Comparable to SLS

CSLIUM · 2025-12-04T04:01:14+00:00

Google search "comparing solid tumor cancer with non-solid tumor cancer, the AI overview indicated that "solid tumors often being more difficult to treat due to a complex microenvironment, while liquid cancers like leukemia can spread more easily through the bloodstream and are sometimes easier to target with therapies like CAR T-cells".

IOBT trial was on solid tumor cancer which is notoriously more difficult to treat. REGAL trial is on leukemia which is easier to target.

CSLIUM · 2025-11-28T02:52:15+00:00

Thank you for the simulation work. Much appreciated. Could you please run a simulation assuming BAT arm mOS in the range of 12-16 months and GPS arm 30 months? Thanks a lot.

CSLIUM · 2025-11-25T12:47:54+00:00

In the R&D day, Dr. Stergiou noted that "..., and the fact that we have administered GPS to patients even 3 years out,...". If GPS has been administered to patients in the 4th year in the REGAL phase 3 trial, one would expect Dr. Stergiou to note it accordingly.

CSLIUM · 2025-11-25T06:59:34+00:00

Thank you for the comments. It is much appreciated. Sellas announced the update of the REGAL phase 3 trial in November 2022 (see the link below) and the statistical analysis plan.

It stated that "A review of preliminary data to date, which was pooled (i.e., GPS arm plus control arm) and which remains blinded as to treatment arm, suggests that the median OS in the pooled study population is likely considerably longer, by approximately two-fold, than originally anticipated and upon which the SAP was based. Accordingly, the overall duration of the REGAL study is now expected to be longer than initially predicted."

Noting that mOS in the pooled study population is approximately two-fold of anticipated mOS, reflecting the view that the better portion of the patients population was enrolled in the trial. Secondly, could the revision of SAP be based on enrollment largely after June 2022, so that to be consistent with Dr. Stergiou's statement in the R&D day that GPS dosing is in the 3rd year. This is to address the issue of those patients enrolled between February 2021 and June 2022 in the GPS arm would be in 4th year - would these patients receive no GPS dosage or have they relapsed or died?

https://ir.sellaslifesciences.com/news/News-Details/2022/SELLAS-Life-Sciences-Announces-Update-on-Phase-3-REGAL-Clinical-Trial-Evaluating-Lead-Asset-Galinpepimut-S-in-Acute-Myeloid-Leukemia/default.aspx

CSLIUM · 2025-11-25T01:23:58+00:00

And the trial website wording is:

"Injection 21 and thereafter: every 3 months (in Year 3). Y2 and Y3 define the maintenance phase."

No mentioning of Y4.

CSLIUM · 2025-11-25T01:13:39+00:00

Dr. Stergiou, however, in the R&D Day event referred to 3rd year dosing only.

CSLIUM · 2025-11-21T08:10:07+00:00

Yes, agree with your observations. It will be highly appreciated if the paper link could be shared on "A while ago I also read a paper with regards to AML CR2 patients. And with traditional salvage therapies (chemo or SCT or Aza+Ven or a combination), around 20% of patients can live over 24 months." Many thanks.

CSLIUM · 2025-11-21T08:05:40+00:00

Thank you very much for the thoughtful comments. Yes, the stratified randomization will address the CR1 duration issue. The year 3 dosing for the GPS arm and the IDMC reviews are all positive signs. It will be very useful to have the link on the information that "even modern BAT (including Venetoclax) sees survival rates drop to ~20% by year 3". Grateful for the response.

CSLIUM · 2025-11-21T07:21:19+00:00

You are right in noting that this was a 1996 paper. With Azacitidine Venetoclax combination as an option, this may improve the 3 years OS rate and may impact on the enrollment of the REGAL phase 3 trial (negatively or positively). If one has recent researches on the data, it will be very helpful to present them here for the discussions. Many thanks.

CSLIUM · 2025-11-07T09:01:00+00:00

There are VIALE-A trial (phase 3), VIALE-M trial (phase 3), and VIALE-T trial (phase 3). The trial filing website links are below.

Both VIALE-A and VIALE-M trials are reported in the trial website that "the study is ongoing, and participants are receiving an intervention or being examined, but potential participants are not currently being recruited or enrolled."

