MGK_2
•
9h ago
"Hütter’s Legacy Reload (Germany): Gero Hütter’s Berlin Patient cure—CCR5-delta 32 king, SAB relic. His 2008 win powers LATCH—a murmur from him flips HIV upside down."

"In September 2020, CytoDyn had this press release: https://www.globenewswire.com/news-release/2020/09/01/2086694/0/en/Global-Health-Leaders-Join-CytoDyn-s-Scientific-Advisory-Board.html

In it, CytoDyn "announced the formation and initial members of its Scientific Advisory Board today including leading HIV, NASH, Oncology, and Rheumatological clinical experts and researchers.

CytoDyn's Scientific Advisory Board members include Dr. Gero Hütter, German hematologist, best known for the bone marrow transplant resulting in the cure of the first HIV patient; Dr. Hope S. Rugo, Professor, Department of Medicine (Hematology/Oncology) and Director of the Breast Oncology Clinical Trials Education Program at University of California San Francisco; Dr. Richard T. Maziarz, Professor, Medical Director of the Adult Blood and Marrow Stem Cell Transplant and Cellular Therapy Program Knight Cancer Institute at Oregon Health & Science University (OHSU); Dr. Jonah B. Sacha, Professor, VGTI-Vaccine and Gene Therapy Institute at OHSU; Dr. Mazen Noureddin, a hepatologist and Director, Cedars-Sinai Liver Transplant Program in Los Angeles; Dr. Norman B. Gaylis, nationally and internationally recognized specialist in rheumatology and autoimmune diseases; Dr. Eric D. Mininberg, Oncology Specialist, Piedmont Cancer Institute, a member of the MD Anderson Cancer Network; and Dr. Lishomwa Ndhlovu, Assistant Professor, Immunology, Department of Medicine, Division of Infectious Disease at Weill Cornell Medicine in New York.""

MGK_2
•
9h ago
"Montefiore’s Neuro Bet: Beyond oncology, the Einstein/Montefiore preclinicals (March 2024) and Cornell’s Alzheimer’s pilot (December 2024) hint at CCR5’s brain inflammation role. A neurodegeneration win’s a $50B market—CYDY’s dark pool."

"27:15 Nader: Yeah, and BTD that we will be filing, Dr. Nitya Ray did a fantastic job on that. There were some patients with brain metastases*. Dr. Ray, explain to us, for a breakthrough designation strategy, are* we going to file for brain metastases and perhaps later on, if we do get BTD on the original submissions, maybe we want to ask for Basket Trial data, but tell us about the Basket Trial please.

27:60 Nitya Ray: The BTD application that is submitted is 28 patients from 3 different trials. And out of the 28, 6 had brain metastases*. They are* all mTNBC patients*. So we have submitted all of the results,* including all of the patients with brain metastases*, now with the FDA and FDA is reviewing it and we are waiting for FDA to respond for BTD application and we expect to hear from them in about 2 weeks. 2-3 weeks. Our CTA application I believe was submitted on November 5. So by January 5, we should hear from FDA. and then we are going to discuss with FDA and* see that forward with brain metastases*. Now,* these are not the only patients with brain metastases because these are mTNBC patients. But, we have other patients in the Basket Trial and not mTNBC, with brain metastases. And so we are very excited about what is happening with these patients. And so we are going to discuss this with the FDA and we do plan, after we receive the response from the FDA on the BTD application that is submitted, we are going to plan for perhaps another BTD just focusing on the brain metastases."

Welcome aboard the CYDY Ihub message board!

Great reply:

Professional_Art3516
•
1h ago
•
Edited 56m ago
I cannot explain my excitement for this unexpected return of Leronlimab in HIV!

This post is a masterful deconstruction of the many different avenues we are pursuing to attack this most elusive virus. It is very exciting to see newer delivery devices, longer acting Leronlimab, and even a potential for livimmune perpetual formulation, which means the body will make it for the rest of one’s life!! Absolutely astonishing how far we have come in such a short period of time!

When the NIH gave the grant to our company, I was very grateful, but I had no idea the significant impact this will have upon this company, but more importantly, the lives of those with HIV !

We are embarking on a journey to cure HIV : before the baby is infected by the mom‘s breastmilk, immediately after a baby is born and contracts, a virus , eradicating it, and those who’ve had the virus for years may get a cure with triple therapy, and lastly, the possibility of preventing HIV from ever entering the reservoirs Has astounding, implications for society, mind you one shot, and you’re protected for the rest of your life, from HIV, inflammation, liver, cirrhosis, Alzheimer’s, and it goes on and on oh my goodness, I think it would be the biggest single discovery and healthcare, ever!

I can feel the excitement building with all my fellow longs, this is real, this is happening, and all the moving parts are being orchestrated by Max and his connections and his know how and his ability to get things done!

Ladies and gentlemen, MGK, thank you for standing by through thick and thin to get us to this point!

I remember one day specifically a few years back when we fell precipitously from 90 some cents to 20 some cents per share, and over the next year worked the way down to $.11! The shorts have decimated the stock with relentless attacks, fake lawsuits, disinformation campaigns, and various other destructive collaborations to work in concert to suck every available dollar from this amazing molecule development!

I’ve said it before, and I will say it again, this will be the biggest comeback in Pharma history, maybe in the history of any company on the brink of financial ruin! We experienced CEOs and CRO is going to jail, orchestrated short campaigns, disinformation attack on various sites, it goes on and on, and on the fact that we are still here and about to present the world with an HIV cure is the stuff that dreams are made of! And that is just one piece of the giant pie that is Leronlimab!

This would be the most entertaining movie one could ever see, and expose so many things wrong with our current drug approval process! from the proper way to run and manage a company, to demonstrating human greed even in the face of helping so many people with so many afflictions!

MGK, you have been my professor in this endeavor, and I have been an eager pupil, voraciously, reading, expanding my knowledge of just what an amazing molecule I own. Along the way, through your postings, the postings of up with stock and various other brilliant minds, I have more shares than I ever thought possible in the most amazing discovery, in my humble opinion, and Pharma history! I have been in pharmaceuticals for the last 27 years, and I’ve never seen any molecule with the potential that this one has and I am dumbfounded that is taking so long for us to get to this point!

But here we are, on the precipice of curing HIV, possibly curing some people with cancer, helping patients with MAS*H, reduce their disease and people liver with scarring , helping reverse that process, that’s preventing the need for a liver transplant and providing a better quality of life!

This is the most exciting journey of my life , I’m so happy to be sharing it with some many extraordinary visionaries, and by that I mean, anybody who purchased the stock after doing their due diligence and purchasing because of science!

This will be the year, so many dedicated shareholders are able to change ZIP Codes!

GLTA!!!

Nice artwork. I agree with you, the chart shows there is an incredible amount of runway for PPS appreciation. I hope you profit nicely.

MGK_2

The Development Of Leronlimab In Both HIV Cure & HIV Reservoir Eradication
As of January 2025, How Many Have Been Cured of HIV? is an amfAR article which describes the current status of the worldwide HIV Cure. Here at CytoDyn, Change is in Development and it's taking place at Breakneck Speed. As things develop and are brought forth into the open, yet other things are just beginning to break out, make their move and strut their stuff. This seems to be the rapid fire pace at which things are happening here now at CytoDyn under the new leadership of Jacob Lalezari. When he came on board just over a year ago, he mentioned that CytoDyn only had just 1 bite left in the apple. This meant that there was no room left for error. Seems that JL took that to heart and he is coming through on those promises. The work invested earlier, is now coming out while even more effort is being reinvested and pumped back into the system. The Waves of research here at CytoDyn really do ebb and flow.

On the topic of an HIV Cure, these research Grants seem to be coming in quite regularly now at CytoDyn. What follows is a compilation of some of the more important research projects CytoDyn has been involved in regarding HIV Cure.

Jonah Sacha was recently Awarded a $966,600 Grant from the Gates Foundation
"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"

With "Oregon Health & Science University" stamped clear across the top of the page, assuredly, that is the site where this work gets done. Jonah has 11 months to get 'er done, so by the end of 2025 it should be completed.

I wrote this in my last post Pushing Forward, which was just a day PRIOR to the revelation of this grant. I have to let you know, that I had no idea.

"So, it is my conjecture that Gates and/or ViiV would take over the research on how to eradicate pre-existing HIV Reservoirs and also, how to prevent the development of anti-leronlimab antibodies in every patient while utilizing the HIV-AAV technique. All of that research could be done while they also get the ball rolling for the clinical trials against vertical transmission utilizing leronlimab-PLS and during the clinical trial against HIV Reservoir formation utilizing Triple Therapy.

It shouldn't have to be mentioned that Gates has more than the required assets to get this done. ViiV has the required scientists and the necessary engineering facilities. This effort would require significant investment in both that research and in conducting clinical trials. But, all here involved stand on the solid rock of validated proof that the drug works and that these protocols in fact do work. Therefore, they are all deeply convinced and are unwavering in the fact that they are working with absolute best molecule. Otherwise, why would Max be SVP at both CytoDyn and at the GF simultaneously? By bringing in Max's prior company, ViiV, they build upon both ViiV's and GSK's shared hope to find the HIV Cure and with ViiV's variety of HIV treatment medications, they can implement many of their long acting oral and sub-cutaneous injectables together with leronlimab in combination, especially for the purpose of Salvage Therapy."

Did Max Lataillade have anything to do with the creation of this Grant which is designed to help delve into and decipher the quandary of the HIV Reservoir? Max is absolutely aware of the need to get to the bottom of the HIV Reservoirs. Max certainly is in constant contact with Jonah Sacha and Jonah has likely discussed the great need for this type of grant. Jonah has likely outlined it in its bare form so that Max could present it to Gates who then quite readily, funded the grant.

Doesn't this $1 million investment by the GF into Jonah scream out loud the utter fact that the Gates Foundation is clearly on board together with CytoDyn and all its partners, OHSU, 3rd party AI collaborator, at least in this case, to seek out insights into the HIV Reservoir for the purposes of the development of novel therapeutic strategies?

My thinking is that ViiV too, would also be very much pleased with this award going to Sacha. They know that when Sacha figures out how to overcome the problem of the HIV Reservoir, then, their own treatment methods using HIV ART drugs would also be benefited. The novel strategies that Sacha develops shall contain leronlimab, because the novel drug does need to contain a CCR5 blockade which operates at 100% R.O. so as to prevent the reformation of any HIV Reservoir. No less than 100% R.O. would be suitable, so maraviroc would not suffice here as it has somewhere only around 78% R.O.

Triple Therapy as described in Planet Of The Apes
Triple Therapy is a recent NIH Funded Development in the HIV Cure Space discovered by Dr. Nancy Haigwood and her group. Again, leronlimab is a key ingredient. Jonah Sacha describes it in the above link. I'm sure you're all familiar with it, but essentially, Sacha concludes,

"In this model of infant macaques, treated early, at 72 hours, it is insufficient to treat with bNAbs or leronlimab by itself, but, if you combine them, together, they are able to, what appears to be, clear the reservoir and prevent reservoir seeding*."*

Let's repeat that: Triple Therapy CLEARS the HIV Reservoir and PREVENTS the HIV Reservoir from Seeding. I'm fairly certain that the bNAbs used in this Triple Therapy protocol are owned by GSK and that the ART used in this Triple Therapy was owned by ViiV. I can easily see Max recommending that the GF take this Triple Therapy into a Phase I Clinical Trial for humans so as to prove out the capacity of this method for the prevention of vertical transmission of HIV and HIV Reservoir formation from Mother to Fetus, administered just after birth, which otherwise would occur without the use of this method.

The LATCH Technique, is the Leronlimab in Allogenic stem cell Transplant to Cure HIV (LATCH) method. This study is a collaboration between CytoDyn and the American Foundation for AIDS Research (amfAR) aimed at exploring a potential HIV cure.
Key points about the LATCH study:

It uses leronlimab to protect CCR5+ donor immune cells from HIV infection during bone marrow transplantation to an HIV+ recipient.

The study protocol was scheduled to complete final updates at the end of December 2024.

The program was expected to launch in 2025.

Researchers are confident in the potential success of LATCH, inspired by a successful cure announced in Germany using donor cells heterozygous for the CCR5-delta 32 mutation.

