Member Info for chester18

What we can say is that the Data from the original 16 subjects convinced SHAPRA and it was good enough for them to allow those protocol changes. We can be fairly certain that the current trial in SA is now assessing Covidity as a Booster.

If this Booster Data is positive and meets the Trials objectives it will mean that gaining MRHA approval would be very straightforward. Probably brings the timeline back on track for a UK Booster Ph3 Trial after the Covid delays we have suffered.

Chester.

Hi bobbust

That's excellent to hear. There is always so much more to consider when trials include very poorly cancer patients who have already been battling with the disease for sometime.

That snippet of information is really appreciated because it answers all of our questions of why we have not had the 1st patient dosed RNS.

A Bit More Patience Required.....

Chester.

If they are trying it as you say as a Booster then the progress would be much slower because again they will only proceed after checking that there is no Toxicity. The first subject of the 18 would be dosed and then observed for a period of time before dosing a second subject.

This would explain why after 7/8 weeks we are still recruiting.

Chester.

With the agreement to expand the negotiating gap to 20%, I thought that was to prevent the need of an Independent Experts services.

The 20% target zone tells us that the original starting points of both companies were miles apart.

Chester.

In March we were told that 22 subjects had been enrolled and with the original trial split into two distinct cohort groups of 20 there were only a further 18 subjects needed, that was on the 29th March 2022.

If there are still places to fill the pace of that enrolment is down to the Lung Institute in Cape Town not Scancell PLC.

Chester.

Normally we are told months in advance when the company has agreed to present at the various BioTech Annual Conferences. Scancell's science is so very relevant to the Immuno-oncology revival that they must still be receiving invites to speak and signing up to also promote their tech.

I agree WTP that it strongly suggests 'In Talks', if they actually come to something is another matter.

Chester.

Question :

Are there any upcoming Conferences that Scancell would normally attend or take part in ?

Again I am trying to gauge if we are in a 'Radio Silent' period or just a period where there is no news to report.

Chester.

Hi AB124

Taking a very practical viewpoint, there may be nothing to share at this moment in time. We know that the 1st part of the Covidity trial will be completed early June 2022 ( the last of the 16 subjects with 2 doses inside the 26weeks trial protocol = early June).

With the ModiFY trial it is a strong possibility that we may not have found a suitable candidate even after 7 weeks. So possibly no news there either.

Set against these gloomy possibilities is the fact that Scancell have gone completely silent, as we've discussed not even a tweet, not even a little chirp....
So that does suggest there are other possibilities and its not a case of nothing to report. Pure speculation with just a hint of plausibility.....

Chester.

Why so quiet ? Scancell will have knowledge how well Covidity worked in those first 16 subjects. Could be in early Talks, maybe.

ModiFY first patient enrolment was 7th April and even if that particular person didn't make it into the Trial we can presume there are many more ready to step forward.

We are now 7 weeks into the process of trial, you would reasonably expect that this amount of time is sufficient to have selected the first potential trial participant and be ready to give the first dose. This is presuming that the selection criteria is fairly accommodating.

Again that FPD may have already taken place and some results already achieved. Could that be the reason for the silence... who knows ...

All we know is that these outcomes are so close to being RNS'ed.

Chester.

I think everyone is on the edge of their seats waiting for the fun to begin.

We've talked out all the what if's....... now it's time for news to drop, telling us what the actual realities are...... can't be long now ....

Chester.

Hi TF

Absolutely, makes me wonder exactly where the SP will be when we know the answer to everyone of those News worthy items. I honestly think we are close to one, two or even three news stories about our trial progress and hope they will each have some positive impact on our investment in Scancell.

Chester.

Hi Violindog

I am definitely on the same page of frustration, which for me, comes from trying to anticipate the timelines. This is probably not a good strategy when trying to anticipate the progress of a trial because as you will already know the best laid plans for a patient with a complicated health issues 'mounts for nowt'.

As you said we will have wait until Scancell have something to share on either SCIB1, Covidity Cohort 1, Covidity Cohort2, ModiFY, GlyMabs, AvidiMab,
Karolinska or even the BionTech TCR.

