ASCO wins from RevMed, Akeso/Summit, more; plus more Lilly and more China; ADA on deck

[Music] Hi and welcome to Biospaces the Weekly. Today we'll get you up to speed on the biggest news coming out of the American Society of Clinical Oncology, your ASCO, in Chicago. These included packed plenaries from Revolution Medicines and Summit Therapeutics Chinese Partner Akiso, plus much more. Outside of ASCO, the past week saw Pfizer's strike an unusual pact with China's Invent, and it's actually reminiscent of a recent deal from BMS and Hangru Pharma, which could signal a more collaborative approach to working with Chinese companies. We'll also cover the latest deals from Eli Lilly, which continues to rack up partners with this GLP-1 Winful. Let's get started. Hello everyone, you all surviving the ASCO rush? Just fairly. It has been a while this year. I feel like in previous years, ASCO had been fading a little bit. Like, companies weren't really saving their big data drops, but ASCO's back, it seems. It seems to have made a definite comeback, and there's a lot of assets that are being talked about that are from recent deals, or even not so recent ones, maybe three years ago. There was one from BMS this morning, and yeah, a lot of companies just seeing whether or not they're going to get returned on the market. Absolutely. I always love ASCO, but I think I went on vacation, and I think I chose a good time to go on vacation this year. I'm not envious. Especially the fact that you were back for ASCO on yesterday morning, but you said you unplugged a little bit. Gabi, you threw your phone in the lake? Yes, metaphorically, and not physically, but yes, I unplugged a little bit and then went up north, and I was super nice. Very good. That would be a very expensive unplug if you literally threw your phone in the lake. Yes, that would not happen unless it was on accident, which has happened before. All right. Well, I guess we should just dive right in. We do have plenty of ASCO to talk about today. It'll keep us busy. Let's get to introductions. Gabi, why don't you go first? Yeah, so I'm Gabi Mason. I'm the senior editor with BioSpace, and I curate our manufacturing brief and our daily newsletter gene pool. Heather? I'm Heather McKenzie. I'm a senior editor at BioSpace, and I put together our clinic space newsletter, which includes ASCO coverage and ADA coverage next week. And I am Emily Armstrong. I am in charge of the BioFarm Executive newsletter, which goes out every Wednesday. And I'm Jeff Axt, managing editor, and with that, let's get right into it. So obviously the top of our show we're really going to be focused on ASCO right now. There were a ton of data coming out of this conference. We'll talk touch on a number of these. But to get started, one of the biggest hype going in was a post-revolution medicine. So they had previewed some data just a month or so ago showing that they're, they're, they're, they're awesome. So this is an asset being developed in pancreatic cancer. I know that's about to say that we got some really exciting results just a couple of months ago when it showed that it would double survival in this really hard treat cancer. So Heather, what can you tell us about revmed at ASCO? Yeah, well, analysts have been absolutely raving about that revmed and directs on this weekend. Every time I looked at my email, it seemed like there was another email from another analyst or another patient group even just talking about the ground breaking outstanding, stunning data. Our writer, Brianna, who covered the event said that the speaker was interrupted for applause several times. But in addition to doubling survival in in phase three trial, revmed presented full data from that trial at ASCO on Sunday. And so in addition to the previous reported survival benefit, directs on nearly tripled the objective response rate compared to chemo. That's quite the result. Certainly, you can tell just by those reactions that people are really impressed with this. Again, this is pancreatic cancer. One of those most devastating diagnoses. I think that the five year survival rate is only around 13%. So this is huge news for that patient community. Yeah, and it's true. This is actually predicting a possible third quarter launch this year for directs on. But I think I think true is right. I think the FDA is not going to sit around on this one, especially with directs on being part of the commissioner's national priority bachelor program. Yeah, that's a good point. And just with all the fanfare surrounding this one that would make a lot of sense to me. But actually, revmed is not alone in working on pancreatic cancer right now. No, they're not. And in the nearing landed another death blow to this terrible disease at ASCO. They presented data showing that. And I do know how to save this one because I've talked to the CEO two times a tablet met anib. Okay, we'll call it a tabby. That's what he calls it. So I added nearly nine months of survival for patients in the first line setting. So just for context, revmed drug is in the second line setting. So I spoke with like I mentioned, down CEO Ben Ziskand, Ziskand last week, who prior to the presentation, it's pretty psyched, you know, about all of the data. But especially the tolerability. So immunaring only observed two categories of grade three or higher treatment related