chumppunk
4 days ago
Gotta thank this ole boy! "Whoa, things are lining/heating up"
There are quite a few interesting things in the mix right now, and to me the biggest has been Max Lataillade recently describing the MOA that was announced in May. I think he has caught a few eyeballs with his illustration of the compound MOA that describes leronlimab in oncology. Thanks Max!
I've mentioned before that I've grown accustomed now to re-read the press releases from CytoDyn and I gain more insights as I do. One thing from the March 18 letter that is now standing out to me is the mention of preclinical work in Stroke, and it seems to me from what I've read, that Stroke preclinicals can potentially be very short. In putting the press releases together, I am led to believe that results from preclinicals in: Glioblastoma, Stroke, TNBC synergy with immune checkpoint inhibitor, TNBC synergy with immuno-conjugate, TNBC MOA, all may be within their windows where those studies could have completed or will do so shortly.
There is so much going on it seems. We also discovered this week that CytoDyn put Prostate cancer into the pipeline at the preclinical stage. That seemed to be different from the way past announcements have been made, but frankly it isn't unexpected that they are looking into this. They had a compassionate use patient years ago I believe who had a successful outcome. I wouldn't be surprised to see Pancreatic also appear on the pipeline. The PD-L1 monotherapy ORR chart across solid cancers tells a story that is compelling for CytoDyn to supercharge due to the compound MOA of leronlimab that Max Lataillade describes.
There are a few papers too that have been mentioned in the past as moving along in the process, but we haven't yet seen published. We also wait patiently to be updated on a number of clinical trials starting, some of which are connected to academic institutions.
As the CRC trial gets underway, we should be mindful of the 2 safety checks, one at 5 patients, and the second at 20 patients. I hope that communication will flow to investors about these moments.
Another big moment is 5 year survival data from the TNBC patients. By my calculations, after looking at earlier press releases, that anniversary is in late July.
I don't know when we might hear something, but there sure seems to be an unusual number of things coming together. I smell a partnership, licensing, or other fun stuff. Just a hunch. Here's another interesting thing happening-
Within the last couple of days we have also realized that CytoDyn has recently submitted results from multiple earlier trials to clinicaltrials.gov . The table of trials marked with "Completed" status or which had "Unknown status", will eventually show many more trials "WITH RESULTS". Actually, only the Basket trial and two additional HIV extension trials remain to have their results submitted. So it seems there is more data to be made public soon.
I would expect the CRC data subset from the basket trial to be presented at ESMO GI Barcelona on July 4 before clinicaltrials.gov is updated with the basket trial results. That CRC data also has potential to demonstrate the new MOA and further solidify the notion that Leronlimab is a platform drug, which in oncology, primes tumors making them eligible for checkpoint blockade — and gives more patients a shot at immunotherapy.
Chump
chumppunk
1 week ago
Another's points posted- "Vindication In The Making"
Welcome and Greetings to All of you.
A small addendum: In the title of yesterday's post, I put the word "Confirmation". Confirmation of what? Confirmation of what was already known. What was already known?
They had more than an inkling that leronlimab worked synergistically with check point inhibitors and they certainly pursued the MD Anderson pre-clinical trial to prove that out.
"26:12 SK: Yeah, so this is very exciting for us. So we signed an agreement with a major academic institution. We're not able to release it yet, because we got to prepare the press release and get their approval, but um but it's looking at leronlimab and checkpoint inhibitors and I think that's a very exciting thing because we're looking at synergistic opportunities with leronlimab. You know, just like HIV, Cancer is treated with multiple fronts, with multiple medications. We think this would be a checkpoint inhibitor would be perfect for this. We also think you could pair with a parp inhibitor and antibody drug conjugate, chemo, radiation. We don't think we'll see any drug interactions with leronlimab and those particular classes of drugs."
No, the MD Anderson findings were never disclosed. MD Anderson owned the data. CytoDyn was shown the data, but had to purchase it in order to reveal it and we all know there was no money back then for that. It was only murine data though, but it gave heading. Instead, we waited, but today, we have human data.
All the naysayers flooded the boards in criticism, but today, 5 remain alive. Why? Synergy. The Synergy that was appreciated in those mice which were administered an ICI following leronlimab treatment.
When Cyrus let us know on 3/14/2023 about this Synergy, he wasn't lying. The Synergy was real and palpable.
"Along with NASH, CytoDyn will focus primarily on oncology. Here, the company will target colorectal cancer and hormone receptor-positive, HER2-negative breast cancer.
