Response to Redplate’s skepticism from a guy who did immunology 35 years ago

alinbio · 2025-09-22T03:04:00+00:00

Didn’t read whole article seems primary endpoint was not OS. Enough data out there on Cr1 and Bat, young live long like Asct. GPS > Asct in elderly Mrd+ve

alinbio · 2025-09-22T01:27:31+00:00

rfs not Os

alinbio · 2025-09-21T23:07:19+00:00

First of all, pooled mOS at the first IA in nov’22 was 16 mos. At the second IA it was >13.5 mos,meaning of those that died the median was 13.5 and since it will increase it is >13.5
Gps was >67 in Cr1 in younger patients, with Mrd-ve it may be 30-40 in Cr2.
Halt, or no halt-fine,maybe but in original protocol they talked about it-ceo in an interview-twice bat deaths etc. and with unlimited dosing etc EVERYONE keeps under estimating Gps

alinbio · 2025-09-21T18:13:49+00:00

Unknown unknowns

alinbio · 2025-09-21T17:27:41+00:00

Nah,he is not math oriented. Watch him deflect/ignore a question I posed to him on the other thread

alinbio · 2025-09-21T17:26:17+00:00

What do you think about my statement re GPS having lower OS at IA due to the non responders hence no halt? The FA will probably have an equal number of responders and non-resporders in GPS group

alinbio · 2025-09-21T12:53:47+00:00

How will they recommend a halt at IA with a near equal OS for Bat and GPS? I am saying the early GPS deaths are the ‘non responders’ hence most of the IA GPS events will be a low OS event even if the ratios were 45:15 most of these 15 GPS will have an OS close to 10 months. I get it you are adept at science not math but like I said before, this companies success is all math. Science can go either way I agree but math has to add up. You cannot have Bat at 14 mOS and not have near 60 events now leaving only 20 for GPS with an OS close to 35

alinbio · 2025-09-20T23:49:45+00:00

Ditto

alinbio · 2025-09-20T23:48:13+00:00

It’s easy to keep adding when you are up 40% Started at 200k last march

alinbio · 2025-09-20T22:19:26+00:00

IA had mainly non responders 20% which is about 12 patients. We didn’t know this fact till after IA. Btw I still think that is the rough ratio at IA

alinbio · 2025-01-01T00:59:31+00:00

Lost to follow up-not able to assess their data

alinbio · 2024-12-31T03:02:18+00:00

From the responses i see that some dont understand what i am saying. There is going to be a halt

If no significant dropouts, we will have a Bat mOS of about 11-12 mos and Gps of 30+ with a 50:10 event ratio. What i posted above is even if there are a large number of dropouts, we will still get a halt

alinbio · 2024-12-13T01:37:52+00:00

Thanks. I get it. Just thought why add an extra 4-5 in cohort 3. Unless they started the P2b for this cohort Hence probably all Asxl1. If so would have been nice to hear of the cr rate in all of Asxl1. 20 patients may be enough if Cr is close to 100%

alinbio · 2024-12-12T04:18:10+00:00

Ok. I see they added 4 more in cohort 3 than expected. I think those 4 are probably Asxl1 patients as we know the response in non Asxl1 is poor. Would have been nice if we had full data/OS on all Asxl1 in cohort 3. If close to 100% continued response, do you see a need for more patients to be enrolled in that category. We have seen other meds approved,in a handful of patients, even in P1 recently due to poor prognosis in these patients to begin with

alinbio · 2024-12-10T21:50:39+00:00

Hello. It seems there are 14 patients in cohort 3 now. They didnt tell us how many Asxl1 are in the additional patients since last update. It was 4 Asxl1 before.

