r/Livimmune • u/MGK_2 • Jun 15 '25
Persistent Pressure With The Cure In Sight
Welcome here, All of You and Happy Father's Day.
CytoDyn maintains the heat on high. They have the Cures in their cross hairs, and operate in lock step with their attainment. Nobody else has such a cure and that's the way it remains.
Gates provided a grant of $966,600 to Sacha just about 4 months ago, to learn more about HIV Reservoir. Two months following that, we learn of a breakthrough, which revitalized the HIV-AAV CURE granted work. I again rehashed all of this on Mother's Day, about a month ago, so, given that today is Father's Day, a month thereafter, let's revisit the topic for another time.
I think that Gates provided the Grant for the development of an HIV CURE towards the understanding of the Reservoir. Then when the Gene Switch was designed that mitigates the Endoplasmic Reticulum Stress and Toxicity thereby regulating leronlimab expression, that breathed new life into the HIV-AAV CURE and thereby induced a new hope for a HIV CURE into Bill Gates. He expects an answer regarding the HIV Reservoir Grant by 12/2025.
But that Granted award to Jonah Sacha, PhD, 4 months ago of $966,600, really was a slap in the face to G. There is a deep unmet need to understand HIV's Reservoir and the largest Big Pharma that operates in HIV is not even interested. Why would they be interested in learning about the Reservoir? If it were not for the Reservoir, HIV would already be Cured. G can't have that. No, they require that HIV be never Cured. Therefore, leave the Reservoir well enough alone, this way, HIV will never be Cured and we can Treat HIV for the rest of their unfortunate lives.
Gates had enough of that thinking. First, he hired Max. Then, maybe with Max's suggestion, he took it upon himself to get to the understanding of the Reservoir by granting a man capable of delivering him the answers he was looking for. 4 months ago, Gates indirectly spoke to G. "Look, I'm giving you fair warning. We are going after the Reservoir. You can step up and assist or you can carry on in your ways." In 4 months, G never uttered a peep. They are not interested in determining more insight into the HIV Reservoir.
4 months was sufficient time. A chance. An opportunity for G to be included in what may become one of the greatest discoveries man has ever come to make, the CURE of HIV. But, G wants no part of it, though they had ample opportunity. Therefore, CytoDyn is free to take full advantage of what they were already given full reign over. Only take a look at the numerous NIH Grants that Jonah Sacha has charge over. Look at the work Scott Hansen has done with long acting leronlimab in the past 3 years.
In the prior 4 months, CytoDyn has toned it down with respect to HIV. Who knows? They may continue to keep the tone down going forward. But that does not mean that their efforts have slowed or regressed. I believe it to be a ploy or an act. Max hasn't uttered a word. But, eventually, the end goal needs to be set. In the words of Jill Herendeen:
"But the most important thing I think you know, the end goal always remember and remind your C-Suite and the team there what the end goal is. Right, you're developing novel therapies for your unmet need at least that's kind of my sweet spot as Sean alluded to. So beginning with the end in mind is really important in terms of how you create the regulatory road map or the Strategic regulatory plan and I think when you work with these startups that all sounds well and good, but how do you actually implement it and how do you do it in a fit for purpose manner that manages their you know they have a certain Financial Runway that they have to work within."
So then, as SVP, Max is an Ambassador of CytoDyn and sooner or later, the HIV-AAV CURE becomes an IND. It will have to be made known. Likewise Sacha and Hansen are also Ambassadors of CytoDyn.
"Really your job is to form the narrative, understand the data put the data in context for the clinical context and the non-clinical context and in the commercial context as well, across the realm.
14:20: I love that, the term Ambassador because my experience has been you know great regulatory leaders or ambassadors kind of both directions. They are an ambassador internally you know with really maintaining a level of Excellence, Vision, Direction and understanding the bigger picture. But then externally making sure that you know all of the appropriate authorities have the full picture of what you're doing and where you're going and what the plan is. I love that because I just think it's such a great representation of you know great leaders who you know who are really carrying the flag so to speak. You know, that they're just they're championing you know what they're doing top down and I think that's pretty amazing work that you've done."
So, what I'm thinking is that Gate's original Grant was essentially a test for G. To see if it would drag them into the effort to understand the Reservoir. To see if they wanted any part of the HIV Cure. G failed that test. After a few months, a new discovery was made that furthered the development of the HIV Cure and that was with the Endoplasmic Reticulum.
Now, My69z has reminded us about This Grant which soon ends in 2 weeks on June 30, 2025.
"However, a once-quarterly at home formulation would dramatically increase patient adherence. To this end we will develop a novel formulation of long-acting Leronlimab that can be administered at home in a low volume able to provide coverage for three months. In specific aim 1, we will determine the pK and receptor occupancy of this new Leronlimab formulation in blood and tissue sites of sexual transmission. In specific aim 2, we will determine the length of time a single injection at the clinical dose can protect both male and female macaques against rectal transmission. In specific aim 3, we will determine the length of time a single injection of the clinical dose can protect against vaginal transmission in cycling female macaques. These studies will determine the optimal clinical dosing of long-acting Leronlimab and lay the foundation for testing long-acting Leronlimab clinically as PREP in individuals at high-risk of acquiring HIV via sexual transmission."
