ohm, I apologize if this has already been addresse
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Posted On: 05/24/2024 7:21:29 AM
ohm, I apologize if this has already been addressed or answered, but I'd like your opinion regarding the proposed mCRC trial which Dr. Lalezari has prioritized as #1 which also requires a partner.
As you know, from CytoDyn's perspective, the trial cannot fail. It has to be successful and yield unassailable results. Therefore, you would think that they already have seen it work in concert with the medication of the expected partner and that those results were good.
We know that it was tested with Keytruda, but I want to rule out a PD-1 blockade for reasons that you have mentioned already many times, that leronlimab secondarily blocks PD-1 through a primary down regulation of PD-L1. Disregard what I have said in my recent posts. I want to play out another scenario. So, let's disregard Keytruda and Merck right now.
I'm thinking, that given a current FDA approval already exists for regorafenib in MSS mCRC, what credence would you give to a potential fully funded combination trial with this Bayer drug?
The drug is already approved. I think it got through the approval by the skin of its teeth, so just barely. But, if a combination trial is statistically significant, it would be greatly beneficial to both Bayer and CytoDyn as well as the CRO involved.
The problem is that it hasn't yet been tested, unless, in the Basket trial, those few mCRC cases were in patients already using regorafenib. Not sure if any biomarkers were already collected in that basket trial. And the validation of the combination of these drugs is so imperative for a future partnership with Bayer to happen, unless they would just buy us out after learning the single leronlimab arm exceeds the combo.
Regorafenib is being tried with PD-1 blocker and its performance might be improved, but to the point of statistical significance, I'm not sure. Surely Bayer is aware of leronlimab's effectiveness in MSS type tumors and is probably considering a combo trial anyway, but do you think it is important that we know in advance that the combo does work well?
If not Bayer, then with who? Does it need to be a combo? The understanding that leronlimab is effective in the cold or MSS type tumors tells us we will achieve unassailable results in the leronlimab monotherapy arm, but then we would not get a partner. It would put us more in the Buy out category.
As you know, from CytoDyn's perspective, the trial cannot fail. It has to be successful and yield unassailable results. Therefore, you would think that they already have seen it work in concert with the medication of the expected partner and that those results were good.
We know that it was tested with Keytruda, but I want to rule out a PD-1 blockade for reasons that you have mentioned already many times, that leronlimab secondarily blocks PD-1 through a primary down regulation of PD-L1. Disregard what I have said in my recent posts. I want to play out another scenario. So, let's disregard Keytruda and Merck right now.
I'm thinking, that given a current FDA approval already exists for regorafenib in MSS mCRC, what credence would you give to a potential fully funded combination trial with this Bayer drug?
The drug is already approved. I think it got through the approval by the skin of its teeth, so just barely. But, if a combination trial is statistically significant, it would be greatly beneficial to both Bayer and CytoDyn as well as the CRO involved.
The problem is that it hasn't yet been tested, unless, in the Basket trial, those few mCRC cases were in patients already using regorafenib. Not sure if any biomarkers were already collected in that basket trial. And the validation of the combination of these drugs is so imperative for a future partnership with Bayer to happen, unless they would just buy us out after learning the single leronlimab arm exceeds the combo.
Regorafenib is being tried with PD-1 blocker and its performance might be improved, but to the point of statistical significance, I'm not sure. Surely Bayer is aware of leronlimab's effectiveness in MSS type tumors and is probably considering a combo trial anyway, but do you think it is important that we know in advance that the combo does work well?
If not Bayer, then with who? Does it need to be a combo? The understanding that leronlimab is effective in the cold or MSS type tumors tells us we will achieve unassailable results in the leronlimab monotherapy arm, but then we would not get a partner. It would put us more in the Buy out category.
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