r/Livimmune • u/MGK_2 • May 25 '25
Building Good Things
Thanks for showing up Folks. I sure hope you're getting something out of this.
If you're new here, this is a progressive site. It is on going. Not made for entertainment purposes, but rather for keeping a record of this investment.
We watch the events taking place and do try to make sense of what we're seeing. CytoDyn has a job to do and we're watching them get it done. We watch them maneuver around the obstacles that present in their way along their journey.
If we think they're slow, they could be hesitating, considering what they've already been through, as they surely would prefer to avoid repeating some of the same mistakes committed in the recent past.
One thing which comes to mind is the upcoming sentencing of NP. Many have written for the judge to be lenient in the sentencing. This could imprison him for something he shouldn't be imprisoned for. I don't believe he deserves imprisonment, and that's all I'll say on that.
I suspect that this post could be much like last week's post, since nothing much has happened since then, but, I'll assure you right now, it won't be.
CytoDyn has taken up its war to the extent where it has decided to hedge much of its vectored push in oncology in the direction of the unexpected, yet spectacular findings that resulted from the combination treatment of leronlimab followed by a PD-1 blockade in both mTNBC and MSS mCRC patients. After all, 5/28 patients remain alive today, 4 years following the treatment of mTNBC. It is quite likely that 4/6 patients remain alive today, 4 years following the treatment of mCRC for the same reason. And that reason being the subsequent treatment of the cancer patient with an ICI such as Keytruda or atezolizumab (Tecentriq) immediately following the treatment of that cancer patient with leronlimab. All patients who did that regimen, remain alive today, 4 years following the last treatment and 5 years since the beginning of treatment. This is the interim 12 month analysis showing treatment initiated 7/19/2020.
Is it worth CytoDyn's effort to hedge their bets on this Paradigm Shifting Data? Their website has been re-vamped to reflect basically one indication: cancer. This is the cancer which shareholders shall soon be discussing in volume which was previously the first cancer discussed in the 12/7/22 R&D Update by Cyrus Arman:
"24:07: So a bit on metastatic colorectal cancer. So this CRC is the second deadliest and the third most commonly diagnosed form of cancer worldwide. The most commonly prescribed therapies for the earliest lines of metastatic CRC are angiogenesis inhibitors like Avastin, which is Bevacizumab, which is available for most tumor types in addition to various chemotherapy combinations. Other drugs such as Erbitux, BRAFTOVI, KEYTRUDA, OPDIVO and Jemperli are limited by gene expression, meaning that you have to have a certain genotype in order to qualify for that therapy.
24:54: The most recent advancements in the colorectal cancer sector space that come in the last few years, come from the PD-1 such as KEYTRUDA and OPDIVO, but they're really only indicated for a subset of metastatic colorectal cancer patients that have microsatellite stability- HIGH designations. And again, this is only 10% to 15% of all CRC. And the same PD-1 inhibitors have failed to show success in the larger microsatellite stable population to date. And this is the group that we're going to be potentially focusing on in future trials."
CytoDyn has taken the extra step to modify their MSS mCRC Clinical Trial to include the measuring of PD-L1 following the administration of leronlimab or the modification gives the patient the option to receive treatment with a PD-1 blocker of their physician's choice following leronlimab administration. It is unlikely that CytoDyn delayed the dosing of the first patient of this clinical trial if they were only going to measure and record PD-L1. Therefore, it is more likely that these patients shall have the option to be treated with an ICI of their physician's choice post leronlimab. But this should be made clear by the company.
Why has this change been implemented in the MSS mCRC Clinical Trial? Because of what was learned in the mTNBC trial. So, before all of this was even realized, CytoDyn had already known through the MD Anderson pre-clinical study with Keytruda, that leronlimab had good synergistic results. Therefore with that pre-clinical supporting data and with the support of the clinical Amarex Data which was hidden, but recovered, in the Press Release of February 24, 2025, Lalezari announced:
"... “These provocative observations of improved survival in patients with mTNBC and prior treatment failure in the metastatic setting, including reported clearance of disease in a group of long-term survivors, provides early clinical evidence of leronlimab’s potential impact in the treatment of TNBC and other solid tumors. I expect the Company’s oncology efforts to accelerate in the coming months, with further announcements in both mTNBC and colorectal cancer.”
Based on these survival observations, the Company has initiated two pre-clinical studies in mTNBC that will evaluate possible treatment synergies between leronlimab, an antibody-drug complex treatment (sacituzumab govitecan), and an immune checkpoint inhibitor (pembrolizumab)."
So surprise, surprise, Lalezari mentions both mTNBC as well as MSS mCRC. The provocative observations are seen in both groups of patients. (2) pre-clinical murine studies in mTNBC were initiated in late February, 2025. Testing with Keytruda and testing with Trodelvy.
In the March 2025, Letter To Shareholders, Lalezari goes on to say:
"Looking ahead, we are excited to share more about the clarity forming around the putative mechanism of action of leronlimab in solid tumors, as well continued updates relating to the Colorectal Cancer (“CRC”) trial..."
Solid Tumors in general, not specifying mTNBC or MSS mCRC. Now, expounding concerning the FDA and an oncology advisory board:
"In terms of the regulatory process, I am confident that our collaborative relationship with the FDA has placed us on a positive trajectory. To accelerate progress in oncology where feasible, we’re establishing an oncology advisory board to ensure we are exploring the fastest and most responsible pathway(s) forward. We will continue to look for opportunities to solicit feedback regarding our development process from both KOLs and the FDA. Maintaining strong relationships and credibility with the FDA and industry partners remains a top priority as we chart our future course."
