Member Info for stu485

Haywire,

We agree on one aspect, i’m not doing this any longer either. Your twisted arguments have been exposed, so no need.

Last point though, if your definition of game changing has now embarrassingly moved on from the 6month being unique prior argument and rapidly over to the , FDA approval of pediatric from 2 adult must be game changing well, what about the trials that actually start with pediatrics,… more game changing than those!?

All, just read company RNS’s for the truth and maybe skip the science expert 😉

Good bye Haywire.

AIMO

Haywire,

Let me start by saying, i can’t actually believe i’m trying to debate with an alleged scientist that a single patient treatment P1 and the result to date, is statistically & scientifically meaningful in the way you claim.

All you/we know of this patient is;

There’s been no reportable safety incident and the patient is alive at approximately six months post treatment. From that information alone you’ve claimed the trial treatment to be “game changing”.

Statistically and Scientifically your claim is inherently flawed.

The company by contrast have only advised;

“Early signs” & “potential efficacy”, not even actually claiming efficacy of any clinical significance has yet been demonstrated, let alone a curable efficacy you purport likely through varied unsubstantiated and inaccurate argument. Advancement straight to Ph2 and pediatric expansion,for example.

So why the gaping chasm between the company communications and your claims?

-Is the company wrong?

-Do you understand the science better than the company?

Could it simply be, the company are required to report the facts as they become apparent and you are not?

To address the current ramp of;

“there’s been no other Car-T trial that’s resulted in r/r AML patient living 6 months post treatment “.

Actually, there’s been NUMEROUS!

Examples:

“The CAR T-cell infusions were well tolerated and only grade ≤2 CRS and one grade 2 ICANS were observed. Five patients achieved CR (3 negative and 2 positive for MRD) with a 1-year overall survival rate of 57.1%.”

Chimeric antigen receptor T-cell therapy in childhood acute myeloid leukemia: how far are we from a clinical application? | Haematologica

CD7 CAR-T therapy: current developments, improvements, and dilemmas - PMC

https://pmc.ncbi.nlm.nih.gov/articles/PMC11141645/

Yes some of those trials have involved CRS but many being of a low and manageable grade. It should also be considered, CRS is less likely to occur within first dose and more likely at dose escalation 🤔

As an aside and just to further highlight how ridiculously premature your arguments are;

Did you know MDA themselves are currently treating r/r AML with an FDA approved drug with OS of 9.3 months being reported ?

So yet again, I’ve proven you wrong!!!

I would ask you to apologise to the board for your misleading “ game changing “ statement but i know you won’t as you didn’t previously when you wrongly tried to excite PI’s here with your jump to Ph2 failed prediction.

I can already hear the CR and MRD-Negative, “must be unique” ramps coming down the same misleading path. Should all here want the truth then properly read the company RNS communications and ignore the misleading ramp gangs desperate manipulative rambling.

AIMO

Haywire,

Interesting !

So were i to post paper(s) you claim do not exist , demonstrating OS greater than 6 months and an acceptable safety profile in Car-T r/r AML treatment, then you’d accept your “game changing” statement is wrong and misleading?

AIMO

Haywire,

Hope you had an enjoyable holiday.

I don’t really like to interrupt the ramp gang here selling the company for many multiples…again (Mr I ), but you did promise to prove to all ( presumably with reference to independent science report papers) , how P1 being alive at 6 months IS a game changer.

I highlight IS for clarity that you’re claiming, it’s a proven fact as opposed to a prospect.

Can you please post the paper(s) ?

Thank you.

AIMO

Haywire,

Sorry for multiple posts🤭 just to add i might take a little while to consider the paper(s) and respond, as i’m off enjoying the holiday and wish you the same.

AIMO

Haywire,

Again for clarity, you’re going to demonstrate with reference to appropriate independent papers , how P1 being alive at 6 months is a “ game changer “ within r/r AML treatment.

Thank you.

AIMO

Haywire,

Yes please do point me to any appropriate independent paper that demonstrates your claim .

I and i’m sure others here, will look forward to reading it, thank you.

