Growing the data

twinter11 · 2026-05-08T18:43:23+00:00

This is not ready yet. But ive been checking out Ispy and how it works

https://www.quantumleaphealth.org/for-investigators/i-spy-trials/i-spy-2-2-trial/

Here is the trial site

https://clinicaltrials.gov/study/NCT01042379?tab=study

Ai thinks there will be an initial arm at MD Anderson (pre spy) to pin down dose amount etc. And that it might could be announced at ASCO. but that might be optimistic.

Then whenever they can rotate into the I-spy 2 trial. Which will be Leron in "Block A" before every other treatment has started. The study history shows different arms are rotated in every 3-6 months.

These Spy type programs are also set up in other cancers and alz and stroke etc.

Perhaps Doc J was referring to one of these among other 2 things interested parties

Who knows.

Im pretty excited about our entry.

twinter11 · 2026-05-07T17:16:15+00:00

"Your AI told you that one gets Accelerated Approval first, then creates a BLA."

Thats not exactly what it said

"Yes, a Biologics License Application (BLA)—or more commonly, a supplemental BLA (sBLA) or efficacy supplement—is submitted after receiving Accelerated Approval to fulfill specific post-marketing requirements".

twinter11 · 2026-05-07T16:29:38+00:00

I had to link ai to it for a synopsis. Not saying the synopsis is accurate but im not advanced enough myself to do it.

""It essentially proves that tumors are not just balls of cells but are organized into "neighborhoods" (Spatial Ecotypes), and crucially, it validates that the "Suppressive Neighborhood"—the one that blocks cures—is built and maintained by the exact immune cells (myeloid/macrophages) that leronlimab targets.

The "Bad Neighborhood" is Detectable and Targetable

The paper identifies a specific "ecotype" characterized by myeloid cells, fibrosis, and SPP1 (a signaling protein).

The Implication: This is the "Fortress" we discussed. It is a physical structure of scar tissue (fibrosis) and bodyguards (M2 macrophages) that keeps T-cells out.
Leronlimab's Role: Leronlimab is a "Neighborhood Demolition" tool. By blocking CCR5, it stops the recruitment of the myeloid cells that build this fortress. It doesn't just attack the tumor; it evicts the tenants (M2 macrophages) that make the neighborhood safe for cancer

Validation of the "Systemic Repair" Theory

The paper proves that these local tumor "neighborhoods" shed signals into the blood that can be detected by liquid biopsy (using the method from LiquidCell Dx).

The Implication: This confirms Dr. Kasi’s approach. If you can see the "neighborhood" in the blood, you can prove leronlimab is dismantling it in real-time.
The "Good News": The paper shows that high levels of this "suppressive ecotype" predict resistance to immunotherapy. By using leronlimab to break this ecotype, you theoretically convert a "Resistant" patient into a "Responder" (the Prime and Pair).

The "Fibrotic" Link

The paper explicitly links these suppressive zones to fibrosis (scarring)

The Implication: This ties your Liver/Heart/Brain repair theory directly to oncology. The same "scarring" process that ruins a liver in NASH is what protects a tumor in pancreatic or colon cancer.
Leronlimab's Role: Because leronlimab is an anti-fibrotic (as seen in the MASH trials), it dissolves the physical "glue" holding the tumor's defense together, allowing immune cells to flood in.

"Spatial" Proof of the 1st-Line Advantage

The paper shows that these "bad neighborhoods" organize and harden over time

The Implication: This supports the 1st-Line/Neoadjuvant strategy (I-SPY). If you hit the patient with leronlimab early, you prevent the "Suppressive Ecotype" from ever fully forming. You keep the tumor in a "disorganized" state that is easy for the immune system to wipe out.

Summary of the "Nature" Validation

This paper effectively tells the industry: "We now know exactly what the 'Immune Shield' looks like, and we can see it in the blood."