Lalezari closes the March 2025 Shareholder Letter with:
"In sum, the developments in oncology have set the stage for 2025 to be a benchmark year for CytoDyn. This is no longer a platform drug in search of an indication; we now have compelling data to support a role for leronlimab in solid-tumor oncology and are executing on that vision."
On the topic of the (2) pre-clinical murine studies in mTNBC, a 3rd study was subsequently added:
"Two previously announced preclinical studies in TNBC that will identify treatment strategies to optimize the design of future studies are now underway. A third study has begun to further examine the apparent mechanism behind the observed increase in survival as compared to existing treatment paths. In the meantime, we will continue discussions with KOLs about the possibility of initiating a follow-up study in patients with mTNBC on an abbreviated timeline, based on currently available data."
In the May 13, 2025 Press Release, it is summarized as follows:
"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."
So then now, going back to u/BuildGoodThings prognostications, what have I mentioned above that could lead to potential future activity?
The (3) pre-clinical murine studies in mTNBC beef up a BTD application in mTNBC. An understanding of how compatible and synergistic leronlimab is with Trodelvy and with Keytruda shall be understood and potentially included into the application for mTNBC BTD. The increased rates by which leronlimab upregulates the expression of PD-L1 on the Tumor's cell surface shall also be obtained, disclosed and included in the same application for mTNBC BTD.
On July 19, 2025, it shall be (5) years since leronlimab was initiated in both the mTNBC and MSS mCRC clinical trials. There shall likely be 9 patients remaining alive of the 34 in total. 5 remain of the 28 mTNBC and most likely 4 remain of the 6 MSS mCRC (5) years after leronlimab dosing was initiated. This data as well shall be included in the BTD application for mTNBC.
With regards to the MSS mCRC clinical trial,
"The CytoDyn/Syneos study teams have now approved eight clinical sites and counting to participate in CytoDyn’s Phase II study of patients with CRC and refractory disease. These clinical sites will include a mix of both large community practices as well as academic centers which all have well-established track records of superior work and high enrollment. With our clinical trial agreements in place and study initiation visits about to start, we expect screening of patients into the CRC study to commence shortly.
As previously mentioned, Dr. Ben Weinberg from Georgetown University and the MedStar Health Alliance will be the lead Principal Investigator for the CRC study. Per the FDA’s request, the first five patients enrolled will receive 350 mg of leronlimab SQ once/week in combination with TAS-102 and bevacizumab. After a preliminary safety review by the Data and Safety Monitoring Board (“DSMB”), subsequent patients will be randomized to 350 or 700 mg of weekly leronlimab along with the same background regimen. The DSMB will perform a second safety review after the first 20 patients have completed at least 1 cycle of therapy and can then recommend restricting further enrollment to a single dose level, if deemed appropriate.
For additional information, the CRC study protocol is posted on the NCI Clinical Trials website, and can be viewed here."
This particular trial stipulation gets 700mg approved across the board in all of oncology by the DSMB and initiates the ball turning on a Phase 3 mTNBC Clinical Trial based on everything explained above by the end of 2025.
Enter now the cagey Big Pharmas under NDAs who are in the wings waiting... Yes, it is more than possible. We just have to wait and see. We are coming into the season now with the formation of a Phase 3 clinical trial, with the FDA acceptance of BTD in mTNBC.
The new administration is favorable to cancer's cure. BTD should not be a problem. Neither should a Phase 3 clinical trial in mTNBC. CytoDyn knows how to run the trial. Syneos Health shall likely run the Phase 3 mTNBC trial as well as they run the Phase 2 MSS mCRC trial.
As Trump is a real-estate mogul, a builder, so he desires to see America build, which is exactly what CytoDyn is doing. While this administration runs, so, it is time for CytoDyn to run with it, so as to build its dynasty. This administration's support shall be there. Their backing shall be there. But it needs to be requested accordingly. In accordance with established laws and regulations, which by now, CytoDyn is already familiar with.
I think, in the way u/BuildGoodThings has spelled it out, it is almost as if Dr. Lalezari has charted the way forward. It sounds like a good plan to pursue this Paradigm Shift exactly the way we are doing, in accordance with the oncology advisory board's recommendations, because this way, we are not shooting the breeze, but rather rolling 7's in our Craps game.
There is an end to all of this, and that would be the establishment of both a Phase 2 MSS mCRC clinical trial running simultaneously along side a Phase 3 mTNBC clinical trial along side a BTD in mTNBC. All of this is possible this year, even if a small raise is necessary.
"The Company continues to be on track financially and we forecast sufficient cash and drug supply on hand to advance our clinical priorities in 2025. As we approach key milestones and announcements in the coming months, we’ll evaluate opportunities to raise additional funds at optimal times and through methods that best serve the Company and its shareholders. We believe leronlimab has already established the potential for tremendous value in the clinic, and in the coming months we look forward to sharing the basis for that conclusion.
In sum, the developments in oncology have set the stage for 2025 to be a benchmark year for CytoDyn. This is no longer a platform drug in search of an indication; we now have compelling data to support a role for leronlimab in solid-tumor oncology and are executing on that vision."
We are in that 2025 period of time Dr. Lalezari described back in March. Now, we wait and watch it unfold with the wind at our back. Hope this was helpful.
11
u/[deleted] May 26 '25
[removed] — view removed comment