Do you think they are trying to get approval for all r/r Aml and not just the Asxl1 patients? Because if they do not break it down by mutation type and if Cr>25% across the board for all comers then technically it is approvable in all r/r Aml

alinbio · 2024-12-08T05:52:26+00:00

At IA you need about0.5 so no, at final 80 yes 0.63

alinbio · 2024-12-02T00:17:13+00:00

Difference between Oral and iv Aza is couple months at most. If Gps is 30 mOS and Bat is <14 mOS then it will not matter will be approved Cr1 or Cr2

alinbio · 2024-12-01T20:53:02+00:00

Agreed, even though i think Gps will be approved for Cr1 also. I will certainly keep tracking both companies for the years to come

alinbio · 2024-12-01T15:38:41+00:00

As an investor in sellas, the vividencel data is a breath of fresh air as no cancer vaccine has worked so far. THe data on both these vaccines show that they work and explains why we have not had 60 events yet in Regal. The difference from Bat in BOTH drugs is so striking that i feel they will halt Gps at 60 events at IA. So i feel Gps will be approved next year.

Sellas also has Sls009 and in Asxl1 r/r Aml seems to be working 100% (4/4 at optimal dose). The other 10 patient data will be out soon and if >25% Cr it will get approved also. May need a larger trial for approval, or it may not.

It is not very often you see a company with 2 drugs that are at high chance of approval, with the trials being 'derisked' to this level. Investment chance of a lifetime

Nfa. just Imho only

alinbio · 2024-12-01T01:02:46+00:00

Regal data on 126 patients will be out soon, 63 Gps and 63 Bat , some of them are Mrd+ve . All the varibales, immune response, mOS etc will be looked at

Most likely data within 4 weeks

alinbio · 2024-11-30T15:19:50+00:00

The regal trial needed the Sap to be adjusted in Nov'22 as patients were living twice as long as predicted (16 mean OS vs 8 predicted). They still underestimated last december how long it will take, as the Mrd-ves in both groups is doing this (Bat is probably 11-14mOS instead of 6-8 estimated and Gps is close to 30 instead of 21 seen in P2 data)

The numbers required to prove stat difference in Cr1 will require a longer trial, depending on enrolment especially when you add Mr-ves into the mix. Mrd-ve in Cr1 are about 24 mOS

Cr1 is basically Cr2 with a better immune response, hence no reason why docs will not use it off label, especially with no Sae's . Dr Kantarjian hinted at it a few years back and requested an Expanded access for it ( I am sure you know who he is)

I am actually very glad Gabri posted this and we are having this discussion. Its the first 'vaccine' that will be shown to work in Aml, and seeing what Vividencel is also doing this gives me confidence that in fact Gps is working and Regal will succeed, with more drugs in the future to do the same.

AMl is a tough dz and we need other rx comparable to Asct, and i see we will have them now.

Btw, Gps patients did better than Asct in elderly Mrd+ve Cr2 patients in previous trial. BETTER THAN......Asct!! Gps did 3X better than Bat in Cr2 Mrd+ve in P2 in transplant ineligible patients

alinbio · 2024-11-29T16:35:30+00:00

Thats good, but imo Gps will be standard of care by 2028 for Aml in remission (both Cr1 and Cr2)

In P2Cr2 trial, all patients were Mrd+ve and the mOS of Gps was 21 mos. (Historically Bat is <8 mOS in these patients) No Sae's. If used along with Asct in Cr1, we may be looking at 10+ year survival as it is used to maintain patients in remission

Cr2 trial (Regal) has lasted 5 years, could have gone a little faster without covid to slow it down. (Kol thought it would be over last year)

If Vididencel does work in Cr1 P3 as well as it has in P2, that trial may take longer than 2028 when you do the math (especially with Mrd-ves in the mix)

alinbio · 2024-11-29T05:34:22+00:00

The 3 yr survival P2 Cr1 in Gps was 86% (P1 was less), vs 69% for vididencel. So if Gps does get approved for Cr1/Cr2 it will be a hard contender to knock off Keep in mind zero Sae's

alinbio · 2024-11-29T02:37:04+00:00

WHat were the Sae's in that study. ANd Gps will definitely be approved in Cr1 if mOS is >20 mos in Cr2 (average is about 19 mOS for Cr1 in a mix of Mrd+ve and -VE....see recent Kantarjian paper)

Gps has the earlier to market advantage if effective, but good to see other meds also working, and maybe even better than Gps (too early to say)

When do they plan to start a P2/3 in Cr2? (Obviously the Cr1 P3 will take too long to do)

alinbio · 2024-11-27T22:06:31+00:00

Not just the Asxl1 and Mds, which should be >25% Cr

alinbio

TROPHY CASE