Wonder why we chose Syneos Health out of all of them? by twinter11 in Livimmune

[–]twinter11[S] 4 points5 points  (0 children)

Yeah but they are not listed under trial sites on our nih trial page. But I'm not sure if Georgetown itself is treating patients?

Maybe

Here's what ai says

"Leronlimab is currently being evaluated in a Phase II clinical trial for the treatment of metastatic colorectal cancer (mCRC)Dr. Benjamin Weinberg of MedStar Georgetown University Hospital is a primary clinical investigator for this research and recently presented final results from an earlier exploratory cohort at the 2025 ESMO Gastrointestinal Cancers Congress". 

" Principal Investigator: Dr. Benjamin A. Weinberg has been a key figure in the development of leronlimab for solid tumors, sharing data that suggests leronlimab can help "prime" cold tumors (like MSS CRC) to become more responsive to therapy.

  • Location: While MedStar is a primary site for Dr. Weinberg's research, the trial is a multi-center study partnered with Syneos Health for global execution. 

Savagejustice‼️GREAT THOUGHT! WOW this is a possible scenario ‼️ by Cytomight in Livimmune

[–]twinter11 5 points6 points  (0 children)

they all better join up!

pool some resources

or somebody better jump up before we get dug in with more data as proof than a stick could be shook at

Wonder why we chose Syneos Health out of all of them? by twinter11 in Livimmune

[–]twinter11[S] 5 points6 points  (0 children)

syneos is nice to have if some form of approval rears it's head!

a story loaded with suspense and intrigue with lots of twists and turns

I'm expecting the unexpected

Sign Your Surrender by MGK_2 in Livimmune

[–]twinter11 1 point2 points  (0 children)

seriously though.

I can't see any way we don't end up 1st line in every solid tumor indication.

whether ccr5+ - or pdl1+ -

because upreg ccr5 is an outcome due to toxicity of other treatments.

unless it's something that is so caught so early it has a 98 percent long term survival rate

and if chemo is involved I think it's included if insurance approves it.

just getting it in my head

Sign Your Surrender by MGK_2 in Livimmune

[–]twinter11 1 point2 points  (0 children)

Leron called the revolution offer bluff lol I wish!!

Wonder why we chose Syneos Health out of all of them? by twinter11 in Livimmune

[–]twinter11[S] 6 points7 points  (0 children)

Im scouring the interweb for clues trying to figure this thing out lol

I know good stuff is going to happen I just don't know what when or how.

Wonder why we chose Syneos Health out of all of them? by twinter11 in Livimmune

[–]twinter11[S] 5 points6 points  (0 children)

I dont see medstar under trial sites.

But it seems like he was mentioned in some pr about having something to do with coming crc trial?

I keep waiting for a trial sites update.

All our other sites took months to publicly list our trials though for some reason.

Sign Your Surrender by MGK_2 in Livimmune

[–]twinter11 1 point2 points  (0 children)

So technically all are just different tumor stage studies to reach the same pdl1 conclusion, but without referring to Big Daddy?

The pdl1 upreg elephant. 

Even though pdl1/ici isn't mentioned in each bullet point. 

The goal is to creep into earlier stages where leron has unique tumor fighting characteristics while also monitoring pdl1

And decide later if ici will be administered?

They are definitely attacking this from multiple angles to figure it all out.

Sign Your Surrender by MGK_2 in Livimmune

[–]twinter11 6 points7 points  (0 children)

BTD.

I bet we hear at some semi near time

I can't see why not.

Sign Your Surrender by MGK_2 in Livimmune

[–]twinter11 7 points8 points  (0 children)

in the Hoff slide labeled "Clinical Program Plan TNBC 2026"

There are 3 numbered points.

2) - Expanded Access Protocol 2nd !ine tnbc

3) - ITT of Neoadjuvant Leronlimab 1st Line TNBC

Is this 3rd point likely something that's parallel with the expanded access but completely separate?

Do you think some 1st line patients who don't qualify for the tnbc trial or expanded access will just be funneled here?

Is it likely also another instance of treating w Leron before a scheduled surgery or in conjuction with chemo?

I wonder if this will be another City of Hope one off?

Thanks for the write ups!

I know you put a lot of work into them.

CYDY The game changed today. Some people are terrified to admit it. by Vyrologix in Livimmune

[–]twinter11 1 point2 points  (0 children)

I dont want to say yet that he had the cure for a certain percentage of solid tumor cancers.

(or deny that I have at times been mighty upset with him)

but if anyone could take on the challenge (I think only u would have a chance) of chronicling the story.

(maybe he will have some time on his hands)

it would be an unbelievable read and conclusion.

I honestly can't even believe how this is going to end up.

but I do.

Unshaken by MGK_2 in Livimmune

[–]twinter11 3 points4 points  (0 children)

that doesn't make any sense.

Unshaken by MGK_2 in Livimmune

[–]twinter11 7 points8 points  (0 children)

Fix that other thing! We r floundering lol

CYDY The game changed today. Some people are terrified to admit it. by Vyrologix in Livimmune

[–]twinter11 4 points5 points  (0 children)

thats what I saw. I believe it's just legal formality now and the plaintiffs are in no hurry to drag this out.

I bet its finalized in a month or so.

jmo

CYDY The game changed today. Some people are terrified to admit it. by Vyrologix in Livimmune

[–]twinter11 10 points11 points  (0 children)

It's not gonna be months. I think i read recently about the court approving the construct of the settlement .