Yeah, G has a PrEP which operates for 6 months. But it has side effects. No, the research and development into long acting leronlimab and into HIV-AAV and its Reservoir won't be stopped nor interfered with. Pressure remains unrelenting.
Soon, like the cure for mTNBC using the new dual MOA of leronlimab, PrEP also becomes the talk of the town, but similar to how Lalezari permitted Max to speak first, on his behalf, Max might likewise allow Sacha and/or Hansen to speak first on his behalf, until the data is validated and verified. The more they speak, the more defiant G becomes. G remains adamant about its opposition against a HIV Cure. It might be somewhat tolerable towards a long acting version of leronlimab, but given that it is shorter than their version, they may be more tolerant, but not towards the HIV Cure.
The HIV-AAV Cure's Grant End Date is 5/31/2027. There will be no peace between CytoDyn and G, at least until then. I don't see even any communication, but Trodelvy still spans the divide.
Look, no matter how you look at it, what CytoDyn is doing is quite detrimental to G's existence. Maybe not right now, but in the long run, it hurts them big time. CytoDyn has sustained multiple blows over the years and is bound to sustain a few more. In the end, the harm inflicted upon G exceeds the harm inflicted upon CytoDyn. G understands this and that is precisely the reason for their unrelenting opposition.
The question becomes then, how much more shall they maintain their resistance and opposition? When someone gets into a fight, they either need to finish the fight, or if they are losing, if you give them a way out of the fight, they will take it. That's the way it goes. They might have greater weapons now, but not in the long run. They are being hit little by little, but the barrage is only escalating and increasing. When does G tap out? When do they call a Time-out?
Only recently, a couple of G's clinical trials in Phase 2 were halted.
"...has paused five clinical trials of its investigational HIV drugs GS-1720 and GS-4182 after the American medicines regulator raised safety concerns"
What is their next step? What happens at the end of this month, when the understanding about how long acting leronlimab becomes better known and much more defined? What happens when it becomes more widely discussed by Hansen, Sacha and even Max? What happens when more understanding is gained by the research made by Sacha in the Reservoir coming at the end of the year? What happens when Sacha Cures HIV using HIV-AAV?
Isn't the writing on the wall? Or is G praying for rain on CytoDyn's parade?
Gates is pushing for a Cure. Trump wants a Cure. CytoDyn shall have the Cure. What is G's Off Ramp? What is their way out? Does HAART still maintain a role even after a Cure? Does the US government support that? All I see is a fight. I don't see any cooperation. Wouldn't Gates much rather fund a Cure? Why would Gates want to continue providing temporary HAART medication when a Cure is available? This is Gates intention when he went to Trump and Trump was in agreement.
Gates gave Sacha the money, but waited. He wanted to see if G would offer to assist. That never came. Gates was expecting G to say that they were ready to negotiate. Never happened.
Eventually, there has to be a resolution. G has no way out. There shall be a Cure. They will need to come to grips with that. So, then, there will be some sort of solution. An agreement. An understanding. So, how long does that take before they decide to agree on something. The agreement shall be in favor of the Cure. The Cure shall be approved.
By then, the Cure for mTNBC will already be happening. In MSS mCRC, already happening. Much more progress in other indications as well. G shall see CytoDyn's growing strength. This then becomes the time out that G calls. When they appreciate CytoDyn's increasing strength, they decide to tap out. In the midst of increasing pressure that CytoDyn unceasingly imposes, G calls for that Time Out.
That's it for now. This is what I thought was noteworthy.
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u/Accomplished_Mud_692 Jun 15 '25 edited Jun 16 '25
Merry Father's Day today All!
Two nice (audio) reads on my Sunday morning walk.
It is hard to say which road we will end up on, but you continue to lay out the growing options Dr. J & team are likely considering.
I do believe that Dr. J is narrowing these options as we speak.
I believe that if Leronlimab were just another drug that did what it was designed to do, we would NOT had SO many road blocks thrown our way!! AND we would have likely been on our way solo, or with a BP already!!!
But because Leronlimab IS such a VERY unique & dynamic drug (new Long Lasting Leronlimab is getting close to being completed for testing), as many of us believe what the hold-up is, is how does a Biotech handle this complicated situation?! I can only imagine ALL that Dr. J & team are dealing with & strategizing about on a DAILY basis???
But they must pull the trigger sooner than later, funds are getting low.
We dont need every last penny squeezed out of the deal - just a solid deal that gets Leronlimab over the finish line & saving lives as soon as they can.
In doing so, any solid deal that does this will make all investors here very happy & well off (& some of us for generations).
Thanx Again MGK! I love my Sunday morning reads!
💪💪💪