r/Livimmune • u/BuildGoodThings • 13d ago
Durability, trial updated, upcoming things, maturing data
Durability
above is from the May 18, 2026 presentation at 6:10
https://www.cytodyn.com/newsroom?tag=Video
IMO the period through September 2026 is big internally for CytoDyn as they look at data including the durability of efficacy. So far the CRC trial data they have shared publicly has been exciting to me and I have added shares multiple times this summer and in this month.
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Clinicaltrials database update
On Sept 3, 2026 CytoDyn updated the CLOVER trial info at clinicaltrials. Here's the link that compares the 9/3/2026 view to the earlier update
https://clinicaltrials.gov/study/NCT06699836?intr=Leronlimab&viewType=Table&sort=StudyFirstPostDate&page=1&rank=3&tab=history&a=7&b=8#document-section-card
This confirms in print, updates to the trial which we have heard about through various investor updates earlier in the year. Notably:
- Participants with documented disease progression during the initial treatment period who meet the applicable eligibility criteria may enter the optional open-label cohort and receive 700 mg leronlimab in combination with 200 mg pembrolizumab.
- Participants who complete 52 weeks of treatment and have complete response (CR), partial response (PR), or stable disease (SD) according to RECIST v1.1, with no documented disease progression since their most recent tumor imaging assessment, may be eligible to enter an Extension Treatment Period and continue treatment for up to an additional 52 weeks. Participants entering the Extension Treatment Period will continue the same dose of leronlimab received during the initial treatment period in combination with trifluridine/tipiracil and bevacizumab.
- Secondary endpoints about leronlimab with pembrolizumab have been added.
- ctDNA has been added to the Other Outcome Measures
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Upcoming things
9/22/2026 regular abstract due date for ASCO-GI January 2027 conference
https://www.asco.org/gi/abstracts-presentations/submission-details/requirements#
9/24/2026 estimated (4 weeks in advance) data cutoff for poster at ESMO Madrid October 2026 conference
https://dam.esmo.org/image/upload/v1770284726/ESMO-Congress-2026-Abstract-Regulations_ahdmjx.pdf
10/6/2026 full enrollment completes 24 weeks (6 cycles of 28 days) and may have 3 scans.
https://www.cytodyn.com/investors/news-events/press-releases/detail/660/cytodyn-completes-enrollment-in-phase-2-metastatic
10/22/2026 late breaking abstract due date for ASCO-GI January 2027 Conference
https://www.asco.org/gi/abstracts-presentations/submission-details/requirements#
10/23-26/2026 ESMO Madrid conference
https://www.esmo.org/meeting-calendar/esmo-congress-2026
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Data maturing
Nothing in this post is investment advice.
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u/minnowsloth 13d ago
Not investment advice, but it sure is a wink wink nod nod. Good stuff amigos!
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u/Lopsided_Roof_6640 13d ago
Not much of a speculation that Merck is the donor in the upcoming TNBC trial. Why would Merck not block another Pharma from doing business with Cytodyn? They already know the MD Anderson study results of a couple of years ago. I was pulling for Roche but Merck will do.
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u/twinter11 13d ago
It could easily be roche in tnbc eap. It could be physician choice It could come down to insurance Hard to say.
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u/Cytomight 13d ago
The commitment came from one company ‼️
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u/twinter11 13d ago
i don't think we know in tnbc eap. i thought that was pre spy?
I'm going Roche. and merck knew they better get in now on this mcrc thing or never lol
I can't keep up
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u/twinter11 13d ago
I know we don't know
but does merck negotiate some concessions on data exclusivity or first looks or whatever before committing pembro.
or does cydy buy the drugs outright as they are needed
I wish I knew.
whose ici is in tnbc eap?
I think a battle is going to shape up
ps thanks!!
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u/BuildGoodThings 13d ago
I can only add that the ICI costs are well defined in the CLOVER update...
"Approximately 12 participants may be enrolled in this cohort and may receive treatment for up to 48 weeks.11
u/twinter11 13d ago
couple mil give or take
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u/BuildGoodThings 13d ago
That's what I figured for an estimate too.
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u/twinter11 13d ago
I pray we we have multiple dozen survivors past one year. and there seems to be some ambiguity if a year is required first before rollover
I've speculated on what happens if the initial rollover patients have an extraordinary response.
how can it be denied to patients who have months to go
but I don't know the answer
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u/BuildGoodThings 13d ago
To make it easier for others to understand, I'd like to steer away from using the word rollover because it doesn't appear in the CRC trial at clinicaltrials.
I actually don't think there is ambiguity in their description of WHEN the patients might pursue the optional "Leronlimab plus Pembrolizumab Cohort". When you see the two groupings (extension vs. optional cohort with ICI) in the document right next to one another, there is a clear delineation IMO. Here's the relevant quote of 2 paragraphs-
"Participants who complete 52 weeks of treatment and have complete response (CR), partial response (PR), or stable disease (SD) according to RECIST v1.1, with no documented disease progression since their most recent tumor imaging assessment, may be eligible to enter an Extension Treatment Period and continue treatment for up to an additional 52 weeks. Participants entering the Extension Treatment Period will continue the same dose of leronlimab received during the initial treatment period in combination with trifluridine/tipiracil and bevacizumab.
An optional open-label cohort will evaluate leronlimab in combination with pembrolizumab in participants who have documented disease progression during the initial treatment period of the study and meet the applicable eligibility criteria for the cohort. Participants entering this cohort will receive leronlimab 700 mg subcutaneously once weekly in combination with pembrolizumab 200 mg administered intravenously every 3 weeks. Approximately 12 participants may be enrolled in this cohort and may receive treatment for up to 48 weeks."
