Member Info for JohnnyB1

Thanks Falsedawn, You are right. I got mixed up and was thinking of how Vulpes report their trades.

I see that Scancell have updated their “Share Info” page following Ichor Medical Systems exercising their option to buy 3,184,630 shares at 4.5 pence per share:-

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

With one exception the updated information appears as expected.

Redmile previously held 241,766,065 shares when this page was last updated on 22 November’22 (This agrees with their holding as detailed in Scancell’s year end accounts for 30 April’22).

Redmile’s holding appears to have dropped by 1,391,681 and is now showing as 240,374,384.

Either we will get a RNS to confirm this OR
It is an error on Scancell’s website (In my experience this page has been prone to errors in the recent past).

I have come to the conclusion (As Konar points toward in his 04.36 today) that the 67% seroconversion rate is based on data from just 3 of the trial participants.

There were 66 Participants in the Covidity trial.

22 vaccine naïve Participants had both 2 x SCOV1 and 2 x SCOV2 vaccinations.

The RNS states: “In vaccine-naïve subjects, the seroconversion rate (the level of detectable antibodies in the blood due to vaccination) was 67% following SCOV1/SCOV2 vaccination, with a broad reactivity against multiple COVID-19 variants, including the currently dominant Omicron variant. These positive results demonstrate that SCOV1 and SCOV2, delivered via PharmaJet's needle-free injection device, induce immune responses in naïve participants.”

If the level of antibodies in the blood due to vaccination is to be determined then the participants would need to remain covid free throughout the trial. If they caught covid that too could create antibodies and this would corrupt the trial data. So, data from patients who caught covid could not be used in determining the seroconversion rate for the vaccine. AIMO

The RNS also states: “three seronegative participants completed all four immunisations without becoming infected with COVID-19; two subjects had vaccine-specific T cell responses specific to RBD and/or NCAP, and two had a four-fold increase in RBD neutralising antibodies.”

“Two had a four-fold increase in RBD neutralising antibodies”. Two out of three equals 67% (rounded up). Note: I could not find a formula to calculate seroconversion rate so I do not know if it is as simple as this.

I have been listening again to the end of Lindy’s Proactive interview on 2 December’21:-

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

This is the conversation from 28 minutes in:-

“How likely is it that there will be a significant partnership announced with a Pharma company?”

“………………………………maybe it will be a deal on Covidity but maybe it will be a deal on the DNA platform because there is still not a really good DNA platform out there and ours works superbly well in melanoma. So I think there is still a very good opportunity out there, there is absolutely no reason why RNA is better than DNA. In fact DNA if we can get a good delivery, hopefully Pharmajet this needle free delivery, give a more sustained immune response, and gives better T cell responses, so ultimately might prove to be the best. We’ve thought about stopping this vaccine several times because this thing moves way too fast. But then we know we need T cells, we know we need more durable responses and we think its all still to play for in this market.”

Events since that interview certainly point to a deal on the whole DNA platform being a distinct possibility:-

Scancell did not stop the covidity trial and continued to full recruitment with safety and immunogenicity data due in Q1 2023.

RNS 15 June’22: SCIB1 to be delivered using PharmaJet Needle-free Injection System. Again this fits in with what Lindy said in the interview.

RNS 8 February’23: Ichor Medical Systems Inc. exercised their options on 3,184,630 ordinary shares at 4.5 pence a share. As stated in the 30 April’22 year end accounts “Examples of performance hurdles include progress in clinical development programs, partnering”

AIMHO

I have looked at Scancell’s year end report for 30 April’22. Ichor Medical Systems is mentioned on page 49 thereof:-

https://www.scancell.co.uk/Data/Sites/1/media/fininfo/scancell-holdings-financial-statements-to-30-april-2022.pdf

It is interesting that it gives “progress in clinical development programs” and “partnering” as examples of a performance hurdles:-

“Within the unapproved options are those granted to Ichor Medical Systems Inc. (“Ichor”) pursuant to the License and Supply Agreement (‘the Agreement’) dated 13 July 2009. Under the terms of the Agreement, Ichor agreed to supply its TriGridTM electroporation device for Scancell’s pre-clinical and forthcoming clinical studies with SCIB1 and gave Scancell an option to license TriGridTM for commercial use on achievement of certain milestones and payment of royalties. In return, Ichor was granted options to subscribe for ordinary shares in the Company. The options have been granted at 4.5p per share and the outstanding 3,184,630 share options vested on 23 April 2016 and have an expiry date of 30 April 2023”.

