The latest Investing Matters Podcast episode featuring Jeremy Skillington, CEO of Poolbeg Pharma has just been released. Listen here.
Hi Ciaskin,
I agree with your maths, it would need to be 28 out of 34 to maintain the 82% level. Scancell do occasionally give out conflicting information and I sometimes find it confusing.
I notice that page 9 of the interim results presentation in January’24 fits in with what you say as it makes reference to “more than 27”, it states:-
Simon stage 1 >8/15 ORR; Simon stage 2 >27/43 ORR
https://www.scancell.co.uk/Data/Sites/1/media/fininfo/2024/scancell-interim-results-fy-2024.pdf
Bajookajr’s link states 27 of 43 patients now enrolled, so agree another 7 patients would take this to 34.
I am no expert but I interpret (on the basis that when they got 9/11 ORR in Simon stage 1 they immediately moved to Simon stage 2, rather than waiting for results on 15 patients) that if they get 28 out of 34 that would be enough and they would not require results from 43 patients. AIMO
The 90% refers to the probability of repeating existing data. Page 10 of the 2023 AGM presentation states: “Greater than 90% probability of replicating this data in the full cohort of 43 patients .”
https://www.scancell.co.uk/Data/Sites/1/media/docspres/agm-presentation-november-2023.pdf
In the 2023 AGM presentation, Lindy says:-
“Again if you like your stats and I’m not going to argue stats with you because I’m not an expert, they tell me if I get 9 out of 11 responses there’s a 90% probability that we will meet that milestone of 27 out of 34 which is really exciting”.
https://www.youtube.com/watch?v=say9mRBFzCo
This is a fuller version of what Lindy says from about 6 minutes in, talking about metastatic melanoma:-
“Metastatic melanoma until very recently, probably five years ago was a death sentence, there was no therapies doesn’t respond to chemo, nothing works in metastatic melanoma. The double checkpoints have now improved that to 50% our intention was to improve that 50% t0 70% because the clinicians told us that would be a meaningful impact for these patients, but a really tough ask, there have been many combination studies in this area that failed to achieve that but we’ve got better than 70% as you can see we smashed it at 82%. So we were supposed to see 9 patients out of 15, we actually saw those 9 responding patients and I’ll show you that data, out of 11 patients. That’s an 82% response, even more exciting there was no toxicity associated with the melanoma vaccine. The checkpoints themselves particularly one of them can be quite toxic but the addition of the vaccine had no additional there at all which again is really good in combinations. So we now move to the second stage, so the first one we had to see 9 in 15, the second stage we need top see 27 responses in 43 patients, or if we see this 82% response rate it will be 27 in 34 patients. Today as we talked to you as its changed again there it’s 21 patients that have been immunized so we’re pretty much going down that route, we only have to get 34 so hopefully proably early next yearwe will finish that but you need to bear in mind they do need to be on the study for at least 3 months to that first scan when we get that first response to see whether they’ve got an objective response. So hopefully sometime in the next half next year we should get that data and see how good it is. Again if you like your stats and I’m not going to argue stats with you because I’m not an expert, they tell me if I get 9 out of 11 responses there’s a 90% probability that we will meet that milestone of 27 out of 34 which is really exciting”.
Hi Bermuda,
Your 12.26, you ask “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.”
According to the Procedure Chart “Surgery (+ tumour assessment and a blood test to check on activity of immune cells)” is visit day 50 (Though confusingly the chart refers to week 6):-
https://modi-1-neoadj.digitrial.com/steps/7
The previous page (page 6 on the above link) tells us that initial screening can take up to 4 weeks to check that the patient is suitable for the study. It also says “You will also need to come to the clinic approximately 6 weeks after your surgery, for a final assessment.”
So once a patient is accepted onto the study it takes a total of about 92 days until final assessment (50 days plus approximately 6 weeks).
Just looking at the link to Lindy’s talk at the Immuno-Oncology Summit, Lindy makes reference to a "universal cancer vaccine". Maybe I am mistaken but I have not heard her refer to a "universal cancer vaccine" previously :-
https://www.immuno-oncologyeurope.com/cancer-vaccines#RobertMeehan
"SCIB1 a DC targeting DNA vaccine gives at impressive 85% response rate in combination with ipilimumab and nivolumab in advanced melanoma. Citrullination occurs in stressed tumor cells and makes an excellent target for a universal cancer vaccine. Modi-1 targeting citrullination is currently in phase II clinical trial."