The same investigators from Germany have expressed interest in running and will conduct another LATCH study in tandem with the amfAR LATCH study, but at their research center in Berlin, Germany.

The LATCH Technique stands for Leronlimab and Allogeneic stem cell Transplant to Cure HIV. I cover the massive advantages afforded by the LATCH Technique of having the ability to use ANYONE who is healthy as stem cell donor in The next Berlin Patient.

'Dr. Lalezari 16:29: LATCH, Stem Cell Transplant HIV Cure

In addition to these two core clinical studies, I'm pleased to announce two other exciting clinical initiatives. First, we are in discussion with the American foundation for AIDS research to partner and co-sponsor a study called LATCH, led by investigators at Oregon Health Sciences University and the University of Washington, LATCH stands for Leronlimab and Allogeneic stem cell Transplant to Cure HIV*.*

The proposed study will evaluate the use of leronlimab to facilitate an HIV Cure in the HIV positive subjects, undergoing stem cell transplantation. Previous reports of HIV Positive patients achieving a cure have occurred when those RARE homozygous CCR5, double negative individuals have been identified to provide donor stem cells for the transplantation.

This study will evaluate the possibility that leronlimab could extend the list of potential donors to include the much larger pool of CCR5 positive individuals. Leronlimab would be administered following transplantation for six months during the engraftment period, to protect the HIV negative, donor cells from becoming HIV infected. The hope is that those donor cells now protected from HIV infection, will then eliminate HIV from the reservoir of the transplant recipient. If successful, this study would obviously bring about much needed positive attention to both leronlimab and CytoDyn. We're exploring this partnership with AMFAR to jointly co-sponsor and fund the research aspects of the LATCH study, which importantly, will not require us to cover the cost of the transplant itself*.*
...
The timelines for the LATCH study, and the pilot study in Alzheimer's disease, involve academic institutions. So both are more likely to start early in 2025. The results of the pre-clinical study of leronlimab and MASH that I described should be available in the fall, which hopefully will give us the data to start pursuing a partnership before the end of the year."

This innovative approach combines leronlimab's ability to block CCR5 receptors during stem cell transplantation, potentially offering a new pathway towards an HIV cure. LATCH only requires leronlimab. It doesn't have any need for bNAbs or ART. As of February 2025, the studies at amfAR and in Berlin could be in their early stages, having just launched or being about to launch.

CMV Vector Vaccine Targeting White Blood Cell "Antigen"
In 2024, Dr. Jonah Sacha received a grant of $479,765 from amfAR, The Foundation for AIDS Research. This funding supports the discovery Sacha made while doing his research, of identifying a specific antigen on white blood cells that, if targeted and destroyed by CD8+ T cells, potentially, could replicate LATCH, with the observance of an HIV Cure and eradication of any/all HIV Reservoirs, in any patient, but this time, without the use of any stem cell transplant. The goal would be to develop a more practical and accessible HIV Cure strategy which would bypass the need for any complex stem-cell transplant procedure.

"First, Jonah Sacha, PhD, of Oregon Health and Science University in Portland, aims to reproduce the curative effects of stem cell transplantation without resorting to the costly, high-risk procedure.

In one of the most startling research findings of 2023, supported by amfAR, Dr. Sacha reported that a monkey infected with SIV, the simian counterpart of HIV, had seemingly been cured after undergoing a stem cell transplant. Crucially, the transplant involved “normal” donor cells as opposed to cells with mutated, inactive CCR5, the critical co-receptor for HIV’s entry into a cell. This CCR5 mutation, which renders most cells impervious to HIV infection, appears to have been central to most of the seven confirmed human cure cases to date.

Given his research findings, it was not surprising to Dr. Sacha that two of these seven individuals— the “Geneva patient” and the “second Berlin patient”—used cells from donors that still had functioning CCR5. He proposed that allogeneic immunity, or a graft-versus-host response—a key part of certain cancer cures following stem cell transplants with normal donors—was involved and might be replicated without requiring a transplant*.*

Documenting what the precise target was in his monkey experiments forms the basis of a new $479,765 amfAR grant to Dr. Sacha. He has preliminary data that a “minor” antigen on white blood cells is involved, and that administering killer CD8+ T cells trained on this target to SIV-infected monkeys would reproduce the effects of the transplant itself*, opening the way for similar approaches in humans."*

Seems to me that this is an amfAR sponsored grant which reproduces LATCH, (an HIV Cure achieved via Stem Cell transfusion of any healthy donor's bone marrow), but without having to do an actual Stem Cell Transplant. Seems to me that in all of his work and research in this field, Jonah has discovered an "antigen" present upon certain white blood cells. Given his friendship and vast experience with CytoDyn's Scott Hansen, Jonah knew that he could train killer CD8+ T Cells on those specific white blood cells containing that antigen, and wipe them all out while simultaneously administering leronlimab. By killing those white blood cells with that "antigen" and by blocking CCR5 with 100% R.O. by administering leronlimab simultaneously, essentially, Sacha would be reproducing the effects of a LATCH stem cell transplant, without having to do a stem cell transplant at all, but would still be successful in eradicating HIV and HIV Reservoirs from the patient.

Well, the only way that I know of to train killer CD8+ T Cells on any "antigen" or any "epitope", would be through the use of a Cyto-Megalo Virus Vector. CMV vector trained CD8+ killer T Cells. Who is the CytoDyn expert on that? Scott Hansen, PhD. I'm thinking CytoDyn would need a partnership on that CMV, somebody like a GSK or ViiV. Max, together with Sacha and Hansen would know who to talk to, but maybe CytoDyn already has their answer in their 3rd party AI collaborator.

As LATCH employs and utilizes leronlimab, so, would this new technique which amfAR granted Sacha to research and develop. It too would employ the use of leronlimab in conjunction with this CMV vector trained vaccination on that "minor antigen". If you recall, the company VIR had a BMGF funded HIV-Vaccine called VIR-1388, which Scott Hansen contributed towards and as a result, won an award from the GF. That HIV Vaccination developed killer CD8+ T Cells to kill HIV by searching out certain HIV epitopes & destroying the HIV virus. Well, that VIR-1388 has been discontinued and VIR is now partnered up with Sanofi-Aventis, so I don't think Jonah would be looking to VIR for any help on this. Why not? Because, Jonah has Scott Hansen at CytoDyn and Scott wrote the book on developing CMV vectors for this very purpose. Sacha shall employ Hansen's expertise in the development of this CMV vector. Similar to how the VIR-1388 HIV Vaccination searched out and destroys HIV, well this CMV vector would train killer CD8+ T Cells to locate and kill certain white blood cells containing that specific "antigen", and that, together with the simultaneous administration of CCR5 bloking leronlimab, would reproduce the HIV sterilizing effects of the LATCH protocol, thereby removing all traces of HIV in the blood serum as well as in the Reservoirs, without performing any stem cell transfusions.

With the sponsorship of the NIH, Jonah Sacha determined that it was possible to prevent at the Placenta, the vertical seeding of HIV from Mother To Child with the use of leronlimab-PLS.
This molecule was also likely developed by CytoDyn's own Scott Hansen, possibly, with the use of CytoDyn's 3rd party AI collaborating partner, where a version of the leronlimab molecule was modified to contain LS mutations which subsequently allowed its half life to be much longer, to exceed 1 month time, and also allowed for the drug to pass through the Placenta barrier. This too, has the potential to become yet another Phase 1 human clinical trial, which I see the GF taking on, possibly in tandem with their Triple Therapy trial which I'm speculating on. A leronlimab-PLS trial, would not necessarily require medications from GSK or ViiV, but if the PLS trial and the Triple Therapy were stacked one on the other, then medications from GSK and ViiV, would certainly be used in the Triple Therapy portion and the mother could be using ViiV meds during the -PLS portion. I'm sure they will be discussing their options.

"Prenatal administration of monoclonal antibodies (mAbs) is a strategy that could be exploited to prevent viral infections during pregnancy and early life. To reach protective levels in fetuses, mAbs must be transported across the placenta, a selective barrier that actively and specifically promotes the transfer of antibodies (Abs) into the fetus through the neonatal Fc receptor (FcRn). Because FcRn also regulates Ab half-life, Fc mutations like the M428L/N434S, commonly known as LS mutations, and others have been developed to enhance binding affinity to FcRn and improve drug pharmacokinetics*. We hypothesized that these FcRn-enhancing mutations could similarly affect the delivery of therapeutic Abs to the fetus. To test this hypothesis, we measured the transplacental transfer of leronlimab, an anti-CCR5 mAb, in clinical development for preventing HIV infections, using pregnant rhesus macaques to model in utero mAb transfer.* We also generated a stabilized and FcRn-enhanced form of leronlimab, termed leronlimab-PLS. Leronlimab-PLS maintained higher levels within the maternal compartment while also reaching higher mAb levels in the fetus and newborn circulation. Further, a single dose of leronlimab-PLS led to complete CCR5 receptor occupancy in mothers and newborns for almost a month after birth. These findings support the optimization of FcRn interactions in mAb therapies designed for administration during pregnancy."

The last HIV Cure that I'll discuss is HIV-AAV.
As you all should be aware, a $5 million grant was awarded to Jonah Sacha by the NIH and it is for the development of leronlimab, that would be delivered to the body through the use of an adeno-associated virus vector in a one-time dose.

"Starting with Jonah Sacha in 12/7/22 R & D Update :

"1:26:58: And so really looking forward to where this -- where the field is going. This is in vivo gene therapy. And currently, the state-of-the-art is AAV vectors or adeno-associated virus. And what you can do is you can actually take leronlimab in sequence. You can put it into this vector, you can then inject that into the muscle. And these myocytes, muscle cells will pick up the AAV vector, and they will then turn into a little antibody factory and produce leronlimab for the rest of your life*."*

"1:29:20: And so, this is why we are so optimistic about the future of leronlimab long acting for HIV prevention and cure. So, we think a long-acting molecule like this where a patient could, at home, subcutaneously dose themselves once every 3 months or perhaps even longer*, will have very high uptake and will be very attractive to patients. And for* functional cure*, by that, I mean, control of viremia, the goal here is to develop something where you could just go in,* get a single shot*. And you have coverage of --* your own body will make leronlimab*. And this is only possible because* leronlimab appears to be very well tolerated in patients and also in our preclinical studies."

And now, more recently, Jonah Sacha's, PhD Work in AAV which was described 2 weeks ago at the AIDS conference in Germany, which had the following results:

Within a week of AAV administration, all four macaques achieved complete (100%) CCR5 receptor occupancy on blood CD4+ T cells, and Leronlimab was detectable in the plasma within two weeks.

Two of the macaques experienced a significant decline in SHIV viral load, reaching undetectable levels between 10-40 weeks post-AAV administration. These low viral levels were maintained for at least 70 weeks.

The other two macaques developed anti-drug antibodies (ADAs) within 5-15 weeks, leading to the clearance of Leronlimab from their plasma and a reduction in CCR5 receptor occupancy.

Interestingly, spontaneous re-expression of CCR5 blockade by Leronlimab occurred about a year after AAV administration in both of these macaques. One of these animals maintained complete CCR5 receptor occupancy, detectable Leronlimab levels, and undetectable SHIV RNA for over a year after this re-expression. The second animal also achieved full receptor occupancy and a decline in viral load, though for a shorter duration of 10 weeks.

This was my take on Investor's Hangout:

"So, in the experiment, they took 4 monkeys infected with SHIV and infected them with the AAV that delivered the leronlimab gene.

Within 40 weeks, 2 of these monkeys had their viral loads down to zero.

With the other 2 monkeys, they developed antibodies against leronlimab which caused leronlimab to stop working. However, one of these 2 monkeys started to make leronlimab again and that same monkey is keeping viral load SHIV levels undetectable.

How can we stop the development of antibodies against leronlimab?

What caused that one monkey to resume making leronlimab after all the antibodies against leronlimab were depleted and once leronlimab was being made again, why did those antibodies not return?"

Ken replies:

"I may not be reading the abstract right. Yes, two monkeys still had undetectable SHIV 70 weeks later*. And yes, a third (of the four) monkeys started to make Leron on its own and has* undetectable SHIV RNA a year later*. But even the fourth monkey's story -- which sounds like the title of my next novel -- sounds pretty good, doesn't it? It also has detectable plasma Leron and declined plasma viremia.*

So, all four of the monkeys had good results, right? As in 100%?