“All share options are equity settled. All options are subject to time vesting schedules (normally three years) to ensure retention and stretching performance hurdles to ensure that rewards are consistent with delivery of strategic goals. Examples of performance hurdles include progress in clinical development programs, partnering”.

I refer to this link on Scancell’s website (Dated 9 January 2018):-

https://www.scancell.co.uk/scancell-to-collaborate-with-biontech

This states “BioNTech’s approach is validated by five top-tier corporate partnerships with Genentech, Genmab, Eli Lilly and Company, Sanofi and Bayer Animal Health”.

It is interesting to see links between some of these companies. Genmab immediately stands out.

But I also note that Scancell’s RNS 1 February’23 states “Following his retirement from Eli Lilly in 2018, Jean-Michel has served on the board of Kymab until their acquisition by Sanofi.” (This completed in April’21)

So Jean-Michel Cosséry leaves Eli Lilly (They have a corporate partnership with BioNTech). Following this he served on the Board of Kymab until their acquisition by Sanofi (Who coincidentally also have a corporate partnership with BioNTech).

At the AGM 21 November’22, talking about Covidity Trial data, Lindy said “We were hoping to do this by the end of the year but we will probably just get into January before we report there”.

The first working day in January (Wednesday 4 January) was just 6 weeks 2 days after the AGM. Scancell’s timescales aren’t always that reliable but I would not expect such innacuracy in such a short timeframe. I suspect something has changed since the AGM.

So, what has changed since the AGM:-

The new Chairman has been appointed. If the Covidity trial results were not as good as expected, surely Scancell would have got that bad news out of the way before appointing the new Chairman?

Previously, the intention was that Covidity would be “partnered” and “developed”. In the interim results there is no mention of “partnered”. Also the word “developed” has now changed to “design”. The interims state “……………Scancell therefore used its proven cancer vaccine concept to design a vaccine against SARS-CoV-2, the virus that causes COVID-19.”

Zakari Therapeutics Ltd is being voluntarily struck off. (I think the consensus was that this company was probably to do with the mAbs. Perhaps it was to do with partnering Covidity?).

To me, it all points to change of plan. Perhaps Scancell are going to simply sell Covidity to a big pharma so that they can concentrate on oncology?.

AIMHO

The references to the Modi 1 trial in the interim results RNS dated 25 January’23 could definitely have been worded more clearly. However, based on the following it is still my interpretation that the three patients in Cohort 1 have continued on the low dose of two citrullinated vimentin peptides:-

The RNS states: “Fourteen patients enrolled and dosed in the expansion phase of the monotherapy arms in the multicentre Phase 1/2 Modi-1 clinical trial (ModiFY). First patient dosed in Cohort 3 of ModiFY in combination with a checkpoint inhibitor (CPI). There have been no safety issues to date”.
(So, a total of 15 patients dosed, 14 in the expansion phase of the monotherapy arms and 1 in Cohort 3).

As Ruck says the RNS also states: “Based on the safety data analysed from Cohort 2, post-period the ModiFY trial was expanded at this dose for Modi-1 monotherapy in three tumour types. To date, 13 ovarian, two breast and three head and neck patients, including one in Cohort 3 in combination with a CPI, have been dosed with no safety issues. Modi-1 stimulates CD4 T cells which may directly impact tumour growth. However, in some patients these T cells may need to be protected by CPIs if the tumour environment is highly immunosuppressive”.
(So, AT THIS DOSE a total of 18 patients, 13 ovarian + 2 breast + 3 head and neck. This must be the 15 in my previous paragraph plus the 3 in Cohort 2).

The RNS also states “To date, 21 patients have been immunised in the ModiFY study and a further 16 have been recruited”.
(This is the 18 refered to in the above paragraph plus the 3 in Cohort 1).

Hi Chester.

