I suspect the successful trial for the Merck/Moderna cancer vaccine will probably be the final nail in the coffin for those hoping Merck will come in and buy out Cytodyn. Merck has been doing quite a bit to prepare for the famous “patent cliff” that it faces in 2028. Let’s take a quick look at what they’ve added recently—including other therapeutic areas like infectious diseases and immunology, as well as oncology—to see why they would pass on Cytodyn.
First, though, a huge multi-national Big Pharma like Merck can’t just pick up a new drug and run with it… just because outsiders like us think/know it will work exceptionally well. They have a great deal of institutional momentum—as well as billions of dollars—invested in their pipeline. Think about the egos in the C-suite, and the reputations/jobs on the line for those executives who argue for or against a particular acquisition. Every acquisition or licensing deal has it’s own contingent of supporters behind it, all invested in the choices they argued and fought for. There are something like 1800 clinical trials going on with Keytruda right now (according to Merck). Just in oncology, that is a great deal of freight moving forward, already budgeted and accounted for. And executives in corporations tend to get in line when consensus is achieved; they tend to close ranks and move forward with conviction. That can lead to group-think, with expectations already banked before trials are done. What are the hot oncology drugs these days? Bi-specifics! ADCs! Not CCR5-inhibitors… Even if Merck expressed interest, where would we fit in their developmental timeline? And what would the Bio/Pharma press say if Merck did a deal with a sketchy outfit like Cytodyn, when other CCR5 inhibitors didn’t do shit in earlier trials?
The big tell for me was they didn’t pursue Revolution Medicines a short while back, even though they have an exceptional cancer drug. They didn’t want to overpay, apparently. Why would they bother with a small biotech like Cytodyn, with hardly any data in cancer, even though the data available is pretty great…
Merck has huge hopes for sac-TMT, acquired in 2022 from Kelun Biotech for $1.4 billion, as they aced a Phase 3 trial in endometrial cancer recently (at an interim look, no less). They have 17 global Phase 3 trials planned for the drug in the next few years (!) financed by a 700 million dollar funding agreement with Blackstone Life Sciences (Blackstone gets a low-to-mid single-digit royalties for their 700 million). And Merck built upon the Kelun agreement with a separate 9.3 billion dollar pact for 7 additional ADCs. Talk about institutional freight and weight and momentum! NSCLC is the first big indication there…
In Small Cell Lung Cancer Merck has MK-6070 from Harpoon Therapeutics, bought for $680 million in 2024, moving into Phase 3 studies. In Myleoproliferative Neoplasms they have Bomedemstat from Imago BioSciences, bought for $1.35 billion in 2023, in a Phase 2b/3 trial. And this year they bought Terns Pharmaceuticals for $6.7 billion, a Phase 2 drug with a Breakthrough Designation for CML. That is $19.38 billion in oncology investments alone (including bio-bucks based on milestones achieved, just to be clear).
Add to these oncology assets an approved COPD drug (ensifentrine) they acquired when they bought Verona Pharma ($10 billion/2025). Same goes for Winrevair for pulmonary arterial hypertension ($11.5 billion/2021). And MK-7240, from Prometheus Biosciences, just passed a Phase 3 trial in UC and Crohn’s disease ($10.8 billion). Last but not least, the Cidara acquisition gave them a Phase 3-ready antiviral for influenza prophylaxis (CD288) as well as a preclinical CCR5 inhibitor in preclinical studies ($9.2 billion/2026). They expect CD388 and Winrevair to be blockbusters. Along with sac-TMT of course. So Merck has spent $60 billion in combined oncology and non-oncology acquisitions… In the last 5 years! Gotta expect a few blockbusters for that kind of money I guess.
The above doesn’t even include the approval of Keytruda Qlex, which covers a significant amount of the expected patent cliff losses. I’d say Merck has done pretty well for themselves, all told. Without Leronlimab in the mix!
