MERCK? REALLY???
There is a lot of speculation--mostly on the other boards, but echoed here--about how Merck is the company behind the recent NDA-inspired radio silence from Cytodyn. Taking a look at their oncology pipeline and recent investments, I'd say probably not. Now anything can happen, and there might be a creeper acquisition going on right this minute... But Merck taking Cytodyn to the Big Dance? Don't hold your breath...
A few years back Merck paid some $4 billion upfront to Diiachi Sankyo for the right to co-develop three ADcs in oncology (with up to $22 billion if they hit all milestones). More recently they acquired Harpoon Therapeutics and their T-cell Engagers for $680 million. Another deal for $1 billion-plus with the China biotech Kelun brought them more ADCs (with one trialed in TNBC). They also have recently paid billions for cardiovascular and pulmonary drugs as a way to diversify their income away from Keytruda (Prometheus and Verona--about $10 billion for each).
And do you think they are sitting things out while others race to find ways to turn cold tumors hot? There are some 1600 trials going on involving Keytruda... For a while, oncolytic viruses seemed to be the answer. And early STING agonists (Stimulator of Interferon Genes) did and still do hold promise. But Merck has discontinued trials for these early approaches, while continuing work on second-generation STING agonists. They also have partnered with Moderna to develop a cancer vaccine that is being tested with Keytruda in melanoma. And of course they are developing sub-Q Keytruda (PDUFA date Sept 23rd). I'd say they have their hands pretty full.
The question is--with all this investment and development in their oncology franchise, is there reason to believe they would come creeping around Cytodyn with $100 million? Especially when Cytodyn's evidence is based on literally a handful of patients who actually received both leronlimab and an ICI? And perhaps you may have forgotten, but Merck owned (and still does) a CCR5 inhibitor they studied in cancer. They bought out Schering-Plough and received vicriviroc back in 2009. After scrapping the drug for HIV, they combined it with Keytruda in a Phase II trial in metastatic CRC (MSS/pMMR). The Overall Response Rate was 5%!! So it flamed out and they discontinued development. Think they are going to dive back into CCR5 again?
Merck does collaborate with a small biotech (an Aussie company whose share-price, like Cytodyn, is in the pennies) with a LAG-3 inhibitor in oncology. Their combo data--in NSCLC and Head and Neck cancer--is far superior to Keytruda monotherapy, especially in patients with negative PD-L1 expression (TPS<1%). Their numbers are so good they will--probably--become the new standard-of-care in those indications. (Watch out Summit!). They started a Phase III in lung cancer earlier this year, so we will know in a couple years. Unless of course the numbers hold up in those patients with negative PD-L1 expression--which might lead to accelerated approval or stopping the trial for overwhelming efficacy in a patient population with unmet needs.
Now this should be headline news, right? But nothing from BioSpace or any other respectable (I'm holding my nose here) journals as far as I can tell/smell. Most telling, haven't heard a peep lately from Merck. In fact Merck didn't even do a licensing deal with my Aussie friends; they just supply the drug and don't even have a marketing agreement with them. (To be charitable, perhaps Merck is waiting for a DSMB review that is scheduled for late Q4 25 or early Q1 26, and they will buy them out when they pass). But--if Merck is not willing to put out some cash for a LAG-3 immuno-therapy drug with great numbers in 2 completed Phase II clinical studies--why do you think they would put out $100 million for leronlimab on the basis of five patients?
You can find out about all my Aussie friends at Immutep.com. Usually I would footnote all this, but I can't figure out how to do it on this website (!!!). If a mod can DM me with some very detailed directions--as if you were speaking to a four year old child--then I would be happy to footnote this kind of material in future posts.
One more comment--Merck is headquartered in New Jersey, right? That is not in Europe, as I understand. And plenty of people made the Tyler Block--Europe connection when that news broke... Like, Mr Block wouldn't be going to Europe unless there was a good reason. So that kind of thinking also suggests a Big Pharma from the USA is not our suitor/savior. But what do I know? Maybe leronlimerck is just around the corner and I didn't see it coming...
Well, while I'm at it--playing with words I mean--why not Merck KGaA? Honestly, I'd say the Euro-Merck would be more likely than Jersey-Merck. And better for Cytodyn. On this side of the pond we'd always always always be second fiddle to Keytruda. But with KGaA we'd be the Euro-Star... and have a nice new PD-L1 playmate. We just might be taking avelumab to the Big Dance sometime this fall! But we must keep our options open... in case a nicer ICI comes along with a better deal. Best hurry though. The data is maturing fast...
