Member Info for JohnnyB1

Maxparker,
Thank you very much for your comments. I appreciate it.
ATB.

When cc24601 first posted the link to the job advert for a Senior Scientist, T Cell Immunology (Nottingham) I was confused by the wording of the advert:-

https://jobs.newscientist.com/en-gb/job/1401764314/senior-scientist-t-cell-immunology-nottingham-/

“This position will support Scancell’s clinical trials using immunological assays performed in accordance with the study protocols. These assays are part of the clinical trial endpoints and will be used to assess the immunological responses to the Company’s vaccines in cancer patients or healthy donors.”

As a “Lay” person the reference to “healthy donors” confused me. I initially thought this can’t be SCIB1 or Modify, maybe this is a reference to covidity?

So I put the wording “healthy donors” into a search on Scancell’s website. You will see that all the links that matched this exact wording were links to Vaccine Publications for Moditope:-

https://www.scancell.co.uk/SearchResults.aspx?q=healthy+donors

The job advert was posted 29 August’22, 13 days after the RNS 16 August’22 for “First patient dosed in cohort 2 of the ModiFY Phase 1 clinical trial”. My interpretation is that the ModiFY trial is hopefully going to plan. AIMHO

I have just noticed that when the last update to the Covidity Clinical Trial was posted 2 June’22 they also added another outcome measure (You will find this under “Other Outcome Measures”):-

“3. Exploratory: The induction of a functional humoral immune response by COVIDITY [ Time Frame: From enrolment through end of study; approximately 6 to 26 weeks ]

c) Analysis of immune responses using intracellular staining, immune cell phenotyping by flow cytometry, cytotoxicity assays, proliferation assay, cytokine analysis, tetramer staining, and T cell receptor repertoire analysis.”

I googled “tetramer staining” and it says “This breakthrough technology enables researchers to precisely measure targeted T-cell responses in infectious diseases, cancer, and autoimmune diseases.”

Can we read anything into Scancell adding this outcome measure? I must admit this is way over my head and I don’t pretend to understand it. However it does look as though (amongst other things) they are having a really good look into T-cell responses. Perhaps they liked what they saw in the earlier (SCOV1 plus SCOV2) part of the trial and wanted to dig deeper?

This is the link to the clinical trial:-

https://clinicaltrials.gov/ct2/show/NCT05047445

Hi Ray,

Thank you for coming back to me. Sorry, I don’t agree with your numbers. I believe that there were 2 populations not 4 in the original part of the trial (each population took both SCOV1 and SCOV2. The difference being the dose amount and the device used).

If you look at the clinical trial website you will see that it lists 6 populations. The top 2 on the list are:-

“Biological: COVIDITY (SCOV1 and SCOV2) administered via needle-free intradermal"

"injectionBiological: COVIDITY (SCOV1 and SCOV2) administered via needle-free intramuscular injection”

You say “The amendment was made on June 2, so almost 3 months on perhaps we are nearing the end of recruitment”.

You are right the amendment was made June 2 but clearly there was a time lag in posting this amendment. If you look under the heading “Detailed Description” it states:-

“When the study commenced in 2021 there were significant numbers of unvaccinated individuals who also had no known exposure to SARS-CoV-2; however as the epidemiology rapidly changed with most people having either been vaccinated, or infected with SARS-CoV-2, or both, the use of SCOV2 only in these populations made rational sense, particularly as it has more mutations in common with the Omicron variant. A protocol amendment submitted in February 2022, permitted the enrolment of participants irrespective of their previous COVID-19 vaccination and/or SARS-CoV-2 infection status, amended the treatment regimen to SCOV2 only, and aligned the administered dose with the doses employed for other DNA vaccines. Immunogenicity analyses will be performed separately for the vaccine-naïve, previously vaccinated and previously infected immunogenicity analysis populations”.

The amendment was submitted February’22 and the RNS 29 March’22 confirms SAHPRA approved this protocol amendment. So we have been recruiting for the for SCOV2 only populations for 5 months now. I suspect that these patients could all be fully dosed by now and may well have had their final end of study assessments.

