Member Info for JohnnyB1

I must admit that I view the new Covidity advert very positively. I think (and hope) that Scancell may have leap frogged into Part 2 of the study.

The RNS 29 July’21 states:-

“COVIDITY-001 Part 2 (UK & South Africa)
After demonstration of safety in Part 1 of the study in South Africa, Scancell will seek approval from the Medicines & Healthcare products Regulatory Agency (MHRA) to initiate a UK extension of the study in which COVIDITY will be given to healthy volunteers who have already received two doses of an approved vaccine. The immune responses from this part of the COVIDITY study will allow the Company to assess the ability of SCOV2 to boost the immune response against current and potential future strains of COVID-19 in pre-vaccinated individuals.”

This was 10 months ago and the landscape has changed a lot since then.

Apart from the delays, we have heard nothing negative about Covidity. Let’s suppose that the trial data has all come out good and Scancell want to move on to Part 2 of the trial.

My understanding is that the original logic for having Part 2 in the UK was due to the fact that such a large proportion of the population has already had 2 doses of an approved vaccine.

I do not have figures but suspect that a large proportion of the population of Cape Town will now have had 2 doses of an approved vaccine. (This would not have been the case 10 months ago).

It would make absolute sense for Scancell to run Part 2 in Cape Town to (dare I say it) expedite matters. They have everything in place there rather than applying to MHRA for approval and then waiting ages for first patient dosed in the UK.

It is worth pointing out that the revised Covidity advert states “The study has been reviewed and approved by SAHPRA and the University of Cape Town Human Research Ethics Committee”.

A great spot C11.

There is definitely a lot more to this than immediately meets the eye. I interpret that new participants will receive only 1 or 2 doses (As opposed to 4 doses for the original participants).

The advert states “Study Duration 2 to 3 months” (I do not completely recall what the original advert said, but I am pretty sure it was about 6 months).

The advert also states “You will receive either 1 or 2 doses of the new COVIDITY vaccine with a needle-free device”.

Compare this to the clinical trials link which states “COVIDITY consists of two doses of the plasmid DNA vaccine SCOV1 (administered on Day 1 and Day 29), followed by two doses of the plasmid DNA vaccine SCOV2 (not before Days 113 and 141 [doses 4 weeks apart]). A final end of study assessment will then be performed 6 weeks after last dose of study vaccine (Day 183 [earliest])”.

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

There is American Society of Clinical Oncology (ASCO) annual meeting 3 to 7 June 2022. Scancell have attended in the past but I do not know whether they will be attending this year:-

https://conferences.asco.org/am/attend

A link to Scancell’s previous attendance:-

https://www.scancell.co.uk/scancell-to-present-latest-scib1-data-at-asco-annual-meeting

C7 and Bermuda. On your good advice I emailed Richard Goodfellow yesterday.

Richard has just kindly emailed me back stating "I have forwarded this to our Finance Director who is currently on annual leave. He will get back to you on his return. Thanks for getting in touch."

As soon as I get a response from the Finance Director I shall share it on here.

I should have asked. Has anyone got Richard Goodfellow's email address?

C7 and Bermuda,
Thanks for the advice. I shall email Richard Goodfellow. ATB

Hi AB124,
I sent a "contact form" to Scancell on the evening of Wednesday 18 May asking for clarification on the "holdings of significant shareholders" detailed on their website. I have just checked my emails and Scancell have still not replied. Rest assured that as soon as I get a response I shall share it on this BB.

I have not contacted Scancell before; does anyone have any experience of their usual turnaround times? (I realise that the nature of an enquiry might affect the response time).

Hi Cleanerworld, I sent a "contact form" to Scancell on Wednesday evening asking for clarification on the "holdings of significant shareholders" detailed on their website. I have not contacted them before so do not know their usual turnaround times. Rest assured that as soon as I get a response I shall share it on this BB.

International Clinical Trials Day is tomorrow. I don’t want to be over optimistic, but what could be a more appropriate way to celebrate than first patient dosed?

https://www.wirralglobe.co.uk/news/20148848.research-capability-expands-clatterbridge-cancer-centre/

“Clatterbridge – which is joining research teams across the UK on Friday to celebrate International Clinical Trials Day – now has a Unit with four in-patient beds where treatment and care can be provided more efficiently and effectively, while training, education and support can be further enhanced.”