These are both areas where checkpoint inhibitors have failed to show efficacy when added to a standard-of-care backbone, Arman said, adding that leronlimab has shown positive signals in both.
“From a mechanistic standpoint, we believe we could get a synergistic effect with a checkpoint inhibitor,” he said.
Leronlimab is currently being trialed in combination with Keytruda (pembrolizumab) in a breast cancer xenograft model in partnership with MD Anderson Cancer Center.
Arman said CytoDyn expects to observe an enhanced anti-tumor effect from the combination and identify immunological biomarkers."
Mazzy is day in and day out on her critical rant. Pretending expertise, she exhibits her lack of understanding. Everything is ass backwards when she open it. When she says fraud, think truth. When she says truth, think lie. What she labels as fabrication, know it as sheer fact, while her assembly of facts together are gobbledygook. Nothing she nor her cohorts say amounts to anything. And she has excuse after excuse.
She puts herself up on a pedestal, claims vast years of experience. Assigns herself all sorts of self worth. But, in the end, CytoDyn gets the last word.
Enter Dr. Lalezari:
"That fantastic day NP refers to has finally come.
"We are thrilled to announce this apparent mechanism behind the improved survival in patients with refractory and metastatic TNBC,” said Dr. Jacob Lalezari, CEO of CytoDyn. “Leronlimab’s ability to induce an inflamed or “hot” tumor environment, that could then be treated with ICIs, would be a game changer in solid tumor oncology. Prospectively confirming these findings in patients with TNBC is a top priority. We have also amended our current colorectal cancer trial to ensure the prospective collection of PD-L1 data in a second type of solid tumor."
Fact is, 5 of the original 28 are alive today. Full Stop. Should not have lived beyond 1 year, but they lived that, +4 more. Guess that is all fake, right Mazzy?
What, you don't like? The Confirmation of Hope? Time works its magic. Thank you NETpositive.
"...Our prayers are answered through vast spans of time where answers are met with a contentment that only passing time can grant.
Cydy’s journey is real, just like most life experiences. Its outcome will likely be different than what we have expected..."
The handwriting is on the wall and it spells out ICIs. Try to decipher or even read what we have already comprehended and understood. Until you can, it continues to fall apart for you Skeptic, Scoffer and Short. Every assumption you make, is shaken to its core by these tremors of truth.
OK, CytoDyn was put to trial and put through the fire, but in the end, the verdict still stands. Lion Lalezari roared loud and clear the Simple Synergy and Effectiveness of the new MOA.
Enough of this, let's move on.
Vindication in the Making? You mean, CytoDyn has not yet been vindicated? That's right. As NETpositive and Tatshensini River suggest,
"In essence, it's about having high hopes for oneself or something, aiming for a distinguished and impactful outcome."
Therefore, the achievement of that Vindication or "Eminence" takes time, therefore, it is in the Making.
If Vindication / Eminence were really to come to CytoDyn, then Cures of these horrible diseases would begin to take shape. A Cure of HIV, and a cure of mTNBC would begin to take shape and materialize as they now are. We may even be shooting for a Cure of MSS mCRC if what I'm thinking is to be discussed at GI ESMO in Barcelona on 7/4/25. Same Synergistic MOA in MSS mCRC as well? I think so.
If Cures do in fact start to materialize, then, competitors of CytoDyn begin to be diminished while CytoDyn begins its Upward escalation. The new US FDA, NIH administrations are now pro-Cure, which means Pro-CytoDyn, while Big Pharma remains anti-Cure and Pro-Treatment, Pro-Expensive Bandaids. The new administration is in negotiations with Big Pharma, but I don't think that goes very far. Unfortunately, or fortunately for CytoDyn, Big Pharma is deeply stuck in their ways.
CytoDyn is watching and waiting to see what comes of those negotiations and discussions. Their definitive actions and decisions might be paused to appreciate how exactly Big Pharma takes and implements their new administrative directives.
The biggest BP CytoDyn is concerned with is G. How shall G deal with the mandatory cut backs in their distribution of their main HIV medications worldwide? How does it deal with not being able to distribute their every 6 month PrEP medication to the HIV+ patients of the world?
We all know G is CytoDyn's arch rival. In every indication, G has stolen the show away from CytoDyn, not allowing not even the smallest of indications to get by, and they did it even with inferior drugs because they have padded the pockets of the prior administrators who signed their approvals. No doubt, they were behind Amarex and are still behind the shorts.
With that in mind, and if Vindication / Eminence were to come to CytoDyn, with Cures of HIV and of mTNBC already taking shape and soon to be made manifest, what would that do to G's money flow if HIV were Cured, if mTNBC were Cured? If Vindication / Eminence were to come in a PR, what would be said that would turn the tables around180 degrees from the imbalance which is in place today?
