reignite industry interest in a modality that has fallen out of favor, and other topics in the spotlight at this week’s American Society of Gene and Cell Therapy annual meeting. The analysts also discuss opportunities to attend and present academic posters at the third BioCentury Grand Rounds U.S. conference June 3-5 in Seattle. This episode of the BioCentury This Week podcast has been brought to you by Jeito Capital.

View full story: https://www.biocentury.com/article/659426

#FDA #GeneTherapy #AAV #CellTherapy #Biopharma

00:01 - Sponsor Message: Jeito Capital
01:43 - Bio€quity Europe Prague Highlights
04:54 - Makary on Thin Ice
14:37 - Grand Rounds Poster Pitch
16:40 - AAVs at ASGCT

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

Transcript

0:00

[Autogenerated Transcript]

Voice Talent: 0:02

BioCentury This Week is brought to you by Jeito Capital, a leading global independent private equity fund with a patient-benefit driven approach, aimed at financing, and accelerating the development of ground-breaking medical innovation. Jeito’s unique investment strategy combines significant capital and collective expertise to support biopharma companies and their management teams-ranging from clinical development to market access for cutting-edge innovations—with one main objective: go faster for the patient. Learn more at jeito.life

Jeff Cranmer: 0:39

Marty Makary's hold on the top job at FDA is slipping. We'll take a look at where the FDA Commissioner stands and potential successors. Plus, solving AAVs redosing problem could change the economics of rare disease gene therapy, and fire back up industry interest in a modality that has fallen out of favor. We'll discuss presentations at this year's American Society of Gene & Cell Therapy that seek to tackle this issue. I'm Jeff Cranmer, host of the BioCentury This Week podcast, and joining me to discuss all of this are Editor in Chief, Simone Fishburn and Steve Usdin, our man in Washington, both just back from our European conference, and Lauren Martz, Executive Director of Biopharma Intelligence, and my fellow Executive Editor, Selina Koch. Simone, Steve, Prague, is it as cool as they say it is?

Steve Usdin: 1:49

No, it's cooler.

Jeff Cranmer: 1:50

Oh.

Steve Usdin: 1:50

Prague is, Prague is an awesome city in part because it's it's a place that's risen from... I wouldn't say from the ashes, but, you know, if you compare it to Pre-Velvet Revolution to now, you know, there's very few places in the world that have gone from being so grim to being so joyful in, in such a short period of time. So yeah, it's, it's,

Simone Fishburn: 2:11

So I, I could talk all day about Prague. I'm now deeply steeped in all these Prague writers from the little Prague bookshops. And yeah, there is so much history, even you know, even 100 years of history there that, that it really wears, wears it on every corner and everybody. So it's a great city. It's a really pretty city. I will say, I don't know if I'm allowed to say this, but the conference center is not in the prettiest part of town. So if that's your only experience, go further into the old town,

Steve Usdin: 2:41

Which, which is probably good because you wouldn't wanna have the old town, you wouldn't wanna have all-- ha- have that there. But no, but it, but it's an awesome city and, and the Bio€quity Europe Conference was awesome. Every single conversation, every single panel was a variation on China, AI, what the hell's going on at FDA?

Simone Fishburn: 3:00

yeah, my um my, one of my favorite things, this was just before the podcast. If you listen to our Bio€quity podcast, you will hear this. somebody said to me, "You know, if I, if I had a dollar for every time somebody said China, I could finance my new funding round, my next funding round." There was a lot of China talk.

Jeff Cranmer: 3:19

Excellent as,

Simone Fishburn: 3:20

also a lot of energy. People, this is not a sleepy conference. This is a conference that people have like really, really hard to be at,

Steve Usdin: 3:28

And, you know, and the interesting thing was, and I think this is different from Europe, than the United States, is the talk about China wasn't like it is in the United States that, oh, they're eating our lunch, everything's gloom and doom, or what are we gonna do about it? It was really h-how are we gonna integrate China into global development and how is that gonna-- you know, how could that actually be a force multiplier for European companies that are engaging with China? That, that was really interesting. Yeah.