adverse events and at least 10% of participants, which is, which is really good. Tolerability, he said, is not only important for quality of life, but it's also important for survival. If patients are so beat up by the first line therapy, that they can't make it to second line treatment. They have about a 51% increase in the risk of death he told me. That's really interesting and very good to point out first line versus second line. We're not always, you know, immediately looking at that. That's obviously really important for patients and physicians. That immunarne, immunarne story was actually our top performing asco story yesterday, even over revmed. So definitely got a really positive reception as well. Is there another third player in this pink reddit cancer space you're going to touch on Heather? Yeah, so another other player is actually therapeutics and they reported impressive new analysis for their candidate, elravles it. Elavris of in combination with chemo and lozartan led to a nearly seven month improvement in median overall survival in patients with K-RAS wild type genomics. It's really good to see all this movement in the pink reddit cancer space. We'll definitely be watching for these and certainly for a potential approval as soon as this year. So another big storyline going into asco was of course a quesos by specific, bed Jeff PD one by specific. So this is sort of the hot modality in the next generation of immuno oncology to try to replace key true to and all the immuno oncology one point. So this is a queso in China and their US partner summit therapeutics. This is one that we previewed ahead of the weekend. And only what did we learn over the weekend? We learned a lot. I wrote three different stories about this drug. So this was one of the besides revmed. This was like also the I would say co headliner of asco. So yeah, this was a huge another huge presentation from asco. I would say this was the co headliner with revmed. Everybody was awaiting the results for this trial, which was testing Ivan Eskamaab in non small cell lung cancer. The drug delivered when analysts were looking for it reduced the risk of death by about 34%, which is pretty great. But there were many, many questions left about how summit is going to replicate these results in a population that's more representative of the US market. So I was heavily weighted towards young Chinese men who who smoked. So we don't have any information on how this drug will work in older populations where kichuta alone is actually struggled. You know, that was just one of the many caveats that was pointed out by analysts in the wake of these results. So they summit got what they needed out of this readout, but still has a really, really tough climb to kind of prove to everybody that this drug is going to work in the US market. So this was, you know, one of many readouts for the drug that are upcoming summit phase three trial that does feature a broader population is expected to read out later this year. So, you know, hopefully they will get some more they will be able to answer some of these many lingering questions with that readout. Yeah, you can imagine all eyes is going to be on that we talked a bit about that China only versus global they had a little bit of issue with their progression free survival data, which was bangering in China and then was a little bit disappointing when they got to the global study. And so the experts we spoke to ahead of this readout were basically saying they needed another bangering really, really good overall survival because you can maybe expect it to dip a little bit when you get to the global population. So yeah, definitely eager to see those global data. Well, those were the two big headliners at Asco, but there was a lot more so try to run through a few of these certainly can't get through them all today. Definitely check out biospace.com for more Asco coverage. But one that we wanted to talk about a little bit more is Merck and all you covered that one too. Yes, absolutely. So there was a presentation of data on Merck's Keelan biotech partnered truck to directed ADC. It lots of acronyms and cancer jargon in that one. But this one was also pretty exciting. Merck is betting on this asset to help offset key trutus loss of exclusivity, which is about to begin in about two years. In a phase three trial of SAC-TMT, which is what they're calling it, which tested the drug in first line, non-small cell lung cancer in Chinese patients, the overall survival data was very strong. BMO capital markets said the results reinforced the drugs potentially differentiated efficacy. So this is pretty key. Merck has really dominated the cancer world for a very long time, thanks to key truta. But with that drug going off patent, Merck has really been challenged to try to basically create a new pipeline. They have really focused on this ADC SAC-TMT. They face some criticism for putting that kind of at the top of the pyramid while summit and many others are kind of driving into this PD1 and VEGF space. So analysts were kind of worried about whether Merck has kind of picked the right horse. They do have a PD1 VEGF, but it's much earlier than summit. So summit's going to make it to the market first if they do make it to the market. Meanwhile, Merck has really been riding on this chopped to ADC. But analysts say that ASCO kind of