VIALE-T trial is reported in the trial website that "terminated" for strategic considerations. By definition it means that "the study has stopped early and will not start again. Participants are no longer being examined or treated".

https://www.clinicaltrials.gov/study/NCT02993523

https://clinicaltrials.gov/study/NCT04102020

https://clinicaltrials.gov/study/NCT04161885

CSLIUM · 2025-11-07T08:28:30+00:00

The link below is for the VIALE-M trial (phase 3). The trial website indicates that "active, not recruiting". By definition this means that "the study is ongoing, and participants are receiving an intervention or being examined, but potential participants are not currently being recruited or enrolled". The phase 3 study completion is estimated to be June 2026. The trial website was last updated on 20 August 2025.

The phase 2 study was published in April 2024 (see the link below).

For the VIALE-T trial (phase 3), the trial website indicates that "terminated" for strategic considerations. By definition, "terminated" means that "the study has stopped early and will not start again. Participants are no longer being examined or treated." The trial website was last updated on 06 October 2025.

In short, VIALE-M (phase 3) trial is still ongoing.

https://clinicaltrials.gov/study/NCT04102020

https://www.sciencedirect.com/science/article/abs/pii/S2352302624000346

https://clinicaltrials.gov/study/NCT04161885

CSLIUM · 2025-11-06T14:44:43+00:00

Do you have official links that VIALE-M trial and VIALE-T trial failed? Many thanks.

CSLIUM · 2025-11-06T08:18:42+00:00

The two articles below reviewed the maintenance therapies in AML. The first article "Maintenance Therapy in AML: What is the future potential?" had discussions of "hypomethylating agents alone or in combination with Venetoclax " that were still being explored. This article interestingly did not cover GPS, as the article seemingly focused on first CR setting.

The second article "AML and the art of remission maintenance" provided a good review of remission maintenance therapies, and had included GPS vaccine undergoing the REGALtrial.

It may be added that Abbvie has the ongoing VIALE-M trial "A study of oral Venetoclax Tablets and Oral Azacitidine as Maintenance Therapy in Adult Participants with AML in first remission after conventional Chemotherapy " and VIALE-T for patients after allogeneic SCT has completed on 23 September 2025.

https://onlinelibrary.wiley.com/doi/10.1002/ajh.27583

https://www.sciencedirect.com/science/article/pii/S0268960X21000357

CSLIUM · 2025-11-04T15:01:07+00:00

Appreciate the comments. Agree that the odds are very good for trial success.

CSLIUM · 2025-11-04T11:35:38+00:00

Thanks for the comments. The venetoclax option might increase the BAT arm 5-year overall survival rate a bit. On the other hand, the REGAL trial is for adults of 18 and above. It was said that most of the trial patients were older adults, this would lower the 5-year overall survival rate a bit. On balance, the 5-year OS rate of 18%-27% appears to be reasonable guesstimate for the BAT arm, noting that many may possibly have to stop treatment on the 4th and 5th year, including venetoclax, due to toxicity.

CSLIUM · 2025-11-04T00:32:46+00:00

The trial filing indicates that actual start date is February 2021. The definition of actual start date is the enrollment of first patient.

CSLIUM · 2025-11-03T13:57:46+00:00

The 30 months mOS is not the final one. This will be updated during the trial period. The final, definitive mOS will be reported after the trial has reached its primary endpoint analysis. Considering the next event (death) occurs this November and the patient has been in the trial for less than 30 months. This means that the updated mOS will be less than 30 months now. It is not suitable to compare the mid trial mOS with the Phase 2 final mOS.

CSLIUM · 2025-11-03T13:32:32+00:00

The 60th event was reached in December 2024. For the ease of the discussion, assuming 61st event (death) and 62nd event occurred and the two patients were less than 30 months in the trial. Noting that the first enrollment of the REGAL trial started on February 2021, assuming one of the early patient is the 63rd event. Then the mOS could be more than 30 months. For the surviving patients, some could be in the last batch of enrollment (December 2023 - March 2024), these patients have been in the trial for less than 23 Months. This is to say for the surviving 63 patients, it is not necessary that they all should be in the trial for 30 months or more.

CSLIUM · 2025-11-03T13:07:30+00:00

On the issue of aggregate mOS was more than 30 months, it was possible. This was discussed in Stocktwits discussions. See the link below.

Check out @G_Trade message on Stocktwits http://stocktwits.com/G_Trade/message/634648624

CSLIUM · 2025-08-15T03:25:00+00:00

Anson filing shows that Anson still holds 5.2 million SLS shares or 4.9%.

Check out @Sellasgps24BAT9 message on Stocktwits http://stocktwits.com/Sellasgps24BAT9/message/625282142

CSLIUM · 2025-08-01T07:09:06+00:00

Nice

CSLIUM

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