Here's the part of the abstract about the two monkeys who developed anti-drug antibodies:

Quote:
The remaining two RMs developed ADAs within 5-15 weeks post-AAV resulting in complete clearance of Leronlimab from plasma as well as a rapid decline in CCR5 RO. Spontaneous reemergence of CCR5 RO by Leronlimab was observed approximately 1 year post-AAV. One of the two animals has had full and sustained CCR5 RO, detectable plasma Leronlimab, and undetectable SHIV RNA in plasma for over 1-year post-reexpression*. The second re-expressing animal has achieved and maintained 100% CCR5 RO for about 10 weeks, has detectable plasma Leronlimab, and has declined plasma"*

and Ken does receive confirmation, that yes, those results were 100% good results.

A few days ago, I spoke about leronlimab HIV-AAV in Pushing Forward.

"...then for the all inclusive HIV Cure, HIV-AAV, ironing out these bugs, becomes the focus.

It is a given, that an HIV Cure can not be realized without the establishment of a solid, reliable blockade of CCR5. The HIV-AAV had good results for the 1st iteration, but they ran into a slight problem with some of the animals developing anti-drug antibodies. In a couple of the animals, anti-leronlimab anti-bodies developed and knocked out some of the leronlimab that was being auto-produced in the body. So, Jonah Sacha still needs to do more work to get that part right. Because, in no way can it be tolerated that the 100% Receptor Occupancy of the CCR5 blockade dissipates or fails for any reason, especially not as a results of anti-leronlimab antibodies. It can not be permitted that Receptor Occupancy fall from 100% for any reason. That simply can not happen, so they need to figure out why those anti-leronlimab antibodies developed in those couple of animals and how to prevent that from ever happening in the future, because as soon as the CCR5 blockade begins to die down, then HIV has the opportunity to rise back up again, and that is because HIV lives in the HIV Reservoirs where the virus waits for the opportunity for leronlimab Receptor Occupancy to fall."

Once leronlimab HIV-AAV approaches human clinical trial stage, my thinking is that it becomes a part of the consortium between CytoDyn, the GF, GSK and ViiV. Max would be in the thick of it all.

This particular linked article sums up what was happening on the front of the HIV Cure prior to everything that was depicted above.
Clearly, CytoDyn is absolutely focused on determining an HIV Cure. Jonah Sacha has been in the thick of it for some time already. Now, with Max's ear, Jonah may be given more of an opportunity to determine the best route to wipe out the HIV Reservoir and determine an HIV Cure. CytoDyn's leadership is in place and the partnerships are in place that should allow this endeavor to move along successfully. Everyone involved deeply desires that an HIV Cure become available worldwide and soon. This is an Urgent matter in everyone's eyes. These plans illustrated above, in my mind, only strengthen the relationships between these 4 companies, CytoDyn, The GF, GSK and ViiV. Much of this will be powered by the financial input of the GF. Sacha's labor & analytical thinking, along with CytoDyn's CCR5 100% R.O. Inhibitor. The auxiliary use of GSK's and ViiVs ART and bNAb medications along with any auxiliary needs they may provide shall also play a massive part in pulling all this together.

If this were not true, then consider the opposite. Would GSK and ViiV be opposed to the grant the GF gave Jonah? Play that out and you'll see that is not in accordance with known facts about GSK and ViiV. Both want an HIV Cure. Max still has great ties and great relationships at both companies. Think it through and I think you'll agree.

CYDY performance:

5-day 36.36%
10-day 30.43%
1-month 100.00%
3-month 150.00%
6-month 150.00%
YTD 172.73%

It sure is. My investment plan allows me to start buying aggressively at .32. I look forward to it holding that area for a bit. I'm so excited for everyone having started purchasing in the last 12 months. The 2 year high will be taken out soon enough.

https://stocktwits.com/trenddetector/message/605310846

https://www.gatesfoundation.org/about/committed-grants/2025/02/inv-079314

Dr Sacha got a $1 million grant from The Gates Foundation per a post on ST.

Just a reminder to keep the topic about CYDY. Who has been right or wrong really isn't on topic nor is who might be a basher or pumper.

MGK_2

Pushing Forward
Greetings Folks.

I'm going to use this post as my basis, even though I didn't write it. I agree with it and both of these guys are friends, so they won't mind me stealing their stuff. This was written by MLAB aka u/Upwithstock:

"I spoke with Flight_19 and we have been in this industry for a combined 60+ years. We both have seen situations where SILENCE was critical to negotiating and protecting a new product development. We have Long Acting LL and we are aware of its preclinical results but waiting to understand when it goes to human trials and how it will be funded. All of that Long lasting info has provided a pretty good clue but nothing solid yet.
On the other front was a more open disclosure of information regarding MASH, many times in the past we heard directly from CYDY of partnerships related to preclinical work. We are very much aware that the preclinical work in MASH produced stellar results on fatty liver and fibrosis! Then we got tickled by two LinkedIn posts one by Max and the other by Yuki (SMC).
There has been a ton more clues that have been bantered about on the message boards regarding MASH. As u/SportyDawg mentioned “ This is about to blow".

As I said in my last post, The CytoDyn Enabling, I feel like its confusing trying to decipher what's taking place right now. We can see it happening, all around us, as the fog lifts, little by little, step by step, baby steps as it were. Earlier this week, we received sort of an indirect communication from SVP Max Lataillade, Head of Clinical Development. Like I said, baby step. SMC helped CytoDyn take another baby step with this from Yuki Sakakibara, Executive Officer at SMC. Today, CytoDyn took its 3rd step in a row with this release on the peer reviewed and published manuscript on CytoDyn's HIV-MDR clinical trial.

From my last post, The CytoDyn Enabling, I leaned quite heavily towards Gate's probable interest in CytoDyn that could be also backed by the US, in support of a collaborative effort towards ending the HIV pandemic. The HIV pandemic ends with an HIV Cure, and not because of any HIV Treatment. Gates wants HIV gone. So does Trump and RFK Jr. The same goes for Lalezari, Lataillade, Sacha and Hansen at CytoDyn. As for the leaders at ViiV and GSK, this too lines up with their own goals.

If the GF backs and funds the advancement and development of the Cure for HIV, then, the GF would run the multiple trials towards this end game. For the time being, the few potential cures for HIV which could be advanced and developed further are 1) The prevention of vertical transmission from Mother to Child with the administration of leronlimab-PLS, Placental LS mutation and 2) The eradication of HIV Reservoirs with the use of Triple Therapy within the 1st 30 days of birth. Lastly, or 3rd) LATCH may also be implemented, but LATCH is really meant for HIV+ patients with blood born cancer like leukemia or lymphoma and the LATCH studies are already being done by (2) outside parties, one of whom is in Berlin, Germany and the other is being done by amfar, so, I'd say that Gates probably won't take this HIV Cure on, but may opt to acquire the rights to further develop it.

Generally, this is how the ball gets rolling towards the HIV-Cure. Start small and work bigger. Preventing the vertical transmission of the virus is the first step. That is preventing HIV from passing from Mother to Fetus by administering leronlimab-PLS just before birth. In newly born babies with HIV + mothers, the next step would be the prevention of the development and establishment of HIV Reservoirs by implementing the Triple Therapy Protocol. Once those (2) trials are underway, then for the all inclusive HIV Cure, HIV-AAV, ironing out these bugs, becomes the focus.

It is a given, that an HIV Cure can not be realized without the establishment of a solid, reliable blockade of CCR5. The HIV-AAV had good results for the 1st iteration, but they ran into a slight problem with some of the animals developing anti-drug antibodies. In a couple of the animals, anti-leronlimab anti-bodies developed and knocked out some of the leronlimab that was being auto-produced in the body. So, Jonah Sacha still needs to do more work to get that part right. Because, in no way can it be tolerated that the 100% Receptor Occupancy of the CCR5 blockade dissipates or fails for any reason, especially not as a results of anti-leronlimab antibodies. It can not be permitted that Receptor Occupancy fall from 100% for any reason. That simply can not happen, so they need to figure out why those anti-leronlimab antibodies developed in those couple of animals and how to prevent that from ever happening in the future, because as soon as the CCR5 blockade begins to die down, then HIV has the opportunity to rise back up again, and that is because HIV lives in the HIV Reservoirs where the virus waits for the opportunity for leronlimab Receptor Occupancy to fall.

Triple Therapy Prevents the Development of HIV Reservoirs, at least in newborns. It may be true that Triple Therapy may also help to eradicate HIV from pre-existing HIV reservoirs. This has not yet been tested. In general, once they figure out how to clear the Reservoirs of HIV, then that would be the answer to the problem of the "blips". There no longer would be "blips" if there were no Reservoirs. If it is determined that Triple Therapy or a modified version of Triple Therapy in fact wipes out pre-existing HIV Reservoirs, then this would amount to another all inclusive HIV Cure, without using Stem Cells and without the auto production of leronlimab.

So, it is my conjecture that Gates and/or ViiV would take over the research on how to eradicate pre-existing HIV Reservoirs and also, how to prevent the development of anti-leronlimab antibodies in every patient while utilizing the HIV-AAV technique. All of that research could be done while they also get the ball rolling for the clinical trials against vertical transmission utilizing leronlimab-PLS and during the clinical trial against HIV Reservoir formation utilizing Triple Therapy.

It shouldn't have to be mentioned that Gates has more than the required assets to get this done. ViiV has the required scientists and the necessary engineering facilities. This effort would require significant investment in both that research and in conducting clinical trials. But, all here involved stand on the solid rock of validated proof that the drug works and that these protocols in fact do work. Therefore, they are all deeply convinced and are unwavering in the fact that they are working with absolute best molecule. Otherwise, why would Max be SVP at both CytoDyn and at the GF simultaneously? By bringing in Max's prior company, ViiV, they build upon both ViiV's and GSK's shared hope to find the HIV Cure and with ViiV's variety of HIV treatment medications, they can implement many of their long acting oral and sub-cutaneous injectables together with leronlimab in combination, especially for the purpose of Salvage Therapy.

The only reason Gates would fund or partner with CytoDyn is because of the possibility of an HIV Cure. The GF would not do this for any other reason. Possibly for long acting therapy, but, to me it would be unlikely. Not for cancer. Not for MASH. The only reason would be for HIV Cure. Since ViiV already has an HIV Therapy program, ViiV's medications would likely be intended for use in conjunction or combination with the HIV Cure. Max Lataillade relates that:

"While I am not an oncology expert, my background is in infectious diseases and HIV, with a deep understanding of immunology and extensive experience in drug development. When evaluating new approaches to treatment and cure, I focus on the mechanism of action (MOA), how well it addresses the underlying process, and, most importantly, how inhibiting that process meets unmet medical needs. This perspective is what makes CCR5 inhibition-particularly with agents like Leronlimab so intriguing in metastatic colorectal cancer and triple negative breast cancer."

Gates hired Max as SVP and Head of HIV Drug Development. He did not hire him as Head of Oncologic Drug Development at the GF. In the statement above, Max mentions both treatment and Cure. His terminology definitely refers to HIV. What are the unmet medical needs in HIV? One, by definition is Salvage Therapy and the other is HIV Cure.

As for Salvage Therapy, this peer-reviewed and JAIDS published manuscript concludes,

"Leronlimab resulted in significantly reduced plasma HIV-1 within one week after addition to failing ART. After 24 weeks combined with an OBT, most participants had plasma HIV-1 RNA levels <50 copies per mL plasma, suggesting utility of leronlimab as a component of salvage therapy*."*

When all else fails, add leronlimab to save life.

Max adds:

"Unpacking CCR5 Inhibition: A Promising Therapeutic Target with Broad ApplicationsCCR5 (C-C chemokine receptor type 5) is a cell surface receptor that plays a pivotal role in immune cell signaling, particularly in inflammatory responses and the recruitment of immune cells to sites of infection.Most notably, it serves as a coreceptor for HIV, facilitating the virus's entry into cells and subsequent infection. Beyond its role in HIV, CCR5 has been implicated in a variety of diseases, including cancer, cardiovascular disease, fibrosis, and autoimmune conditions, due to its involvement in immune cell trafficking and inflammatory pathways. Recently, attention has shifted toward its role in oncology. CCR5 contributes to the spread of cancer through multiple processes: it promotes angiogenesis to support tumor growth, skews macrophages toward a pro-tumor M2 phenotype, aids in the spread of distant metastases, neutralizes chemotherapy effects by promoting DNA repair, and recruits immunosuppressive CCR5+ regulatory T cells into the tumor microenvironment. Therefore, therapeutic strategies targeting CCR5 to block its activity could hold significant promise as part of future treatment pathways."