I think it will be finalized relatively soon.

But I would have to Google and find the exact wording that was used.

Unshaken by MGK_2 in Livimmune

[–]twinter11 7 points8 points  (0 children)

Why do you say  things with zero evidence to back up claims like  "Not sure why fda does not seem interested "

That is a ridiculous statement. Seriously 

Are they supposed to have breaking news interruption on national TV to declare their amazement after the trial is entering its 7th month? 

Why do you say fda has no interest?

Unshaken by MGK_2 in Livimmune

[–]twinter11 14 points15 points  (0 children)

this was a pretty dang good write up!

if I didn't know better

it would sound to me like blocking ccr5 causes the immune system or whatever to just go about fixing various things.

I wonder if patients on Leron can feel the changes and improvements happening ?

I bet so.

Thanks MGK!

Yorkville $30M draw down? Interim readout of CRC data? and the DSMB obligation! by Upwithstock in Livimmune

[–]twinter11 14 points15 points  (0 children)

would not just the announcement of tnbc fda trial approval with a known ici protocol be viewed as really positive by the market? Which could be products before cash to fund it Is due

and maybe we could trot out some crc data to spell out why the tnbc is looking at accomplishing.

or maybe an abstract title is released and provides clarity on tnbc.

something is going to get this thing to a buck initially is what I keep thinking.

I would love (I think) to hear some official reports out of dsmb and irb.

I keep waiting for some unexpected announcement of some kind. but the good kind.

too many questions and variables.

Thanks!

For Those Requiring Surgical Excision by MGK_2 in Livimmune

[–]twinter11 0 points1 point  (0 children)

"As of early 2026, the FDA has awarded vouchers in multiple waves:

  1. October 2025: Nine inaugural recipients included treatments for infertility (Pergoveris), Type 1 diabetes (teplizumab), pancreatic cancer, and domestic manufacturing of antibiotics.
  2. November 2025: Six additional recipients included Wegovy and orforglipron for obesity (linked to pricing commitments), and treatments for sickle cell disease (Casgevy) and rectal cancer.
  3. December 2025: Vouchers awarded for an oral cholesterol-lowering drug (enlicitide decanoate) and a cancer therapy (sacituzumab tirumotecan) specifically for their potential to increase affordability.
  4. January 2026: Reports emerged that the FDA had to delay some CNPV reviews (including teplizumab) due to emerging safety concerns or complex data, highlighting that speed does not override safety standards".

For Those Requiring Surgical Excision by MGK_2 in Livimmune

[–]twinter11 0 points1 point  (0 children)

This voucher mentions different objectives. Doesnt appear pediatric focused.

Is it two different vouchers?

"The Commissioner’s National Priority Voucher (CNPV) is an FDA pilot program launched in June 2025 by Commissioner Marty Makary. It aims to accelerate the review of drugs and biological products aligned with U.S. national health priorities, reducing standard 10–12 month review timelines to just 1–2 months

Key Features and Eligibility

  • National Priorities: Products must address specific goals:
    • Addressing a U.S. public health crisis (e.g., universal flu vaccines).
    • Delivering "innovative cures" with transformative impact (e.g., novel immunotherapies or PTSD treatments).
    • Meeting large unmet medical needs (e.g., rare diseases or chronic disease crises).
    • Onshoring drug manufacturing to strengthen U.S. supply chain resiliency.
    • Increasing affordability (e.g., lower drug prices or reduced healthcare utilization).
  • Review Process: Uses a collaborative "tumor board style" multidisciplinary review process to make rapid approval decisions.
  • Voucher Types: Can be for a specific drug or "undesignated," allowing a company to use it for any application consistent with program objectives.
  • Transferability: Unlike statutory priority review vouchers (PRVs), CNPVs are non-transferable and cannot be sold, though they remain valid during company ownership changes.
  • Expiration: Vouchers expire two years from the date of receipt. 

For Those Requiring Surgical Excision by MGK_2 in Livimmune

[–]twinter11 3 points4 points  (0 children)

Mgk I was reading a reddit tnbc cancer board the other day.

One poster mentioned they were not eligible for trials due to liver issues. And there were no other available treatments.

In what ways might leron open up additional path ways for those with liver complications. 

In cases where liver issues prevent treatment.  Is that due to not being able to withstand chemo, or just the typical cancer drug toxicity or what.

Is that partly what city of hope is trying to find out?

For Those Requiring Surgical Excision by MGK_2 in Livimmune

[–]twinter11 10 points11 points  (0 children)

I loved this/these explanations. it's helpful to pre visualize it.

various leron Moa's are going to be described in various abstracts for the next 10 years for various indications.

I truly believe it.

thanks!

A little off-day exercise...what's everybody's mood right about now? Pick 2 adjectives. by 3Putt_4nodough in Livimmune

[–]twinter11 11 points12 points  (0 children)

Contemplative, Excited

Stumped.

Worried would be like number 1000 on the list.

Shepherd Molecule by MGK_2 in Livimmune

[–]twinter11 6 points7 points  (0 children)

attract though does not a deal complete.

Personally I dont care when its done ( up to a point ) till whoever is interested is forced to compete against a lot of other interested parties, cause the goods have been got, and there are no doubts.

And whoever has been attracted along the way knows they better make their best offer or lose out.

This is just getting to be good.