The RNS 29 March’22 states “To date, 22 vaccine-naïve subjects have been enrolled”. We know that 16 of the 22 will have had both doses of SCOV1 and both doses of SCOV2 by now. We also know that the other 6 were enrolled at the time of the RNS but we don't know the exact dates they were enrolled. If these 6 were enrolled and had had their first vaccinations on or before 24 February’22 they will have had their final end of study assessments by Friday 26 August’22 (i.e. Day 183). In the unlikely event that these 6 had their first vaccination on the day of the RNS they would have their final end of study assessments by 28 September’22 (Day 183)

I think we are very close to an update. AIMHO

ATB

Hi Ray,

The first part of the trial (SCOV1 and SCOV2) stated “Enrolment: 40(Anticipated)”. There were 2 populations i.e. needle-free intradermal and needle-free intramuscular. So 20 anticipated in each population.

SAHPRA agreed to the Clinical trial amendment 29 March’22; this refers to “Estimated enrolment: 80 participants”. This number never made sense to me previously because there are a total of 6 populations in the whole phase 1 trial and 80 does not divided by 6.

However, the link in your post makes it clear that these 80 consists of 4 SCOV2 only populations of 20 each.

So the net result of this is we have a phase 1 trial with a total estimated enrolment of 120 consisting of 6 populations of 20 each. This is the link to the clinical trials website:-

https://clinicaltrials.gov/ct2/show/NCT05047445

The RNS 29 March’22 states “To date, 22 vaccine-naïve subjects have been enrolled”.

We know:-

1. Enrolment will attempt to continue until at least 10 evaluable participants receive all protocol-required SCOV2 vaccinations for each immunogenicity analysis population. However, should the epidemiology be such that certain populations cannot be enrolled, the Safety Review Committee may determine that enrolment for that population be considered complete”.
2. “Eligible participants will be randomised 1:1 to be vaccinated by either IM or ID needle-free injection in blocks determined by their previous COVID-19 vaccination and SARS-CoV-2 infection status”

My conclusion is that the enrolment for the first part of the trial (i.e. SCOV1 and SCOV2) was complete at the time of the RNS. The 22 enrolled will have consisted of 11 for each of the 2 populations and was therefore sufficient.

We know that the trial protocol amendment was submitted in February’22; so I would go further and say that the 22 were probably already enrolled at the time the protocol amendment was submitted. AIMHO

I have only just found this link, I don't know if anyone has mentioned this previously:-

https://www.withpower.com/trial/phase-1-covid-19-8-2021-ac2e4

https://www.fiercepharma.com/pharma/astrazeneca-ceo-cant-be-sure-covid-shot-vaxzevrias-future-company-weighs-wider-split

I find the article a bit confusing on covid vaccines but it does say:-

“AZ is also looking for "external opportunities,” Soriot told the news service. The drugmaker is eying bolt-on deals, which could include small and mid-sized companies well-versed in the oncology and cardiovascular arenas, he added.”

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Suppose that, on reaching their final end of study assessment, each patient was asked (if they are happy) to “like” the Covidity advert. This would result in the very pattern of likes that I witnessed (one on Fridays and one on Mondays for 4 weeks followed by a large number of “likes” on the final Friday and Monday of the study).

For your information this is what I witnessed:- At 10.30 am Friday 19 August there were 60 “likes” (i.e. there had been no “likes” since Monday 15 August); at 4.25 pm that day there were 101 “likes” (as evidenced by my post on this BB at that time). That surge of 41 “likes” happened COMPLETELY independently.

I regret making my post that day; at the time I thought it was significant and would be of interest to people. With hindsight I should have just collected the data and posted this later. I did not foresee shareholders adding their “likes” which will have affected the data.

I think that some of the “likes” on Friday and yesterday were patients. Others Friday through to Yesterday may have been Lung Institute staff (celebrating the end of the trial?) as well as shareholders and who knows who else.

IF (NOTE I SAY IF) all the patients in all groups have now had their final end of study assessment, does anyone know what happens next and the likely timescales before issuing a RNS with the trial results? (I know Scancell will have been on top of it throughout collecting data from the Lung Institute, Synexa etc).

I apologise for the length of this post and if I am beginning to sound like Craig David.

You may recall that before the recent surge in “likes” I noticed a pattern emerging of one “like” on a Monday and one “like” on a Friday. I have been thinking about this and believe that this now makes sense.

I have been looking at the Clinical trial amendment agreed by SAHPRA 29 March’22. This is the link to the clinical trials website:-

https://clinicaltrials.gov/ct2/show/NCT05047445

(For ease I will refer to these patients as Group A and Group B) It states:-

(Group A): “Vaccine Naive and Previously Vaccinated participants: Two doses of SCOV2 (administered on Day 1 and Day 29) with a final end of study assessment performed 6 weeks after last dose of study vaccine (Day 71)”.