AIMO

Haywire,

Just for clarification (if it wasn’t clear already), i do anticipate P1 and or P2 to demonstrate MRD- Negative , why?

Because it’s not unknown and has been demonstrated in other similar Car-T AML trials.

Plus we also know, MDA have a specialism in conducting such particular advanced and sensitive testing where some other clinical establishments do not .

I also expect the ramp gang to claim it’s unique and unheard of, should i be correct in my expectation.

Ps

I’m also very well aware of the arguments for expectation of Durability in such MRD-Neg event, but let’s not jump to far ahead .

AIMO

Haywire,

Could you please point me to the RNS which states the clinical response you’re claiming?

Only all i know of is a statement of “ early signs of efficacy “

Secondly, you claim the first two patients being alive is a game changer. Well i know you’re not a fan but evidently you read all my posts so , i’d suggest you look back and pick on any of a bunch of Car-T trial examples I’ve posted with OS superior to that which your suggesting is game changing.

You’re wrong again as with your predictions of a jump to phase 2 that didn’t materialize!

I suspect it’s the reference to MRD- negative that’s really fired you up. Didn’t you want others to know that’s already been demonstrated in other Car-T AML trials 🤔

MRD- negative- i suggest all research a little in anticipation !

AIMO

JRDC,

Thank you for introducing some realism to contrast the recent competition between SocialistB & Addledbrain for the most ridiculous posts ever !

I believe your question on OS rates is extremely, patient and treatment specific but in general 6months to 1year appears to be the benchmark. Argument could be made that with recent advancement in treatments, the latter might now be more appropriate.

I don’t understand the logic of your statement that, should CR’s be evident in such a small cohort, it would be “game changing”?

See attached , one previous trial example.

So a genuine question, why game changing when we know CR’s have proven to be relatively common in previous Car-T trials for r/r AML ?

ASH2024

“Breakthroughs of CAR T-cell therapy in acute myeloid leukemia: updates from ASH 2024

A trial of CD19 CAR T-cell in ten t(8;21) AML patients showed a high safety profile, without severe non-hematological toxicities, and remarkable efficacy, with a 100% response rate, including 60% attaining MRD-negative CR. The 12-month OS and LFS was 45.0% and 46.7%, respectively [7]”

AIMO

HFH,

That was a very desperate and frankly pathetic failed effort to try and find fault within my post , see below for some examples of terminated trials.

My earlier post remains unchallenged as a fact.

Your post however proven at best inaccurate and very misleading.

Enjoy your weekend , maybe spend it doing some research!

“Examples of Terminated/Discontinued R/R AML CAR-T Trials

CD123-Targeting Biodegradable CAR-T Cells (University of Pennsylvania):

A trial investigating a transiently expressed CD123-specific CAR-T cell was terminated early due to a lack of efficacy, with no detectable CAR-T cells or reduction of CD123-positive cells in the bone marrow.

SC-DARIC33 (Seattle Children's Hospital):

This Phase 1 trial using a proprietary DARIC T-cell platform was put on hold and eventually terminated after a Grade 5 serious adverse effect was reported.

CYAD-01 and CYAD-101 (Celyad):

Celyad's Phase 1 programs for autologous (CYAD-01) and allogeneic (CYAD-101) CAR-T therapies for AML and MDS were discontinued due to insufficient clinical activity.

Lentiviral CD123-CAR-T Cells (NCT03766126):

Although the study did not show significant vascular toxicity, it was terminated because no patient achieved a clinical response.

Reasons for Termination

Lack of Efficacy:

Some trials, like the biodegradable CAR-T cell study, were terminated because the therapy did not show any promising anti-leukemic activity or clinical response. “

AIMO

OB,

Oh dear, looks like you get somewhat defensive when your posts are called out.

Thanks though for the confirmation that my previous posts did not contain any falsehood and simply stated the known facts.👍

I tremble at the thought of the Karma brought on by telling the truth here .

Have a nice weekend.

AIMO

HFH,

You appear to want me to elaborate and explain further why your post is at best, inaccurate...so I will !

Firstly, the good news.

