Agreement In The Making?

OK, so this is a reminder of last weeks post, Persistent Pressure With The Cure In Sight. Here, I'm going to build off of it. If you haven't read it, then it might be worth first taking a look at it.

I said that if these things begin to take shape, then watch. I do see the possibility of an agreement under construction which later on could be incorporated into an overall partnership.

Unlike Truth Seeker's Cynicism, I continue to suspect discussions are happening today, concerning long acting leronlimab. As I said in the prior post, the grant entitled: "A Solid-Phase, Long-Acting CCR5 Monoclonal Antibody for HIV Transmission", has an end date June 30, 2025, which is only 8 days from now.

"Abstract Text:
PROJECT SUMMARY
With 36 million people currently living with HIV worldwide and no vaccine currently available, developing a pre- exposure prophylactic (PREP) HIV regimen that protects against sexual transmission remains a top global health priority. Recently, a CCR5 blocking monoclonal antibody, Leronlimab, has shown exceptional safety, tolerability, and anti-HIV activity in multiple clinical trials. Given that sexual transmission of HIV is almost exclusively mediated by CCR5-tropic variants, Leronlimab may be extremely effective as a PREP reagent. We confirmed the ability of once-weekly administered Leronlimab to protect macaques from rectal transmission of CCR5-tropic SHIV. 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*.*
Public Health Relevance Statement:
PROJECT NARRATIVE
The development of a pre-exposure prophylactic reagent that potently inhibits transmitted HIV with minimal toxicity, lack of potential for drug-drug interactions, and infrequent dosing would greatly slow the HIV epidemic. Given that nearly all mucosally-transmitted HIV is CCR5 tropic, we will test the ability of a novel, extended half- life CCR5 blocking antibody formulated for maximum concentration to prevent mucosal transmission of HIV using the macaque model. Success of these studies would establish a new, user-friendly pre-exposure prophylactic weapon for the fight against HIV*."*

This NIH project has significant implications, not only for HIV PrEP, but for all potential long acting leronlimab indications. As a result of this NIH project, Jonah Sacha, PhD and his team shall have:

• Developed a SELF-Administered At Home Formulation that would greatly increase patient compliance and adherence.
• The formulation shall be one of low-Volume, such that only a small amount is necessary to be subcutaneously injected. Remember, CytoDyn's 3rd party AI Developing Partner is working with Scott Hansen, PhD and Jonah Sacha, PhD in the development of long-acting leronlimab.
• The Optimal Clinical Dosing for long acting leronlimab shall be determined for HIV-Prep, but this knowledge shall be extractable for other diseases as well. Diseases for which Scott Hansen, PhD expands the development of long acting leronlimab as treatment.
• The capacity for long acting leronlimab to prevent the transmission of HIV and to be functional and operable within the mucosa for a long acting period of time shall be determined.
  • One of the most difficult areas of the body to treat are the mucous membranes, as the blood supply to these areas is reduced and diminished. The purpose of the mucous membranes is to catch invaders, bacteria, viruses, fungus, mold, mildew before they enter the blood stream. But sometimes, some of these invaders actually infect these mucous membranes, instead of getting caught and trapped by them, and then, the body has great difficulty in the eradication of these microbial, fungal and viral infections because the medications including anti-biotics cannot reach these membranes due to the reduced blood supply. Therefore, the infection festers within the mucous membrane and slowly leaks out the infection to the blood supply to subsequently infect the body.
  • But, if long acting leronlimab has the capacity to reach the mucous membranes and remain there for 3+ months with a single subcutaneous injection, then, CytoDyn has something amazing which could have implications in any mucosal borne infection, even the very difficult to treat, rhinosinusitis.

Currently, what this NIH project, soon ending on June 30, 2025, is going up against is the recently approved Yeztugo. Yup, G struck first with their every 6-month HIV-PrEP subcutaneous injection. This is not a self administered injection. Patients are required to have this subcutaneous injection performed by a medical professional. In addition, the cost of this medication is over $14,000 per injection or $28,000 per year amounting to $2,350 monthly just to prevent HIV. Yeztugo doesn't work and is not even indicated if the patient is already HIV+. Actually, if it is given to a patient with HIV, then HIV resistance to it would build. This is not very user-friendly, but long acting leronlimab shall surely be. In addition, leronlimab is not only effective against Preventing HIV, but also in the Treatment of HIV, unlike Yeztugo which is only used in the Prevention. Yeah, G struck first, but it seems like G wants the US government to pay for their HIV-PrEP medication.

