Scancell Share Discussion Threads

[inanaco] 17/4/2024 15:25

what scancell has told us .......

The SCOPE trial has now successfully transitioned into the second stage, which will recruit a further 27 patients (for a total of 43). The aim is to achieve at least 18 further responses (i.e., 27 responses in total) which would statistically demonstrate that SCIB1, in combination with doublet therapy, exceeds currently achievable ORRs. Recruitment is on track with data available in H1 2024. Based upon the first 13 patients there is a greater than 90% probability that the second phase will also be successful.

H1 2024

we are in Qtr 2

[ivyspivey] 17/4/2024 15:22

Nigel agree completely.
The only thing that matters to 99% of folk invested here or elsewhere is the share price as you can’t buck the market.
You can never count your chickens Nana bit if the share price is higher here than HVO by end of June I will be a happy bunny.

[inanaco] 17/4/2024 15:09

Crumbs advised us he is using his skillset learnt from studying scancell to move into better things

what i would say those demanding more information from Scancell would appear to be far more stressed about holding than me ...

but what do i know .... Ivy holds HVO at 18 times earnings

Barclays 7 times earnings

Rolls Royce 14 times earnings

I thought it expensive ... hey the AIM market knows what its doing

for 10 years we have watched wave after wave of Val shareholders go broke

you can't beat experience

[inanaco] 17/4/2024 14:47

Nigel not really ... always stated SCIB1 was good enough alone for the investment

which is why its a no risk strategy for me ... plus i have a far more diverse portfolio than most here, after all I do live well off dividend income

having seen the share as low as 3.5p sitting here at 10p will not change my outlook

bermuda reduced his investment here on moditope news so is not exposed with Crumbs who Bought MKA

ATB

[nigelpm] 17/4/2024 13:46

Spot on Bermuda - Inanaco is guilty of having very bullish views and always looking on the positive side - that's not surprising when you have (as publicly stated) a huge amount riding on the outcome - c. £150k.

A high risk strategy that could easily go wrong.

[bermudashorts] 17/4/2024 13:35

inanaco,

It's not worth discussing this further. On several occasions Scancell has released data for SCIB1 even though it has yet to meet the 70% threshold so the argument that they need to wait for the endpoints to be met for Modi1 don't hold fire. We have seen updates for just one or two patients for both products and updates with only safety data, it doesn't have to be efficacy - anything would be nice!

However you want to explain it away, it's disappointing to me that we have heard nothing about the combination and neoadjuvant arms of the Modi1 trial. Looking at the wider picture, I'm also disappointed that this trial has been running for over 2 years now and so far has not produced the frequent updates we were told to expect.

Hopefully the news flow will improve starting with the forthcoming presentation. I hope you're right and that it does included updated monotherapy results.

[inanaco] 17/4/2024 13:04

Octupus :lindy is not talking about good t cell generated from the vaccine but "good t cell Reponses" because of the vaccine

so it is a material change hopefully prompting an RNS update if they are using current data known


"I am also looking forward to presenting early data from patients receiving Modi-1 as a monotherapy in range of hard-to-treat solid tumours, which has shown good T cell responses, safety and tolerability. Following on from AACR, there has been significant interest in the clinical development of therapeutic cancer vaccines, and I am excited to demonstrate the progress Scancell has made in this class of immunotherapies."

[octopus100] 17/4/2024 12:43

Its great that they are making presentations however unless they are presenting new data, which it isn't obvious they are - what is the point of releasing an RNS?
I guess on the plus side they wouldn't be presenting data if there were any negative developments.

[inanaco] 17/4/2024 12:34

CheckMate 214
nivolumab + ipilimumab vs. sunitinib
phase 3 550 vs. 446 Untreated, advanced or metastatic renal cell carcinoma with clear cell composition,

performance status of ≥70% PFS (median): 12.3 months vs. 12.3 months)

OS (median): 55.7 months vs. 38.4 months

ORR(median): 39.3% vs. 32.4%

[inanaco] 17/4/2024 12:22

Yes Roger one in the eye for Biontech and Moderna

[inanaco] 17/4/2024 12:21

Modi1 in Renal

7. Conclusions
Despite the clinical success of current anti-CTLA-4, anti-PD-1/PD-L1 agents, a significant number of RCC patients remain unresponsive or even develop resistance. In such a complicated tumor immune environment, blocking a single checkpoint may result in the activation of other immune modulators. Targeting novel ICIs (LAG-3, TIM-3, and TIGIT) and B7-family ligands alone or in association with first-series ICIs may be future promising approaches for RCC treatment. In addition, further preclinical or clinical studies need to assess the validity and applicability of prognostic biomarkers, which might help to personalize checkpoint combination therapy and ultimately increase the clinical response rate.

