Latest / BioSpace / Disc’s redemption, China’s rise, Veradermics’ validation, ESMO’s headliners
Transcript
- Jef: Hello, and welcome to Biospaces the Weekly. I'm your host, Jeff Axt. We got some big news from Disc Medicine early Monday morning as the biotech released positive phase three results for its previously rejected rare disease drug. Veridermics also reported positive phase three data. This is from their hair loss candidate, and they provided validation for investors who supported the big IPO they had in February. On a more macro scale, we'll also check in on the rising number of deals that have been struck with Chinese biotechs. Spoiler alert, the country has easily surpassed the US in terms of inbound licensing interest, but the US still has the lion's share of biopharma MA action. And finally, with the annual ESMO Congress kicking off in Madrid on Friday, we'll preview some of the biggest presentations that the industry is keeping an eye on. Let's get started. Hello. I am just back from not getting selected for jury duty. Thank goodness. Heather: Hmm. Jef: I'm so glad I made it in time for this podcast recording. How you guys survived the morning. Heather: Congratulations Annalee Armstrong: it's I've been through Heather: We Annalee Armstrong: it this morning. My four year old refused to get on the bus today. Heather: Yep. Jef: boy. But he made it to school? Annalee Armstrong: We made it, we made it. I dro yeah, I had to drive but we made it. Jef: my gosh. Heather: How did he finally agree to go in? Because the last picture I saw, he was sitting in the back seat and you had your laptop. Annalee Armstrong: Yeah, well he did actually once I got to school he was like, Okay, this is this is happening. And he did willingly go in. Yeah. Jef: Resignation. All right. Well I guess the other thing to check in on is the postseason baseball. Tampa Gate Bay clinched last night, Heather. Heather: Yes, they did. happy to give an update there. I was cheering for Cleveland, only because Tampa Bay is in the Blue Jays division and they're very annoying. their Annalee Armstrong: Yeah. Heather: ballpark is very annoying, especially with all its rings and how they mean different things. But regardless, the Dodgers, well the the Brewers gave me an early birthday present last week by sweeping the Dodgers out of the playoffs. And not that they did it for me, but you know, so Jef: I knew you'd be happy with that though when I saw it. Heather: Yeah, so the so it's gonna be the Brewers versus the Rays, and whichever team wins, it will be their first world championship. Annalee Armstrong: Ooh, I love that. I love Jef: That's exciting. Yeah. Heather: There. Annalee Armstrong: that so much. Like I always get tired. I love watching like good I'm I'm more of a hockey fan, but I love watching good hockey. But it's so tiring when it's like the same team just in the Stanley Cup year after year. Yeah, yeah. Heather: Hmm. Yeah. I know. Yeah. See this Jef: Yeah, this is why we were rooting against the Dodgers. Heather: is this is gonna yeah, it's gonna be it's great for baseball, especially with the possible lockout coming up. It it's just good to have this. Yeah. Jef: Yeah, we will see what becomes of baseball, but should be a a fun World Series. That'll be good to watch. Heather: Definitely. Starts Friday for anyone who's interested. Friday, yeah. All right. Yeah. Jef: All right. Well getting Friday it starts. All right. I'll be there, maybe. Without the Braves involved, I'm kind of a a more casual watcher, but World Series is always fun. Annalee Armstrong: Ha ha ha. Jef: all right, well, let's turn to our show now, starting with introductions. Heather, why don't you start us off? Heather: Sure. I am Heather Mackenzie, senior editor here at Biospace, and I'm in charge of Clinica Space, which hits your inboxes every Monday morning. Jef: Alright, and Annalie. Annalee Armstrong: And I am Annalise Armstrong, senior editor. I do the weekly Biofarm Executive newsletter, which hits your inboxes every Wednesday. Jef: And we are missing our Gabrielle Mason today. She puts together our daily Gene Pool newsletter and our weekly manufacturing brief on Tuesdays. And last but not least, I am Jeff Axt, your managing editor. Okay, now fully diving into our show. let's head to China. First. So last week, Annalie, you hosted a webinar with four biotech leaders to talk about how the US can really thrive given all the changes that are going on right now. And this actually proved especially timely. I mean, the China topic's kind of always timely. We knew we wanted to address some of the issues going on. But just this past week, a China rolled out new restrictions on the ownership of some biotech technologies. So Annalie, tell us about that latest update. Annalee Armstrong: Yeah, so great conversation last week. If you haven't had a chance to watch that, definitely check it out. It is on the Biospace website. But yeah, so right off the bat, I'll tell you that these new policy proposals that China rolled out sound like a real major kind of escalation in this like tit for tat between the US and China, specifically over how the biotech industry there is is really rising. but this wasn't as big as it seemed. so what China wants to do is restrict the transfer of ownership for biotechnology platforms in five key areas that include cell and gene therapy and small nucleic acid drugs. So essentially, China wants to ban foreign companies from buying a cell therapy or gene therapy platform company that can be used to create drugs, of course. But the policy very clearly accepted licensing deals. Jef: Right. So if licensing deals are making up the majority of these Chinese deals, then it's basically business as usual. Annalee Armstrong: Yeah, pretty much. So actual MA of Chinese companies by a foreign buyer, like an American headquartered company, is exceptionally rare. another well-timed thing in this this China debate, Global Investment Bank Locustwalk put out a really great report that looked exactly at licensing deals with Chinese firms, confirmed, of course, that those are just going crazy. however, MA is just not