"Responding in a statement, Save HIV Funding campaign manager Maxx Boykin said that "the FDA's approval of lenacapavir for HIV prevention has the potential to be a pivotal moment for the broader fight to end HIV. It's a reminder that prevention must be a national priority, backed by serious investment and political will*."*

"Ending the epidemic requires equal focus on prevention and treatment, delivered through equitable, community-driven systems*," Boykin continued. "This moment calls for* bold public funding, strong private sector leadership, and a shared commitment to making HIV prevention accessible, affordable, and a cornerstone of our national response*."*
...
Reporting on the FDA approval Wednesday, The Associated Press pointed out that "global efforts at ending the HIV pandemic by 2030 have stalled*. There still are more than 30,000 new infections in the U.S. each year and about 1.3 million worldwide."*

Without governmental assistance, this drug won't be purchased, not at that price at least. Insurance companies now need to foot the entire bill? Yeah, right. Patients not covered by insurance certainly won't pay out of pocket $30k/year to have sex. Government is not coming to the rescue. What then are they really celebrating? Are they counting on a political turn around? Or are they looking for an assist from their collaborations with generic pharmaceuticals? How much did their trials actually cost them that they need to charge that exorbitant price? They better get ready to fall on their knees and beg, otherwise, they might be left out to dry.

On the other hand, the ending of this long acting leronlimab NIH project is approaching, now, only a week away and the disclosures could be quite impactful. I suspect Max is all over this as is Jonah and Scott. Silence is Golden goes the expression and Silence might be the best sound heard at the moment.

Yet, the left interprets the Silence as hesitation. Not I though. They don't realize who is at the wheel. There is no bluffing behind that Secret and Silent exterior. Yes, 4D chess, or would you prefer 5 moves ahead Black Hole Mazzy? Oh yeah, you believe CytoDyn has zilch in motion and that nothing is happening. OK. Edumacation. Things are happening whether they publicly say them or not and time is closing in on the deadlines of which we know about.

The partnership / agreement doesn't need to be in HIV PrEP. It doesn't even need to be in HIV. Long acting leronlimab has implications across the broad spectrum of Inflammatory and Infectious disease as well as across the CCR5+ MSS type Cancers, which are 85% of all Tumors. As such, we should be watchfully waiting to see what comes out of this NIH project completing soon. It could take a few weeks following the completion date before anything is actually disclosed, but the agreement / partnership b/w Lalezari / Max and Gates, might at least be in process.

Gates wants to stop the HIV epidemic / pandemic. He is spending $Billions every year on HAART to keep patients HIV load at near zero. US allocations for this purpose have been severely cut. Neither Gates nor Trump want people to even contract the disease. If the contraction of the disease could be prevented, then what need is there to treat it.

With that in mind, Do you think G really wants to prevent HIV from being contracted? Think again. Even if it means selling Yeztugo for $28k/year which is so overpriced. Seems like they hung themselves with the rope they took, so they are left with no choice but to massively overcharge. What else is new with them? I think they would definitely rather sell their Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) or their currently halted Phase 3 replacement for Biktarvy indefinitely as a Treatment for HIV, because Treating an Actual Disease makes a patient far more compliant and adherent than expecting a healthy, non-infected patient to remain compliant and adherent, year after year for the sole purpose of allowing him or her to have sex. Additionally, the Preventative medication costs $28k/year and requires a medical provider to administer. Celibacy might be an alternative.

The NIH project ends in 8 days and the news on this is soon forth coming. The news in MSS mCRC is also soon forth coming, in the next 12 days on 7/4/25, with the poster being disclosed in only 3 days on 6/25/25. Personally, I believe that what this Project reveals becomes very attractive to both GSK and ViiV who both have a great interest in the eradication of HIV and AIDS unlike G.

As we already know, Max Lataillade, DO already has an incredible relationship with GSK, ViiV, as he has worked at both companies. He is currently employed by the Gates Fund and therefore has a personal relationship with Bill Gates. Max, as the Head of HIV Drug Development at the GF shall be all over the results of this completed project. Personally, as Max Lataillade, Jonah Sacha and Scott Hansen all work together for or with CytoDyn, I believe that they already know these results and are already in discussions with the appropriate parties. I believe the findings shall be remarkable, unbelievable and impressive which shall demand further expansion of the long acting molecule. That expansion comes from The GF, GSK and ViiV.

Silence is Golden, but the time is approaching quickly. Word is all about mCRC and mTNBC, but lips are pursed and tongue is tied on HIV. Hmmm... but again, as per my previous post, there are also other HIV NIH projects due this year. Yeah, the one on the HIV Reservoir is due at the end of the year.