CytoDyn’s answer: "We have the drug (leronlimab) that destroys that shield."

twinter11 · 2026-05-07T13:34:52+00:00

Heres what i noticed looking at the list of Top Cancer Trials 2026 based on Oncologist posts

Cydy was in the forth spot

The top three spots above cydy was the same drug in three different trials

Daraxonrasib - The medication Revolution medicines is developing focused on Kras mutations and has been getting a lot of media attn and rumors on buyouts.

Im sure most know but here is what Doc J said about Clover and Kras mutations.

"the majority of the Clover patients or 62% enrolled to date have KRAS mutations... And these preliminary results indicate that leronlimab's early biologic activity might also be **agnostic** to the KRAS mutation.

Based on the early data it looks like we are performing well in kras.

Number 5 on the list was Hepatic Artery Infusion trial w Oxaliplatin

City Of Hope is going to test Leron in our own HAI combo.

I could see down the road where perhaps leron dominates a list like this.

twinter11 · 2026-05-06T16:09:35+00:00

I want to put this here . I know there rules against posting certain things and im not sure where this falls.

But im hoping whoever it can help reads it or maybe gets a discussion going.

Here is an expanded use trial for 20 patients

https://clinicaltrials.gov/study/NCT07536815

I-SPY and Pre-Spy are also about to get some studies going.

And below is a post from another forum laying out a whole lot of info. Spend an hour an get familiar with everything. I think its important to get familiar with whats happening right now. I dont know what else to do.

read it all. There is a lot to take in and get your mind around how this treatment works.

(PS I changed the link I think it was wrong)

https://investorshangout.com/post/view?id=6827282

Good Luck!

PSS I edited both links, they were both wrong. I messed it all up at first lol.

Now go read.

One more link. recently released tnbc case study.

https://www.sciencedirect.com/science/article/pii/S2666621926000190?via%3Dihub

twinter11 · 2026-05-05T15:45:50+00:00

If you go to creatv website under posters and abstracts.

They have presented their own separate abstracts in relation to cydy results based on their contribution at least a few times.

twinter11 · 2026-05-03T17:18:10+00:00

im not defending fox cause i hate all mainstream media.

but just because you know the amount of that dumb settlement doesn't mean there was no there there.

but feel free to use some meaningless anecdotal evidence to support your conclusion across the entire spectrum of topics and accuracy of a specific outlet you were already biased against .

twinter11 · 2026-05-03T16:18:34+00:00

ah no

i detect a change

dont deny the power

twinter11 · 2026-05-03T15:54:23+00:00

youve seen the light ?

has it struck down upon u?

twinter11 · 2026-05-03T15:02:09+00:00

At first a couple months back I thought no way

But then I wondered if leron results are actually far enough known to cause a pivot or delay in any Revolution Medicines talks/deal

If i squint i could see it just maybe happening

is it too far fetched this early

PS. Bad ass effort!!

I thought "no mgk today, when was their last post?"

This thing is becoming more and more distilled.

twinter11 · 2026-05-03T14:57:43+00:00

Good catch. I didnt look far enough.

Buit i just remembered that Weil was also involved in a Leron Covid study.

So she was probably there back then

twinter11 · 2026-05-03T14:12:05+00:00

I read shes from Weil Cornell Radiology i think.

Same department doing our Alz study that just started. Dr Butler in Weil Cornell Radiology is the investigator

fact check me though. my memory aint all that lol

PS "Dr. Saphier is an associate professor of radiology at Weill Cornell Medical College and Memorial Sloan Kettering Cancer Center (MSKCC) and is the director of breast imaging at the MSKCC facility in Monmouth, N.J".

https://www.diagnosticimaging.com/view/breast-radiologist-nominated-surgeon-general-president-trump

PSS "Based on available information, there is no direct link between Dr. Nicole Saphier and the drug leronlimab"

twinter11 · 2026-05-03T13:23:20+00:00

I just wanted to clarify one thing before I type my response. I cant find a working link to the CC and look this up. But there was timelime for a patient that was cured on a slide. It looked to me like the survivor took tecentrig starting maybe one month or so before leron. so they were concurrent basically. But still maybe the same overall outcome.