So chances of some news are pretty scarce..........

Chester.

Top Sleuthing JB1......

The important point I was making about our Twitter Output is that with the large funding came a sense that the company is being put onto a new corporate level. The offices in Oxford, right in the heart of the biotech immunology hub, the large increase in the number of highly paid scientists and the communication or engagement of internet media, especially Twitter.

To just stop cannot be that the person assigned 'the job' is just a bit busy, those instructions come from above, so it is strange to me.

Unless its simply a case of them being flat out busy replacing all the cardboard walls..... I'm going to ponder on that thought.....

Chester.

I've just noticed that Scancell have not Tweeted or Re-Tweeted on any subject since 26th April. That is a bit strange because there did seem to be a concerted effort by the company to engage more on Twitter especially Re-Tweeting all things Immunology and upcoming Events and Conferences.

Is it me trying to find some hidden meaning or could this be a deliberate action to ensure radio silence is assured.

Chester.

SCIB1 worked, and after 5 years I think 14 subjects out of 16 were still alive. Amazing result when you consider that all of those people were at the end of the line as far as treatments were concerned.

At the time Cancer Immunotherapy was unpopular due to large well reported failures, the means of delivery 'Electroploration' is not the most enjoyable way to be administered with a drug ( but it worked well ) and the device used by Scancell in the trial ( Ichors TriGrid ) had not achieved FDA approval which hampered the start of the Phase 2a part the trial for 2.1/2 years. Plus the trial was under funded due to the lack of Large Pharma interest.

The bottom line meant it was down to Scancell to prove SCIB / Immunobody worked to such a level that it could not be denighed. Why the huge hold up in the USA is anyone's guess but it halted progress for us while Checkpoint Inhibitors gain huge momentum.

We are where we are today because of the finance supplied to Scancell by Vulpes Life Science and Redmile Group.

Chester.

Hiya JB1

Thank you for pointing out that it was early December for the last of the 16 original subjects which means there is a good chance that the Covidity news will arrive in just a months time.

What will be important is the immunological responses as the dose escalation moved forward. We have not seen any toxicity issues in over 7 months so its all down to 'did the T Cells take out the Nucleocapsid Protein as well as the Spike Protein. Also is the data going to be good enough to attract a large pharma partner to help push through the 2nd phase of the trial ?

Is this the Scancell Holdings PLC chat board, where the range, depth and indeed potential of that science is discussed and pondered over, or have I clicked on the wrong page ?

Chester.

Hi Violindog

As you say 7 months has passed so I re-checked the Trail Protocol.
First subject was dosed 5th October ( announcement date ) and just before Christmas the trial was halted at 16 subjects.
The Trial was over 26 weeks so the very last of those original 16 will not complete the study until the Mid / End of June 2022. I would expect there to be a Full Data read out of those first 16 at some point in July.

The Trial didn't start recruiting again until late March and also there were the Protocol changes allowing subjects that have either, had Covid in the past or had a Covid Vaccine in the past to be included. We don't know exactly how far along that recruitment drive we currently are without a Scancell update, we can presume that it is still open and working through the required 24 subjects.

This second cohort of the Ph1. will conclude all of their 26 weeks late November / Early December 2022 with the Completed 'Covidity Trial Read Out' later in January or even February 2023.

That is the true timeline of the current Trial / Protocols but it does not mean that we definitely have to wait for any 'Materially Important News' as the trial is Open Label, which means early news is more likely.

I'm going to file Covidity News under 'Due Sometime in July'..... but hope I'm wrong........

Chester.

Hi Chelsea7 , Ruck and All

That is a very important point when considering the outcome of the soon to be ModiFY Trial. What we all desire is that our faith in Scancell and Scancell's science is rewarded and the results are incredibly positive. What is of paramount importance is the journey of those people who have signed up to be our test subjects.
After all this time waiting for 'ModiTope' to be tested we should remember that someone who is very poorly may have this trial, as C7 says, as their last chance to be given a new lease of life.

It will be an incredible platform to fight some awful cancers when its proven to work.

Chester.