A Means to an End

It occurred to me that my previous post Changing Gears left people hanging. So, I felt compelled to follow up and give an answer.

Part 2.

So, I would say we have hit upon a link of sorts that exists between Merck and CytoDyn that cannot be denied.

As I alluded to in that post, there must have been a massive conflict of interest in CytoDyn's management BOD and Cyrus' intentions when it came time to making the decision to proceed or not to proceed with a fully funded MD Anderson combination Keytruda Clinical Trial for mCRC. While it would have been greatly in favor of CytoDyn to pursue this trial, the BOD incredulously made the unbelievable decision to walk away from it, completely against Cyrus' wishes. As we know, "Any government divided cannot stand. It will fall... eventually."

Was there an argument between Cyrus and Tanya? I'd say more than likely yes. He was still VP and remains as such. I believe the reason why the BOD decided the way they did was due to their 1st allegiance to the FDA and not doing anything that would risk the hold getting lifted. After all, they came too far to blow it at the last mile. However, it remains possible, that Merck did not want the MD Anderson Phase II Combination trial for mCRC to happen. After all, Merck just completed their own trial of Keytruda with their own CCR5 blockade Vicriviroc and the trial just finished last week. It failed. Maybe they needed time to see if their own CCR5 blockade would work before experimenting with ours at MD Anderson?

Could Merck have influenced the BOD in one way or another and push to cancel the free trial? The trial that Cyrus arranged which would provide CytoDyn with a vast amount of FREE unequivocal Research Data so valuable to CytoDyn. That would have provided that pot of gold, free of charge to CytoDyn. The unassailable and unequivocal data set which Cyrus absolutely required in order to properly present the Company to Big Pharma so as to receive proper bids and valuation. Merck could have been against proceeding in this trial because they had their own to try first and that might have influenced our BOD to pull the plug. Maybe Merck said, "wait, we want to try out our drug first. If it fails, we will be knocking on your door." And that was all which was necessary to get the BOD to comply.

Now, with Dr. Lalezari as CEO, CytoDyn is back on board in the pursuit of mCRC and his decision is supreme. Why wouldn't that fully funded MD Anderson trial still be an option? Maybe it still is available, but it would have to be a combination trial ONLY. The two drugs cannot be pitted one against the other. You cannot have leronlimab beating Keytruda. No absolutely not. Given that Keytruda is on the ticket, the FDA accepts the trial.

From this BioSpace Article March, 2023, Cyrus confidently asserted:

"These are both areas where checkpoint inhibitors have failed to show efficacy when added to a standard-of-care backbone, Arman said, adding that leronlimab has shown positive signals in both.

“From a mechanistic standpoint, we believe we could get a synergistic effect with a checkpoint inhibitor,” he said.

Leronlimab is currently being trialed in combination with Keytruda (pembrolizumab) in a breast cancer xenograft model in partnership with MD Anderson Cancer Center.

Arman said CytoDyn expects to observe an enhanced anti-tumor effect from the combination and identify immunological biomarkers.**"

From the May 2024 Letter to Shareholders, Dr. Lalezari stated:

"It is imperative that the Company generate unassailable results in the clinic and I believe the above trials can accomplish this*. Starting the oncology study and related fundraising is the top priority of the Company at this time"*

Both of them boldly claim the effectiveness of leronlimab in mCRC. Cyrus says it could generate a synergistic effect with Keytruda resulting from the combination of the two drugs, while Lalezari points to the unassailable results both must have appreciated. Certainly, both men have also seen the unassailable results that shall be described in the coming (2) journal articles in mTNBC. When Amarex was forced to hand over the raw data of these trials, it had to be decoded and put into FDA Good Clinical Practice format which took hours and hours of painstaking work, but it got done thanks to Bernie Cunningham, Joseph Miedling and the auditors Cyrus put into place for such work. What they found must have been truly amazing so as to compel them to put those results into a peer reviewed journal articles.

In my prior thesis which u/psasoffice had also helped me determine, The Timeline and The Connections as to why CytoDyn pulled out, I discussed Kivlighn's role in the matter. Remember, I put forth that Kivlighn had pulled it away from Merck. That he took the free trial opportunity away from them so they could just buy us to perform the trial themselves. I said that Kivlighn caused CytoDyn's BOD to pull out of the trial in hopes of forcing Merck to swoop in and buy CytoDyn outright. I wrote:

"Kivlighn needed to determine CytoDyn's best path to partner. Kivlighn began changing the direction of the company while Cyrus Arman was sick. Cyrus was headed down the "do it alone" path. His main goal was MASH, but he also wanted to partner in Oncology and he wanted HIV, cure, long acting and was eyeing the resubmission of HIV-MDR. When Cyrus was out on MLOA, Kivlighn had the opportunity to modify or change Cyrus' original heading. Kivlighn wanted the company sold. He wanted the company partnered or bought out.

At some point, because of the results of the MD Anderson study, I believe Cyrus Arman had negotiated with MD Anderson on a CRC trial where CytoDyn would supply all the leronlimab, while MD Anderson did everything else. MD Anderson offered this to Cyrus and Cyrus was all in. Just waiting for the hold to lift. But, while Cyrus was sick and out on MLOA, and because Kivlighn had Merck experience and because Kivlighn "knew" how to make the company obtain a partnership, he recommended that CytoDyn turn down the MD Anderson offer to perform the CRC trial and to take that away from Merck. Almost like a "bait and switch". Kivlighn was thinking that if Merck really wanted CytoDyn, that they would come on in, swoop down and buy it outright, completely before anything was proven by trial, that might raise the asking price as they knew its capacity already given the study was with Keytruda, MD Anderson and leronlimab. They could do the trial themselves if they bought CytoDyn. Maybe, Kivlighn wanted to prevent Merck from thinking that they can wait to see how well leronlimab does in the MD Anderson sponsored trial which would give Merck some time before making the offer to buy CytoDyn. He wanted to take that away from Merck and force them to buy now. Because if the MD Anderson trial were to proceed in CRC, the good results would make CytoDyn even more valuable. I'm really not sure what Kivlighn was thinking, but whatever it was, it sure did piss off many people, especially Cyrus Arman."