On 19 March’24, I posted that Scancell Holdings had made a filing of a “Statement of capital following allotment of shares” at Companies House that day. It showed that 1,000,000 shares have been allotted at a price of 10 pence each:-
https://find-and-update.company-information.service.gov.uk/company/06564638/filing-history
It did not make sense because no share options for 10 pence could be found in Scancell’s accounts. I raised the question with Scancell and they have emailed the following response:-
“I apologise that your email has not been responded to earlier.
Unfortunately, there was an error on the SH01 form filed at Companies House and the allotment price shown should have been £0.045 not £0.1. An amended SH01 has been submitted to Companies House and their site will be updated in due course.
The allotment related to the exercise of share options, and I’ve attached a copy of the relevant RNS.”
This is the RNS they attached:-
https://www.lse.co.uk/rns/SCLP/block-listing-application-to-aim-i1jcwgms4055mk9.html
So, it was Richard Goodfellow exercising another 1,000,000 of his 4.5 pence options.
I agree, the language of the lady on the MM site has changed, she now says “But neither applied to me as I’d had a good partial response and no impactful side effects”. This lady on the MM site is actually the SECOND patient to be assessed in Cohort 4.
It is worth a reminder about the FIRST patient in Cohort 4. The RNS 31 July’23 states “Modi-1 treatment were well tolerated in Cohort 4 with no safety concerns. Encouragingly, the first patient to be assessed has shown a tumour regression at their first radiological assessment at 8 weeks. The remaining patients have not yet been assessed radiologically.”
In summary:-
Patient 1 Cohort 4 showed a tumour regression at their first radiological assessment at 8 weeks.
Patient 2 Cohort 4 says she has had a good partial response.
Hi Violin,
I am no expert on this. My take is that Scancell’s shares in issue have increased by 1,000,000. These have been issued at a price of 10 pence each. Someone (or more than one person) has spent £100,000 to acquire these. Maybe we will find out more in the next few days?
I will correct myself. It is definitely not Richard Goodfellow. Looking at the link again I see that these 1,000,000 shares were bought for 10 pence each.
(For example, if you look at the two Statement of capital following an allotment of shares on 15 January'24 relating to the recent capital raise these are at 11 pence).
On the other hand, the Statement of capital following an allotment of shares filed 14 November'23 was definitely RG, these shares were purchased at 4.5 pence each (500,000 x 4.5 pence = £22,500 and 260,000 x 4.5 pence = £11,700).
SO IF IT IS NOT RG THEN WHO IS IT?
I see that Scancell Holdings have made a filing at Companies House today. It shows that 1,000,000 shares have been allotted:-
https://find-and-update.company-information.service.gov.uk/company/06564638/filing-history
I suspect that Richard Goodfellow has exercised some more of his remaining share options. Perhaps he is expecting some good news soon and wants to be in a position to sell.
I suspect that the news could be something bigger than a manure delivery to his allotment :-)
I don't know if this meeting has been mentioned before. Samantha Paston, Head of Translational Research, Scancell, will be speaking at Biologics mRNA Vaccines & Oligonucleotide Therapies September 2024 in the Netherlands:-
https://oxfordglobal.com/biologics/events/mrna-vaccines-oligonucleotide-therapies-2024#:~:text=mRNA%20Vaccines%20%26%20Oligonucleotide%20Therapies%20Europe%202024&text=An%20intensive%202%2Dday%20meeting,of%20vaccines%20and%20oligonucleotide%20therapies.
Click on "Show more speakers".
"Presentations at these high-profile conferences follow the SIGNIFICANT RECENT PROGRESS that Scancell has made in both pre-clinical and clinical development" (Capitals are mine for emphasis).
Hopefully this is over and above the progress that we have already been made aware of.
Good spot BOJO. Thankfully this does not appear to have affected Scancell's share price. (I can't remember fully but I think Lindy said something along the lines of that if Ultimovacs trial results were good it could have a positive effect on Scancell).
Ray, thank you for your comments.
C11, I always preferred Thunderbirds. I will be glad when we eventually hear the words "Scancell are go" rather than "Voyage to the bottom of the sea".
Sorry about lower case, something must have been wrong with my caps lock.