But there are a couple avenues that might make sense for Merck to get in the act and make a play for leronlimab. The first is that Merck doesn’t have much in the way of colorectal cancer assets. With great results for leronlimab in mCRC, Merck could conceivably spend a few billion in bio-bucks to license (or more to buy) a Phase 3-ready asset they would put to work rather quickly as part of a new SOC. And then, they could develop the ICI/leronlimab combo at their leisure… Or develop it more aggressively if they thought it would fit into their Big Picture plans.
One of Merck’s marketing executives might get all hot and bothered about the revolutionary possibilities that two effective cancer therapeutics, delivered subcutaneously, might have on the cancer treatment paradigm. That would be a far-thinking executive… but he or she might be out there. And they could easily be at BMS, or Roche… because, along with Merck, all three have a subcutaneous ICI. In fact, apparently Hoffman recently said they have a commitment from some un-named Big Pharma to provide an ICI for the proposed TNBC trial. If it turns out to be BMS, or Roche, or Merck, and they use a sub-q ICI in Cytodyn’s trial, and position themselves as “the future” of cancer care via a subcutaneous cure and/or long-term cancer management… well, that would be very significant. It would demonstrate to me that whatever company it is, they are serious about taking full advantage of Leronlimab’s strengths, and share a vision for patient-friendly cancer therapeutics. In other words, they would be all-in with Leronlimab and an ICI as the sub-q future… and they would market it that way, and wouldn’t be tempted to slow-walk development to preserve existing capital commitments. It would be an important tell that would make me take that company very seriously as a partner or owner… even if it was Merck, finally coming to their senses.
Hey, even if Merck doesn’t pull the trigger, I hope they are in the boardroom as negotiations progress. They would probably read the room and bid up the price, just to stick it to BMS or Roche or whoever… even if they didn’t really want the asset. I’d be okay with that!
By the way, I’m not really sold on the personalized Merck/Moderna cancer vaccine. Too expensive, works only to prevent recurrence after surgery… I mean, it's great for high-risk melanoma patients... But I think it will take a great deal of additional extensive development... Because Leronlimab (with or without an ICI or chemo?) does essentially what the cancer vaccine does—mobilize the immune system to search and destroy. And it takes down the defensive stroma tumors shield themselves with. And it revitalizes the immune system to prevent remission/recurrence. And it is off the shelf. I’ll write more about this some other time.
For now, I'll say good bye, Merck. I wish I could say it's been real...
First, though, a huge multi-national Big Pharma like Merck can’t just pick up a new drug and run with it… just because outsiders like us think/know it will work exceptionally well. They have a great deal of institutional momentum—as well as billions of dollars—invested in their pipeline. Think about the egos in the C-suite, and the reputations/jobs on the line for those executives who argue for or against a particular acquisition. Every acquisition or licensing deal has it’s own contingent of supporters behind it, all invested in the choices they argued and fought for. There are something like 1800 clinical trials going on with Keytruda right now (according to Merck). Just in oncology, that is a great deal of freight moving forward, already budgeted and accounted for. And executives in corporations tend to get in line when consensus is achieved; they tend to close ranks and move forward with conviction. That can lead to group-think, with expectations already banked before trials are done. What are the hot oncology drugs these days? Bi-specifics! ADCs! Not CCR5-inhibitors… Even if Merck expressed interest, where would we fit in their developmental timeline? And what would the Bio/Pharma press say if Merck did a deal with a sketchy outfit like Cytodyn, when other CCR5 inhibitors didn’t do shit in earlier trials?
The big tell for me was they didn’t pursue Revolution Medicines a short while back, even though they have an exceptional cancer drug. They didn’t want to overpay, apparently. Why would they bother with a small biotech like Cytodyn, with hardly any data in cancer, even though the data available is pretty great…
Merck has huge hopes for sac-TMT, acquired in 2022 from Kelun Biotech for $1.4 billion, as they aced a Phase 3 trial in endometrial cancer recently (at an interim look, no less). They have 17 global Phase 3 trials planned for the drug in the next few years (!) financed by a 700 million dollar funding agreement with Blackstone Life Sciences (Blackstone gets a low-to-mid single-digit royalties for their 700 million). And Merck built upon the Kelun agreement with a separate 9.3 billion dollar pact for 7 additional ADCs. Talk about institutional freight and weight and momentum! NSCLC is the first big indication there…
In Small Cell Lung Cancer Merck has MK-6070 from Harpoon Therapeutics, bought for $680 million in 2024, moving into Phase 3 studies. In Myleoproliferative Neoplasms they have Bomedemstat from Imago BioSciences, bought for $1.35 billion in 2023, in a Phase 2b/3 trial. And this year they bought Terns Pharmaceuticals for $6.7 billion, a Phase 2 drug with a Breakthrough Designation for CML. That is $19.38 billion in oncology investments alone (including bio-bucks based on milestones achieved, just to be clear).