Note: Days 1, 29 and 71 will all fall on the same day of the week (i.e if Day 1 is Friday then Days 29 and 71 are also Fridays).

It goes on to state:-

(Group B): “Previously Infected participants: A single dose of SCOV2 (administered on Day 1) with a final end of study assessment performed 6 weeks after last dose of study vaccine (Day 43)”.

Note: Days 1 and 43 will fall on the same day of the week (i.e if Day 1 is Monday then Day 43 is also a Monday).

From a practical point of view (as well as an administrative one) it would make sense to keep groups A and B separate and to vaccinate one group Fridays and the other Group Mondays.

It would also make sense to start vaccination with Group A as their study duration is 28 days longer than Group B. It would again make sense to vaccinate Group A at a slow rate (say 1 patient per week) to start with (We know that under the original protocol Lindy said that patients were dosed with SCOV1 at a slow rate to start with”).

So say for example they vaccinate the first 4 patients in Group A (with their first dose of SCOV2), one per week, for the first 4 Fridays. If they are satisfied with study results on those 4 they could then vaccinate ALL the remaining patients in that Group with their first dose of SCOV2 on the fifth Friday (The first patient in Group A would also receive their second dose of SCOV 2 that same day).

The following Monday (after the fifth Friday) they could start vaccinating Group B. The first 4 patients in Group B could then be vaccinated (with their one and only dose of SCOV2), one per week, for the first 4 Mondays. They could then vaccinate ALL the remaining patients in that Group with their single dose of SCOV2 on the fifth Monday.

The end result of this is that you would get one patient from Group A and one patient from Group B reaching their final end of study assessment (on Fridays and Mondays respectively) for 4 consecutive weeks. On the following Friday and Monday ALL the other remaining patients in Group A and Group B respectively would reach their final end of study assessment.

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Sorry, should read "I think you are right about retirement age with UoN".

Bermuda,

I think that you are right about retirement. Companies House has her date of Birth as "August 1957" so she is 65 this month:-

https://find-and-update.company-information.service.gov.uk/company/03234881/officers

Hi TorquayFan,

I too read your posts with interest and respect you for coming forward with your view, so thank you for that.

Correct me if I am wrong, I don’t think that you are talking about my whole post at 15.56 (& 15.59). I think you are just talking about my comments regarding the Covidity advert.

I find Scancell a very interesting share to own, but in what can often be a news vacuum it can possibly be quite addictive googling “Scancell”, “covidity” etc. on a daily basis searching for information (When often there is none). It is in such a moment of tedium that I noticed that the Covidity advert seemed to be going through a pattern of getting a “like” on Mondays and Fridays. This culminated with the 66 “likes” it received on Friday.

After approximately 17 months of owning Scancell shares and now sitting on a loss (having bought at an average of about 20.8 pence) I found the upsurge in “likes” activity very interesting and felt it was worth sharing on this BB.

It was not my intention to hype this up and apologise if it has come across that way. I was simply trying to say that the Covidity advert has suddenly received all these “likes”; what is the explanation, maybe some good news is imminent. I guess that only time will tell.

ATB

Hi Chester,

Thank you for commenting, I appreciate it. I too will be looking at this on Monday.

ATB

Hi Jamboian,
No need to apologise, it didn't even cross my mind, I just assumed it was a typo. I'm grateful for your earlier comment and agree with it. ATB

Hi Ray,

If my theory holds I suspect that the Covidity advert will receive more “likes” on Monday. That is unless Bob Geldof and the Boomtown Rats turn up for their final assessment on Monday; they “don’t like Mondays”.

That would be very unlikely though, Bob is 70 years old and does not live in Cape Town :- )

Hi Dracula, thank you for your comments.

To be totally honest, I don’t have the knowledge to answer that question and would not want to give incorrect information. It would be a good question for one of the more medically minded posters.