There is a lot of speculation--mostly on the other boards, but echoed here--about how Merck is the company behind the recent NDA-inspired radio silence from Cytodyn. Taking a look at their oncology pipeline and recent investments, I'd say probably not. Now anything can happen, and there might be a creeper acquisition going on right this minute... But Merck taking Cytodyn to the Big Dance? Don't hold your breath...
A few years back Merck paid some $4 billion upfront to Diiachi Sankyo for the right to co-develop three ADcs in oncology (with up to $22 billion if they hit all milestones). More recently they acquired Harpoon Therapeutics and their T-cell Engagers for $680 million. Another deal for $1 billion-plus with the China biotech Kelun brought them more ADCs (with one trialed in TNBC). They also have recently paid billions for cardiovascular and pulmonary drugs as a way to diversify their income away from Keytruda (Prometheus and Verona--about $10 billion for each).
And do you think they are sitting things out while others race to find ways to turn cold tumors hot? There are some 1600 trials going on involving Keytruda... For a while, oncolytic viruses seemed to be the answer. And early STING agonists (Stimulator of Interferon Genes) did and still do hold promise. But Merck has discontinued trials for these early approaches, while continuing work on second-generation STING agonists. They also have partnered with Moderna to develop a cancer vaccine that is being tested with Keytruda in melanoma. And of course they are developing sub-Q Keytruda (PDUFA date Sept 23rd). I'd say they have their hands pretty full.
The question is--with all this investment and development in their oncology franchise, is there reason to believe they would come creeping around Cytodyn with $100 million? Especially when Cytodyn's evidence is based on literally a handful of patients who actually received both leronlimab and an ICI? And perhaps you may have forgotten, but Merck owned (and still does) a CCR5 inhibitor they studied in cancer. They bought out Schering-Plough and received vicriviroc back in 2009. After scrapping the drug for HIV, they combined it with Keytruda in a Phase II trial in metastatic CRC (MSS/pMMR). The Overall Response Rate was 5%!! So it flamed out and they discontinued development. Think they are going to dive back into CCR5 again?
Merck does collaborate with a small biotech (an Aussie company whose share-price, like Cytodyn, is in the pennies) with a LAG-3 inhibitor in oncology. Their combo data--in NSCLC and Head and Neck cancer--is far superior to Keytruda monotherapy, especially in patients with negative PD-L1 expression (TPS<1%). Their numbers are so good they will--probably--become the new standard-of-care in those indications. (Watch out Summit!). They started a Phase III in lung cancer earlier this year, so we will know in a couple years. Unless of course the numbers hold up in those patients with negative PD-L1 expression--which might lead to accelerated approval or stopping the trial for overwhelming efficacy in a patient population with unmet needs.
Now this should be headline news, right? But nothing from BioSpace or any other respectable (I'm holding my nose here) journals as far as I can tell/smell. Most telling, haven't heard a peep lately from Merck. In fact Merck didn't even do a licensing deal with my Aussie friends; they just supply the drug and don't even have a marketing agreement with them. (To be charitable, perhaps Merck is waiting for a DSMB review that is scheduled for late Q4 25 or early Q1 26, and they will buy them out when they pass). But--if Merck is not willing to put out some cash for a LAG-3 immuno-therapy drug with great numbers in 2 completed Phase II clinical studies--why do you think they would put out $100 million for leronlimab on the basis of five patients?
You can find out about all my Aussie friends at Immutep.com. Usually I would footnote all this, but I can't figure out how to do it on this website (!!!). If a mod can DM me with some very detailed directions--as if you were speaking to a four year old child--then I would be happy to footnote this kind of material in future posts.
One more comment--Merck is headquartered in New Jersey, right? That is not in Europe, as I understand. And plenty of people made the Tyler Block--Europe connection when that news broke... Like, Mr Block wouldn't be going to Europe unless there was a good reason. So that kind of thinking also suggests a Big Pharma from the USA is not our suitor/savior. But what do I know? Maybe leronlimerck is just around the corner and I didn't see it coming...
Well, while I'm at it--playing with words I mean--why not Merck KGaA? Honestly, I'd say the Euro-Merck would be more likely than Jersey-Merck. And better for Cytodyn. On this side of the pond we'd always always always be second fiddle to Keytruda. But with KGaA we'd be the Euro-Star... and have a nice new PD-L1 playmate. We just might be taking avelumab to the Big Dance sometime this fall! But we must keep our options open... in case a nicer ICI comes along with a better deal. Best hurry though. The data is maturing fast...
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