Add to these oncology assets an approved COPD drug (ensifentrine) they acquired when they bought Verona Pharma ($10 billion/2025). Same goes for Winrevair for pulmonary arterial hypertension ($11.5 billion/2021). And MK-7240, from Prometheus Biosciences, just passed a Phase 3 trial in UC and Crohn’s disease ($10.8 billion). Last but not least, the Cidara acquisition gave them a Phase 3-ready antiviral for influenza prophylaxis (CD288) as well as a preclinical CCR5 inhibitor in preclinical studies ($9.2 billion/2026). They expect CD388 and Winrevair to be blockbusters. Along with sac-TMT of course. So Merck has spent $60 billion in combined oncology and non-oncology acquisitions… In the last 5 years! Gotta expect a few blockbusters for that kind of money I guess.
The above doesn’t even include the approval of Keytruda Qlex, which covers a significant amount of the expected patent cliff losses. I’d say Merck has done pretty well for themselves, all told. Without Leronlimab in the mix!
But there are a couple avenues that might make sense for Merck to get in the act and make a play for leronlimab. The first is that Merck doesn’t have much in the way of colorectal cancer assets. With great results for leronlimab in mCRC, Merck could conceivably spend a few billion in bio-bucks to license (or more to buy) a Phase 3-ready asset they would put to work rather quickly as part of a new SOC. And then, they could develop the ICI/leronlimab combo at their leisure… Or develop it more aggressively if they thought it would fit into their Big Picture plans.
One of Merck’s marketing executives might get all hot and bothered about the revolutionary possibilities that two effective cancer therapeutics, delivered subcutaneously, might have on the cancer treatment paradigm. That would be a far-thinking executive… but he or she might be out there. And they could easily be at BMS, or Roche… because, along with Merck, all three have a subcutaneous ICI. In fact, apparently Hoffman recently said they have a commitment from some un-named Big Pharma to provide an ICI for the proposed TNBC trial. If it turns out to be BMS, or Roche, or Merck, and they use a sub-q ICI in Cytodyn’s trial, and position themselves as “the future” of cancer care via a subcutaneous cure and/or long-term cancer management… well, that would be very significant. It would demonstrate to me that whatever company it is, they are serious about taking full advantage of Leronlimab’s strengths, and share a vision for patient-friendly cancer therapeutics. In other words, they would be all-in with Leronlimab and an ICI as the sub-q future… and they would market it that way, and wouldn’t be tempted to slow-walk development to preserve existing capital commitments. It would be an important tell that would make me take that company very seriously as a partner or owner… even if it was Merck, finally coming to their senses.
Hey, even if Merck doesn’t pull the trigger, I hope they are in the boardroom as negotiations progress. They would probably read the room and bid up the price, just to stick it to BMS or Roche or whoever… even if they didn’t really want the asset. I’d be okay with that!
By the way, I’m not really sold on the personalized Merck/Moderna cancer vaccine. Too expensive, works only to prevent recurrence after surgery… I mean, it's great for high-risk melanoma patients... But I think it will take a great deal of additional extensive development... Because Leronlimab (with or without an ICI or chemo?) does essentially what the cancer vaccine does—mobilize the immune system to search and destroy. And it takes down the defensive stroma tumors shield themselves with. And it revitalizes the immune system to prevent remission/recurrence. And it is off the shelf. I’ll write more about this some other time.
For now, I'll say good bye, Merck. I wish I could say it's been real...
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