Jeff Cranmer: 3:55

that's excellent to hear as we are working on our program for the China Healthcare Summit, which will be in early November in Shanghai, 13th edition of the conference. Putting it on once again with BayHelix and McKinsey. hopefully uh that whets your whistle to come join us in China. And the, the talk with Pazdur went well, Steve? I know uh that was a big highlight of the conference.

Steve Usdin: 4:19

Oh yeah. Yeah, we did the, uh-- we did the fireside chat or the pub chat or whatever you wanna call it with, with Dr. Pazdur and you know, he was as provocative and interesting a-as ever.

Jeff Cranmer: 4:29

Excellent. Well, as Simone said, we'll have a Bio€quity Europe podcast recorded on stage in Prague with my fellow host, Stephen Hansen. That will be out later this week. We'll also have on our sister podcast Steve's conversation with... Karen Knudsen of the Parker Institute. All right, Steve, Friday afternoons in the Trump administration uh always interesting. So we got word Wall Street Journal breaking the story that Marty Makary is on thin ice. Bring us up to speed, Steve

Steve Usdin: 5:09

So yeah, so uh you know, people listen to this podcast frequently read BioCentury won't be terribly surprised to know that Makary is on thin ice. But I think it's important to say, you know, what is it that we know and what don't we know? So I've spoken with people who are in touch with HHS Secretary Robert F Kennedy Jr., with Chris Klomp, who's essentially running HHS on a day-to-day basis, and other senior HHS officials. They've been looking for ways to push Makary out for months, so that, that's not really new. Makary wasn't Kennedy's choice for the job. Kennedy was never a fan of Vinay Prasad's. And there's a lot of reasons for the HHS displeasure with Makary. It centers on the chaos and leadership churn at FDA. Makary's frequent appearances in the media, including social media, aren't doing him any favors with HHS. What every HHS secretary and every president wants is a set it and forget it FDA commissioner. They don't want the commissioner in the news a lot because it's often bad news and it's almost always a controversy that doesn't win any votes. I don't think there's very many voters that wake up, read about the real-time review program or the plausible mechanism pathway and say, "Well, I want to go out and vote for Republicans in the midterms because of that," you know? So the administration... It may be the administration thinks that they're gonna gain some support by talking about food coloring and food additives, things like that, but Those are things the HHS secretary can do without the FDA commissioner opining on them. The reporting in The New York Times and The Wall Street Journal, and The Wall Street Journal did kind of break this story o- on Friday as I said, it revealed what BioCentury readers and listeners have known for a long time. There's this, this kind of angst about FDA and about Makary. From the perspective of the life sciences, FDA's rejected and dealt setbacks to a a string of therapies, mostly but not entirely for rare diseases. A lot of its decision-making seems to be arbitrary. The policies that have been announced, the commissioner's National Priority Voucher Program, the real-time reviews Were not carefully considered and they're likely to have unintended negative consequences. Some aspects of them may not even be legal. FDA has lost about twenty percent of its staff over the last year. Makary said he has plans to hire three thousand reviewers, but there's no evidence that he's even reversed the continuing attrition. So that's all on one side of the equation. and then on the other side of the equation, there's the reality that this isn't really up to this being Makary's future, isn't up to Kennedy or Klump or the people at HHS who are trying to get him pushed out. It's up to Donald Trump. If you read the, the Wall Street Journal story carefully, it says that Trump had okayed a plan to oust Makary. No one, and I think probably even including Trump, knows exactly what that means. I think what it means is that as I wrote in Friday, it means that Makary's gonna go. That isn't really much of a doubt, but nobody has any idea of when it is gonna happen. I actually think that all of this publicity that's happened over the last few days will delay-- it may delay his departure. I'm not sure. But I think it may delay his departure because I think that the, the plan was to give him a kind of a soft exit. It wasn't for him to leave with a cloud over his head. and this all, all this publicity makes that more difficult to achieve.

