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

Transcript

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

• BioSpace Marketing: Yeah. Spaces the Weekly. Today we'll get you up to speed on the biggest news coming out of the American Society of Clinical Oncology, or ASCO, in Chicago. These included PACT plenaries from Revolution Medicines and Summit Therapeutics Chinese partner Aquiso, plus much more. Outside of ASCO, the past week saw Pfizer strike an unusual pact with China's Innovation. And it's actually reminiscent of a recent deal from BMS and Hangrupharma, 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 its GLP one windfall. Let's get started. Hello everyone. Y'all surviving the Asco rush? Just barely. It has been wild 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. You seem to have made a definite comeback and 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 gonna get return on their investment. Absolutely. Yeah. I always love Asco. ⁓ but I think I went on vacation and I I think I chose a good time to go on vacation this year. I'm not envious. Well, especially the fact that you were back for ASCO on yesterday morning. But ⁓ but you said you you unplugged a little bit. ⁓ Gabby, you threw your phone in the lake, did you? 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 son in the leg. 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. Gabby, why don't you go go first? Yeah, so I'm Gabby Mason. ⁓ I'm the senior editor in with Biospace and I Curate our manufacturing brief and our daily newsletter, Gene Poole. Heather? I'm Heather Mackenzie. I'm a senior editor at Biospace, and I put together our Clinica Space newsletter, which includes ASCO coverage and ADA coverage next week. And I am Annalee 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 ta touch on a number of these. ⁓ but to get started, one of the biggest hype going in was of course Revolution Medicines. So they had previewed some data just ⁓ a month or so ago showing that they their their asset, their accent. So this is an asset being developed in pancreatic cancer. And I was I was about to say that we got some really exciting results just a couple of months ago when it showed that it would doubled survival in this really hard to treat cancer. So, Heather, what can you tell us about RevMed at ASCO? Yeah, well, analysts have been absolutely raving about ⁓ about RevMed and Diraxon ⁓ this weekend. They ⁓ every time I looked at my email, it seemed like there was another email from another analyst or or another patient group even just talking about the the groundbreaking, outstanding. stunning data. ⁓ Our our writer, ⁓ Brianna, who covered the event, ⁓ said that the ⁓ the speaker was interrupted for applause several times. ⁓ but in in addition to ⁓ it doubling survival in in a phase three trial, RevMed presented full data from that trial ⁓ at ASCO on Sunday. and so in addition to the previously reported survival benefit, ⁓ Diracan 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 thirteen percent. So this is huge news for that patient community. Yeah. And and truist is actually predicting a possible third quarter launch this year ⁓ for Duraxon. ⁓ I think I think Trist is right. I think the FDA is not gonna sit around on this one, ⁓ especially ⁓ with Draxon being part of the Commissioner's national priority voucher 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, Red Med is not alone in working on pancreatic cancer right now. No, they're not. And ⁓ Imioneering ⁓ landed another death blow to this terrible disease ⁓ at at ASCO. They presented data showing that, ⁓ and I do know how to say this one because ⁓ I've talked to the CEO two times, a te ⁓ a Tebidmetnib. Okay, we'll call it a TEBI, that's what he calls it. ⁓ added ⁓ nearly nine months of survival for patients in the first line setting. ⁓ so just for context, ⁓ Revmin's drug is in the second line setting. ⁓ so I spoke with ⁓ Like I mentioned, ⁓ CEO Ben Ziskand, ⁓ Zeskind last week, who ⁓ prior to the presentation, I think was pretty psyched, you know, about all of the data, but especially the tolerability. ⁓ so embuneering only observed two categories of grade three or higher treatment related adverse events in 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 fifty-one percent 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, but that's obviously really important important for patients and and physicians. ⁓ that immunoneering immuneering story was actually our top performing ASPO story yesterday, even over RevMed. So definitely got a really positive reception as well. ⁓ is there another a third player in this pancreatic cancer space you're gonna touch on, Heather? Yeah, so another another player is Actuate Therapeutics. ⁓ and they reported impressive new analysis ⁓ for their candidate, El Raglysub. Lacrasiv in combination with chemo and losartin, ⁓ led to a nearly seven month improvement in median overall survival in patients with ⁓ KRAS wild type genomics. Really good to see all this movement in the pancreatic cancer space. ⁓ we'll definitely be watching for these and certainly for a potential approval as as soon as this year. So another big storyline going into ASCO was of course a Kiso's Bispecific Veg FPD1 bispecific. So this is sort of the hot modality in the next generation of immuno oncology to try to replace ketruda and all the immuno oncology 1.0. ⁓ so this is a Kiso ⁓ in China and their US partner Summit Therapeutics. This is one that we previewed ⁓ ahead of the weekend. Annalie, 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 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-highlig co-headliner ⁓ with RevMed. ⁓ everybody was awaiting ⁓ the