I was not aware that “we were told that Scancell were seeking approval to move the Cohort 1 patients on to the full dose of Cohort 2” so thank you for pointing that out.

ATB

I have been trying to get a perspective on the progress of the Modi 1 trial. I feel that things seem to be going pretty well (AIMHO):-

Cohort 1: Three patients in this cohort received two citrullinated vimentin peptides at a low starting dose. The interim financial results advised that one Ovarian patient in this cohort has stable disease. I interpret that these three patients have continued on that low dose of two citrullinated vimentin peptides (I cannot see anything that tells me that their dose was highered or changed in line with Cohort 2, but please correct me if I am wrong). If this is the case this strikes me as an amazing result.

Cohort 2: Three patients in this cohort received a higher dose of both the two citrullinated vimentin peptides plus a citrullinated enolase peptide. The interim financial results advised that one Ovarian patient in this cohort has stable disease and that the Head and Neck patient in this cohort has now shown a confirmed partial response with further regression of their tumour at Week 16. (Note: On Macmillan, 5 December’22 this patient said “I have a 12 week gap before the next vaccine and scan now but for today I am floating on air”. Maybe she will provide an update on this on or around 27 February’23).

Monotherapy Arms: On 31 October’22 the first patient in the expansion phase of the monotherapy arms was dosed. This first patient will reach their Week 16 between 15 to 21 February’23 (Perhaps we will have an update on the monotherapy arms after this).

I can't see a porpoise behind it, I just can't fathom it out.

Previously, as we are all aware, the intention was that Covidity would be “partnered” and “developed”.

This is no longer happening and Covidity has now been “designed” (I also note that Pharmajet has been used “successfully”).

The question I am asking myself is will Scancell sell the vaccine it has “designed” to big pharma?

The Chairman’s statement dated 28 October’22 in FULL year accounts to 30 April’22 states:-

“Given the large size of later stage trials, the Company intends to partner this programme once it has generated proof of concept data from the Phase 1 trial. The Company is also using PharmaJet® needle-free injection systems in this trial as well as in the SCOPE trial of SCIB1.”

"ImmunoBody® platform"

“………Scancell is therefore also using its proven cancer vaccine concept to DEVELOP a vaccine against SARS-CoV-2, the virus that causes COVID-19.”

Contrast this with the Chairman’s statement dated 24 January’22 in HALF year accounts to 30 October’22,
the following wording has changed:-

“As previously disclosed, given the large size of later stage trials and the competitive landscape the Company does not intend to do further trials and will focus its resources on the oncology platforms. The Company has SUCCESSFULLY used PharmaJet® needle-free injection systems in this trial.”

"ImmunoBody® platform"

“……………Scancell therefore used its proven cancer vaccine concept to DESIGN a vaccine against SARS-CoV-2, the virus that causes COVID-19.”

(I have put some of the words in block capitals for emphasis).

Not an article as such but Scancell is mentioned amongst a list of other companies:-

“Jan 25 (Reuters) - Securities analysts revised their ratings and price targets on several European companies, including………………….. Scancell Holdings Plc : Stifel raises target price to 30p from 26p”

https://kalkinemedia.com/au/business-news/business-sectors/europe-research-roundup-amplifon-spa-gn-store-nord-renault

Looking at the recent video posted by Marcus, Richard Goodfellow certainly comes across as very happy. Happy, no doubt, with Scancell’s progress to date but a bit too happy for someone who may appear to have left the company with not much more than his pension and a round of applause at the AGM.

If you look at the “share info” page on Scancell’s website you will see that, as at 22 November’22, “Scancell Holdings plc directors and related holdings” were 12,143,222 shares (1.49%). (This was after the date RG left):-

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

This figure can be reconciled to page 20 of Scancell’s accounts for the year ending 30 April’22 detailing “Directors and their interests” (Note this was before RG left):-

https://www.scancell.co.uk/Data/Sites/1/media/fininfo/scancell-holdings-financial-statements-to-30-april-2022.pdf

If you add the shares of S Adams 69,623, J Chiplin 2,000,000 and Lindy 1,796,432 (Ignore RG 258,823 because he left before 22 November’22) this totals 3,866,055.

Add 6,343,840 jointly owned by RG and the Trustees of the Scancell Employee Benefit Trust.