Simone Fishburn: 8:35

Steve. When I think about this, I, I take your point that it might actually delay it because just that's the quirk of this administration or every administration. They like to set the tone rather than be seen to be reactive. But all that aside, when I think about Makary, when I read the things you've written and other people, in a way, there's a curious upside to this, in that what I think seems to have brought him down is that he's only ever acted politically. And he's been, you know, subject to being pulled in this direction politically, in that direction politically. He's gone with the wind. He's gone with his gut. But all the way along, this just seems to have been clouded by political considerations rather than the science. And, you know, when I say there's an upside, I mean, it's actually good that that's not working out, is what I'm trying to say. I think that you talked about a previous commissioner who very early on was faced with a political kind of interference and said, "I have to clamp down on this now, otherwise it's going to plague my entire tenure."

Steve Usdin: 9:42

Yeah. So, so, so what I've heard from... Yeah, so, so what I've heard from other commissioners, and I don't know Makary, but I've known every other commissioner going back to Mark McClellan, and they all say a variation of the same thing, which is that if you let the White House, if you let politicals in the administration think that they can push you around on one thing, there's never gonna be an end to it. They're gonna push you around on everything.

Simone Fishburn: 10:06

And that's the story of this.

Steve Usdin: 10:08

the sort of this, and it's not, and it's not so much the of FDA commissioner preserving their power or their perquisites or something like that. It's really about um the effect on public health of having political appointees who aren't public health experts making decisions and influencing decisions in ways that may be well-meaning, may be intended to satisfy political constituencies, but aren't likely to result in decision-making that's the best for the American people.

Simone Fishburn: 10:40

All right, very quickly, you're gonna tell everybody who's next uh in line, who's, who the candidates are?

Steve Usdin: 10:46

I have no idea. I don't think... I, I, I've heard various rumors, but you know, they, they, they're only rumors about who might be the next commissioner. But what is fairly certain is who's going to be the acting commissioner. So there's, there's likely to be an acting commissioner It could be for some time depending on what happens with the composition of the Senate after Makary leaves, whenever he goes. And again, we don't know when he's gonna go. But after he goes, there's gonna be an acting commissioner. There's actually pretty tight legal criteria for who can be the acting commissioner, and there's also a strong incentive for the Trump administration to adhere to those criteria because if they don't, if they name somebody to be acting commissioner who doesn't comply with the parameters of the law, then any decisions that that commissioner makes could be determined to be null and void. So I don't think they're gonna do that. The most likely uh course of action is to promote somebody from within as the acting commissioner. There's three people who would be qualified and who who seem to be in the running. Grace Graham, who's the Deputy Commissioner for Policy, Legislation, and International Affairs. Lowell Zeta, the Deputy Commissioner for Strategic Initiatives, and Kyle Diamantas, who's the Deputy Commissioner for Human Foods. I've heard that the most likely interim or acting commissioner would be Kyle Diamantas, but any one of those three could get it. It's also possible there's a, there's a list of people who are outside of of FDA who are appointees, senior appointees at other parts of HHS who could get the job. In the past, twice, NCI directors have gotten that job as uh on an acting basis, and one, Andrew von Eschenbach, was converted to get it on a permanent basis.

Jeff Cranmer: 12:35

And if you're curious about who some of the other candidates are Tracy Beth, Høeg, Sean Keveney and others Steve has a tidy table in his story listing everyone that has a shot and could be the next acting FDA commissioner should all this come to pass.

Steve Usdin: 12:56

And, and I'm sorry, just one, one, one final point, which is that there is a history, there's a tradition at FDA of having FDA commissioners who have served in that job for quite a long time and have been very important in policymaking.

Jeff Cranmer: 13:10

All right, we're going to take a quick break, and we'll be back to talk AAVs and the American Society of Gene and Cell Therapy annual meeting.

Voice Talent: 13:23

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Jeff Cranmer: 14:37

All right. Well, you heard it there uh BioCentury Grand Rounds right around the corner but not too late to register. it is in, as you heard the awesome city of Seattle, which has become something of a biotech innovation hotspot. And, well podcast listeners, you're in luck. you can email conferences@biocentury.com or hit me up on LinkedIn. and we'll share a discount code with you And that's good for delegates uh presenting companies. still a few spots left for presenting companies, and we also have posters. Uh, Simone, word on the posters?