Also the 2nd link did not work. If you search "mass spectrometry" on Scancell's website it takes you there.
i don’t have the medical knowledge so perhaps others might comment. i was just looking at this article on the texas biomed web site:-
https://www.txbiomed.org/news-press/news/welcome-shouxiong-huang/
dr huang would definitely be into scancell’s science:-
“i am working to identify specific metabolites that can activate unconventional t cells to fight infections,” dr. huang says. “because these cells are conserved across populations, we hypothesize that activating them could work as an alternative to combine with other immunotherapies and help fight different bugs.”
i am sure that he will at the very least poke his head around the door to see how the primates are getting on with covidity (assuming texas biomed got official approval for these studies; as at 1 october’23 they were waiting for this).
as an aside, i see he also mentions mass spectrometers. lindy mentioned mass spectrometry as recent as 26 october’23:-
https://www.scancell.co.uk/vaccination-with-post-translational-modified-****citrullinated-peptides-induces-cd8-t-cell-responses-that-mediate-antitumor-immunity
Looking at Scancell’s website they have 5 antibodies.
One of these is the one that Scancell hope to bring into the clinic themselves.
Then there is SC129, the one that they have done a deal with Genmab. The RNS 22 Oct’22 states “Genmab has been granted the exclusive right to develop and commercialise the Scancell antibody in multiple novel potential therapeutic products for any and all potential disease areas, excluding cell therapy applications.”
So Scancell were clearly happy for Genmab to have exclusivity over that antibody (excluding cell therapy applications, which I understand Genmab did not want so there was no sense in lady giving it away).
That leaves 3 other antibodies.
At the recent investor presentation, when talking about the 5 companies interested in the antibodies, Lindy said the trouble is they all want exclusivity (Or words to that effect, I can’t remember precisely).
“Exclusivity” is a bit unclear, or at least it is to me. E.g. 2 companies might be interested in one antibody, 2 companies interested in another antibody and 1 company interested the remaining antibody (other combinations are available). All 5 companies might even want exclusivity over all 3 antibodies and perhaps even any antibodies that Scancell might develop in the future?
Hi Cleaner,
I couldn't find anything about storage either but it is "off the shelf". With Moderna now looking at off the shelf (albeit mrna) let's hope the press coverage will draw attention to Scancell's off the shelf vaccine :-
https://www.shropshirestar.com/news/uk-news/2024/02/04/new-mrna-cancer-vaccine-from-moderna-trialled-in-british-patients/
This is part of what David Pinato says (This is all copied from the above link):-
He said the vaccine being tested in the trial is an “off-the-shelf vaccine” rather than one that is tailored to each individual patient.
While personalised vaccines can be very effective, they can take weeks to make and rely on a large tumour sample.
There is also not enough data at present to say whether personalised vaccines are in fact better than broader cancer vaccines, he said.
The Moderna vaccine, he added, is looking at specific traits across a number of tumours.
“It’s basically looking at what is the most frequent hit that you can target in cancer?,” he said.
“And so that has got incredible advantages in terms of the turnaround time, the fact you can make doses of the vaccines ahead of time even before meeting the patient. That is really the advantage.”
Dr David Pinato is named in Rob23460's link and Cleaner's first link. He is the Investigator of the UK arm of Moderna's mRNA-4359 "ready made" vaccine.
I thought the name was familiar. He is also Principle Investigator in Scancell's Modi-1 trial:-
Dr David Pinato, Principal Investigator at Imperial College, commented: “Advanced ovarian cancer is an aggressive cancer which is hard to treat. A disease control rate of 44% with Modi-1 in patients who have exhausted most treatment options is very encouraging”.
Lindy was asked about the Presentation at the AGM, at about 50 minutes in she says :-
“It’s postponed for 2 reasons one is we weren’t allowed to do it while we were in that post period so until the accounts were out that’s why it all got delayed and everything we couldn’t quite get it together then we were right up against the AGM so we thought it was better to do the AGM and then perhaps waited a couple of months or something before we then do another one in which we do much ..INAUDIBLE.. so in certain this was part of it basically giving you an update now as part of the AGM which is what we’ve done but we were happy to talk to bigger share? …INAUDIBLE”
https://www.youtube.com/watch?v=say9mRBFzCo
Unfortunately a couple of possibly important bits were not audible to me. I don't know if anyone can hear what she says.