Member Info for KonarA

That's a very good point EE and one I had forgotten.. they don't have to actually recruit the full 43 if they hit their end points.

You are not alone in that thinking WTP. I couldn't help come to the conclusion this morning, that it was a lot of window dressing before telling us the timelines have dropped further. Lets not forget that recruitment for SCIB1 was originally planned to be completed by the end of calendar year 2023 yet we are in Q3 2024 with still 1/3rd of patients to recruit, let alone dose and assess.

At the time of the initiation of the ISCIB1 trial, I expressed concern that it could slow down recruitment to SCIB1. I just hope that we have some way of progressing ISCIB1 to Phase2/3 without the need for supporting data from SCIB1.

But, for the sake of balance.. that is a very impressive list of clinicians talking about iSCIB1, and I really hope they aim to be involved in the later trials. If you wanted to make pharma sit up and take note , then that's one way of doing it.

If they copy and pastes from another message board, the content becomes there's. And this is not the first example of this topic being raised by this poster... in fact it is a recurring theme.

"It could be 10 mill then stop or the start of a large stake with plans to acquire Scancell.

It’s not unreasonable to speculate a pharma is buying, given the patent cliffs for those in Melonoma sector with Scib so far blowing their treatments out of the water."

I see you are back on this approach again. I am still waiting for you to provide an example of a Big Pharma buying up a biotech on the open market.

I'm sure I read that scib1 covered about 1/3 of the population, and iSCIB1 100%. Reasonable to assume then, that for every one successfully recruited to SCIB1 there are 2 eligible for ISCIB1.

In terms of recruitment rates for iSCIB1, its worth remembering that a large number of people that applied for the SCIB1 trial and failed screening, are probably now eligible for iSCIB1. They may be able to fill the entire cohort with already known patients.

Still can't even trade on my platform

"Could I also get my half year worth train tickets from tfl ????"

Yes - https://tfl.gov.uk/corporate/publications-and-reports/refunds

With Diggle being on the BoD for some time, it did feel like it was only a matter of time before Redmile got their seat.

I do wonder if this is Redmile looking to progress their investment within the timeframe of their latest extension. No reason to think that we can't get both Moditope and Immunobody to a very marketable position in that time. If the SCIB1/iSCIB1 results live up to expectation then I can see a deal being done on that within the next 12 months. If nothing else, we should get a sponsor for the phase 3 trial.

A new board member - the quid pro quo for the CLN extension I guess.

I was thinking the same myself... why drill further and risk stuck pipes if it flows well above the salt. Bank the production and move on.

If you just boil it down to its basic principles...

Our hypothesis - "If our cancer vaccine shrinks tumours, we believe people with cancer will live longer" - that is the purpose of the study in its purest form.

So the first question is "Does the vaccine shrink the tumour?" - in our study, this is a primary objective and we are looking for either an objective response or complete response. As soon as we observe that in a patient, we start to try to answer the second part..

"Do people with cancer live longer after the tumour responds to the treatment" - we are now looking at secondary outcomes -

The ongoing measure of the response (does the tumour continue to shrink throughout the follow up period, does it shrink further or does it regress and grow again)

Duration of Response (how long is the tumor observed to be responding)

Progression Free Survival - (how long do does the patient live before the disease starts to progress again)

Overall Survival Rate (how many people survive and for how long)

These secondary measures are actually intended to prove that shrinking the tumor actually translates to patient benefit. There is no point spending money on a product, even if it is proven to shrink tumours, if that actually doesn't result in a benefit, and the patients continue to die.

So in that context, it makes absolutely ZERO common sense, and would fundamentally run contrary to the purpose of the study, if the investigators said "if a patient does regress within the two years, we are going to pretend it never happened in the first place and ignore them from our data".

How are those slides relevant to the trial design/outcomes?

Of course recist needs to be able to define when a patient is considered relapsed. Its important for when measuring duration of response - in the case of the scope trial this is a secondary outcome:

"Duration of response, measured from the point of first response (complete response or partial response) to the date of disease progression (per RECIST 1.1) or death due to any cause.

The duration of response will be assessed in the context of overall survival.

But the fact that a patient may relapse, doesn't mean a ORR wasn't achieved. It doesn't even make clinical sense to ignore/invalidate the initial ORR - especially if it translates to improved OS.

My gut feel.. FWIW, is that we are close enough to the full results now, that Scancell will be holding back for the full reveal when they have all the results in. Releasing more data at this stage just dilutes the impact. I think they are going headline grabbing in Q4.