Simone Fishburn: 15:19

First of all, I have to say, this conference is shaping up to be extremely interesting. Very hot conference, so we've got all these cutting-edge topics that we're gonna be discussing. Also David Baker is going to give a keynote, and Mary Brunkow is gonna give a Horizon Session, and I'm gonna be interviewing Chris Arendt, the CSO of Takeda. So we have a lot of headliners there. But what I wanted actually to do with this podcast is I know that we have entrepreneurs and academic entrepreneurs who listen to us. And if they don't, go find one and tell them they should. But I do get people telling me that. Anyway um we would really love to see them. This is a conference for them. This is a conference where they can come and really present their work. We have poster presentations, which is just a great way to get your information and get your discoveries, even if they're really early stage, in front of VCs and pharmas and people that we think of will be the people who one day partner with you or invest in you. And these posters have been really successful in the past. Very much encourage academic entrepreneurs or would-be entrepreneurs or wanna-be entrepreneurs to come to the conference, and if they've got some cool work, send us a poster

Jeff Cranmer: 16:38

Yep. it's gonna be a good time for sure. Well over in Boston, other side of the country, the American Society of Gene and Cell Therapy is holding its annual meeting this week. The meeting is featuring multiple preclinical presentations that describe strategies to enable repeat dosing or overcome preexisting immunity to AAV vectors. Lauren has been digging into this for a story that is out now on BioCentury. Lauren, what have you found?

Lauren Martz: 17:10

Thanks, Jeff. so this is the second year in a row that we've looked into this issue of immunity against AAV vectors as a theme from the ASGCT meeting. And I think it's, it's just because it's so important and because there really have been some big steps forward over the past year. Taking a step back, immunity against AAV vectors causes several different problems. It's obviously, you know, a, a major contributor to the toxicity issues that we always, are on the lookout for with all of these different AAV therapies. It's also, as you mentioned, behind two really big limiting factors for the applications of these gene therapies. The first is between thirty and sixty percent of people, you know, any people, have preexisting immunity to AAV vectors, which means they can't get an AAV gene therapy at this time at all. You know, even if you have a terrible rare disease and a gene therapy is developed for it, you're not eligible for it. And then there's also the issue of only being able to dose an AAV gene therapy one time. And if you think about the impact that that has on just anyone trying to develop a gene therapy for a rare disease, it's, it's really limiting because once you have a gene therapy approved or a gene therapy in a late-stage development for any indication, especially a rare disease That's going to be used to treat many of the patients with the disease. So the market then begins to shrink. And if the gene therapy isn't durable, you can't dose it again. You can't help patients in the future. So we don't know how long some of these gene therapies are even going to last for patients. So it's a huge problem, and if it's solved, you know, these are two slightly different issues that need to be solved. But if they are solved you solve a lot of the financial disincentive that exists for developing AAV gene therapies.

Selina Koch: 19:02

And if I could jump in and just say, yeah, I mean, changing the economics for rare diseases is, is huge because of course in aggregate they're not rare at all, even if any one of them is rare. but it-- the conversation I think was something that drops out of it often or that gets ignored is the promise in prevalent diseases, right? There's this whole concept of vectorized biologics where you can encode an antibody or protein therapy as DNA sequence, give it as a gene therapy. So much open, wide open territory that could be traversed there if there was a way to do this. And then just, what was it, last week or recently on one of these podcasts, we were discussing how, in vivo CAR T therapies whether they were gonna be successful was completely gonna hinge on the durability of that first treatment, because these are what is an in vivo CAR T, but a gene therapy, right? They're delivered with a lentiviral vector, which can't be redosed. But what if it could? Back to you, Lauren.