Yes,great news for P1 & P2

Yes, there's no safety signals reported to date in P1,P2,P3.

Yes, there's been "signs of early efficacy" reported.

Yes, the FDA have approved expansion the Paediatric cohort

All undeniable and positive steps in the right direction.

I'll even add as an aside (as it appears topical), the Risk/Reward here is massively superior to that of Avacta.

BUT

To claim the results to date are truly "remarkable" and of "immeasurable value to major pharmaceuticals" is evidently, FALSE !

Your presumption that P1 & P2 are only alive as of the date of announcement, due to the results of treatment with HG-CT-01 is exactly that, a presumption.

In actual fact we do not know this to be the case and do not know the present disease condition within the patients.

Personally and with reference to the largest scientific review of previous Cart-T r/r AML trials, I'm anticipating CR's as it's been proven common within such trials. Unfortunately what's also proven common is the rate of relapse, many sadly in 6m-1 year window.

Until a significant cohort has been treated with evidence of curative durability in response, your statement is one of wishful thinking but also and evidentially false , at this juncture and with the respect to the pertinent facts communicated.

Maybe you're getting ahead of yourself with Haywire's help by believing in his incorrect prediction that the company would jump straight to Ph2 due to the remarkable efficacy demonstrated in P1& P2 ? Just think on that point for a moment.

The company is continuing with the std trial design and dose escalation , so pondering Haywire's argument, what might that mean?

AIMO

OB,

Seems when it comes to actually understanding the science, you don’t!

I’m waiting for you to explain any false statement in my previous post, that you were so quick to try and discredit.

…Why would you do that !? 🤔

AIMO

OB,

Other than your nonsense , would you like to point out any false statement in my post ?

I’m afraid for you and the gang, my post is factual.

Have a good day.

AIMO

HFH,

No, it is not “ remarkable “ !

Many previous Car-T r/r AML trials that are now sadly terminated, initially produced patient Complete Response, one Paediatric trial had a 70% CR in a significant cohort size.

So please stop making false statements .

I’ll leave it at that and not elaborate further if you and others stop with the BS.

AIMO

Subush,

Were you a genuine investor you would also be asking questions of Haywire !

Why did he try to convince all that P1 & P2 efficacy was so incredible, Ph1 would have no need for further dose escalation ?

Some may have believed him and made investment decisions on his now proven wrong predictions.

So if this board might benefit from anyone shutting up, you might want to look in Haywire's direction!!

I note he's still not man enough to admit his mistake.

AIMO

Haywire,

In Science mistakes are made , they are recognised and scientists move on having learned from that mistake.

You on the other hand refuse to recognise your mistake and that makes me wonder, do you actually work in science?

You posted that the company may jump straight to a Ph2 trial following P3. The RNS of today clearly states, they are NOT and will continue with the second dose cohort of Ph1.

Your incorrect prediction was based on your thoughts that efficacy within the first dose cohort was so incredible ,further dose escalation and continuation of Ph1 wouldn't be necessary, you were categorically wrong .

Maybe you should have a chat with the company and explain to them how they've got it wrong and why they should jump straight to Ph2 .

Every one makes mistakes refusing to recognise them is childlike and very... unscientific !

AIMO

Haywire,

The RNS is very, very clear and should be commended for being so.

Your posting however, suggesting a transition to Ph2 clinical trial upon P3 treatment given the miraculous efficacy that must have been apparent has been proven incorrect ,not by me but by the company, all as the RNS of today.

So again, would you like to publicly apologise for any false excitement you may have promoted with your incorrect prediction?

AIMO

Good news for P1& P2 and a clear and well delivered RNs.

Was the FDA approval for incorporation of part G-rex process or some other ,... HK ?

Would have liked update of early efficacy but accept Ph1 is primarily to qualify safety.

Haywire, seems you were incorrect in your thoughts and posts suggesting a transition straight to Ph2 upon P3 treatment.

The company state they are continuing with Ph1 dose escalation all as the standard trial design.

Would you like to accept your error and publicly apologise for any false excitement you may have promoted ?

AIMO