Member Info for Bermudashorts

Ciaskin,

Thanks, I'm with you now!

Publication of the full application usually happens 18 months after the filing date although under certain circumstances Scancell can apply for an earlier publication (5 months from memory). So it will be a while yet.

Ciaskin,

Sorry, it's been a busy day and I'm being a bit slow - can you explain the question in your 14.13?

The SITC Annual Meeting abstracts were published yesterday - below is link to Scancell's abstract. Looking forward to seeing the full poster when it has been uploaded to Scancell's website.

https://jitc.bmj.com/content/11/Suppl_2/A1711

A new patent application from Scancell has been listed in today's UK Patents Journal:-

Title: Vaccine compositions and uses thereof

Date Lodged: 19 September 2023

We won't know any further details until the application is published.

https://www.ipo.gov.uk/p-pj?startYear=2023&startMonth=August&startDay=30th+-+7006&endYear=2023&endMonth=November&endDay=1st+-+7015&filter=scancell&perPage=10&sort=Publication+Date

Cooley are Scancell's solicitors and it's probably as simple as they have the facilities, are prepared to hire them out as part of the service and it's a convenient location.

The SCIB1 clinical trial record on clinicaltrials.gov has been updated today with the addition of 2 new study centres - Guys & St. Thomas' in London plus Southampton. Also Royal Free London has changed from not yet recruiting to recruiting. There are now 9 study centres actively recruiting with the extra 2 presumably shortly to open for recruitment. Hopefully recruitment will be fairly swift when MHRA approval is received to open the iSCIB1+ cohort .

https://classic.clinicaltrials.gov/ct2/show/NCT04079166?term=scancell&draw=2&rank=3

Also a quick update from Trinity Delta on today's results - I haven't read previous posts so apologies if already posted.

https://www.trinitydelta.org/research-notes/business-update-and-fy23-results/

Violindog,

There is no suggestion that Scancell have failed to complete their accounts in time, BDO have failed to audit them in time.

regarding the new research picked up by wtp (thanks).

this is a moditope, likely modi-2 research paper from scancell which was published yesterday in the bmj's journal for immunotherapy of cancer. it's pretty heavy stuff but the findings are potentially significant for the future development of modi-2. to help understand the paper it's worth highlighting the background of moditope at a very basic level - please feel free to ignore if it bores you to death.

the whole moditope platform is built on the generation of cytotoxic cd4 t cells to target peptides produced as a result of post translational modifications. peptides are presented to the immune system via mhc molecules on the cell surface and there are two classes of mhc. mhc class i displays peptides to cd8 t cells whereas cd4 t cells recognise those displayed on mhc class ii.

the new research reveals that scancell have now discovered that ****citrullinated peptides can be processed and displayed on mhc class i and this stimulates high avidity cd8 t cell responses to ****citrullinated peptides resulting in potent tumour killing. we already know that moditope generates cd4 t cell responses and this new research raises the prospect of a vaccine that triggers both cd4 and cd8 responses.

worth noting that scancell used the services of proteome sciences (another vulpes investee company) for this research.

will close this longer than intended post with the final paragraph of the paper:-

'this study presents the first evidence that ****citrullinated proteins in the tumor environment can be targeted by vaccination induced cd8 responses to mediate a potent antitumor effect. this may open exciting new avenues for the treatment of cancer using cd8 as well as cd4 responses targeting ptm antigens.'

https://jitc.bmj.com/content/11/10/e006966#block-system-main

The accounts are due by 31st October and I'm sure every effort is being made to meet that deadline.

Ciaskin,

Haven't had time to keep up with all of these conferences - do we know for sure that Scancell are attending ESMO and if so, have they had any abstracts accepted for presentation?

Ruck

Thanks for the explanation

Re. Your 8.31

Absolutely not unless you think Lindy Durrant and the auditors have colluded to deceive investors. A couple of points:-

1) BDO are completely independent and if the reason for the delay wasn't exactly as stated they would immediately have insisted that Scancell withdraw and correct the RNS.