Yeah, this project revolves around the HIV Reservoir. The Reservoir is the main obstacle to an HIV Cure. Nobody has tackled this problem, but Jonah, along with the GF who sponsored the million dollar research shall have the answer by the time the year is done. Remember, who wants an HIV Cure and who doesn't want an HIV Cure? I suspect they have an answer to the eradication of the HIV reservoir which includes long acting leronlimab and I'm telling you right now, we can thank both Jonah Sacha and Scott Hansen as well as the 3rd party AI collaborating partner for that as they determine the cause of the Reservoir and the appropriate solution. This is yet another means by which CytoDyn shall own another HIV Functional Cure, though not AAV administered. I'm thinking via some sort of subcutaneous injection, similar to how a Vaccine is administered.

"Sacha's research revealed that HIV-infected cells in the reservoir display unique markers on their surface, which could be targeted by new therapies."

and

"to support a comprehensive analysis approach of the HIV reservoir that will provide significant insights into the mechanisms of antiretroviral therapy rebound, contributing to the development of novel therapeutic strategies*"*

Stealthy Technological development done Secretly. CytoDyn is diversified in its research. Remember, OHSU is its partner and Jonah's team along with his counterparts are spot on and exceptional in their research, otherwise why do these sponsors including Gates pay OHSU and Jonah millions of dollars to get it done?

With the long acting project ending in a week or two; with the GF, GSK and ViiV chomping at the bit for a longer acting solution, for Cure and for PrEP, now, with the ending of this project, it sits at the ready to be fast tracked and with the upcoming answer to the HIV Reservoir due by the end of the year, do you think there are no discussions? Keep in mind, the HIV-AAV Functional Cure project was recently boosted and lifted with the recent discovery of the Endoplasmic Reticulum Gene Switch, and that Functional Cure project has end date of May 31, 2027 with recent 2025 cash infusion of $1,943,700 to Jonah's Team. This was the most recently written abstract on the Functional Cure Project:

"Abstract Text
PROJECT SUMMARY
With the most people ever in history currently living with HIV, stopping the HIV epidemic remains imperative. Combination antiretroviral therapy (ART) limits viral replication, but is not curative. Thus, there is an urgent need to design a functional cure via elimination of the viral reservoir*. Timothy Brown, aka the Berlin Patient, and Adam Castillejo, aka the London patient, were cured of HIV following leukemia-related, MHC-matched, allogeneic hematopoietic stem cell transplantation (HSCT) from a CCR5-deficient donor. While a CCR5-deficient immune system can demonstrably yield a functional HIV cure,* allogeneic stem cell transplantation is not scalable to the general population and alternate approaches are needed. We have demonstrated that the CCR5-specific antibody Leronlimab can pharmacologically mimic a CCR5 deficient donor by occupying all available CCR5 molecules. In order to deliver Leronlimab as a gene therapy option, new delivery modalities are needed. Here, we are proposing to utilize our novel directed evolution technique to generate AAV vectors specific for T and B cells*. These novel* AAV vectors will facilitate in vivo delivery of Leronlimab expression here, but more importantly will support the future use of other anti-HIV approaches including CRISPR-Cas9, chimeric antigen receptors, and broadly neutralizing antibodies by delivering these therapeutics to the relevant immune cell type*. In specific aim 1, we will generate and characterize* AAV bearing capsids that target T and B cells specifically across both macaques and humans*. In aim 2, we will demonstrate proof-of-concept utility of these new AAVs by* delivering Leronlimab to SHIV-infected, ART suppressed macaques to determine if a functional cure can be achieved with this approach*. This work would expand our knowledge of the* mechanism of HIV cure by showing the utility of long-term antibody-based competitive CCR5 inhibition and establish a new set of AAV vectors to support in vivo delivery of anti-HIV therapeutics.
Public Health
Relevance Statement
PROJECT NARRATIVE
The development of curative approaches for HIV infection is now recognized as both a necessary and attainable goal*. Hematopoietic stem cell transplantation* [LATCH] resulting in a CCR5-deficient immune system has been shown to functionally cure HIV infection in two separate patients, but such an approach is not scalable to the general population. We propose here to develop novel AAV vectors targeted to immune system cells to support delivery of therapeutics such as HIV-targeted CRISPR-Cas9, chimeric antigen receptors, broadly neutralizing antibodies, or CCR5-blocking antibodies to mimic a CCR5-deficient immune system."

How many people on Earth would benefit from a safe HIV Cure? How many on Earth would demand a Cure if one could readily be had? What kind of pressure would that put on US FDA if word of these long acting results gets out to public knowledge? Pressure, pressure, pressure to bring this about on a world wide scale.

What happens to CytoDyn when an agreement to get this mobilized is announced? Let's wait and see what comes out of this. So pay attention to what our speculation was last week in Persistent Pressure With The Cure In Sight, because as I just said, I believe that this has been building and now, with the coming end date of the long acting project in sight, as well as other HIV projects on the proximal horizon, an agreement / partnership could be coming to fruition in the near future.

Hey, this could be a dud also. We'll just have to wait and see. Eyes and ears open.