Lauren Martz: 19:58

Exactly. And so again, if we can solve these problems, I think it just burst this field wide open. The biggest advance that we saw over the last year was maybe not even at this meeting, but uh we did hear about an ESGCT in the fall, a patient with a high enough level of neutralizing antibody titers against the AAV vector for a gene therapy in a Genethon trial for a disease called Crigler-Najjar syndrome was treated with this gene therapy. So what Genethon did was they treated the patient with an IgG depleting enzyme imlifidase. Uh, this is approved for um other indications. It's used in other settings, but uh there's been a lot of speculation that maybe if we bring down the IgG antibodies that preexist in, in these patients, for long enough, you can treat them with an AAV gene therapy, and it will be successful and reach its target, express the gene that you need it to express. And we will hear an update at ASGCT from Genethon on clinical data from that trial. Hopefully we'll see some additional information about how that's been working in that particular patient and what the next steps are you know, introducing this gene therapy for more patients who have preexisting antibodies, maybe taking it to other indications. So that was sort of the big thing that happened. And then when you look at this meeting versus last year, there is a diverse set of strategies that are proposed to tackle this problem. So the IgG-depleting enzymes are sort of the focus of this preexisting antibody issue, preexisting immunity. When you think about the problem of redosing, it's a little bit more complicated because you have a little bit... There are more entry points for therapeutic intervention. So you want to prevent this immune response when you're giving the first dose, and then you want to deplete whatever immune response still does result. So you still probably have that need for depleting the IgG antibodies, but there's also a lot of work around how do we prevent those antibodies from being produced in the first place. Many different groups are proposing different strategies to deplete the B cell activation or, you know, take out the B cells in general. There are some really extreme proposals like CAR Ts, which you, you have to kind of weigh the safety and benefits of, of using something like that. But different combinations of B cell-depleting antibodies or B cell-targeting antibodies are also proposed. And then there's another set of, you know, this isn't a new idea, but as we're designing new AAV vectors, trying to design them in a way that evades the immune response has been a longstanding goal. There's some work around that. And then some more innovative ideas like cloaking the vector in extracellular vesicles, for example, that help it evade immune response from the start.

Simone Fishburn: 22:56

Lauren, I suppose my question is this, your lead up to this when you describe the problems that are being addressed at the ASGCT conference, as you pointed out, those are longstanding questions, right? We've known about redosing being an issue. We've, we've known about that for a while and the various limitations, and Selina, your sort of what if is obviously a really tantalizing one. What if you could solve this? And so what I want to ask you is whether, you described now just several different strategies that companies and innovators, I guess they're not all companies, right, are taking to address it. Do you think that there's a sort of critical mass now? Do you think it's... You know, what I like to think about, is this ultimately an engineering problem? Is it something that you keep hammering away at it, you try different, different ways, and the field is sort of incrementally getting to solve this? And I ask this because gene therapies, I don't know if it's more than any other, but it feels like it, has just got this history of waves where they try it and then it, there's a disaster and it goes away, and sometimes it's a commercial reason and whatever. We're still knocking on the door really with gene therapies. But I think what I'm really asking is whether there's reason to believe that this massive activity that you're talking about can actually change the trajectory, start to solve some of these longstanding questions

Selina Koch: 24:20

Are we at a tipping point?

Simone Fishburn: 24:22

Are we at a tipping point. There we go. Thanks, Selina.

Lauren Martz: 24:25

We have a history of identifying things maybe before we get to the tipping point. So um we may be

Simone Fishburn: 24:31

That's what we pay you the big bucks for, Lauren, you know.

Lauren Martz: 24:34

We may be almost getting to a tipping point. I will say, I don't think there's a massive amount of research around this, this topic. I think that it's something that people are working on. I think, that companies and academic groups are chipping away at the problem. I think that what we've seen, we have a patient with preexisting immunity who was dosed with an AAV gene therapy, and, and we'll see how durable that effect was. I, I think that's, that's a big step

Simone Fishburn: 24:59

And that...Sorry, that patient would've been screened out of earlier

Lauren Martz: 25:02

Oh, that patient would have absolutely been screened out of earlier trials. I think there's still this challenge of preclinical models not translating to humans when you're talking about the immune system. Huge, issue.

Simone Fishburn: 25:17

Shocked, shocked to hear this.

Lauren Martz: 25:18

Shocking problem, but um, so,

Selina Koch: 25:21

Lauren, how much of the data would you say at this year's meeting is maybe in non-human primates, say, instead of mice or whatever? Are we seeing an advancement in that way? So,

Lauren Martz: 25:31

There are some studies in non-human primates, which is of course a better model than a mouse model for this. But it, it... There's still, you know, even with the clinical trials with gene therapies that we've seen, there are always unpredictable things that happen. So I think, what we're expecting to happen is if you dose someone with preexisting immunity with an AAV vector, and maybe the strategy that you've chosen doesn't work, hopefully that it just... it won't be effective. But we don't know what the risks are. We don't know how ethical it is to bring like a redosing strategy into humans, and I, I think it's just gonna be a relatively slow process. But hopefully the first step is that you can treat patients with preexisting immunity, and then you can use some of these B cell depleting therapies that are becoming safer and more standard in inflammatory diseases and cancers as a way to sort of bridge this immunity problem. And maybe in the future we'll have vectors that, that evade the immune system completely, you know. the... I think we're, we're moving in the right direction.