The same page also states “During the year, 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”. You also need to add these 1,933,327 shares.

3,866,055 plus 6,343,840 plus 1,933,327 = 12,143,222 (This agrees to the “share info” page on Scancell’s website).

Lindy was able to sell 6,840,633 of the 8,773,960 (i.e. about 77.97%) of the shares she held jointly with the Scancell Employee Benefit Trust.

I just wonder what will happen with the 6,343,840 shares jointly owned by RG and the Trustees of the Scancell Employee Benefit Trust. If RG is allowed to sell exactly the same percentage as Lindy he could sell about 4,945,985 shares.

We have established Lindy sold some of her shares to Redmile. It is worth pointing out that if RG sold 4,945,985 shares to Redmile it would take their holding over 30% (to 246,712,050 about 30.26%).

RG also had various options over a total of 7,380,000 shares (At 4.5, 8.15 and 33.2 pence). Maybe he exercised the lower priced options when he left? Maybe he can still exercise these before they expire? Who knows?

If you look at the link on my 14.24 post you will see that the previous filing was the termination of appointment of RG on 21 November'22. The striking off decision probably happened after 21 November'22; otherwise why bother to delete RG they would surely have applied to strike off Zakari on 21 November'22 (i.e. why bother with unnecessary admin?).
Like others are saying, it points a recent development?

I see that Lindy and Dr Sally Adams have have put in an application to Companies House to strike off Zakari Therapeutics Limited.

I am not overly concerned, but whatever Scancell’s original plan for Zakari Therapeutics Limited was they have clearly changed their mind.

https://find-and-update.company-information.service.gov.uk/company/13408042/filing-history

If Covidity protects against Covid 19 variants might it also protect against the common cold? :-

https://www.biorxiv.org/content/10.1101/2023.01.03.519511v1.full

“Emerging data suggest that previously acquired heterologous memory responses might explain the very broad spectrum of COVID-19 manifestations and disease severity among infected subjects, as previous “common cold” induced immunity likely conveys at least partial protection. Unexposed individuals sometimes display SARS-CoV2-specific T cell reactivity, conceivably induced by previous exposures to hCoVs that share some common epitopes”.

“Our data suggest the potential feasibility of targeting non-Spike antigens in the new generation of vaccines. In fact, it has been previously shown that certain class I-restricted NP (Nucleocapsid Protein) responses correlate with less viral replication and highly favorable outcomes”.

“Thus, previous infection and/or vaccination induces broad immunological memory capable of recognizing S1/S2 proteins from novel variants of SARS-CoV2, but at least partial loss of protection is likely against highly divergent variants such as omicron. However, exploiting and/or inducing additional M (Membrane) and NP (Nucleocapsid Protein) -directed T cell immunity might provide additional layer of protection against the emerging threats from future variants if anti-Spike cross-reactivity is diminished”.

“In summary, to our knowledge, this is the first study to comprehensively investigate the cross-reactivity of SARS-CoV2 and hCoVs against all three major immunogenic antigens of coronaviruses, namely S (Spike), M (Membrane) and NP (Nucleocapsid Protein). Our data supports the hypothesis that a broadly-specific universal anti-CoV T cell-directed vaccines and cellular therapy products are feasible as preventive or rescue immunotherapies”.

Hi Ray, Thank you for coming back to me on that. Like you say it shouldn't be too long before we hear.

Sorry, perhaps I should have said regarding my 17.34 question. Lindy makes these comments between 5 mins 40 and 6 mins 20 into the AGM presentation.

This is part of a post that I made 30 December'22. My question probably got missed amongst all the comments that day; I just wonder if anyone knows the answer please:-

Talking about Avidimab at the AGM Lindy says “Potentialy next year we are hoping to go out and try to sell that to other companies as a revenue generating deal because it could enhance a number of the antibodies on the market”. “Again the Covidity vaccine has actually used that Avidimab and validated it in the clinic and indeed we are using that now in the new SCIB1 product”.

This is something for the more scientifically minded, so please correct me if what I am saying is incorrect. I interpret “….used that Avidimab and validated it in the clinic” as Lindy effectively telling us that Avidimab has proven to have worked in the Covidity trial.