What would G's reaction to that PR be? More Mazzy attacks? No doubt, but she is voiceless anyway. More short attacks? Assuredly and they'll begin at first to double and triple down, even while the share price doubles and triples skyward. G has $$ to burn and burn it shall. But, they'll have more $$ to burn and they'll burn that all up as well, until they're all burnt up. To the point of being Blinded and Astonished by the Asteroid they never saw coming. They have lost sight of the shorting of which they're engaged in. Muscle memory is all they shall have to go on and that shall wipe them clean.
Since that is possible, that the PR is so hard hitting, that G finds themselves in dire need to retaliate, despite all the ammunition they throw at CytoDyn, it won't be enough to overcome the shareholder reaction to the implications of the PR. G wipes out their retaliatory efforts and are left muted and castrated.
Then, following that PR which comes, CytoDyn can move along. What PR comes?
The PR that incorporates this new Synergistic MOA into a partnership agreement with a prominent ICI manufacturer in a Phase 3 Clinical Trial against mTNBC. When that is announced, I think it comes to the point, that G realizes, they no longer can keep this thing suppressed, so they pull back and let it ride.
Now, given the fact that it was from even before Cyrus that CytoDyn knew something was happening with ICIs. Chris Recknor knew about the reduction of CTCs with leronlimab. Recently, Creatv Bio said this about CTCs and CAMLs in mTNBC, and they said this about the same biomarkers, but in MSS mCRC.
"CytoDyn has received FDA clearance to initiate a Phase II study of leronlimab in patients with relapsed or refractory micro-satellite stable colorectal cancer (CRC) (NCT06699835). The drug, leronlimab, targets CCR5 marker on the tumor.
*Creatv will perform the LifeTracDx***® *liquid biopsy in a number of CytoDyn studies including NCT06699835. The LifeTracDx***® test is based on analyzing two biomarkers: (1) circulating tumor cells (CTCs) and (2) Cancer Associated Macrophage-Like (CAML) cells, which are macrophages that engulf tumor cells. Both CTCs and CAMLs contain tumor material.
By tracking CTC and CAML counts, and CAML size at various time points, LifeTracDx® can provide prognostic insights and predict treatment response. CytoDyn is also interested in the expressions of CCR5 and PD-L1 markers on the tumor. *These markers can change over time. LifeTracDx***® *can provide this information by a blood test - no tissue is required. The LifeTracDx***® assay will help CytoDyn to better evaluate the effectiveness of their drug."
Chris Recknor was already aware of this. He worked with Creatv Bio when he was with CytoDyn. Take note their insignia lower right.
Are the two ESMOs virtually identical as far as a Synergistic MOA depending on an ICI together with leronlimab? Yes.
This synergistic MOA has been known for sometime, but is only being revealed today, because of PROOF of its efficacy. The proof is tangible, it is not theoretical. The people are alive today. They survived their cancers. They overcame their disease. These are Facts which can not be denied.
CytoDyn is setting their negotiation table. CytoDyn owns the cards. CytoDyn is negotiating. They could be doing it before ESMO Barcelona, or they do it following. Regardless, they are in a negotiating mindset / mode. Give and Take. Counter offers as well?
Cures are on the way and somehow, I don't see G as part of it, despite the potential which Trodelvy offers. This new partnership puts CytoDyn in the lead for a long time. Enemies back away because any attempt at an attack only results in further loss, so they give their blessings to the new entity.
The declaration of the new Synergistic MOA is a Sign that something else is coming. That something else is a PR that completely turns everything around 180 degrees amazingly all at once. Its hard for me to comprehend it really.
CytoDyn is setting the table of negotiation for that agreement to be signed. I mean look at how quiet CytoDyn is right now. I believe Scuffer is on point here and here.
"I think the lack of more aggressive promotional efforts is a choice by CYDY management, not an omission. And I do believe that management’s goals are in alignment with shareholders."
Can we not understand that when CytoDyn is at these conferences quietly, watching and waiting the US administration carry out their new directives for Big Pharma, CytoDyn, in the backdrop, plotting its course, negotiating its potential paths forward. Don't see this as coming to fruition way on down the road. We've already come so far and for so long. Now, It's time. The administration has caught on and is on board; Big Pharma won't have any part of it.
I'm just putting 2 and 2 together here. I'll let you figure it out on your own. I hope it was helpful. It does seem as though pieces are falling into place.
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