Patients have been admitted to the new Clatterbridge Unit; although we have no way of knowing what trial, significantly they are on “the same trial”!!!!!!:-

"Patient Lorraine Wilby was one of the first people to be admitted to the Unit. She said: “I was one of the first patients moved on to this ward. It is brilliant all being in the same place with the staff but also with people on the same trial. It’s a huge comfort having someone close to talk to. They are a fabulous team, I’ve so much respect for them all.”

I have just emailed Scancell to see whether they are willing to clarify this matter.

AB124
Yes, I agree to disagree (By way of compromise I'm even posting under your heading). Like you say we should hopefully find out. ATB

Thank you C7. I am busy gardening today plus my car is in a garage for brake work. I have only held shares since about March 2021 so it would be quite a digging job for me. If I get the time later I will try to find out.

AB124, thank you for your comments, I appreciate it. Your 00.25 post states “all in all I'm not sure the evidence is conclusive that Diggle holds them is correct”. Just for clarification the wording of my original post was “Conclusion: 2,380,952 shares sold to "a private individual" must have been sold to a Director of Scancell, Martin Diggle I suspect.”. So I am only suspecting Diggle.

In my view there are 2 possibilities:-
The 2,380,952 shares sold to "a private individual" must have been sold to a Director of Scancell OR
Scancell have made a gross mathematical error in their identity of significant shareholders as at 8 December 2021:-

https://www.scancell.co.uk/share-info

Looking at the facts:-

“Scancell Holdings plc Directors and related holdings” held 19,242,678 shares as at 10 August 2021. As at 8 December 2021 this figure has dropped to 14,782,997. This figure is only 4,459,681 lower (i.e. the number of shares sold to Redmile). Allowing for the 2,380,952 sold to a “private individual” this figure should have dropped by 8,773,960 (i.e. 4,459,681 in respect of Redmile plus 2,380,952, plus as Bermuda points out 1,933,327 in respect of Lindy’s remaining shares that she jointly owned with the Trustees).

It is worth noting that the Total number of shares in issue at 8 December’21 is 815,218,831 is the same figure as at 10 August’21. So the 1,933,327 jointly owned shares still exist somewhere under the heading “Scancell Holdings plc Directors and related holdings”.

We know that the complete transaction had definitely gone through over a month before 8 December 2021. Scancell published its results for year end 30 April 2021 on 29 October 2021:-

https://www.scancell.co.uk/Data/Sites/1/media/fininfo/annual-report-to-30-april-2021signed.pdf

Again I refer to page 20 thereof which states:-
“Since the year end, Professor Lindy Durrant has sold 6,840,633, joint ownership shares previously awarded to her through the Scancell Employee Benefit Trust and no longer has an interest in the 1,933,327 shares which were held jointly by the Scancell Employee Benefit Trust and Professor Durrant.”

Thanks Chester and Bermuda. Bermuda, you are right about the 1,933,327 joint ownership shares. I deliberately did not mention these as I did not want to over complicate what was already a lengthy posting. Assuming a Director did buy the 2,380,952 shares maybe they were also given 1,933,327 joint ownership shares as well?

Separately, it is some time since the last update on significant shareholders on 8 December 2021. I do occasionally look at this page in the hope of eventually getting an update that might throw light on the circa 41 million share trade near the end of December.

Firstly I draw your attention to Exhibit 1. This shows the identity of significant shareholders as at 10 August 2021:-

https://web.archive.org/web/20210918044111/https://www.scancell.co.uk/share-info

This shows that “Scancell Holdings plc Directors and related holdings” held 19,242,678 shares as at 10 August 2021.

We can match this figure to Scancell’s financial accounts for the year ending 30 April 2021 (Exhibit 2):-

https://www.scancell.co.uk/Data/Sites/1/media/fininfo/annual-report-to-30-april-2021signed.pdf

If you look at page 20 thereof and add up the number of shares owned and jointly owned by Directors as at 30 April 2021 (Ignoring C Holloway’s 100,000 shares as he resigned 28 July’21):-
69,623 + 2,000,000 + 1,796,432 + 258,823 + 8,773,960 + 6,343,840 = 19,242,678 shares. (You will note that this total agrees with that referred to in Exhibit 1).

The RNS 9 September 2021 states:- “An existing institutional investor has agreed to purchase 4,459,681 of the Shares at 20.38p pence per share and a private individual has agreed to purchase 2,380,952 shares at 21 pence per share”.