2) This isn't aimed at you personally, but it's ridiculous and dangerous to draw any conclusions from an individual patient on a clinical trial. This is nothing to do with whether the news is good or bad as you'll remember I said exactly the same when Trish had the wonderful response in the monotherapy cohort.

Busicat,

I'm sure Scancell aren't considered less important than any of BDO's other clients, many of whom will be smaller than Scancell anyway. We are coming to the end of the busiest time of year for audit and BDO will be operating at full capacity. All it takes is a small delay in getting information back from Scancell or unpredicted events such as staff sickness for timescales to slip and deadlines to be missed.

I honestly think it's as simple as that and I'm bemused at the price reaction.

Whilst it's tempting to imagine all sorts of reasons for this delay, sometimes things are really as simple as they seem and you have to take what you're told at face value.

The whole point of an audit is that the auditors and the process are completely independent. BDO are old hands at this, they specialise in audit for AIM listed companies and absolutely would not risk their reputation by allowing the audit to be used as some sort of excuse to delay publication of the annual report . Nor would Scancell ever behave in such an unprofessional manner.

Scancell have told us that the reason for the delay is that the auditors require more time and have stressed that it's the standard audit. So no hidden reasons and also nothing to suggest there are any issues whatsoever with signing off as a going concern. Even though the results are likely to show less than a years cash, as I understand it the auditors simply have to know that the directors have a credible plan for ongoing funding and of course they'll have that.

So accepting the RNS for what it is, it's disappointing and must be very frustrating for Lindy.

Ee

What ongoing closed period?

EE

Are you saying that the fact that the trials are open label means dirctors can't deal or exercise any options?

Konar,

The time to objective response ranged from 2.3 to 12.5 months and the median time was was 2.78 months. Median progression free survival was 11.5 months.

Ciaskin - thanks very much for your 10.02

Bobbust -

The doublet therapy of Yervoy (Ipilimumab) plus Opdivo (Nivolumab) in advanced inoperable melanoma was approved based on results from the CheckMate 067 clinical trial. The results of that trial give some indication of the sort of response rates you might expect when patients are treated with the doublet therapy alone as standard of care treatment and therefore what SCIB1 might be bringing to the table.

CheckMate 067 was a large trial recruiting over 1000 patients who were randomised to one of 3 different arms of the trial. The ipilimumbab plus nivolumab arm consisted of 314 patients and 61 (19%) of those had a complete response to treatment , their tumours had disappeared completely ie. on imaging no trace could be found. A further 122 patients (39%) had a partial response, their tumours had shrunk by at least 30%. So a total of 58% of patients showed an objective response with tumour shrinkage ranging from 30% to 100%. On top of that a further 38 patients (12%) had stable disease. The combination produced significant improvements in survival rates and duration of response.

So to answer your question, the doublet therapy when used alone does produce responses in excess of 90% tumour shrinkage, but never as far as we know in such a high proportion of patients. The caveat is obviously that patient numbers are still very small and we don't yet have any information regarding the patient population in terms of PD-L1 status, BRAF status, extent of metastatic spread etc. However we do know that all of them have stage IV melanoma even though the trial is designed to recruit both stage III and stage IV.

Chester,

Thanks for that. I think that around 45% to 50% of patients are HLA-A2 positive and so suitable for SCIB1.

Your point about iSCIB1+ is an interesting one because they are effectively re-running stage 1 of the trial with iSCIB1+ so are looking for 9 responders from 11 patients and then presumably iSCIB1+ takes over and SCIB1 is retired. But the results published last week have set a very high bar and it's a pretty tall order to expect iSCIB1+ to better those results. Time will tell.

Looking forward to the Modi-1 results in particular at the World Vaccine Congress as so far we've only really had very high level ovarian monotherapy results. Also worth keeping an eye on ESMO which follows hot on the heels of the WVC. ESMO is basically Europe's equivalent of ASCO - it's a massive high profile scientific conference with around 30,000 attendees and would be good to see an offering from Scancell.