Selina Koch: 26:31

so you list a bunch of targets in this story that people are, are trying, you know, for the various-- either to prevent new B cell responses, address existing ones, address the T cell component of it, so on and so forth. And you all-- whoever's listening to this can go read the story and see these various targets. But because it's still, there's lots of things being proposed and it's still early does that mean right now would be a good time for the field to get together and think about how do we create standardized assays so we know how to use these things effectively in individual patients?

Lauren Martz: 27:10

This would be a great time to do that. It's something that we talk about for a lot of different targets, a lot of different drug classes. Assays to measure neutralizing antibodies are not standard. They're all measuring different things from what I hear. You can read about it in the story. Um, so it's hard to tell, which of these approaches is working better at bringing down the antibodies, which is going to address the T cell component, which is gonna be a, a... probably going to be an issue when you come to redosing. So you sort of need to inhibit both of those processes. Yes, it would be wonderful if people came together to

Simone Fishburn: 27:46

count me skeptical here. How many times have we said if the industry would get together and solve this thing, they'd all do better from it?

Selina Koch: 27:56

Oh my gosh. Um, I don't know, PD-1 might come to mind.

Simone Fishburn: 28:00

Yeah. It's just, what about a single assay? As I said, they did it in COVID 'cause they had to, so we know that they've got that muscle in there somewhere. Not holding my breath on that one, I'm afraid.

Selina Koch: 28:11

Just making an appeal yet again.

Simone Fishburn: 28:15

Well, if they do, then we'll definitely point it back to your comment on this podcast, Selina. We'll be like, "Maybe we, we can influence." Yeah

Jeff Cranmer: 28:22

Lauren, I'm curious, are there any uh other things you're watching at the conference?

Lauren Martz: 28:28

Always. Yes, there's a lot of interesting stuff within the abstracts that will be presented this week. So a few disease areas that stood-- or there are indications that stood out as hot to me this year. muscular dystrophies, including but beyond DMD. There's a, there's a lot of research on limb-girdle muscular dystrophy, for example. I'm gonna be looking into those. Gene therapies for the eye, of course, always a big topic. There's a lot of research into retinitis pigmentosa and the different genetic forms of that disease. those are two things that stood out to me. going back to Selina's comment on the encoded antibodies, one thing that I saw quite a bit of was strategies... Well, first of all, DNA-encoded antibodies, the, you know, vectors to create drug factories in the body. There, there's quite a lot of that. There are also different strategies to tune expression of the-- and levels of the transgene and the protein that's produced from gene therapies, which I think will be increasingly important as you're talking about long-term production of therapeutic proteins, not just replacing a lost gene, for example. There's a lot of activity on in vivo CAR Ts as always. There are a few new companies that are new to BioCentury in, in this list and a few different strategies to um create the in vivo CAR Ts. Yeah, just a lot of, a lot of interesting topics within the abstracts

Jeff Cranmer: 29:51

Excellent. Well I'll drop a link in the show notes to Lauren's story as well as Steve's story on Marty Makary's tenuous grip on the FDA job. We'll see what happens there. Steve, of course, always working the phones, and Lauren always digging into the abstracts. Uh, that's how we roll here at BioCentury. Thanks for tuning in. Look out for our special Bio€quity Europe episode this week, as well as The BioCentury Show's interview with Karen Knudsen of the Parker Institute. And a thank you to Kendall Square Orchestra, which provides the music to BioCentury's podcasts.

Voice Talent: 30:34

BioCentury would like to thank Jeito Capital for its continued support of our BioCentury This Week podcast and our 26th annual Bio€quity Europe conference this May in Prague, Czech Republic.