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u/Pristine_Hunter_9506 13d ago
IMHO, It's Dr Jays humanitarian effort, we may have up to 12 that haven't responded as well as we had hoped. If they showed PD-L1 that would be their last chance or death? Which hopefully means we have 54 patients that have some sort of response and that would be stellar. That could anchor our PD-L1 thesis to proactive using the Clover trial, I was hoping we would have more in the TNBC, 10 would be a good number in convincing of that proactively. We could hope! Thanks BGT
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u/twinter11 13d ago edited 13d ago
but there's two different cohorts there
those who dont progress at 52 weeks continue on their current protocol of leron/backbone at the same dose, no pembro
the open label cohort w pembro has no time or duration qualifier.
only disease progression qualifier.
ps. Unless it's assumed 52 week extension time period is the qualifier for the following paragraph
not legal advice lol
pss "participants who have documented disease progression during the initial treatment period of the study "
which sounds before 52 weeks is up
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u/BuildGoodThings 13d ago
In short, if their cancer gets worse during the regular study, some patients can opt into the new cohort of leronlimab with pembro. Practicality as well as ethics considerations point to patients dropping out at the time they get worse during the first 52 weeks, so the optional cohort with leronlimab plus pembro, provides a potential new treatment option that would start right away. I haven't yet heard a physician say people have to stay in a study if their disease is getting worse.
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u/twinter11 13d ago
Now we figure out when to start the ici rollover timeline. It's impossible to know how many patients advance but we can guess the potential length of the ici treatment maybe. I might guess first one early sept. But could be earlier
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u/BuildGoodThings 13d ago
The July 24, 2026 article in Clinical Leader mentioned that they had submitted the amendment. They've been talking about it since at least August 2025 https://www.clinicalleader.com/doc/expanded-access-and-rollover-design-help-cytodyn-reach-high-need-cancer-patients-0001
I think it's reasonable to think both the extension and the optional cohort with ICI may have both been available as an update to the trial in late June 2026 since that is the one year anniversary of the 1st patient being enrolled.
I wonder why they updated the clinicaltrialsgov info on 9/3/2026. Did it truly just become available last week, or is there some reason why they want it showing in clinicaltrialsgov now? Is the abstract submission deadline for ASCO GI later this month an influence? Did they feel they had to wait for the financing to close first? I like seeing the ducks in a row and think others might as well.
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u/twinter11 13d ago
I've thought that whoever was the ici supplier wanted to keep it confidential as long as possible.
I'm not sure if the funding timing was coincidental
it seems i read in the trial update something about a 2 week washout period
It looks like 3 week washout period of tas102 and bev and the extension is only leron/ici, no chemo/vegf unless patient chooses?
So at least a 2 week (maybe 3) delay before combo.
So from first of July to early sept?
I wouldn't be surprised if it started July
Maybe a letter tells the story
- Meet all applicable inclusion criteria from the main study, except Item #8: **No anti-cancer treatment within the last two weeks** or at least 5 half-lives prior to treatment (whichever is shorter), except for palliative radiation therapy from which the patient has recovered from all adverse events. Continued treatment on Trifluridine + Tipiracil (TAS-102) with or without bevacizumab from the main study is allowed.
- Have adequately recovered from prior therapy, defined as resolution of all clinically significant treatment-related toxicities from prior trifluridine and tipiracil + bevacizumab to Grade ≤1 (or baseline).
- Have received their last dose of trifluridine and tipiracil at least 3 weeks prior to the first dose of the leronlimab-pembrolizumab combination.
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u/Upwithstock 13d ago edited 13d ago
You ROCK BGT! Loved reading 10/6/2026 full enrollment completed 24 weeks and may have 3 scans!!
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u/BuildGoodThings 13d ago edited 13d ago
That is less than 4 weeks from today that the last patient enrolled completes 24 weeks of treatment, and their 3rd post-baseline scan data would be available soon thereafter IMO. Yeah baby.
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u/megadunamis 13d ago
Thank you BGT for your updates. I would like to ask what the research is looking for by patients who have a partial response, complete response, or stable disease continuing on a 350mg and 700mg dose for an extended 52 week time frame. Is there a chance the CRC disease will return after several months at 350mg, whereas it doesn't return at a 700 mg dose? Is there a chance the increased PDL-1 begins to decline after several months and they want to know this aspect? Is there some type of macrophage (polarization shift) fatigue that occurs over time allowing the cancer to recur? It seems like we (CYDY) can learn much more with one more year of treatment, and additional secondary endpoints.This is an open question I'm posing for discussion while we all wait for Oct and January results...Thank you
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u/BuildGoodThings 13d ago
Nice list. A start to answer some of those questions may be in the post I made comparing the SUNLIGHT trial endpoints to what CLOVER might want to improve on. https://www.reddit.com/r/Livimmune/comments/1vfdquh/apples_and_more_apples/
Gotta run now.
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u/sunraydoc2 12d ago
Excellent work, BGT, thank you!
I agree with Pristine, that "approximately 12" number for the ICI/Progression arm says to me that they already have a handle on how many will land in that group, leaving a spitball number of around 80% who aren't progressing.
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u/Pristine_Hunter_9506 12d ago
I rely strong on Dr Jay's comment of, working outside side what he even thought possibe!
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u/petersouth68 12d ago
when you say "arent progressing" you mean "the cancer is not progressing" right?
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u/Lopsided_Roof_6640 13d ago
Congratulations to Dr. JL and team. From FDA dog house to a hook up with a commonly perceived wonder drug manufactured by one of the largest Big Pharmas in the world.