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Ee

I apologise if I should have understood that from your post but it wasn't obvious to me because SCIB1 has never been trialled in this setting - ie. in combination with PD-1 CPI in the adjuvant setting. So how can you compare at this stage?

Keytruda is approved as an adjuvant therapy in melanoma and the Moderna trial was a randomised study with Ketruda alone as the control arm versus Keytruda plus the Moderna Vax. So the 49% figure is the reduction in the risk of recurrence/death when taking the combination versus treatment with Keytruda alone.

That is the whole point of my last sentence - if the phase III study is successful it validates the combination setting for cancer vaccines.

Ee

Seriously? Think if I was about to face surgery to have melanoma removed but was told I was in the very high risk category of it returning and someone offered me a vax which halved the chances of recurrence I'd jump at it. Credit where credit is due.

Success of any cancer vaccine is great news for Scancell but as 2cvguy mentioned earlier, this is particularly important as it establishes the utility of cancer vaccines in combination with checkpoint inhibitors.

Violindog,

Sorry, missed your post. Don't worry, the Moderna clinical trial won't have any impact on recruitment to the SCIB1 trial because it's in a different setting and recruiting from a different patient population. Moderna's trial is in the adjuvant setting - patients who have had their tumours surgically removed and are vaccinated to prevent recurrence whereas Scancell's trial is recruiting patients with advanced inoperable melanoma with tumour in situ.

Chelsea

Absolutely spot on.

Thanks for that Burble. I think she's also an investigator for the Moderna mRNA vax.

Really good to see that Heather Shaw, one of the SCIB1 study investigators will be presenting a poster at ASCO in Chicago in June. The abstract title:-

A DNA plasmid melanoma cancer vaccine, SCIB1, combined with nivolumab + ipilimumab in patients with advanced unresectable melanoma: Efficacy and safety results from the open-label phase 2 SCOPE trial.

Presenter: Heather May Shaw, MD, FRCP, MRCP | Mount Vernon Cancer Center

Abstract: 9535

| Poster Bd #: 319

ASCO isn't just another scientific conference, it's the largest oncology conference in the world and it would have been disappointing if Scancell were not represented.

https://meetings.asco.org/meetings/2024-asco-annual-meeting/316/program-guide/search?q=

Ruck,

Have just read the rest of your last post. This is what Scancell actually said about the 90% figure:-

'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.'

So they're not saying that there's a 90% probability that the 85% will be repeated in the full 43, they're saying that there's a 90% probability that the trial will be successful ie. reach the 70% response rate threshold.

I think 3 patients were recruited to the SCIB1/Keytruda (pembrolizumab) arm of the trial. So could be 24 patients recruitied to the SCIB1/doublet CPI arm and 3 to the SCIB1/Keytruda which gives the total of 27. Or Violindog may well be right and it could be 27 recruited but only 24 dosed.

Looks like recruitment has slipped again. Originally it was meant to be complete by end of 2023 then it slipped to Q1 and now it's Q2.

After hours TR1 showing Tang Capital have bought just over 3% of Redx. This is the same Tang Capital that effectively scuppered Redx's RTO onto NASDAQ via the acquisition of Jounce.

https://www.londonstockexchange.com/news-article/REDX/tr-1-notification-of-major-holdings/16434979

Proactive interview with Andrew Newland highlights the work involved

https://www.youtube.com/watch?v=hxu_XmeIpDA

Johnny - thanks for that, appreciated

Moonparty,

Worth remembering that the combination arm of the Modi1 trial is only recruiting head and neck and renal cancer patients and originally intended to combine with a single checkpoint inhibitor. As at the end of January they were waiting for approval from the MHRA for a protocol amendment to change the setting of the renal cohort from 3rd line to first line and the combination from a single CPI to to the doublet therapy of Opdivo (PD-1) and Yervoy (CTLA4). Assume they are still waiting for this approval from MHRA and therefore not currently recruiting to the renal cancer cohort. So it may well be that they have only been recruiting to the head and neck cohort which means recruitment has been slower than expected. All we know is that as at July last year they had recruited and dosed 3 combination patients to the safety run in cohort 4. We don't know whether any further patients have been recruited since and if so how many.

As for the neoadjuvant study, as at the 30th January they had recruited a total of 2 patients. The first was a monotherapy patient. He/she had been dosed and resected and their tumour was undergoing analysis. A second patient had been recruited to the combination arm and was about to receive his/her first dose. I'm not sure what the interval is between dosing and surgery, perhaps someone else here can tell us, but I expect it's several weeks.

You'll note that all RNSs simply say early data from these arms will be reported in 2024 but I've listened again to the interims webcast and fortunately Lindy is a little more specific. It will be late this year - possibly Q3 but more likely Q4.

Given that they're only recruiting head & neck cancer patients at the moment, I'm pretty certain that there are no hidden reasons (positive or negative) for the lack of combination/neoadjuvant updates - they simply haven't recruited enough patients yet.

Nevertheless I hope that Scancell will at least provide a progress report on recruitment and possibly early safety data. Perhaps they will.

The Moditope patent wasn't delayed due to a discovery - the discovery of Moditope was made and as is absolutely normal in bio/pharma, the following period was spent gathering the evidence to support the patent application. We have been told that Moditope has an incredibly broad patent and it would be unthinkable for a company to hold up clinical trial updates (which only need to be very general) while they research and submit another patent application.

Ee

Modi patents were filed years ago - what possible IP related reason could there be for witholding Modi1 trial updates?

Yes you're absolutely right in that quote it most definitely refers to Moditope but in other places - SCOPE results presentation for example she uses the term for SCIB1. Perhaps she meant the ImmunoBody platform as a whole rather than SCIB1.

Ray - so what did she mean when describing SCIB1 as a potential universal vaccine?

Ee

Possibly but they also used that term for SCIB1 which of course is a melanoma only vaccine and nothing to do with citrullination so I still think Chelsea's off the shelf as opposed to personalised is the intended meaning. Quite right too to highlight the advantage of Scancell's vaccines over those generating so much interest and excitment from BioNTech/Moderna .

Chelsea, I agree - am pretty it's universal as distinct from personalised cancer vaccines.

WTP

Good spot but no, that SH01 relates to two different tranches of shares and are in addition to the 1m exercised by Richard Goodfellow. Number of share options being exercised this time - 120k @ 8.15p and 40K @ 5.25p. Total shares in issue now stands at 928979977.

You may remember that in May 2020 the senior management team took a 25% pay cut for 3 months due to Covid. At the same time they were all granted 1m share options each with a strike price of 8.15p. So John Chiplin, Cliff Holloway, Lindy Durrant, Sally Adams, Richard Goodfellow and Keith Green all have 1m options at 8.15p - could be any one of those but the small no. of shares involved makes me think that it's more likely to be other members of staff exercising options awarded as part of the Company's share incentive scheme.

Moonparty -

RG has already exercised one tranche so this is the second. I think he has approx. 600k left.