Exhibit 3: this shows the identity of significant shareholders as at 8 December 2021:-

https://www.scancell.co.uk/share-info

We have previously established that Redmile was the institutional investor who bought 4,459,681 of Lindy’s Shares. This is confirmed because as at 10 August 2021 (Exhibit 1) Redmile held 237,306,384; on 8 December 2021 (Exhibit 3) this had increased by 4,459,681 to 241,766,065.

Exhibit 1 shows that “Scancell Holdings plc Directors and related holdings” held 19,242,678 shares as at 10 August 2021. As at 8 December 2021 this figure has dropped to 14,782,997 (Exhibit 3). Surprisingly this figure is only 4,459,681 lower (i.e. the number of shares sold to Redmile). I would have expected this figure to be 6,840,633 lower (i.e. 4,459,681 in respect of Redmile plus 2,380,952 in respect of the private individual).

Conclusion: 2,380,952 shares sold to "a private individual" must have been sold to a Director of Scancell, Martin Diggle I suspect. I rest my case.

I agree with what you are saying Chester. However, I would expect that Scancell could have full data on the first 16 on or around 2 June’22.

Lindy’s Proactive video was 2 December’21 and we know that 16 patients had been recruited at that time. Lindy said (about 21mins 45 seconds into the video) that all 16 had had their first dose and some of these had had their second dose (of SCOV1). Safety and immunogenicity data should therefore be available approximately 26 weeks later, taking us to 2 June’22. This is the video link:-

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

In the meantime this study points to us being on track:-

https://www.pnas.org/doi/10.1073/pnas.2118312119

“Significantly, however, in the absence of detectable virus-neutralizing antibodies, systemic or lung-resident memory CD4 and “helped” CD8 T cells provided effective protection against the relatively antibody-resistant B1.351 (ß) variant, without lung immunopathology. Thus, induction of systemic and mucosal memory T cells directed against conserved epitopes might be an effective strategy to protect against SARS-CoV-2 variants that evade neutralizing antibodies. Mechanistic insights from this work have significant implications in the development of T cell–targeted immunomodulation or broadly protective SARS-CoV-2 vaccines.”

Maybe the Clatterbridge Cancer Centre will soon start recruiting for the Modi-1 trial (They may even have started already, the information on the Clinical Trials site was correct as at 15 April’22).

“The Clinical Trials team at Clatterbridge Cancer Centre – Liverpool now has four in-patient beds, which will allow the Trust to increase experimental medicine and world-class research for cancer patients across the region."

“Prof Christian Ottensmeier, Clatterbridge’s Director of Clinical Research, said: “The Early Phase Trials Unit is another example of how Clatterbridge is expanding its research capabilities to increase the number and complexity of our clinical trials, which are so crucial to extending our knowledge of treatments for cancer.”

“It shows the Trust’s commitment to research and innovation at our new hospital in the Knowledge Quarter of Liverpool, where we have helped to create a growing community of people committed to furthering science and medicine that will improve outcomes for people with cancer across Cheshire and Merseyside.”

https://www.clatterbridgecc.nhs.uk/news/new-clinical-trials-unit

TF, I appreciate your comments, thank you.

Bermuda,

I see that it is a general point that you are making and it is a completely valid one. Perhaps I did not word my 11.08 post as well as I could have done.

Thank you C7, Crumbs, Ruckrover and Cars for your supporting comments. Thinking about this AB124 I do accept that it is a grey area however I am certainly not “going out on a crusade to promote Scancell's Trials” as you put it. If I wanted to do that I would have emailed the Lorraine show not Janey Godley; I did not email the Lorraine show.

Bermuda, thank you for your comments; I really did not think of the ethical minefield. With hindsight perhaps I should not have sent the email. That said, if it transpires that it is of any help whatsoever to Janey I will have no regrets.

When I saw the Lorraine interview my thoughts were of empathy for another human being. I recalled that ovarian cancer was one of the 4 cancers that Modi-1 was being trialed for.

I did think for some time before sending an email. If I had life threatening cancer would I want to know all of the options available to treat that cancer? Yes I would and I would probably spend days on end researching it.

I stated in my email that I am not medically trained and I do not know if this particular treatment would help her. However, I felt that it was worth bringing it to her attention just in case it may be of any help to her. I said that I really hope that her chemotherapy is successful and that she does not even need to consider this clinical trial.