helped them prove their case. They're showing that it showed that Merck has kind of laid out a really great long-term plan. All of that data is starting to come out of the clinic and they're starting to see that these drugs are going to make a mark in some of these solid tumors. So I wrote a story about how analysts think that Merck's hard work is finally paying off after all of that. So you can check that out at BioSpace. So basically Merck is going to stay king of oncology for a little while longer at least. Yeah, absolutely. And analysts also said that summit, and Akizos data did not exactly, you know, in the reign of King Ketruda, certainly not yet. Again, we're going to have to see those other readouts. But Ketruda still has some time to go. Absolutely. All right. Well, like I said, there's so much more ASCO. We'll try to cover just a few more here before I move on. Speaking of the PD-1 VEGF space, another readout that we were closely watching was Beontek and BMS' partnered by a specific antibody. Pum-- Pum-- So you guys know this one. Pum-- Pum-- Pumatomic? Pumatomic? I feel like I've heard that one said by one of you much more smoothly. But anyways, that one readout another win. Gilead showed off an ADC from its recent acquisition of tubeless, so potential $5 billion acquisition there that is maybe already starting to show some evidence. But it could pay dividends in the long run. Eli Lilly, not as big a name, typically in the cancer space, but definitely very much involved. They showed off what's called "extra-- what analysts," I should say, called "extra-renary survivor results for its approved retinhibitor retivemo." The company is hoping that this could actually help drive broader testing paradigms into earlier stages of lung cancer for that, again, already approved asset. And then another company with a huge presence at ASCO was Pfizer. So Pfizer showcased data across more than 40 abstracts plus three late breaking sessions and several oral presentations. But it was interesting. Analysts actually gave the impression that, you know, it was all well and good. Some good data there, but they're really much more looking forward to readouts coming up down the line for Pfizer. So check out all of those stories on biospace.com. And last but not least, let's touch briefly on Moderna. Gabby, what can you tell us about Moderna at ASCO? All eyes were kind of on Moderna's personalized cancer vaccine. So for patients with late-stage melanoma, their vaccine combined with ketruda actually halved the risk of death or disease recurrence at five years. So these are mid-stage results. And they also included overall survival increase of 53%, which Jeffery's analysts called encouraging and that the readout builds confidence for pivotal phase three data, which is expected later this year. So analysts at William Blair view that coming readout as quote, one of the largest catalysts in biotech within the next 12 months. In quote. Wow, that's huge. I mean, a personalized mRNA based NLS, mRNA based personalized cancer vaccine. That is huge. That's a huge title. It's Moderna itself too. Absolutely. 100%. And it especially kind of really comes on the tail end of a tough year for Moderna, especially related to their mRNA technology, especially because of RFK juniors, HHS. He promoted a lot of skepticism around vaccines, particularly around mRNA. So because of the kind of changing sentiment in the US, earlier this year, Moderna said they were ending investment in their future vaccine programs for infectious diseases. So clearly it's taken a big toll on their company, but the tides may be turning, given kind of recent concerns of both antivirus and Ebola. So just this week, the coalition for epidemic preparedness innovations announced up to 50 million for Moderna's early stage, Ebola vaccine candidate. So the funding is supposed to help push the program into clinical testing and targets the virus that is currently circulating. And that's in the Congo and Uganda. So Moderna does have other late stage, kind of later stage, Ebola programs in development, but none that target this specific strain. There actually aren't any approved vaccines or even candidates in clinical development that target this type. So that's that's that's pretty big. The mRNA science underpinning this program is also the same that spikebacks Moderna's COVID vaccine was built off. So pretty notable stuff and a lot happening there. Yeah, I remember when they can basically the rest of their infectious disease program and we're going to focus on the cancer side of things. So good to see positive news coming out of the cancer vaccine, but also good to see that they're not totally out of the infectious disease game, especially as these outbreaks are occurring. All right, well, that's your ASCO summary for you. That was a lot, but as I said, there's even more. So definitely check out our website for additional ASCO stories, but moving on now, we want to talk a bit about China. This is obviously an ongoing narrative and bio check these days. And as highlighted by ASCO's presentation on Ivan Eskrab, there's a ton of assets coming out of China. And there's also more and more focus on the data that is being generated for these assets out of China as we talked about are these from Chinese population or from a more global population. So I feel like we're at a time