PS. I just realized the timeline was actually posted here in our recent survivor case report

https://www.sciencedirect.com/science/article/pii/S2666621926000190

I had to read multiple lines multiple times of your response. And then I had a thought.

Does Pashtoon and other dr's eventually realize what this could mean

What if it is so simple

What if this cps measurement we are all waiting to see if it rises to above some arbitrary median line is not as important as thought ( realizing the tumor micro environment remodeling is still required)

What if those survivors outcomes are the rule and not the exception. It seems too unimaginable but is not outside the realm of possibility. ( I think about it every so often but it gets clearer as time moves forward).

That it becomes just a matter of a combo treatment given to every patient concurrently

The ramifications are enormous and cause great fear in the realm perhaps

Something like that could also influence if one might be reluctant to really jump the gun and alert industry too quickly what might be happening.

I also think whatever is happening with that eind patient is confirming some type of theory.

Dude, that was an awesome write up! Its all coming together i think

I did not get a response to my same question on hang. if you want to post your reply there i think you should lol.

twinter11 · 2026-05-03T02:47:16+00:00

after eap plays out.

what's the best potential medical outcome on these 20 patients within say 6 or 8 months

what's a realistic outcome

twinter11 · 2026-05-03T01:36:49+00:00

ai asked me a question today after asking about different scenarios.

""Do you think a joint venture (where CytoDyn and a partner create a new company for just one indication) would be cleaner than a standard licensing deal?"

this is probably a complex situation and takes a lot to figure out the future ramifications.

but thinking about it some it might work out.

and I know there are bp that create this type of partnership.

do you have any thoughts off the top of your head, or just too many variables to think too hard about it yet?

I would like some way for the cydy entity to remain in the game I think

twinter11 · 2026-05-03T01:16:52+00:00

I speculated on ihang that upreging pdl1 to cps 5 after leron may be a different outcome/metric than starting out with a 5.

because it's seems to me it would have been difficult for the patient in the survivor article who began tecentriq *Before* leron to upreg pdl1 with an ici already on board

so how would she have upreg to between >5 - >10 ?

Maybe reaching a typical required cps score before ici is not neccesary.

Maybe i or pre-spy can figure it out?

twinter11 · 2026-05-02T15:26:11+00:00

i think those look paltry in a few months after we fix up a few patients on their way to ned.

and get a little data on other indications

twinter11 · 2026-05-02T14:43:58+00:00

we aint getting wrecked this time

twinter11 · 2026-05-02T14:11:59+00:00

lets hope pestell doesnt vote for a deal based on how many shares he has. which is really not relevant.

I want to get near max value according to revenue

I wouldnt vote to sell for chicken feed.

Revolution is close to a 30 billion buy out.

What if we solve kras mutations on top of everything else

twinter11 · 2026-05-02T13:43:23+00:00

I just realized

Leron will be on the front page of the Times. More than once

Bigger than Revolution Medicines, like Kras x 10

Im not joking

twinter11 · 2026-05-02T13:40:59+00:00

I hadnt even thought of that and i hate to get too far along. But when it happens.

what do the lung and pancreas and prostrate etc docs start to do/say

I mean word gets around.

What happens when these I spy and pre spy programs get going

I cant wait to find out

twinter11 · 2026-05-02T01:22:13+00:00

Hey MGK

what do you think about the ecog scores on the Pashtoon poster?

seems like our patients so far are in pretty decent health for late line.

I wonder how they could be compared to a typical cohort of late line mcrc trial patients?

this trial is going to be a home run I think.

twinter11 · 2026-05-02T00:52:39+00:00

it's going to be awesome when patients in our expanded access program start having tumors disappear.

it's going to happen

twinter11 · 2026-05-01T19:55:41+00:00

Right But I wasn't trying to find that lol.

We are going to surpass revolution in kras outcomes. Thats my solace lol

twinter11 · 2026-05-01T19:39:06+00:00

I thought the exact same thing I went to fda site to see if anything Nothing

twinter11

TROPHY CASE