results ⁓ for this trial, ⁓ which was ⁓ testing Ivan Escomab in ⁓ non-small cell lung cancer. so the drug delivered what 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 this trial 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 quiet alone has actually struggled. you know, that was just one of the many caveats that was ⁓ pointed out by analysts in in the wake of these results. So They Summit got what they needed out of the 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 this drug that are upcoming. ⁓ Summit's phase three trial that does feature a broader population is expected to readout 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 gonna be on that. We 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 bangarang 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 basic basically saying they needed another bang orang, 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. Mm-hmm. Well, those were the two big headliners at ASCO, but there was a lot more. So we'll try to run through a few of these. Certainly can't get through them all today. Definitely check out biospace.com for for more ASCO coverage. But one that we wanted to talk about a little bit more is Merck. Annalie, you covered that one too. Yes, absolutely. So ⁓ there was a presentation of data on Merck's Keelan biotech partnered Trop 2 Directed ADC. Sorry, 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 Keytruda's loss of exclusivity, which is about to begin ⁓ in about two years. So, in a phase two 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 drug's potentially differentiated efficacy. So this is pretty key. Merck has really dominated the cancer world for a very long time, thanks to Keytruda. 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 faced 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 VEG F state or ⁓ 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 Mark markets ⁓ first if they do make it to the market. Meanwhile, Merck has really been riding on this ⁓ TROP 2 ADC. But analysts say that ASCO kind of helped them prove their case. ⁓ they're showing that or 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 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 you know, ⁓ analysts also said that the Summits, Summit and Aquizo's data did not exactly ⁓ you know, end the reign of King Kitruda. Certainly not yet. Again, we're gonna have to see those other readouts, but Keytruda still has ⁓ some time to go. Absolutely. All right. Well like I said, there's so much more to ask. I will try to cover just a few more here before we move on. ⁓ speaking of the PD one bed jess space, another readout that we were closely watching was Beyond Tech and BMS's partnered by specific antibody Pum Pumit you guys know this one. Pumatamig? Pumatamig Pimatomic okay. I feel like I've heard that one said by one of you much more smoothly. But, anyways, that one right out, another win. Gilead showed off an ADC from its recent acquisition of tubulus, so potential $5 billion acquisition there. That is maybe already starting to show some evidence that 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 analyst, I should say, called extraordinary survival results for its approved ret inhibitor, Retivmo. ⁓ 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 Keytruda actually have to the risk of death or disease recurrence at five years. So the these are mid-stage results and they also included overall survival increase of 53%, which Jeffries 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 upcoming readout as quote one of the largest catalysts in biotech within the next twelve months. End quote. Wow, that's huge. I mean, a personalized mRNA based, no less, mRNA-based personalized cancer vaccine. That is huge. That's a huge catalyst for Moderna itself, too. Absolutely. A hundred percent. And it especially kind of really comes on the tail end of a a ⁓ tough year for Moderna, especially related to their mRNA technology. ⁓ especially because of RFK Junior's HHS. ⁓ he promoted a lot of skepticism around vaccines, particularly around RNA. 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 hantavirus and Ebola. So just this week, the Coalition for Epidemic Preparedness and 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 Spike Vax, 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 gonna 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 in biotech these days. And as highlighted by ASCO's presentation on Ivan Esc Nab, 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 a 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 innovate 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 a these assets into the mix, but what really struck me is how similar this deal is what to one made just last month by Bristol Meyer Squibb with another Chinese company, Hangru Pharma. Under 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 Biofarm Executive this week that looks at how upfront payments are starting to rise as these Chinese companies become savvier in their deal making. Pharmers 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 pep becoming more willing to wait for some later stage data. And I don't I 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 Biofarm 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 in, you know, the six hundred million dollar range. But the totals in 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, Lily has continued its deal making streak, has also turned to China. So this week they struck up a a pact worth potentially more than three million, sorry, excuse me, three billion, of course, ⁓ with HISCO Pharmaceutical Group to collaborate on a clutch of early stage assets across undisclosed