[rogerbridge] 17/4/2024 12:19

An interesting comment by Lindy "off the shelf,"

[inanaco] 17/4/2024 12:01

Bermuda

Scancell expects the initial topline data readout from this double checkpoint arm of the study in Q4 2023.

they clearly felt a read out at 15 patients gave the green light for 43 patients

indeed they even calculated probability of success at 90%

[inanaco] 17/4/2024 11:57

15 Jun 2022 07:00 scib1 doublet cohort announced

10Th of july 2023

Scancell Holdings plc (AIM: SCLP), the developer of novel immunotherapies for the treatment of cancer and infectious disease, provides an update on its two ongoing Phase 1/2 clinical trials with lead cancer vaccine assets SCIB1/iSCIB-1+ and Modi-1. Encouraging data from these open label studies provides validation for the Company's decision to concentrate its strategic focus and resources on these two assets.



"I am very encouraged by the data we have seen so far from both the SCOPE trial with SCIB1 and the ModiFY trial with Modi-1, which support the decision to sharpen our focus on these two assets" said Scancell CEO Lindy Durrant. "With SCIB1 we have a clear potential development pathway involving a registration trial which could move this product rapidly towards the market. Additionally, I am pleased to see that Modi-1 is having an effect on disease control in ovarian cancer in these very heavily pre-treated patients, although we believe the true value of our vaccine is probably in combination with checkpoint inhibitors. We remain well positioned and funded to continue the development of these high-potential assets to the next near-term value inflection points."



SCIB1/iSCIB1+



The open-label, Phase 2 single arm SCOPE trial is investigating the safety and tolerability of using SCIB1/iSCIB1+, Scancell's lead ImmunoBody® cancer vaccine, in combination with checkpoint inhibitors in patients with advanced melanoma. The current trial is designed to determine whether any clinical effect is unlikely to be due to checkpoints alone based on the rate of clinical responses in each cohort, i.e., with either a single or double checkpoint combination.



The trial is progressing well, with 73% of the required number of patients receiving SCIB1 in combination with two checkpoint inhibitors (ipilimumab and nivolumab) recruited to date. Scancell expects the initial topline data readout from this double checkpoint arm of the study in Q4 2023.

--------------------------------------------------------------------------------

proof that no patient data released prior to topline result

which is exactly what i said today

"""" designed to determine whether any clinical effect is unlikely to be due to checkpoints alone based on the rate of clinical responses in each cohort"""

[bermudashorts] 17/4/2024 11:47

inanaco

They haven't achieved that endpoint for the trial - the first 13 patients show a response rate of 85% but the endpoint won't be achieved until they get their minimum of 27 responders of 43 patients. Don't get me wrong, I think it's excellent that they are providing SCIB1 updates along the way and I had hoped for the same for Modi1. As you say, perhaps they simply haven't recruited enough patients yet but it would be nice to have some sort of progress report!

[inanaco] 17/4/2024 11:20

Nigel prior to SCIB1 data at 82% declared "nothing material happened"

[inanaco] 17/4/2024 11:14

Bermuda
yes but they had a clear target and they achieved that endpoint with less patients
with SCIB1.

They only added more patients to get to 13 as described in the first cohort from the Jan Update you may get the results on a further two taking it to 15 to complete that cohort

they have not released any data on the 43 arm

[bermudashorts] 17/4/2024 11:06

inanaco - and yet they are managing to report on the SCIB1 study which has exactly the same issue. Maybe recruitment is slower than planned but you'd hope that at least some Modi-1 combination patients would have reached their first scan and certainly some neoadjuvant ones would have. Failing that though why not just give a progress report on recruitment and safety? Hope they will.

MarkingTime - ......or perhaps we'll get a full update at ASCO, time will tell.

[nigelpm] 17/4/2024 11:04

Meanwhile the market will remain sceptical.

Quite rightly as well. The obvious conclusion from the lack of data/updates is simply that nothing material has happened.

[inanaco] 17/4/2024 10:51

its the data that comes from the resected patients which is going to drive this forward how are those T cells working in the TME and the extent of infiltration

if the cancer is resisting ... How ?

that then opens the field up with other checkpoints as well as potentially a novel checkpoint

many of these hard to treat cancers don't have checkpoint approval as they have failed or are still in trial

this is a major fact finding trial for the entire moditope platform

its my personal opinion that Yervoy added will really drive this as it acts on Regulatory CD4 T cells

in past testing of human blood with Modi1 (from ovarian patients) to get a better picture they wipe out regulatory t cells from the samples

i should not be concerned by any delay ....

after all Lindy said we have "Good T cells response"

[markingtime] 17/4/2024 10:35

Very good point, Bermuda. We were indeed told to expect regular updates - and in my mind that was likely up to three per year. We haven't had them.........Now there may yet prove to be a good reason for that (such as not wishing to undermine some commercial discussions or sitting on the data whilst some sort of new patent is filed), but we won't know until they say something. Meanwhile the market will remain sceptical.

[inanaco] 17/4/2024 10:27

bermuda

with modi1 and checkpoints without some sort of comparison to check point mono data .. the data is worthless

that requires numbers treated to the first measurably end point at least

ATB

[ruckrover] 17/4/2024 09:32

Morning Ivy,Just nodded off for a couple of years - are we minted yet?

[ivyspivey] 17/4/2024 09:24

Morning it explains the different views here so different expectations from unbridled positive to less optimistic.
What we need imo is a real update not just a rehash of what we already know