That said, I know that it is Lindy’s intention to partner Covidity if it is to progress any further. I wonder if Scancell are already in discussions with potential partners. Say if Covidity results are fantastic, I think it would attract a lot of interest from Pharma companies and I certainly get the impression that covid vaccine trials with the bigger Pharma companies seem to be accelerated a lot more. AIMHO

CONTINUED FROM LAST POST:-

We know another 6 participants (3 to each of population 1 and 2) had been recruited at the time of the RNS 29 March’22. In the highly unlikely event that these 6 had their first vaccination on the day of the RNS they would be assessed by 28 September’22 (Day 183). However, we know that the clinical trial protocol amendment was submitted in February’22. I suspect (but have no way of knowing) that the 6 had already been recruited in February’22 (Otherwise, why would Scancell submit an amendment and continue to recruit to populations 1 an d 2?).

My conclusion is that if those 6 had all been recruited on or before 17 February’22 then they will have been fully assessed by yesterday (Day 183). AIMHO

I realise that my comments about the Covidity advert yesterday did not get much traction on this BB. However, I believe it is significant that yesterday morning the advert had a total of 60 “likes” (i.e. since the advert was originally posted) and finished with 126 “likes”. There must be an explanation for that. Maybe there will be a RNS next week? AIMHO

This is the link to the Clinical Trials website:-

https://clinicaltrials.gov/ct2/show/NCT05047445

On 29 March’22 there was a RNS stating “SAHPRA approves clinical trial amendment allowing testing of COVIDITY vaccine candidate in a real-world setting”

The clinical trial website update on 2 June’22 confirms this stating “A protocol amendment submitted in February 2022, permitted the enrolment of participants irrespective of their previous COVID-19 vaccination and/or SARS-CoV-2 infection status, amended the treatment regimen to SCOV2 only, and aligned the administered dose with the doses employed for other DNA vaccines”

This goes on to say “This study is expected to enrol up to 80 participants at a single centre in South Africa. Enrolment will attempt to continue until at least 10 evaluable participants receive all protocol-required SCOV2 vaccinations for each immunogenicity analysis population. However, should the epidemiology be such that certain populations cannot be enrolled, the Safety Review Committee may determine that enrolment for that population be considered complete”.

I interpret that we need at least 10 evaluable participants from the following 6 populations:-
1. Biological: COVIDITY (2 x SCOV1 and 2 x SCOV2) administered via needle-free intradermal injection (Assessment Day 183)
2. Biological: COVIDITY (2 x SCOV1 and 2 x SCOV2) administered via needle-free intramuscular injection (Assessment Day 183)
3. Biological: COVIDITY (2 x SCOV2 only) administered via needle-free intradermal injection to vaccine naive and/or previously vaccinated participants (Assessment Day 71)
4. Biological: COVIDITY (2 x SCOV2 only) administered via needle-free intramuscular injection to vaccine naive and/or previously vaccinated participants (Assessment Day 71)
5. Biological: COVIDITY (1 x SCOV2 only) administered via needle-free intradermal injection to previously infected participants (Assessment Day 43)
6. Biological: COVIDITY (1 x SCOV2 only) administered via needle-free intramuscular injection to previously infected participants (Assessment Day 43)

We are now on Day 144 since the RNS. Sufficient numbers of populations 3, 4, 5 and 6 could well have been assessed by now. AIMHO

That leaves me attempting to determine whether populations 1 and 2 could have been fully assessed yet. The original 16 participants (of populations 1 and 2 combined) will all have been fully assessed by around 2 June’22. We know the 16 will comprise 8 participants from Population 1 and 8 from population 2; the clinical trials website effectively tells us this:-
“Eligible participants will be randomised 1:1 to be vaccinated by either IM or ID needle-free injection in blocks determined by their previous COVID-19 vaccination and SARS-CoV-2 infection status”

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Thanks Violindog, Going up, now 113 "likes", I just wish there was a direct correlation with the share price.

If anyone is interested and to put this into context, this is the recent history of "likes" for the Covidity advert :-

Date : Number of “likes”

Monday 25 July: 42
Friday 29 July: 43
Friday 5 August: 44
Monday 8 August: 45
Friday 12 August: 46
Sunday 14 August: 55 (9 likes from shareholders).
Monday 15 August: 60
Friday 19 August: 101

Following my post on this BB on Saturday 13 August, the Covidity advert closed with 55 “likes” on Sunday 14 August (It is a fair assumption that the 9 additional “likes” were from SCLP’ers).

On Monday 15 August it received a further 5 “likes” (Some of these could well be from SCLP’ers, there is no way of telling).

Tuesday 16 to Thursday 18 August zero “likes”.

Today Friday 19 August 41 additional “likes”