The one thing that HIV-AAV would definitely offer its patients is a PERMANENT CCR5 Inhibition. Once HIV-AAV is fully developed and working, any patient who receives the one time injection, would develop a Permanent CCR5 Inhibition. This essentially means that it would be equivalent to taking a leronlimab sub-cutaneous injection weekly for the rest of their life. What kind of promise is Max referring to here given that a Permanent CCR5 blockade would provide tremendous benefit towards the prevention of and treatment of a score of various and different disease paths.

If HIV-AAV becomes an output of the GF consortium, all of a sudden, patients develop an immunity to HIV. High levels of inflammation would be dramatically curtailed. Cancers become less symptomatic and more treatable and more susceptible to chemotherapy. This revolutionary one-time injection becomes a massive turning point in the standardization of drug excellence. It becomes the standard in HIV health care across the globe.

However, the implications are massive. In a way, HIV-AAV becomes the one-time treatment for MASH. It becomes the one time treatment for MSS mCRC. The one time treatment for Long COVID. For Alzheimer's Disease. Etc... Why? Because, Anyone who receives HIV-AAV develops lifetime leronlimab Receptor Occupancy. Therefore, that patient has leronlimab treatment for CytoDyn's entire Pipeline. HIV-AAV satisfies the treatment regimen for all potential leronlimab indications.

But, as we go forward, HIV-AAV has run into some issues with anti-drug anti-bodies, so work on the vector is yet required. But, still, going forward, CytoDyn takes baby steps in all the indications. Remember Max finds leronlimab intriguing in metastatic colorectal cancer and triple negative breast cancer.

For MASH Yuki says:

"In a great collaboration with CytoDyn Inc., we are pleased to share promising preclinical results demonstrating the efficacy of leronlimab (a CCR5 antagonist) in liver disease models. Using our STAM (MASH-HCC) and CCl4-induced liver fibrosis models, leronlimab monotherapy successfully reversed liver fibrosis—an area with significant unmet medical need. These findings suggest that leronlimab’s anti-fibrotic potential may extend beyond liver disease, with possible implications for other fibrotic conditions, such as those affecting the lungs and heart. We look forward to its continued development and success."

In patients who would receive HIV-AAV, fibrosis of any etiology would be minimized. MASH in general would be minimized. But, nobody would receive life long leronlimab via HIV-AAV, when receiving it for only a short period would do the trick. The way out is that the cost of the one time HIV-AAV administration would be so much more than the shorter treatment. It would not be worth it from the patient's own wallet. HIV-AAV would only be covered by health insurance if the patient were HIV +. For patient's wanting it "off label", they would be forced to pay for the drug "out of pocket" because health insurance would not cover the cost since it was prescribed "off label". Most of these patients would not have the money to purchase HIV-AAV on their own, especially when the actual leronlimab would be available via prescription for their particular ailment and therefore covered by insurance. It would be cost prohibitive to receive the one time HIV-AAV single injection for anything but HIV, but it would remain available for HIV + patients who are prescribed the Cure.

All of this has to be worked out. How the medications function together. How they interact with each other. How they compliment each other. How they work together. How leronlimab may be incorporated together with ViiV medications. How can the GF scientists benefit the collaboration? How do the ViiV scientists work? What type of resources does the GF and ViiV offer to CytoDyn, especially against G?

I see Trump and RFK Jr backing such a collaboration. As for them, the sooner an HIV Cure, the better so as to minimize indefinite payments for HIV Therapy. I see Lalezari wanting to get as many of his indications in his pipeline solidified before he reveals his way forward publicly. He wants to take MSS mCRC down the road a bit. He wants to get MASH and Pulmonary Fibrosis down the road further before he makes known any revelations.

I'm thinking that in the discussion between themselves, between Gates, CytoDyn, ViiV and GSK, decisions are being made. Plans on how to proceed are being decided. As time moves forward, we get more information so we can see this play out. So just be patient please.

It is unfolding. It is happening in a path which is more than plausible.

You are right. The move up, which has been quite modest, is related to shareholders increasing confidence CYDY has turned things around as a company. Pumps always have trading rooms at the heart of the moves. I have been a member of several subscription rooms targeting stocks and this move isn't close to being how those work. Nor has CYDY been discuused on the ones I still follow.

Is there a ton of speculative posts on message boards? Sure. They have basis in what is possible. Some are ridiculously optimistic but others are likely.

What folks need to see are human trials being initiated by CYDY and loosening up of some of the companies tightly held details/arrangements with GF, GSK, VIIV (should any exist) and the institutions funding some of the research. We are one announcement away at reducing the naysayers position to nothing. History gives them a lot of runway to be confident so I don't blame them for being that way.

Lab_Monkey_

"Cytodyn is one of our first vintage investments and we never lost faith in the science."
E. Douglas Grindstaff II , Trustee, Mega-Angel Investor, Board Director, Serial Tech and Biotech Entrepreneur.

Doug recently responded to Max Lataillade's post on LinkedIn about leronlimab and why CCR5 is so intriguing in metastatic colorectal cancer and triple negative breast cancer.

Cytodyn is listed as one of 6 companies in their portfolio. His reply was:

"The potential impact of CCR5 inhibition is significant for anyone with metastatic colorectal cancer and triple negative breast cancer as weak as hiv. Finally l, the true potential is beginning to be recognized. Cytodyn is one of our first vintage investments and we never lost faith in the science."

I would love to know when Doug initially invested in Cytodyn, stating that it's one of his "vintage" investments. Sounds like he's got diamond hands though.

Page 6 under curated portfolio:

https://edouglaspartners.com/#About

In case you found the link didn't work:

Original Article: Clinical Science
Leronlimab Treatment for Multidrug-Resistant HIV-1 (OPTIMIZE): a Randomized, Double-Blind, Placebo-Controlled Trial
Gathe, Joseph C. MDa; Dejesus, Edwin MDb; Ramgopal, Moti N. MDc; Rolle, Charlotte-Paige MDb; Yang, Otto O. MDd; Sanchez, William E. MDe; Lalezari, Jacob P. MDf,g; Krishen, Alokg; Sacha, Jonah B. PhDh; Hansen, Scott G. PhDh; Meidling, Joseph MBAg
Author Information
JAIDS Journal of Acquired Immune Deficiency Syndromes ():10.1097/QAI.0000000000003648, February 20, 2025. | DOI: 10.1097/QAI.0000000000003648
Buy
PAP

Metrics
Abstract
Background:
Leronlimab is a humanized ?-IgG4 monoclonal antibody that blocks C-C chemokine receptor type 5 (CCR5). We investigated leronlimab as a treatment option for people living with multidrug-resistant HIV-1.

Setting
and Methods: In a phase 2b/3, multicenter, randomized, double-blind, placebo-controlled study conducted in 21 hospital centers in the United States, treatment-experienced people living with HIV (PLWH) with documented drug resistance were randomly assigned once weekly leronlimab (350 mg subcutaneously) or matching placebo for one week overlapping existing failing antiretroviral treatment (ART), followed by a 24-week single-arm extension with weekly leronlimab combined with a new optimized background treatment (OBT). The primary endpoint was achieving ≥0.5 log10 reduction in plasma HIV-1 RNA from baseline at the end of the one-week double-blinded treatment period.

Results:
52 participants were enrolled (25 leronlimab and 27 placebo). After the one-week randomized phase, by the intent-to-treat analysis 64.0% (16/25) receiving leronlimab achieved ≥0.5 log10 reduction in plasma HIV-1 RNA versus 23.1% (6/26) receiving placebo (p=0.0032), while by per protocol analysis 72.7% (16/22) receiving leronlimab achieved ≥0.5 log10 reduction in plasma HIV-1 RNA versus 24.0% (6/25) receiving placebo (p=0.0008). Leronlimab was generally well tolerated with no drug-related SAEs reported. Overall, 175 adverse events were reported by 34/52 participants, with 120 (68.6%) adverse events categorized as mild.

Conclusions:
Leronlimab resulted in significantly reduced plasma HIV-1 within one week after addition to failing ART. After 24 weeks combined with an OBT, most participants had plasma HIV-1 RNA levels <50 copies per mL plasma, suggesting utility of leronlimab as a component of salvage therapy.

https://journals.lww.com/jaids/abstract/9900/leronlimab_treatment_for_multidrug_resistant_hiv_1.602.aspx

So do I. He was full of interesting stories. Not sure about him but I think we'll see more of the old time CYDY posters coming around pretty soon.

Market Size and Sales Projections:

Liver fibrosis treatment market size: The global liver disease treatment market is expected to exceed $12 billion by 2030, with a large portion due to fibrosis treatments.
Heart fibrosis treatment market: The heart failure market is massive, with global sales projected to reach over $20 billion in the next few years.
Lung fibrosis treatment market: The global market for lung fibrosis drugs is projected to reach approximately $5-7 billion by 2030.

If this drug was able to reverse fibrosis in all three organs (liver, heart, and lungs), it could easily address a combined global market worth in excess of $30 billion to $50 billion or more.

https://www.reddit.com/r/LeronLimab_Times/comments/1it68g2/liver_preclinical_results/#lightbox

Executive officer at SMC lab posted about the latest results about the CYDY fibrosis study. Quite encouraging for other indications beyond the liver. Haeart and lungs mentioned.

BuildGoodThings

5 to raise an eyebrow, 4 that make one blush, 3 to keep it simple, and 2 you may want to gush.
FIVE TO RAISE AN EYEBROW,
Alzheimers' https://www.cytodyn.com/newsroom/press-releases/detail/633/december-2024-letter-to-shareholders “I am pleased to announce the [clinical] study is now fully funded by an outside foundation, and the protocol will soon be submitted to both the FDA and the Cornell IRB.”

Breast Cancer https://ascopubs.org/doi/10.1200/JCO.2022.40.16_suppl.e13062 “These [clinical] studies suggest that mTNBC pts dosed with leronlimab had high clinical benefit, i.e. longer PFS & OS with few TEAEs, and leronlimab resulted in a drop in circulating TACs in the majority of pts correlating with early therapy response.”

Colorectal Cancer https://www.cytodyn.com/newsroom/press-releases/detail/633/december-2024-letter-to-shareholders “we recently completed the kickoff meeting with Syneos Health, the CRO for the [clinical] study, and enrollment efforts are set to begin in January [2025].”

Fibrosis https://www.cytodyn.com/newsroom/press-releases/detail/634/cytodyn-announces-findings-of-statistically-significant “The three studies demonstrated statistically significant reversal of liver fibrosis with leronlimab monotherapy (compared to an isotype IgG4 control arm with p-values across all 3 studies < 0.01)”

HIV https://plus.iasociety.org/webcasts/planet-apes-learning-immunogenicity-animal-models “cumulatively this data suggests that the virus reservoir was indeed actually cleared in these animals.”

FOUR THAT MAKE ONE BLUSH.
Clinical hold removed https://www.cytodyn.com/newsroom/press-releases/detail/618/cytodyn-announces-fda-has-lifted-clinical-hold

Samsung debt restructured https://www.cytodyn.com/investors/sec-filings/all-sec-filings/content/0001558370-24-004802/cydy-20240403x8k.htm

Suit with Amarex resolved https://www.cytodyn.com/newsroom/press-releases/detail/622/cytodyn-announces-settlement-with-amarex-clinical-research

Upcoming Clinical Trials sponsored https://www.cytodyn.com/newsroom/press-releases/detail/633/december-2024-letter-to-shareholders

Alzheimers’

HIV (LATCH)

(also potentially) Pulmonary Fibrosis

THREE TO KEEP IT SIMPLE,
Safety- Results from numerous clinical trials contain safety data. CytoDyn has indicated in December 2024 that they are compiling this safety data from many trials into a manuscript. https://www.cytodyn.com/newsroom/press-releases/detail/633/december-2024-letter-to-shareholders “CytoDyn is preparing a draft manuscript summarizing the integrated safety data from the almost 1,600 patients who have now been treated with leronlimab.”