happening. you know, foreign buyers are not buying Chinese companies. US firms accounted for 91% of all global MA value so far this year, compared to just one percent for Chinese companies. Jef: And with license deals, it was something like almost sixty percent in terms of total deal value is going to China now versus twenty six or something for the US. So quite the the discrepancy between those two deal types. Annalee Armstrong: Yeah, for sure. And it's worth noting that four year, I think it was 2024, obviously the US did have the bulk of those licensing deals. So China has certainly shifted and they are now getting most of them. so it yeah, that that's a big change in how the business is running right now. Jef: Right. And some experts have been worried that China might crack down on these foreign investments and try to keep it at home. And that's kind of what this new policy does. But again, it's i it accepted the licensing deals, so not so much. Annalee Armstrong: Yeah, and China just re revealed their latest five year plan. They want to have something like a quarter of all drugs on the market, the global markets, to be originated in China. So they're just trying to keep the technology that pumps out these drugs at home. but they're happy to have the foreign buyers come in and license the assets to bring them elsewhere. Jef: Right. So what else did you learn in the report? Annalee Armstrong: Yeah, I had the chance to talk to Locustwalk CEO Jeff Meyerson. he was he had a really great perspective on this kind of US versus China biotech battle. So a lot of biotech leaders and lawmakers have been raising concerns that China licensing deals are really taking over the industry, kind of taking money from US biotechs. but in reality, Meyerson pointed out that those deals are rising at the same time that these US-based biotechs are having an absolutely awesome MA year. so acquisitions are just not an option for Chinese companies, as we've talked about. they view licensing deals as essentially a fundraising event, just as a biotech in the US would raise a VC round. so at the same time that all of these these deals are happening, VC has really bottomed out for Chinese biotechs. They're just not getting money that way. so they need these licensing deals to survive. So that's what they're doing. Jef: That's really interesting. And I I also remember reading your story, which listeners, check it out. It's in Biofarm Executive today, Wednesday, as you're listening to this. I read in the story that you wrote that because they need these licensing deals, they're more willing to take, you know, back ended deals, a lot of milestones, royalties, whereas US companies are really trying to front end the deals as much as possible. Annalee Armstrong: Yeah, for sure. And the data that Locustwalk has presented also shows that upfronts are pr are higher for US biotechs, whereas Chinese biotechs are willing to take less upfront. so yeah, it's just some really interesting dynamics to add to kind of this major debate that's happening in the industry right now. Jef: Yeah, very interesting. Well, like I said, check out that story that Analy wrote. It's really helpful to digest the landscape right now. But also check out that webinar, which is, a full deep dive, hour-long discussion with Analy all of her expert panelists who were really dynamic and into the discussion. It was really fun to watch. Alright, well, lots going on with the China situation. We will continue to keep tabs on that. But speaking of biotech, we had a couple of really encouraging clinical trial readouts this week that we want to dive into. first, let's start with disc medicine. the phase three results they posted on Monday might actually set up a redo with the FDA. So thinking back to February, you may recall that the FDA surprised disk, and actually the entire industry was pretty surprised by this decision, when they rejected the lead asset called Bitopertin. It's for a rare disease that causes pain when exposed to sunlight. We call it EPP for short, and I'm not going to try to butcher the full name, but it's a pretty devastating and very painful disease that doesn't have a lot of treatment options. And so DISC was really optimistic with this application earlier in the year, but like I said, the FDA rejected that in February. That was after previously granting a commissioner's national priority voucher, which of course does not guarantee approval, just a speedier review. So Heather, you spent a lot of time covering this story. What can you tell us about the details? Heather: Yeah, I've been in this story for a while and yeah, it's just it's just such a brutal, very rare disease, but it causes intense pain crises as well, for which people apparently take opioids, even though according to the CEO of disk, it doesn't work. so they desperately need something. so yeah, disc rebounded in a big way on Monday as its lead asset, Bit of Purton, hit all primary and secondary endpoints in a pivotal phase three trial. so the FDA's main issue back in February seemed to be that they were unsure whether the percent change in PP9, which is a biomarker of the disease, was reasonably likely to predict clinical benefit, which is the requirement for accelerated approval. but in the Apollo trial, Bidapurton reduced PP9 by 41.4% compared to placebo. and increase the time patients were able to spend in the light by twelve point two hours during month six of the trial. so both co-primary endpoints hit with what CEO John Kizell told me was a high degree of st statistical significance. And it did look like the p values were about as good as you could get. Jef: Yeah, very low, very st statistically significant, and across all those endpoints, a clean sweep there. Heather: Yeah, it was it was really good to see. and Disc plans to resubmit by the end of this year, which means it's October twentieth today. So they've got a lot of work to do in the next two months. Jef: And I wonder if what sort of time frame we'll expect for that review if they'll get some sort of accelerated review. They obviously don't still really have the C P V to guarantee