where the industry is learning some pretty hard lessons about the need for this robust global data because pharma is more and more continuing to turn to China to stock their pipelines. So this was really put on display last week when Pfizer offered up to $10.5 billion to assemble a 12 molecule pipeline with China's in-event biologics. One of the really interesting parts of this deal is that four of those assets will actually come from Pfizer. It's not only interesting that Pfizer's throwing these assets into the mix, but what really struck me is how similar this deal is to one made just last month by Bristol Meyer Squibb with another Chinese company, Hangru Pharma. And under the terms of that agreement, BMS will put more than 15 billion on the line to advance a 13 asset pipeline again with four assets from BMS. So definitely some interesting deals coming out of China more and more farmers turning to them for assets, but also in a more collaborative way than just buying them up and taking them on their own. Right, and that's not the only kind of shifting deal dynamic as we talk about these China to big pharma deals. We have a story in bio-farm executive this week that looks at how upfront payments are starting to rise as these Chinese companies become savvier in their deal making. Farmers are also adjusting beyond offering their own assets up as part of the deal. They're also seeking out more platform deals and they're becoming more willing to wait for some later stage data. And I don't when I say that I don't necessarily mean phase three. I'm just saying that the they believe that kind of the low hanging fruit has been picked. They're willing to kind of wait and see how an asset plays out to make sure that they actually have some hard data before they launch into deals. So some really fast moving deal dynamics happening there. So you can check out bio farm executive this week to get more on that. Absolutely. And just more and more money being thrown around. I mean, you commented on the upfront payments and we have seen some of those and you know the $600 million range. But the totals and bio bucks we're seeing now in the multi billion dollar range. So higher and higher deals being struck with China. Well speaking of deal making, we can't go an entire podcast without talking about Eli Lilly and all the deals they're making right now. So no surprise Lee has continued its deal making streak has also turned to China. So this week they struck up a packed worth potentially more than three million, sorry, excuse me, three billion, of course, with high scope pharmaceutical group to collaborate on a clutch of early stage assets across undisclosed indications. And then actually not from China, but just across the L.O.C. and South Korea, Lilly linked up with hand me for a GLP two agonist that's being trialled for short bowel syndrome. So expanding in the metabolic space, but different than the GLP ones that have made it famous. So, and only you reported in late April that Lilly was already on track to set new records this year. I think at that time the company had already put about 21 billion on the line for these transactions. The total is gotta be pushing 30 billion by now. Yes, I as soon as I'm off deadline today going to be redoing my analysis, compiling Lilly's deals, which I did at the end of the first quarter. We had such a trend in those first three months that I wanted to get that on the record. And I mean, now we're. at June 2nd, there's still a whole month to go here. And Lily just won't stop. Like you said, we can't go a whole podcast without talking about Lily. We can't go five minutes without writing a story about Lily around here. So you can check that out next week. In BioFarm Executive, I'll be working on that this afternoon to kind of put that in context with maybe how other big farmers have done deals in the past. Because I think that Lily is breaking some records here. Yes. I mean, certainly their own records, but maybe across farmer as well. Right. When we did the analysis at the end of the first quarter, they had already signed six deals, which was the same as all that they did in 2023, which was the most for 10 years. So this is unprecedented territory, even for Lily. I mean, if you're going to be going into unprecedented territory, hitting that $1 trillion market cap last year, it might as well be setting some other records as well. So it's always, as we've said, I feel like on repeat at this point, it is really nice to see that money being fueled back into the industry. All right. So one last thing to touch on here before you wrap up. As we record this on Tuesday, June 2, it is Luke Garrick's day, which commemorates the life of Yankee Star, Luke Garrick, who died from ALS in 1941. Heather, what's the latest in this space? Yeah. So just to recognize Garrick for a minute, he was one of the all-time baseball greats. He was nicknamed the Iron Horse for his 2,130 consecutive games played. It's not amazing. I love that you jump in this opportunity to talk baseball. Thank you for that. Heather, what's the fun moment for a second? So this is a record that wasn't broken until 1995, when Cal Ripon of the Orioles broke it. But enough about baseball and onto ALS. So I hadn't heard anything about brainstorm South therapeutics or their South Therapy in a while. But then that last week, they popped up