Results-

Breast Cancer (Clinical data) https://ascopubs.org/doi/10.1200/JCO.2022.40.16_suppl.e13062

COVID-19:

Mild to Moderate (Clinical data) https://www.sciencedirect.com/science/article/abs/pii/S0149291824002601

PASC (longhaulers) (Clinical data) https://d1io3yog0oux5.cloudfront.net/_548f7e2407751e8b8211e6928a8d3dca/cytodyn/db/259/3461/pdf/PIIS016344532400080X.pdf

HIV cure

AAV viral vector https://plus.iasociety.org/sites/default/files/2024-09/e-poster_454.pdf

Triple Therapy (ART+ bNAbs + Leronlimab) (also prevention) https://plus.iasociety.org/webcasts/planet-apes-learning-immunogenicity-animal-models

HIV prevention

Mothers to Newborns https://www.tandfonline.com/doi/full/10.1080/19420862.2024.2406788#abstract

Fibrosis/MASH

(Clinical data) https://www.postersessiononline.eu/173580348_eu/congresos/ILC2022/aula/preposter_439168274_3.png

Preclinical https://www.cytodyn.com/newsroom/press-releases/detail/634/cytodyn-announces-findings-of-statistically-significant

Platform- One drug for multiple diseases + long acting versions in development https://www.cytodyn.com/pipeline

and TWO YOU MAY WANT TO GUSH.
Potentially help patients with fewer side effects

The total 2030 potential treatment market size for diseases below may be more than $300 billion annually

Alzheimers

Cancer: Breast: HR+/HER2-

Cancer: Breast: mTNBC

Cancer: Colorectal

Cancer: Glioblastoma

Chronic Fatigue Syndrome

Covid: Long-Haulers (PASC)

HIV Inflammation (biologics drugs)

Pulmonary Fibrosis MASH

---------------------

CytoDyn and Leronlimab

---------------------

All the above are for entertainment, not investment advice and not medical advice. 2/18/2025

Tanya liked the post as well. It is one thing for CA to like it but having Tyler and Tanya like as well is more interesting given their concerns with legalities etc.

Great post by Max! There are likes of that post from some interesting folks as well as comments from very impressive folks in the field.

“While I am not an oncology expert, my background is in infectious diseases and HIV, with a deep understanding of immunology and extensive experience in drug development. When evaluating new approaches to treatment and cure, I focus on the mechanism of action (MOA), how well it addresses the underlying process, and, most importantly, how inhibiting that process meets unmet medical needs. This perspective is what makes CCR5 inhibition-particularly with agents like Leronlimab so intriguing in metastatic colorectal cancer and triple negative breast cancer.”

And:

“Unpacking CCR5 Inhibition: A Promising Therapeutic Target with Broad Applications
CCR5 (C-C chemokine receptor type 5) is a cell surface receptor that plays a pivotal role in immune cell signaling, particularly in inflammatory responses and the recruitment of immune cells to sites of infection. Most notably, it serves as a coreceptor for HIV, facilitating the virus's entry into cells and subsequent infection. Beyond its role in HIV, CCR5 has been implicated in a variety of diseases, including cancer, cardiovascular disease, fibrosis, and autoimmune conditions, due to its involvement in immune cell trafficking and inflammatory pathways. Recently, attention has shifted toward its role in oncology. CCR5 contributes to the spread of cancer through multiple processes: it promotes angiogenesis to support tumor growth, skews macrophages toward a pro-tumor M2 phenotype, aids in the spread of distant metastases, neutralizes chemotherapy effects by promoting DNA repair, and recruits immunosuppressive CCR5+ regulatory T cells into the tumor microenvironment. Therefore, therapeutic strategies targeting CCR5 to block its activity could hold significant promise as part of future treatment pathways.”

CYDY's Dr Max L:

https://stocktwits.com/DoubleD83/message/604547143

Reminder:

All major U.S stock markets will be closed on Monday February 17, in observance of Presidents' Day.

MGK_2

The CytoDyn Enabling
Greetings & Welcome. Come on Guys, you thought I'd miss a Sunday?

Lots of Speculation here, but based on Facts.

My inkling is that things should start to ramp up this coming week, or to play it safe, by end of 1st quarter. I figure that since the last Letter To Shareholders on 12/17/24, that which has taken place at CytoDyn is very important.

"As we enter 2025, I am truly excited about the possibilities that lie just ahead*."*

I figure that at this moment, CytoDyn is deciding on what it must or how it must take action upon certain questions or necessary decisions. Are these in line with what Gates would hope for or even with what he would push for if his fund, the GF would fund the development of an HIV Cure using leronlimab as the key molecule? I think that should Gates in fact be interested in CytoDyn's HIV indication, (and why wouldn't he be interested, after all, leronlimab is a monoclonal antibody CCR5 blockade that does everything which only it can do), then he would definitely prefer to see CytoDyn successful in their other indications. Gates would like to see to it that the majority of things previously discussed by Lalezari in the prior Letter To Shareholders 12/17/24, in fact, do come to pass for the benefit of CytoDyn and also to financially fortify the company with whom he intends to partner with.

So a quick overview follows of what Lalezari discussed in that Letter To Shareholders. He discussed the MSS mCRC clinical trial enrolling now; the launch of 2 new murine studies in mTNBC and a repeat study in Glioblastoma Multiforme, GBM going on right now, this time utilizing the combination of leronlimab + temozolomide and if successful, a Pilot Study in GBM could then follow.

Everything which we have been recently discussing regarding MASH and fibrosis of any cause was also brought up in that letter. He brought up the NIH and the Long COVID grant award being pursued by CytoDyn. He indicated that CytoDyn would put on hold the already designed, planned for, bought and funded Chronic Fatigue Syndrome Pilot Trial, while we wait for the NIH to respond to our application. He indicated that if the response comes back in the affirmative, then the CFS Pilot Trial would be cancelled [because the 2 indications are related], but if the NIH responds in the negative, then CytoDyn would resume initiation of the previously planned for CFS Pilot Trial.

Lalezari discussed the fully funded Alzheimer's Pilot Study which takes place at Cornell Medical Center in NYC and is slated to begin soon. He spoke on HIV Cure concerning the amfAR LATCH study and the LATCH study in Berlin, Germany. Both of these Pilot Trials are slated to begin in 2025.

Then, he goes on to discuss the manuscripts. He mentions 2 manuscripts that were able to receive peer review and subsequently get published and mentions 5 manuscripts that are still pending publication for various reasons.

Why is all of this rehashing important? Well, everything that Lalezari does is very important. The manuscripts provide the validation behind the drug. It would be so much better if CytoDyn could point to these publications for the scientific evidence instead of to the results page of the clinical trial. The published peer reviewed manuscripts provide the scientifically significant data evidence proving to the world leronlimab's safety and effectiveness.

The murine studies help CytoDyn to focus its efforts and to zero in on its objectives rather quickly and inexpensively. The Pilot Trials are bought and paid for by 3rd party sponsors. The work in the LATCH trials only brings the HIV Cure that much closer and that labor is being done for us by (2) different 3rd party sponsors.

Everything Lalezari discusses here in the Letter To Shareholders 12/17/24, he assuredly desires realized and actualized, but for whatever reason, they still are waiting to be completed. Gates would read this same Letter To Shareholders and would understand Lalezari's plan. Gates' response would be in the affirmative. That he would be on board and would want the same things for CytoDyn as does Lalezari and Max. Because when CytoDyn benefits, the closer Gates gets to the realization of his own plans for an HIV Cure. I believe Gates is only interested in CytoDyn's HIV indication for HIV Cure. LATCH would be included for that as it is an HIV Cure, but LATCH really won't be the main solution because LATCH is meant for HIV+ patients who have some sort of blood born cancer, like a lymphoma or a leukemia. But, the GF would take LATCH under their own HIV Cure wing when the time comes.

Gates may have become impatient and therefore could determine to find reasons why these items which Lalezari is seeking remain pending. He could determine to intervene and to help along the process of peer review to get those papers published. He could speak to those at the NIH to see what's happening regarding the approval or denial of the NIH grant for Long COVID. We all know that Gates' father died of Alzheimer's Disease and for that reason, Gates could opt to take on CytoDyn's Alzheimer's Disease Indication under the partnership's umbrella. Therefore, Gates could usher along the FDA approvals of the Alzheimer's Disease Pilot Trial's protocol. In general, Gates could search out CytoDyn's road blocks and dismantle them.

So, there are many reasons why the GF could choose to step in, at least in part, to help inch along some of these slow moving processes. The GF could have been taking some of these steps in the prior 2 months, the period since that last Letter To Shareholders. Therefore, we may learn of the status of some of these possibilities in the coming PR, hopefully coming this week or next, 2 months following the last letter, but again, to be safe, by end of 1st quarter.

In the next PR, I would expect to hear about advances in the directions which Lalezari described, in some or even all of the items which Lalezari delved into. Everything Lalezari mentioned were active but yet to be fulfilled or completed. Lalezari did not mention any dead items such as the HIV-MDR indication. Everything he mentioned were promising or pending so therefore may now be described to have advanced and if so, Gates might have had his own small or large contribution towards that particular advancement. Remember, the pull Gates has as a result of his prior affiliations, his wealth of connections, his relationship with Max, his shared aspirations with the US President and with the Secretary of Health and Human Services. Their ultimate goal is an HIV-Cure, but we take baby steps until we get there. I figure that these special men could hold meetings, conversations and discussions on how to handle any obstacle in their way or slowing things down.

Regarding MASH, hopefully, we get an answer and soon, but if we released that PR disclosing the results, then we could be lighting a fire under the suitor to initiate the agreement. If there is no agreement, then, I think we should try to get an EUA because the rate at which we breakdown fibrosis and scar tissue is so much faster than either resmetirom and/or semaglutide. If GSK wanted to get into the MASH and anti-fibrosis business, then licensing leronlimab would be an incredible solution. The only reason why Gates would potentially be interested in MASH is because of the high incidence of MASH in patients who are HIV+. Max is already very familiar with GSK and of course he now works for the GF. I just don't know if Gates would want to enter the MASH scene, even if it were for HIV+ patients. He might not consider it an HIV disease.

Gates could desire Alzheimer's Disease too, because his dad died of the disease, but he might want to see how this Pilot Trial pans out first. He'll probably want LATCH, HIV-PLS and HIV-AAV, as they are all HIV Cures, so therefore, what ever Gates needs to do in order to speed CytoDyn up would be his interest. Gates could do CytoDyn a favor by speaking to the heads at the NIH regarding Long COVID, to help get CytoDyn in or to at least make a decision sooner rather than later. What ever is necessary to get G off our backs would also be of great help, if he has power in that regard. With Max's guidance, if Gates feels or believes that it would be worthwhile and / or helpful, he might consider resurrecting the HIV-MDR BLA. Thousands of patients would prefer leronlimab to help them control their HIV instead of their current HAART.

So, with regard to all these things, I figure that Max and Gates have been considering and in discussion to the point of maybe even deciding upon. Look, Trump has a 4 year window. RFK has a 4 year window. They want an HIV Cure before their administration is over. Gates wants it ASAP as does Max. They have enough evidence that their answer lies in the leronlimab molecule. They realize beyond a shadow of a doubt, that the only way to cure HIV is by CCR5 blockade. Every HIV Cure thus far has required either a CCR5 blockade or stem cells that were missing CCR5 receptors. The Cure must entail blocking CCR5 and leronlimab is the best molecule for that purpose.

Lalezari would be very much in favor of the GF being on board or at least taking CytoDyn's HIV indication. He would be very much appreciative if Gates in fact would help in speeding things along and by helping to eradicate road blocks. Why? Because millions of people are walking this Earth not even knowing that they are HIV+. The virus isn't going anywhere until the cure is implemented, but Lalezari has given that responsibility to Max to allow him to focus on the other indications. Certainly, a great deal of trust exists between Max and Lalezari. JL knows Max won't steer this ship into unfriendly waters. But JL is after this just as much as anyone else and looks forward to an Abbreviated Time Line.