indications. And then actually not from China, but just across the Yellow Sea in South Korea, Lily linked up with Han-Me for a GLP two agonist that's being trialed for short bowel syndrome. So expanding in the metabolic space, but different than the GLP ones that have made it famous. So Annalie, you reported in late April that Lily 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. That total has got to be pushing 30 billion by now. Yes, I as soon as I'm off deadline today. Going to be redoing my analysis, ⁓ compiling Lily's deals, which I did at the end of the first quarter. We had such a trend in those first three months that I I wanted to get that ⁓ on the record. And I mean, now we're we're at June 2nd. There's still, you know, a whole month to go here and Lily is j they just won't stop. Like you 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 the on that this afternoon ⁓ to kind of put that in context with maybe how other ⁓ big pharmas 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 pharma as well. Right. When we 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 ⁓ unprecedented territory even for Lily. I mean, if you're gonna be going into unprecedented territory, hitting that one trillion dollar market cap last year, you know what? 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 we wrap up. As we record this on Tuesday, June second, it is Lou Gehrig's Day, which commemorates the life of Yankee s a Yankee star Lou Gehrig, who died from ALS in nineteen forty one. Heather, what's the latest in this space? Yeah, so just to ⁓ to just to recognize Gehrig for a minute. ⁓ he was ⁓ one of the all time baseball greats. He was nicknamed the Iron Horse, ⁓ for his ⁓ two thousand one hundred and thirty consecutive games played. Isn't that amazing? ⁓ I love that you jumped on this opportunity to talk baseball. Thank you for that, Snap Heather. so this is a record that wasn't broken until nineteen ninety-five when Cal Ripkin of the Orioles broke it. ⁓ but enough about baseball and on to ALS. so I hadn't heard anything about brainstorm cell therapeutics or their cell therapy neuron in a while. ⁓ but then that last week they popped up again. ⁓ so they announced that ⁓ a regulatory veteran whom we know quite well here at Biospace, ⁓ Peter Pitts, is joining their board to help out with their next FDA bid. ⁓ so if you're not familiar with neurone, just a little bit of background, ⁓ the the therapy missed the f missed the endpoint in its phase three trial several years ago, and the FDA recommended they not apply for approval. ⁓ then there was a ton of post hoc 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 3B trial. That's all in a very small nutshell. ⁓ so last week, ⁓ brainstorm CEO Haim Levovitz told me that they're that the company is in a better place financially than they were a year ago, but they're still awaiting ⁓ final funding to start that trial. So notably, ⁓ and 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 ⁓ that they are very patient-centric and and they are not ⁓ you know kowtowing to investors anymore. Yeah, I remember that. He took issue with the fact that the company was trying to charge for this exp 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 You know, 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 there'll be a safety event in one of these expanded access programs that could derail the whole drug development program and then a potentially promising candidate would never make it to market where 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 Pitts and Brainstorm talked it out, and you know, whether they made changes 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 this treatment forward. It's one of those many neurological diseases that is 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. I 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 at Biospace. had to do with the drug that eventually became ⁓ Biogens Cal Sodi and and a woman who was trying to get access to it and then she did eventually get access, but then she she succumbed to to the disease. And ⁓ yeah, it's just it was one of those really, really ethical, thorny ⁓ stories that I that I find so interesting. It really is. The one I was reporting on back in the day, MPO one, it's changed hands a few times. Back then, like I said over ten years ago, it was with Neuraltis. And the patients who are either in the f 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 the need to get them to market as soon as possible. Yeah. Hopefully Brainstorm will come up with the funds soon. ⁓ Lovabeth said 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 weekend 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. ⁓ Lily will elaborate on recent data for its next gen obesity asset, Ratatride. Retratrutide. I'm really stumbling over drug names today. I think I got that one close. Retructride. It's close, yeah. And then ⁓ Say it again, Annalee. Retatritide. Retatride. I'm gonna practice that one because that's one I think we're gonna be hearing a lot more about. We'll be talking about it a lot more on the podcast. So that'll be coming from Lily, and then Rival Novo Nordisk will present on its own next gen candidate Kagrasema. Hey, I love Novo today for giving me an easy-to-pronounce drug name. ⁓ Kag Ricema actually has been a bit overshadowed of late. It failed to best Lily Zetbound in a Novo sponsored trial earlier this year, so it'll be good to see what Nova has to say about it now. And then, of course, you know, 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 Boeing or Engleheim, along with their partner, Zealand Pharma, ⁓ plus Roche, Structure 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.