again. So they announced that a regulatory veteran who we know quite well here at BIOS Base, Peter Pitts, is joining their board to help out with their next FDA bit. So if you're not familiar with neurons, just a little bit of background, the therapy missed the end point in its phase three trials several years ago. And the FDA recommended they not apply for approval. Then there was a ton of post-talk analysis and brainstorm decided to give it a shot. But then in 2023, an FDA at-com voted overwhelmingly against approval, 17 to 1. So they pulled the BLA and decided to proceed to a phase three B trial. That's all in a very small nutshell. So last week, brainstorm CEO, Haim Levevitz, told me that the company is in a better place financially than they were a year ago. But there's still a waiting final funding to start that trial. So notably, this is interesting. Pitts has been a vocal critic of brainstorm in the past around the company's expanded access program. But apparently, they have convinced him that they are very patient-centric, and they are not counter-telling to investors anymore. Yeah, I remember that. He took issue with the fact that the company was trying to charge for this experimental treatment through the expanded access program. I actually-- I reported on a different ALS therapy over a decade ago at this point. But I remember having a lot of discussions over these around these expanded access programs. And it's just a really hard place for a company. They want-- even when they are doing everything right, trying to push patients first, they want patients to have access to these drugs. The risk is that they'll be a safety event in one of these expanded access programs. I could derail the whole drug development program, and then a potentially promising candidate would never make it to market, or would actually help the most amount of patients. So I feel like each one of these is a case by case basis. I'm sure pits and brains where I'm talked it out. And whether they may change this, or he just better understands it, it's good to see that they have an ally now as they go back to potentially to the FDA to push this treatment forward. It's one of those many neurological diseases that has got huge unmet need. I mean, ALS is-- we were talking about pancreatic cancer. I feel like I would put pancreatic cancer and ALS together in the same breath with one of the worst diagnoses you can receive. Which I think is why I've jumped on coverage of both. It's actually interesting that you mentioned that kind of dilemma that companies have with the expanded access programs, because one of the first stories that I wrote about biospace had to do with the drug that eventually became biogenes calcote. And a woman who was trying to get access to it. And then she did eventually get access. But then she succumbed to the disease. And yeah, sister, it was one of those really, really ethical thorny stories that I find so interesting. It really is. The one I was reporting I'm back in the day, MPO1. It's changed hands a few times back then. Like I said, over 10 years ago, it was with neurologists and the patients who were either in the early phase trial or were too advanced to even get in that. But after that trial ended, everyone wanted access. And so they did this research. They figured out what the drug was made of. They ordered the ingredients online. They were testing themselves and recording the data. So I was reporting on it in that context of this DIY medicine. But it just goes to illustrate the desperation in this patient population and the need to access these experimental treatments as soon as possible. And then you need to get them to market as soon as possible. Yeah, hopefully a brainstorm will come up with the funds soon. Love it. So they're waiting on final funds. So hopefully we see that. That's starting soon. Absolutely. All right. Well, with Asco wrapping up, we are now looking ahead to next week and already when the 2026 American Diabetes Association or ADA for short, will kick off in New Orleans. So we of course expect to see the two giants, Eli Lilly and Nova Nordics. Lilly will elaborate on recent data for its next gen obesity asset, Retatcha Tried. Retrat true time. Really stumbling over drug names today. I think I got that one close. Retratide. It's close. Yeah. And then I'm saying again, the handling. Retat Trotide. Retat Trotide. I'm going to practice that one because that's one. I think we're going to be hearing a lot more about what we're talking about a lot more on the podcast. So that'll be coming from Lilly. And then rival Nova Nordic will present on its own next gen candidate, Kagrasemma. Hey, I love Nova today for giving me an easy to pronounce drug name. Kagrasemma actually has been a bit overshadowed of late. It failed to best Lilly's that bound in a Nova sponsored trial earlier this year. So it'll be good to see what Nova has to say about it now. And then of course, those are the two with the duopoly on the market currently. But there are plenty of others trying to break into the space. We expect updates at ADA from O'Ringard, Angloheim, along with their partners, Yilan Farma, plus Roche, Structured Therapeutics, and Viking Therapeutics, just to name a few. So once again, stay tuned to BioSpace for all of those updates. And thanks for listening. We'll see you next week. [MUSIC PLAYING]