Regarding the US President and RFK Jr., I think they would be happy if it is done within their administration, but certainly, the sooner the better. Don't they want to cut down on all those world wide HAART expenses? Don't the HIV+ patients of the world deserve this cure like tomorrow? So anything that speeds CytoDyn along its track, would speed the US towards their goals as well. US President and RFK Jr. also have those necessary connections to lift road blocks and to clear out any interferences. They too understand that the only way to a cure is via CCR5 blockade. They do allow the other Big Pharmas to do their thing, develop more HAART or even more long acting PrEP, but they know that all that is done without the use of a CCR5 blockade. Therefore, they know that won't make a difference anymore once the cure is out.

Somebody has to tell G that their time is short and I think the right person to inform G of that doomed fate would be Dr. Lalezari. Why? Because CytoDyn owns the CCR5 blockade and nobody else does. Big Pharma's hands are tied without this drug. It is because of leronlimab that G goes down, so the owner of leronlimab needs to do the talking, the explaining and the advising.

I'm thinking that the road to HIV Cure might be paved a bit smoother than what we are used to. Free of pot holes, except, of course, for those challenges which are inherent within the indication itself. There won't be that many road blocks in getting there, and the other indications which we are traveling along, might also become a little easier to navigate as we continue to chart our course. I think CytoDyn is beginning to feel much more confident going forward and as a result, CytoDyn should be seeing more & more green lights as it receives the ammunition it requires to progress from baby steps to the pace of a healthy jog. From the US to Gates, let the CytoDyn enabling begin, and it likely has already begun.

This is an AI generated piece which is kind of cool:

whomes101

Just for fun….
I asked ChatGPT to write a poem about CYDY.

Title: Cytodyn’s Ascent

In the depths of innovation, a beacon shone bright, Cytodyn’s promise, a hope in the night. Yet shadows gathered, cloaked in disguise— Pharma giants with greed in their eyes.

With whispers and schemes, they tightened the chain, Market makers played their endless game. Trials delayed, and doubts were spun, But the battle for truth had just begun.

Once halted by hands both ruthless and cold, The dream of salvation refused to fold. Through legal storms and trials’ strain, Cytodyn pushed through the endless rain.

A platform of healing, bold and vast, A science too strong for shadows to last. The tide would turn as faith held fast, And darkened days became the past.

Then came the moment, a break in the skies— Data unchallenged, truth couldn’t lie. The stock once shackled, beaten and bruised, Soared like a phoenix, long overdue.

For those who believed through thick and thin, A new era of medicine would begin. Cytodyn, the wonder, the world would see— A platform for healing, finally set free.

No longer held by invisible hands, Its promise now echoed through distant lands. A victory earned through struggle and strife— A testament to science, to hope, and to life.

MGK_2's latest:

Fog Lifting?
Let's pick it up from where we left off...

I'm putting this out on a Saturday because I may not be around tomorrow.

We are waiting to see what developments might arise as a direct result of the Statistically Significant murine study assessing leronlimab's capacity to Remove Fibrosis Regardless of Etiology. In addition, we are also hypothesizing on the question of nearly 23% Institutional Ownership and in that same discussion are considering the possibility of funding that may be directed towards the development of an HIV Cure.

Greetings Folks. Disclaimer: You will be reading speculation based on facts.

The message we are getting from Lalezari is that CytoDyn is interested in negotiating for a partnership or a licensure agreement on any front. The following quote is taken from the above link.

"While CytoDyn is prioritizing its oncology objectives for 2025, it is actively seeking partnerships to advance leronlimab’s clinical development for liver fibrosis and other potential indications. These positive preclinical findings represent a crucial step towards developing a much-needed treatment for liver fibrosis. The potential for partnerships and further clinical trials suggests that leronlimab could eventually offer a new therapeutic avenue for patients with this serious condition. Furthermore, the potential application of leronlimab to other fibrotic diseases may broaden its impact across multiple therapeutic areas. This development positions leronlimab as a promising candidate in an area of high unmet medical need and reinforces the potential of CCR5 antagonism as a therapeutic strategy."

So, we wait and see what happens, right? No, it is not that simple. The events as of late do seem to be a tad bit confusing. It had been considered that because of such great results in the initial murine study, a partnership or a licensing agreement could be in the works, and that was the explanation for why Melissa Palmer was a no-show at MASH-TAG. But, this article says, that after the confirmatory 2nd murine study, CytoDyn is "currently and actively seeking partnerships to advance leronlimab's clinical development for liver fibrosis and other potential indications". A bit confusing. Why?

Well, if there were no partnerships or licensing agreements in MASH or liver fibrosis, given the amazing results of the initial murine study, why was there no poster hung and no presentation made, when the MASH-TAG conference granted permission to present those initial results? Why was the initial request made to make that presentation of the initial findings, and then quickly followed by the retraction of that request and subsequent turning down their approval to present?

The second murine study more than confirmed leronlimab's statistically significant capacity in both the MASH indication and in the fight against fibrosis of any etiology. These confirmatory findings would have only reinforced Melissa Palmer's presentation had she actually made it. She could have said something to the effect "that CytoDyn was waiting for the results of the 2nd murine study in the coming weeks or month, and so, for any of you listeners who might be interested, look out for those soon to be released results". But none of that was said or done because she did not show up and did not present. Despite that, the confirmatory results are absolutely good, but the article and Press Release both illustrate that CytoDyn still has no public offer for partnership or for licensing. So, the question persists, why did CytoDyn shut down the presentation of the initial results at MASH-TAG? Awkward.

Maybe the answer is because CytoDyn didn't want to present only the initial findings, but wanted to make these results public only after the confirmatory results proved validity? Then, why did they say that they wanted to present the initial results if they were able to get late approval to do so?

"These exciting findings have been submitted as a late breaker abstract to the MASH TAG conference and, if accepted, will be presented at the meeting in January."

Maybe it was that CytoDyn did not want to create any enemies before the confirmatory results validated leronlimab's effectiveness against fibrosis of any etiology? Maybe that is why CytoDyn called it off? Has the thought process now changed so as to use these validating and confirming results towards the justification of qualifying for the coming Idiopathic Pulmonary Fibrosis (IPF) Pilot Trial, and not to use those results, at least not initially, in the indication of liver fibrosis and cirrhosis? Maybe the explanation to the question is that CytoDyn did not want to risk the IPF Pilot Trial.

Taken from Goodness Gracious GF or GSK?, I'll re-iterate the discussion on IPF:

" I'm grateful for the press release last week, but many questions remain unanswered.

"As a side note, we have been contacted by colleagues at a major academic institution who indicated that, if the liver fibrosis reversal results are confirmed in the follow-up studies, they would be interested in funding a pilot study of leronlimab in the treatment of patients with pulmonary fibrosis at their own center."

Essentially, as a result of the findings of the most recent murine study which are stated here:

"The third study, concluded in January 2025, [resulting in a p-value across all 3 studies < 0.01] evaluated reversal of liver fibrosis in mice who received carbon tetrachloride, a liver fibrosis-inducing agent, from birth to sacrifice at day 35.

“The management of patients with advanced liver fibrosis due to a variety of etiologies is an area of enormous unmet need in the field of hepatology. The results of these three preclinical studies support both the biologic activity and potential clinical benefit of leronlimab’s ability to bind to CCR5 receptors on hepatic stellate cells, leading to a reversal of established liver fibrosis,” said Melissa Palmer, MD FAASLD, the Company’s Lead Consultant in Hepatology."

We can therefore make the assumption that the Pulmonary Fibrosis Pilot trial is a GO. I really love this trenddetector!! GSK teams up with the Center for Regenerative Medicine (CReM) at Boston University and Boston Medical Center. This Pilot Trial was contingent upon the determination of the fact that leronlimab certainly is capable of removing fibrosis regardless of its etiology, p-value < 0.01."

By the way, just to remind you of the meaning of a p-value of < 0.01. This means that the likelihood of these results happening by placebo or without the use of leronlimab are less than 1/0.01 or less than 1 out of 100. In order to be statistically significant, the minimum p-value is 0.05 or 1/0.05 or 1 out of 20. In this murine study, Leronlimab beat this minimum threshold by 5x.

Back to the discussion. So if IPF is therefore a Go, but CytoDyn's MASH indication is still looking for partnerships, maybe it was more important for CytoDyn not to disrupt the IPF relationship who offered the IPF Pilot Trial who trenddetector considers could be GSK together with CReM at Boston University hosting the trial at their Boston Medical Center. Certainly, this relationship would be valuable enough to protect it and to not compromise it by making any early advertising presentation of leronlimab's capacity against the MASH indication or towards its capacity to remove liver fibrosis?

These questions remain unanswered. Moving on...

From my perspective, the Max Lataillade's recent announcement of why he decided to work at the GF was really nothing new to me. Most of what he said, he had already communicated here. Max's most important statement there in is, "Now, I've joined the Gate's Foundation with a clear and ambitious goal: ending the HIV epidemic." then he goes onto explain it. "Yes, it's a big goal. But with current and near-term, long-acting antiretrovirals, whether oral or injectables, - we have a real opportunity to halt HIV transmission and make strides towards ending the epidemic.

These children deserve a future without the looming threat of HIV, a condition that is currently lifelong and often fatal in communities like theirs. Together, let's push the boundaries of what's possible and finish the job!"

Max came on board as CytoDyn's SVP and Head of Clinical Development because of Jonah Sacha's work in the development of a cure for HIV. Don't think that Max didn't notice This Article, which was re-introduced by Bio4. Jonah has since had not less than 4 or more major breakthroughs regarding HIV Cure and I discuss some of them here.

We have all heard of the recent discussion Bill Gates had with the US President. The discussion concerned the topic of HIV Cure and that both individuals were very much interested in being involved with that Cure. Bill Gates recently hired Max Lataillade as his SVP and Head of HIV Drug Development at the GF. Recently RFK Jr, has been confirmed as the US Secretary of Health and Human Services.

RFK Jr. is fixin to make and enact huge transformations and major changes regarding Big Pharma. Keep in mind that the GF is not a part of Big Pharma. RFK's new mandates won't interfere with the plans of the GF. But the changes that RFK Jr. does make shall have a profound effect on BP and how BP plans on delivering their expensive long acting HIV treatments without also providing the answer to the question for an HIV Cure.

Right now, it is all hearsay, but the moment shall soon arrive when it is publicly announced that the GF and CytoDyn have joined forces, together with GSK and ViiV, led by the GF and CytoDyn's Max Lataillade, SVP of HIV Drug Development and of Clinical Development, together, in confidence with Jonah Sacha and Scott Hansen, all in an effort to develop leronlimab as the drug which makes an HIV Cure a reality. That is the bombshell which we are waiting to hear.

Lalezari has not been discussing this because the story is sort of unfolding as we go, playing itself out on the fly. How Lataillade was hired. The timing and the topic of discussion of Gate's interview with the US president. Max's reasonings and motivation for working at the GF. None of this has been discussed directly by CytoDyn, but a lot of indirect statements have been made. This post has over 17,000 views and offers explanations for how this has unfolded thus far. There are other things of concern for Lalezari to worry about. Lalezari has everything else on his plate. MSS mCRC, MASH, IPF, GBM, Alzheimer's, CFS, etc... Maybe, he is waiting for some reportable news on one of these fronts before venturing out on something that may or may not be happening on the HIV Cure front. Lalezari, for the time being, is keeping his cards close to his vest.

Because nothing on the HIV Cure front is set in stone, there exists some ambiguity on the outcome. So then, it is probably safer for us to expect to hear something of concrete value on something that Lalezari is working on. I think we could expect that to be on the current MSS mCRC clinical trial that should now be enrolling. Hopefully, we also hear an update on the IPF pilot trial that should now be confirmed. Maybe headway has been made on the Alzheimer's front and on the GBM front. Maybe leronlimab is chosen for the NIH Long COVID grant. Something along these lines should be announced in the next PR.

My thinking is that an announcement of plans for the HIV Cure or a MASH partnership would follow the next PR.

My speculation is that to me, it is clear that Lalezari placed HIV-Cure into Max's hands.

"We also welcomed Dr. Max Lataillade as Senior Vice President and Head of Clinical Development, capitalizing on his significant pharmaceutical experience and connections to help oversee the Company’s global research and development strategy, as well as to support our programs in inflammation and HIV."