Seems we held an "Investigator Day" recently and we now have a Clinical Advisory Board for SCOPE..

"Our newly appointed SCOPE clinical advisory board are encouraged by the exceptional results from the ongoing SCOPE trial."

That's a pretty epic mistake to make!

Not only is it 50% less revenue generated from the sale of the shares, but a number of people inferred from the exercise of the option that Scancell weren't in a close period. I could well imagine a number of sells went through on that basis - if I remember correctly the price dropped that day.

BTW the numbers in that may not be accurate, Scancell initially said a 13 plus an additional 27... but in the January update they said the target recruitment was 43. I can't remember if these numbers were clarified at the time.

Would it be ethical for the trial to continue to recruit people to Scib1 group, once iscib1 was available?

Well neither treatment has been proven to work, so the ethics of it would be debatable, but from a very practicle purpose it would be difficult to convince a patient to take the (arguably) lesser treatment of scib1 once iscib1 was approved and available.

So do you think the first iscib1 patient suggests the scib1 cohort has completed recruiting?

I do, but more than that I think it suggests Scancell have hit their targetted end points for Scib1, but thats just a gut feel. They could of course have started the iscib1 cohort and just be treating those patients who are ineligible for scib1 (HLA dependent). But if I was in charge of the trial, I would not want to fill that cohort of patients with the unknown variable (HLA negative patients), as I would also want to prove that iscib1 works in HLA patients as well (if not better) than scib1.

So if the trial of scib1 and iscib1 has progressed much further than the data in the abstract, why hasn't Scancell updated the market further?

AACR have a rule that says once the abstract is approved for presentation, then no further data from the trial can be released until after the abstract has been presented. This is to ensure that all the latest data is unveiled at AACR. Why do they do this - they want to maintain their position of prestige I guess.

So in terms of latest position we shouldn't read too much into the abstract?

We really shouldn't. The data is old.

So should we expect an update from Scancell at AACR or through RNS?

I believe that Scancell will have lots of data up their sleeve, and if it is good they will be deperate to present it at AACR. Particularly since they are presenting directly alongside the higher profile MRNA vaccines. What better way to grab the headlines than outshining MRNA? Keep in mind that AACR rules prevents them from publicising any data before the event, I believe there is a very good chance that Scancell will release data in the session and in an RNS monday.

So an RNS is practically guaranteed?

Conferences have come and gone where we expected an RNS, and never received one, so no guarantees. But if I was pushed for a guess, I would say an RNS Monday saying Scib1 has completed recruitment.

The following is my understanding of what we can read into or infer from the abstract. This is just my understanding - as usual I am happy to be corrected and to hear alternative views. I wrote this, this morning but wasn't able to post at the time, and the board has moved on a bit since then, but I will post it anyway. So in the form of a question and answer...

The abstract doesn't contain much new data, why?

The deadline for the abstract submission was January 6th. The last Scancell patient update was 27th November. At the time of the last Scancell update, 13 patients were dosed with 11 showing an objective response. The abstract submitted at the beginning of January to AACR is based on those same 13 patients.

But the abstract mentions 19 patients dosed. Why the difference?

Between the end of November and the beginning of January, another 6 patients had been recruited onto the trial and started treatment, but not yet reached imaging to be include in the observed results.

So if the data was from the beginning of January, are we not further on by now?

Yes, it is very reasonable to assume that we have recruited and treated much more patients between January and now. Many more patients will have reached the imaging stage and every observed response reduces the P value (the statistical likelihood that the responses are just luck and not down to the treatment).

Is there anything else to make you think we are further along than the 13 or 19 patients mentioned?

The aim of the first stage of the trial was to get 27 out of 40 patients to respond to the treatment (scib1). At the last update they had 11 out of 13. This means they needed 16 more patients out of the 27 to be recruited to show a response. Once Scancell achieved 27 responders, they would stop recruiting for for this stage (having achieved the target). if everybody that was recruited after the 13 all responded, the minimum we would need to recruit in total would be 16 (27-11). If we maintained an 85% objective response rate we would have needed to recruit roughly 19 more (19*0.85) to give 16 responders out of 19 treated. The 16 new responders along with the 11 that already responded would give us our target of 27 and recruitment to scib1 group could be stopped. We then have iScib1, which with the addition of Avidimab, is expected to be a more effective treatment than scib1. We treated our first iscib1 patient on the 26th March.

Interestingly, any data produced by the study after the submission of the abstract, is also under embargo until the start of the session in which the paper is presented. So Scancell couldn't update us on the Scope trial, even if they wanted to, without risking having the abstract pulled.