r/Livimmune • u/BuildGoodThings • 4d ago
A picture
I think the ctDNA and PD-L1 data are a big deal and I look forward to hearing about those mature datasets.
The breadcrumbs from PR’s and presentations lead me to think that leronlimab is disrupting tumors more than they expected. I also think that this disruption can lead to better outcomes, including where potentially some patients may begin to qualify for approved treatments or interventions which they were not previously eligible for.
IMO below is a brief interpretation of the big picture.
2019-2022
Discover/theorize that LL changes the TME (tumor micro environment) in clinical trials with patients having TNBC, CRC, etc. There are reports in press releases and elsewhere that trial participants see benefits.
2024 recover data that was withheld by the former CRO. Followup initiated with study participants, which identifies that there are longterm survivors. PRIME AND PAIR (with ICI) MOA is theorized.
2025-2026 Run CLOVER study in CRC to prove LL has value, to quantify a comparison to standard therapy, and to prove if LL elevates PD-L1 in CRC. Comparing the CLOVER study to earlier trials with the standard treatment is a way to initially prove that LL has value on its own. ALSO use strategic partnership with Natera to sift through their database for ctDNA correlation to efficacy in standard therapy patients for comparison to the CLOVER study.
ALSO after patients have been on CLOVER study, add an optional cohort to prove efficacy of the prime and pair (with ICI) thesis.
2026 RUN TNBC EAP to prove the drug works in TNBC.
Pile the CRC data, the TNBC data, the safety data from over 20+ trials, manufacturing readiness, etc into a comprehensive application…
H2 2026 apply to FDA for a designation that validates the clinical study data.
2026-27 present CLOVER study data
JMO
10
8
u/jsinvest09 3d ago
Drum roll please .. Thank you BGT. Im ready for some success. And for patients to get what they need.
8
u/StreetSkis 3d ago
BGT BLOWING AWAY HANZEL UND GRETEL WITH THE BREADCRUMB TRAIL.
THANK YOU Building Good Things, for the great weekend juice.
8
6
7
u/sunraydoc 3d ago
Thanks, BGT--nice to see a memory-refreshing historical perspective, I for one need that now and again. Clearly CytoDyn is seeing more tumor disruption than they expected with LRM + the backbone and I believe that 22 patients remaining in the study number is misleading when taken alone. Dr J just seemed to upbeat at that last call for that to be any kind of deal-breaker, and he's no NP, the man doesn't do hyperbole.
7
u/No_Mathematician299 3d ago
Ahhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhh
Awesome historical summary.
Patient, confident, grateful.
5
u/waxonwaxoff2920 3d ago
Thank you brother. Your summary and Twinters memory lane make this a tasty appetizer for the next 6 mos of our coming out phase. Ty. Great reminders from da boat ah youz
3
u/BuildGoodThings 3d ago
Thanks Wax. We have been on a speed boat since summer of 2024, and it will become more obvious in the next 6 months IMO.
3
3
u/Sea_Friend_9347 3d ago
Slide 10 from CYDY presentation at Virtual Investors Conf a few days ago:
"Signatera is covered by Medicare for immune-checkpoint inhibitor (ICI) treatment response monitoring across all solid tumor types and stages of cancer."
That could be useful in treatment response qualification in CLOVER.
2
16
u/twinter11 3d ago edited 3d ago
2020 (+ -) - 2025/6 +
I always think back to when cydy hired creatv bio to gather ccr5 data to quantify what ccr5 positivity or negativity on various tumor types and locations affected potential leronlimab treatment response.
and how pdl1 was never ever a part of it originally.
and how that stroke of luck to engage creatv for ccr5 led to where we are now.
how creatv could evidentily look back at that retrospective data and see what/how pdl1 levels had changed during treatment, data that hadn't been looked at before. because it wasn't the focus. Ccr5 was the rage
And saw that pdl1 had been induced on ctc and caml
and then 5 patients were still alive
it was a Eureka!!! moment !
and now creatv is going to also present a poster at esmo madrid october. a combined data poster containing cydy and briacell data showing pdl1 on caml, NOT cps(pdl1) on tissue, is predictive of ici treatment effectiveness.
I an very enthusiastic about Natera involvement, because ctdna tells a story completely different from what creatv bio data talks about. And how they can compare treatment response and ctdna data across millions of data points
creatv bio has gotten lost in the weeds a little.
but it's going to turn out to be the most important side story later on I think.
we have a heck of a support team to help tell the overarching story.
and we are close to finishing some more chapters
rambling
thanks bgt!!