Max is well aware of CytoDyn's HIV-AAV, LATCH, bNAbs Triple Therapy, PLS Placenta LS Mutations and 17 Long Acting leronlimab versions being developed by Scott Hansen. Max's vision is to end the HIV epidemic. He plans on using long acting oral as well as long acting sub-cutaneous injectables to achieve his goal to end the pandemic. He knows the ultimate way to end the epidemic is via an HIV Cure which he does not believe to be more than 4 years away, and that is within the current administration's time frame. The current administration is becoming more and more frustrated and tired with dolling out HIV treatments to the world. The US President and RFK Jr's aim would be to better focus in on delivering an HIV Cure and Max, Lalezari and Gates share that lofty, yet attainable ambition.

Max understands that he needs to maintain status quo of treating HIV with current long acting HAART medications, but his eyes do not lose focus on the end goal. He shall work with US governmental regulations to slowly cut back on HIV treatments while increasing funding towards HIV Cure. He does not give in to anybody's demands for more HIV treatments if an HIV Cure is the better route to take. Yes, I'm making lots of assumptions, but this is how it rolls here on this channel. The HIV Cure continues to be a process in development. In fact LATCH is under going 2 distinct pilot trials this year. I suspect the GF could take up the further study of PLS Placenta and the bNAbs HIV Cures and in addition, might also take on HIV-AAV.

With the addition of the GF, I think that CytoDyn stops taking baby steps, as u/Upwithstock has always called them. Yes, baby steps become a thing of the past once the GF comes on board. CytoDyn starts taking grown up steps or leaps and bounds with the backing of the GF. Small compromises become a thing of the past. Later, large demands become more of the norm. Compromise no longer accepted. This is how I'm putting this together. Max is working on something and he has tremendous experience, tremendous contacts and tremendous connections. Max and Gates have something planned, somewhere in the world. Soon, it comes to light. His demands and his expectations shall not be small and the US President is all in favor of Max's presentation.

HIV is being kept at bay by the treating drugs, but a plan and a method to determine and prove out an HIV Cure is underway. This may be happening even without public disclosure. The transfer of money is what would mandate public revelation. The 23% Institutional Ownership comes into play here. Maybe there has yet not been any transfer of money. Maybe that is why there has not been any announcement. Maybe it is a glitch. Regardless, the US President is on board. RFK Jr. is on board. Gates is on board. Lalezari is on board, Lataillade is on board. Sacha is on board. Hansen is on board. The US President wants HIV Cured and so does RFK Jr, so hurry up and in Max's own words, "Together, let's push the boundaries of what's possible and finish the job!". I think that was the US President's message to Gates. [Give me your plan and if it is something that I can go along with, you will see my support.] Just like Lataillade, I see that the US President is a caring individual as is RFK Jr. and deep down, they want to see that this HIV epidemic is cured, preferably under this administration.

This is how I see CytoDyn's HIV Indication continuing. If it is not this way, then it would propagate through the NIH, but that would be a much slower path. Things are in place for the GF to take this over to the next level and with the addition of Max working for both, it totally make sense to me. Since he is there, I believe the transfer away from NIH and towards the GF could be taking place with NDAs in place of course. Given that this is in place with NDAs signed, small compromises would be made towards HIV treatments, but when too much is given, then, it becomes time to make this new plan for HIV Cure known to the world.

We don't know, but everything that is going on indicates to me that something is happening behind the scenes. This is our front row seat to how things unfold for the development of a global, world wide HIV Cure. This is where it gets brought to you, front and center, the breakdown of how HIV gets cured, how IPF gets taken down and how MSS mCRC meets its match.

I see what you did there. Still waiting to hear the seedy details of the COB's supposed interoffice relationship. Maybe this weekend you'll spill the beans on what happened and how it affected CYDY's progress.

https://www.clinicaltrialvanguard.com/news/cytodyn-shows-statistically-significant-fibrosis-reversal/

CytoDyn Shows Statistically Significant Fibrosis Reversal
ByJon Napitupulu February 7, 2025
CytoDyn Inc. announced positive preclinical results for leronlimab, demonstrating a statistically significant reversal of liver fibrosis in three separate studies conducted with SMC Laboratories. These studies utilized different models of liver fibrosis, including a high-fat diet and a fibrosis-inducing agent, and all showed leronlimab monotherapy significantly outperformed the control group. The company believes this is due to leronlimab’s ability to bind to CCR5 receptors on hepatic stellate cells.

This preclinical success strengthens the potential of leronlimab as a treatment for liver fibrosis, an area with significant unmet medical need. Current treatment options for liver fibrosis are limited, and the progression to cirrhosis can lead to liver failure and the need for transplantation. Leronlimab’s mechanism of action, targeting CCR5 receptors, suggests it could offer a new and potentially effective approach to managing and even reversing this condition. The diverse models used in the studies provide a broader base of evidence for leronlimab’s efficacy. This could accelerate the development of leronlimab for liver fibrosis and potentially expand its application to other fibrotic diseases in organs like the lungs and heart.

The studies evaluated leronlimab in mouse models using both a high-fat diet combined with a single dose of Streptozocin, and a fibrosis-inducing agent. All three studies demonstrated a statistically significant reversal of liver fibrosis (p-values < 0.01) compared to the control group. While CytoDyn is prioritizing its oncology objectives for 2025, it is actively seeking partnerships to advance leronlimab’s clinical development for liver fibrosis and other potential indications. These positive preclinical findings represent a crucial step towards developing a much-needed treatment for liver fibrosis. The potential for partnerships and further clinical trials suggests that leronlimab could eventually offer a new therapeutic avenue for patients with this serious condition. Furthermore, the potential application of leronlimab to other fibrotic diseases may broaden its impact across multiple therapeutic areas. This development positions leronlimab as a promising candidate in an area of high unmet medical need and reinforces the potential of CCR5 antagonism as a therapeutic strategy.

Source link: https://www.globenewswire.com/news-release/2025/02/06/3022021/19782/en/CytoDyn-Announces-Findings-of-Statistically-Significant-Fibrosis-Reversal-Across-Studies-with-SMC-Laboratories.html

All major U.S stock markets will be closed on Monday February 17, in observance of President’s Day.

This may or may not involve leronlimab but it sure is nice to see Max doing his thing:

Max Latalliade https://m.facebook.com/groups/622470341583807...tid=wwXIfr
Max Latalliade….This is why I joined the Gates Foundation!
On a recent trip with colleagues from the Gates Foundation and the University of Washington, we visited a remote village in Uganda to evaluate clinical trial sites for a novel long-acting agent. It was in this far-reaching gold mining community that I was warmly embraced by the most beautiful children. Yet, due to the local social, behavioral, and economic challenges, HIV transmission remains high.
After nearly 20 years as a physician scientist and researcher in Pharma-successfully developing several antivirals and antiretrovirals for HIV and HCV-I've had the privilege of advancing the science and strategy behind long-acting agents for HIV treatment and PrEP. Now, I've joined the Gates Foundation with a clear and ambitious goal: ending the HIV epidemic.
Yes, it's a big goal. But with current and near-term long-acting antiretrovirals-whether oral or injectables-we have a real opportunity to halt HIV transmission and make strides toward ending the epidemic.
These children deserve a future without the looming threat of HIV, a condition that is currently lifelong and often fatal in communities like theirs. Together, let's push the boundaries of what's possible and finish the job!

We have a great team behind us and they all have the best of intentions.

I'm curious where the "friend w benefits" claim came from? I've seen posts about this before but never saw anything detailed.

I am 50/50 at best on Tanya as COB. I think the last shareholder's vote showed I'm not alone in wondering if her role should be continued.

Life bans may or may not exist but I can assure you some previous members have attempted to have posting privileges reinstated and have been denied. Repeatedly.

It is nice to hear from posters like him who actually know details of what went down although it is almost ancient info at this point. Some really enjoy that stuff. I guess it helps pass the time while we wait on the next CYDY progress update. I certainly enjoyed Dr Patterson's TED Talk back in the day.

It is a public message board. Speculative comments are expected and welcome. What doesn't serve much purpose is people repeating their old grievances. At some point people should move on as hanging on to that old baggage is unhealthy. You have to let the Cytodyn team do their thing and we'll see where things go this year. I know you are frustrated by the share price. It is understandable.

Super Bowl comes on later. In the meantime you might want to turn on the the Animal Planet and watch the Puppy Bowl. Your blood pressure will thank you.

The market doesn't open until tomorrow and you can use all the old stupid shit against CYDY then because leronlimab deserves better, right?

https://www.reddit.com/r/Livimmune/comments/1il7b2g/analysts_price_target30_days/#lightbox

MGK_2

Goodness Gracious, GF or GSK?
Greetings to you Folks, let's get right into it if you don't mind. Lots to cover.

Will shotgun around a little bit, but hopefully, by the end, should have a conclusion.

First off, Welcome Aboard to many new subscribers to the Livimmune sub-reddit. Wax is still at it and many thanks to him for his moderating efforts.

Wow, what a week we had! Really liked the PR. Didn't you?

"VANCOUVER, Washington, Feb. 06, 2025 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, announced today positive results from its preclinical studies with SMC Laboratories (“SMC”).

The three studies demonstrated statistically significant reversal of liver fibrosis with leronlimab monotherapy (compared to an isotype IgG4 control arm with p-values across all 3 studies < 0.01). The first two studies, completed in late 2024, evaluated leronlimab in the STAM™ model of metabolic dysfunction associated steatohepatitis (MASH) with fibrosis in mice who received a single dose of Streptozocin at birth and were then fed a high fat diet from weeks four to twelve. The third study, concluded in January 2025, evaluated reversal of liver fibrosis in mice who received carbon tetrachloride, a liver fibrosis-inducing agent, from birth to sacrifice at day 35.

“The management of patients with advanced liver fibrosis due to a variety of etiologies is an area of enormous unmet need in the field of hepatology. The results of these three preclinical studies support both the biologic activity and potential clinical benefit of leronlimab’s ability to bind to CCR5 receptors on hepatic stellate cells, leading to a reversal of established liver fibrosis,” said Melissa Palmer, MD FAASLD, the Company’s Lead Consultant in Hepatology.

Dr. Jacob Lalezari, CEO of CytoDyn, added, “We are very encouraged by these initial findings, which add to the growing body of evidence that leronlimab’s core mechanism of action, binding to CCR5 receptors on cells, could translate into a variety of meaningful clinical benefits for patients across a number of medical conditions. As the Company continues to prioritize its oncology objectives for 2025, we look forward to establishing the right partnership to further the clinical development pathway for leronlimab in the treatment of fibrosis of the liver and potentially other organs, such as the lungs and heart.”

CytoDyn is currently in discussions with several third parties regarding next steps in an effort to expand on these promising findings. The Company intends to explore a number of potential synergies and partnership opportunities in the coming months as it furthers its clinical development pipeline, including opportunities that might explore the potential widespread applications for leronlimab as a treatment path for fibrosis in other organs."

Cyrus Arman had these words which in retrospect are foretelling: thanks u/Pristine_Hunter_9506

"DA: Are the mechanism of actions different for the alcoholic forms of steatohepatitis and the fibrosis? Can leronlimab potentially be used for those conditions as well?

CA: While that has yet to be definitively determined, I believe so, because our imaging data shows that leronlimab may actually attenuate and reverse fibrosis*. The question then becomes whether it matters* how the fibrosis developed*. Was it* due to alcoholism or obesity, or perhaps because the patient has HIV*? Indeed, it turns out that patients who are living with HIV have a much higher propensity for fatty liver disease and subsequently NASH as a result.*

Patients with HIV are susceptible to other infections, including hepatitis C, which is known to cause liver disease and liver damage*. In addition, patients who have been living with HIV for many years and received earlier-generation antiretroviral therapy often suffer from metabolic dysregulation that causes accumulation of fat in the liver as a side effect of these medications.*

Given this information, CytoDyn may be looking at a subpopulation of patients in our next NASH trial who have HIV and NASH. Since our molecule was originally developed as an HIV treatment, and we’ve shown that leronlimab suppresses viral load in the body, we think we are in a unique position to treat HIV plus NASH. Further down the road, the question of whether it matters how fibrosis developed will be one that CytoDyn will address*."*

I'm grateful for the press release last week, but many questions remain unanswered.

"As a side note, we have been contacted by colleagues at a major academic institution who indicated that, if the liver fibrosis reversal results are confirmed in the follow-up studies, they would be interested in funding a pilot study of leronlimab in the treatment of patients with pulmonary fibrosis at their own center."