If this conjectured hypothesis is right, then Kivlighn must also have believed, that the data in both the mCRC murine study and the mTNBC trial which he had also seen, in his opinion, was powerful enough such that a Phase II trial was not even necessary and a pull out of the trial would surely induce Merck, (who was also privy to the same murine data), to purchase the Company. What Kivlighn failed to consider though, (if this whole scenario is true), is that CytoDyn never owned the MD Anderson data and CytoDyn now has no way to prove that the MD Anderson results in fact do amaze unless they decide to purchase that data from MD Anderson. In addition, he also failed to recognize that Merck was running their own combination Keytruda + CCR5 Blockade Vicriviroc against mCRC simultaneously. So, then the BOD, Kivlighn and possibly Merck could be all to blame for the cancellation of this otherwise windfall and gratis trial that CytoDyn could have immensely benefited from.

As to the pursuit of what the FDA intended for CytoDyn to proceed once coming off hold, which is the Inflammation and Immune Activation trial, it initially did not draw sufficient support from the public and therefore did not result in an increasing share price to the point to raise funds without completely depleting available shares. Therefore, CytoDyn now has its CEO and VP in concert back on the mCRC train again. But a partner is necessary and fund raising has become #1 priority.

Look, all of the companies are out to find the best weapon against these MSS tumors. Right now, there is no solution. Leronlimab is the solution and the data that proves it is in the hands of MD Anderson. Soon, data for it is forthcoming in the (2) peer reviewed journal articles in mTNBC. But regarding mCRC, that data resides with MD Anderson and it is only in a murine study, but apparently good enough to have been offered a fully funded Phase II combination trial with Keytruda. So, Dr. Lalezari made the decision to shift gears to this new mCRC indication but he needs money. He also needs a partner. But he has Cyrus there at his side and Cyrus somehow got MD Anderson to create this Phase II trial.. How did he do that? He must have spoken to some Merck people, wouldn't you think? to see if they also wanted to take the profound murine mTNBC results and apply them towards mCRC in a fully funded human, phase II combo trial? Maybe he can do it again and if need be, without Keytruda?

But this time around, the only way the trial could be run is as a combination only trial. The two drugs could not be pitted against each other. If they were synergistic before, then they are kept that way. Regardless of which PD-1 blockade is used, it should remain a combination trial because of the partnership. The partnership is more important than which drug is doing the work. But, Why would we want to experiment with another PD-1 blocker when we already have seen the results as synergistic? We wouldn't unless we were forced to. Meaning, Merck fails to enter while another PD-1 comes in and partners. Would that induce a Merck counter bid? Assuming they have found no solution to their expiring patent problem, it probably would.

After all, why is every drug out there failing to extend their patent? Is Keytruda simply unable to treat MSS type tumors despite all means of assistance? But we have evidence of their synergism. Given that the only known substance on Earth that is capable of treating these MSS tumors is leronlimab, why have we not been the #1 choice to combine with? Until now, with the hold said and done with and given the new change in priority to mCRC, and with Merck's Keytruda with their own CCR5 blockade Vicriviroc Trial which failed, will Merck now be interested to take a second look at CytoDyn? How long will this search go on for? How many patients?

The provocative data is coming in peer reviewed journal articles that prove leronlimab treats the very difficult mTNBC. Merck already knows from the murine study that it treats the MSS mCRC tumors. What matters is that they know the data and that the data is unassailable as per Lalezari and Arman. They know that by combining with leronlimab, they would have a successful result. The only problem is that they cannot show that leronlimab is better at it than Keytruda. Therefore, they cannot have a standalone leronlimab arm and a standalone Keytruda arm. The two cannot be pitted against each other. And I thank Respert24 for this ingenious answer.

"Notice they didn't create a Dud-Only arm versus a Keytruda-Only arm. A surefire way to inadvertently show that a different drug is better than your own. Keytruda is already "proven" and is going to want to run a trial that shows they can extend their patent. Similar to this trial, if we ended up in a trial with them it would, in my humble opinion, be Keytruda + LL all day. Maybe both of the doses we've had in studies (350/700).

What I don't expect is a trial that Cytodyn would run if there was no partnership, which is to compare and contrast LL to Keytruda. If Merck is running it they're just trying to show that together you see a better result, and boom! They've got new life and we've got the exciting new darling of the oncology world.**"

CytoDyn have seen the data on mCRC, but it is not in their pocket. However, they do have the mTNBC data, but no priority to target that right now. Is that because, Merck or MD Anderson might have an interest in treating mCRC MSS type tumors? So, it seems like this won't be solved until Merck finds a solution to their problem before their patent expires. Patent expiration is the end all to all of this and they have 4 more years of trying to find something that will extend it. Something that allows it to be used on all MSS tumors, not just mCRC or mTNBC, but 85% of all cancers.

Given that Keytruda is the Darling of the Oncology World and given leronlimab is the only drug that can treat 85% of the oncologic tumors out there while Keytruda can only help less than 15%, doesn't it make sense for them to come together in combination therapy to treat the entirety of cancers across the board? In this way, so many of the world's problems could be wiped out in one solid partnership. Isn't the name of the game to have a therapeutic solution to the entirety of this disease? And who can't work with Lalezari? That is no excuse.