that, but you never know. Heather: Yeah, I asked that question of of John and he said that they are guiding towards six months, but I I think he said something like, You never know, we'll have to wait and see. So maybe they're sort of hedging but sort of hoping. Jef: Yeah. Well, for the patient population, I'm hoping for a speedy review and a good result in the end. another one that also had a big week was Veridermics. So this is a hair loss biotech that went public earlier this year and has actually done really well in the public markets. So in this past week, they reported that an oral version of minutoxidal, which is rogain, the the generic name for rogain, improved hair growth in men with patterned hair loss. So Annalie, you covered this one. What can you tell us? Annalee Armstrong: Yeah, so the the hair loss space has been really interesting lately. If you haven't been following it yet, this is definitely something you should be keeping your eye on. so this was a phase three trial that Vera Dermix was running, testing the oral monoxidyl candidate in about 500 men. So the drug improved hair growth, which is measured by like they literally count the hairs on a small patch of skin on the scalp. so the drug improved hair thickness, it improved the number of hairs overall as compared to placebo. on some kind of secondary endpoints, there was an improvement in patient recorded outcomes and in investigator perception of hair growth. So Viradermix intends to use this data for a regulatory application. they're also running a bunch of under of other studies to kind of like continue to build the case for this drug, including one that has all women. Jef: Interesting. Yeah, and I mentioned already, so Veridermics IPO'd earlier this year. At one point, they were up like 600, some percent. That's come down a little bit, but they're still performing very well, up over 200% since their debut. Gabrielle, our colleague who's not with us today, actually spoke with CEO Reed Waldman earlier this year. And exactly what you said with this interest in this kind of unique hair loss space, it's so similar to the GLP1 space in the fact that it's like really consumer driven. And Waldman told Gabby exactly that. they're looking to tap into this growing interest of consumer driven health care that happened with the weight loss drugs. So that's very interesting. Annalee Armstrong: Yeah, and particularly hair loss. Like there's this whole community of people who suffer from this disorder, who are, trading ideas. there's whole Reddit threads, like this universe is very large. people are really, really looking for some solutions that work. I actually got to speak with Pa Pollage Pharmaceuticals earlier this year. They're a rival to Viradermix. They're actually developing a novel candidate that is not related to Rogaine. so they are also waiting on some major data. but it's a really fascinating space. so you can take a look at kind of all our coverage if you're interested. Jef: Yeah, definitely an interesting one that we have been following and will continue to follow. All right, last major topic on our agenda for today is of course Esmo, starting in just a couple days over on the other side of Atlantic from us in Spain. So there's a number of companies that of course we'll be watching for, but there are a few standouts. And so, Heather, you helped preview this event. What is the excitement that you're hearing about? Heather: Yeah, so in three letters, A, D, C, antibody drug conjugates Jef: Yes. Heather: our conjugates are going to be really big this year. that's what analysts told our staff writer Tristan Manilak, who who wrote a really terrific in-depth preview that it's shaping up to be a big year for antibody drug conjugates. one closely watched asset is Merck and Kellen Biotech's SAC TMT. Again, that has a longer name, but I'm not going try. So this summer, Merck reported that SAC TMT plus Ketruda met the primary endpoint in a phase three trial. It improved progression-free survival compared to the PD1 block blockbuster and chemotherapy combo in patients with a type of non-small cell lung cancer. there was also a positive trend in overall survival. So Merck and Kellen didn't provide details at that time, detailed data, but they are expected to on Sunday at Esmo. I actually I spoke with Alan Northrop, he's Merck's VP of chemistry, about SAC TMT, and and he shared how the asset is differentiated in the TROP two ADC space. I won't give away any further details, but that piece will be up on Biospace this week. Jef: Ooh, a little teaser. I like it. Heather: And aside from that, analysts are closely watching for more data on Moderna and Merck's personalized cancer therapy. that asks that extended survival without disease recurrence, again combined with ketruda, king ketruda, in patients with melanoma in a phase three trial this summer. so they are also expected to present more detailed data on that. And then of course you have Summits, Akezo Partner.pd1 VEGF Biaspecific Therapy, Ivaneskimap, and they'll be presenting phase three data in gastrointestinal cancers. Jef: I'm definitely very interested in both of those. The SAC TMT too. that's another asset we've followed closely. But I I know that Merc and Moderna's personalized MRNA based cancer vaccine has been a somewhat controversial one, rewinding all the way Heather: Hm. Jef: back to when MRNA was in the spotlight. And so I'm really excited for that one to to carry through and maybe help RNA technology get over this hump that was caused by the political storm that surrounded COVID. mRNA is really promising technology and it's just gotten caught up in a lot. So I know that one's one that's really watched closely. And then of course Summit and Akizos, I've been asking about one of the top assets coming out of China to help them achieve their five year plan of five blockbusters by 2030. So curious to see how that one turns out as well. All right, well that's our show. Thank you all for listening. Don't forget to subscribe on all your favorite podcast channels and tune in next week when we'll be all four of us back in action here on the weekly.