Essentially, as a result of the findings of the most recent murine study which are stated here:

"The third study, concluded in January 2025, [resulting in a p-value across all 3 studies < 0.01] evaluated reversal of liver fibrosis in mice who received carbon tetrachloride, a liver fibrosis-inducing agent*, from birth to sacrifice at day 35.*

“The management of patients with advanced liver fibrosis due to a variety of etiologies is an area of enormous unmet need in the field of hepatology. The results of these three preclinical studies support both the biologic activity and potential clinical benefit of leronlimab’s ability to bind to CCR5 receptors on hepatic stellate cells, leading to a reversal of established liver fibrosis,” said Melissa Palmer, MD FAASLD, the Company’s Lead Consultant in Hepatology."

we can therefore make the assumption that the Pulmonary Fibrosis Pilot trial is a GO. I really love this trenddetector!! GSK teams up with the Center for Regenerative Medicine (CReM) at Boston University and Boston Medical Center. This Pilot Trial was contingent upon the determination of the fact that leronlimab certainly is capable of removing fibrosis regardless of its etiology, p-value < 0.01.

With the nudging of Cyrus Arman's prior comments and now shifting towards an All-Inclusive form of CytoDyn's HIV over-all Indication, in my most recent prior 2 posts, I had posed the premise that if the existence of 21% Institutional Ownership is Real, then the scenario I had illustrated continues to hold merit. u/Upwithstock also brings together these same key players who I also consider with in his own post: The deal is coming! GSK?

The possibility of changes along the lines of what I've described and discussed with in those couple of speculative posts could be what is currently taking place or what is being planned to take place. From a numbers and quantities perspective, u/Upwithstock formulates a nearly flawless justification for his CYDY valuation.

So, as we already know, and as I've already said on multiple occasions, the Gate's Fund is whole heartedly in favor of the notion of curing HIV. Not only treating HIV, but the establishment of an HIV cure. I wrote this in Whats Next?:

"The two of most importance right now are Max in HIV and Melissa in MASH. It is more than interesting that Max sits right under Bill Gates at the GF as Head of HIV Drug Development while simultaneously sitting right under Jay Lalezari at CytoDyn as SVP of Clinical Development. It is certainly one of Bill Gate's most burning desires to be the backing of an HIV cure. And to do that as rapidly as possible. He absolutely needs that as his legacy. He would absolutely love to be the foundation that has brought the HIV cure to the world. That emanates from his being."

In addition, it is not only Bill Gates of the GF, but consider this comment by u/perrenialloser. Yes, the CEO of GSK Emma Walmsley shares that burning desire to cure this pandemic. If this collaborative effort between the GF, CytoDyn, ViiV and GSK (headquartered in London, England) does in fact actually materialize, then Emma Walmsley more than likely would receive half if not more of the credit considering GSK's 76.5% ownership of ViiV and the actual physical and clinical work exerted by GSK and ViiV together with CytoDyn so as to achieve such a daunting feat. CytoDyn's Jay Lalezari main objective and concern is for the molecule's approval. Max greatly desires success for both of his employers, CytoDyn and the GF. Max also has a strong, burning desire to have a part of HIV's demise. All of us know how hard Jonah Sacha and Scott Hansen have travailed against the stubborn mutations of HIV. Cyrus has always been behind attacking HIV in its Early Line Phases, such as at the time just after birth with the Triple Therapy or even just before birth with the placental LS mutation version of leronlimab.

Recently, the GF brought on ViiV's Max Lataillade, as Head of HIV Drug Development at the GF. For those who are unaware, this is the same Max Lataillade as SVP of Clinical Operations at CytoDyn, u/Biostocktraderbyday felt the need to repeat that, as do I... Max Lataillade had been SVP at ViiV who is currently 76.5% owned by GSK, 13.5% owned by Pfizer and 10% owned by Shionogi.

The hypothesis which I've been putting before you recently is that I'm both suspecting and absolutely speculating that the GF, personified in the form of Bill Gates, could be in discussion via Max Lataillade concurrently with CytoDyn's Jacob Lalezari, CEO, and could be putting together plans for CytoDyn's HIV indication. Bill Gates has already had a few good discussions with the media concerning his long conversation he had with the US President regarding Bill's intentions on the topic of HIV. He communicated to the US President the potential of soon having ready an actual cure for HIV.

Like, these conversations with the media happened out of the blue. They just came out of nowhere. Why would Gates mention something like this? I mean, the GF has been backing HIV Treatments all around the world. They back all the treatments whether made by G, by ViiV or by Merck. But why publicize this particular conversation? Could it have anything to do with the fact that a Cure is now being discussed, not just another Treatment? Assuredly, that makes the mention that much more pertinent and important. Discussion on the logistics of how something like this could go down, if something like this could actually materialize. Nobody would ever dream to announce or even publicly mention that the GF could actually be taking over the entirety of CytoDyn's HIV Indication, all the while remaining focused on the area of an HIV Cure. No, that is too big a step to take for any media outlet to take, except for what is heard here on this board.

CytoDyn however, is much more than an HIV Cure. The GF is primarily interested in the indication of HIV Cure, but GSK certainly shares that interest with the GF as their massive ownership of ViiV proves, but GSK is attracted to CytoDyn for many more reasons. Consider too the fact that CytoDyn's Max Lataillade has worked for each of these 4 companies. ViiV, GSK, the GF and CytoDyn.

In fact, the possibility does exist that the CytoDyn HIV Indication becomes a part of the Gate's Fund where as by becoming a part of such a greater group of collaborators, CytoDyn could exist under a much stronger and better protection umbrella, shielded against the unrelenting onslaught by G. The GF may also be having discussions with G, considering that the new US government may be cutting back on their funding of G's HAART drugs to the world, I would think that the GF's funding for G's HAART drugs would need to get discussed in regards to a potential HIV Cure. Think of that; could there ever be a harmony between G and CytoDyn? For all these years, CytoDyn has been plagued by G's unremitting resistance. There was never an end to their onslaught and there never would be an end, if it were not for something to change. And as I can tell, change is in motion and I think the GF has moved and initiated the 1st step. To me, this makes sense. Hopefully, it does to you too. In Cyrus' own words, I think all of this could be on the table:

"1:31: 40: So, in terms of what potential timelines can look like, I think it's really important to highlight that from a value-creation standpoint, and I've mentioned this before, we truly do need to generate a large robust and what I call unequivocal data set that will leave no questions left on the table, right? And that a strategic partner would find attractive and attractive enough to do a real value-accretive deal with the company.

1:32:14: And so, we've gone through and knocked out what the potential timelines are across each of the different areas that we presented on today. And we're -- as I mentioned before, NASH & Oncology are our priorities. However, because this is all going to be funding dependent, we're going to focus on NASH initially and work with co-development partners to the extent that we can to develop in oncology. "

1:33:35: We continue to contribute in medical meetings and peer-reviewed publications. Again, the CD02 trial data is in process for that right now. We're going to continue to reshape our team [hiring Jay, Max, Melissa and Richard] and our capabilities in order to meet our goals. And at some point following the achievement of earlier metrics listed on the slide, we're starting a corporate rebranding as well."

Lalezari is all about success of this molecule. Translation, anything to get the drug approved. It is the very meaning of insanity, to do the very same thing over and over and over again, expecting different results each time. If the same things are done, then one ends up with the same results, and that is what should be expected. In CytoDyn's case, those results have always been no approvals. Lalezari has shown that he is rational. That he is not insane. That he is done with that old school approach brand of thinking. Since he was brought on board as CEO, he has shown that he is all about the latest and the greatest. What has happened since his inauguration as CEO? Nothing but an incredible transformation of the company, ripening it as for the picking.

So today, as we have thus far surmised, it certainly could be that Bill Gates, out of nowhere, comes up with this hypothetical plan to take over CytoDyn's HIV clinical indication. Again, I remind you that this is speculation.

Well, the truth is that, if this in fact were to happen, Bill Gates would then be fulfilling possibly one of the most important humanitarian endeavors of all time, which would be the swift undertaking and realization of the cure for HIV. Yes, the world would greatly benefit and the HIV/AIDS pandemic would be eradicated. As a result, Gates would gain massive publicity, honor and praise. Therefore, he greatly covets that very honor, that it would be credited to him. That accomplishment which has since proved itself insurmountable was surmounted by his efforts. Gates desperately would covet that honor for himself and he has hired just the man Max ready, willing and with the capability to deliver that great hope and promise into his hands. So Gates is ready to pay handsomely to receive that honor and prestige. So how exactly can this be done?

To achieve such a goal, there would have to be a unification between a few groups. High reaching goals, like the Curing of HIV requires like minded folk working together, so bring in Emma Walmsley, CEO GSK, thanks perrenialloser. Like a collaboration or a conjunction of peers. On one end, you have the target group who of course would be CytoDyn, and the end goal of course would be to unify this group CytoDyn together in the HIV indication with a member of their group that is like minded in the same indication and that would be ViiV. The Gate's Fund would be the source of funds to make this CytoDyn partnership with ViiV a success. GSK as having 76.5% ownership of ViiV would benefit by the collaboration and may have additional roles in this collaboration. Maybe CytoDyn is mulling it over. Maybe Lalezari has presented Gate's deal to his closest confidants, to his inner circle, to his leadership team and then to his Board of Directors as they could be working the deal. Maybe they are discussing and deciding. CytoDyn shall not be undersold. A question comes to my mind in that if this does happen, would the GF, or GSK demand that a part of CytoDyn's Board is dismantled at least in part? I would recommend that CytoDyn maintain its current form as much as is possible while still proceeding with any such talks, because any break up before complete buy out only weakens CytoDyn, making them into a lame duck, throwing any/all future talks to the behest of only a few. For now, the talks continue...

For so long, the only medications for HIV has been ART or HAART which is really only an HIV Treatment. Curing HIV does not happen while taking HAART medications. If a patient stops taking their ART medications, HIV soon returns and eventually turns into full blown AIDS which is 100% lethal if not treated. Where as with an HIV Cure, it would be given once and HIV would be eradicated forever in that individual and no further treatment would ever again be warranted. But the HIV Treatment of ART therapy is what the Gates Fund, GSK and ViiV have been pedaling for ever so long, and they have made their livings by propagating those HAART HIV Treatment medications because an HIV Cure medication was never available. However, only recently, CytoDyn has established a few new methods by which an HIV Cure could be achieved. Both Gates and GSK/ViiV realize and understand that by harnessing the power that they perceive to be possible with the use of leronlimab, they have a great opportunity right now, with the support of the current US government, to quickly stop HIV in its tracks once and for all.

Back in 2020, it appears as if GSK/ViiV was already in talks with CytoDyn for the development of an HIV medication for the HIV-PrEP indication which included leronlimab though named as Pro-140 so as to "hide" their involvement with CytoDyn. Now, here we are, watching Gates declare his desire and the US President's agreement towards this end goal. So it seems that the foreshadowing back in 2020 may now be coming to the forefront through Gate's recent conversations with the US President. Suddenly, the US President could declare that the GF could be taking over CytoDyn's HIV Indication. Wow! Do you understand what time it is? Do you understand what day you are living in?

In case none of this pans out as I've described, because it may not. I've said all along, this is speculation based on facts. I do believe that it will happen though. But in case it does not happen, remember, there are 2 LATCH pilot trials that are taking place this year, being performed by 2 different sponsors. LATCH is another HIV Cure that will very likely be successful in reaching statistical significance as it has already been 100% successful on every try. LATCH is the curing of HIV by the IV transfusion of the infected patients bone marrow which is replaced by the bone marrow of a healthy patient without the need of that donor's bone marrow to have the CCR5 delta 32 mutation. The donor can be anybody with healthy bone marrow. Of course leronlimab is necessary to effect the cure. That HIV-Cure is definitely coming and if the GF and/or GSK want a part of the action, CytoDyn's HIV Indication is up for discussion.

So, if what I've laid out is true, then Lalezari needs to discuss with his leadership team and Board of Directors, in order to decide whether to accept, modify or reject the proposed deal. The result of their meetings takes CytoDyn into the next Phase. And all of us already know what I expect to happen, on that fateful day, to G and to all of CytoDyn's enemies, once that PR is released. We are currently in that time frame of which we patiently wait, but now can definitively perceive What's Next.