Member Info for JohnnyB1

News blackout. There is a lady with a PhD who has written a number of articles on Covid vaccines as well as articles on women in vaccine science. She is clearly something of an authority on this; she also has 32,000 followers on twitter. One of her articles was about variant proof and all coronavirus vaccines; however the article made no mention of Scancell. I suspected that she may not have heard of Covidity, so on 30 July’22 I made a comment about Scancell on her blog together with a link to Scancell’s website. To date I have not received a reply, it simply states “Your comment is awaiting moderation, when it is approved it will be visible here”. If and when I get a response I will let people know. I feel that it is unlikely that she is ignoring my comment as she has replied to other peoples’ comments. Maybe she has contacted Scancell and been told that they will give her an interview when Phase 1 trial data is published. Who knows, this is purely speculation, but I feel that it is worth mentioning (I deliberately have not named the lady in this post).

According to the Clinicaltrials.gov the estimated study completion is December’22.

In the RNS 29 March’22 Lindy said “Additionally we anticipate this will accelerate recruitment of volunteers in our COVIDITY Phase 1 clinical trial, and look forward to announcing data later in 2022”.

The same RNS also states “To date, 22 vaccine-naïve subjects have been enrolled and the COVIDITY immunisations have been well tolerated, with no safety concerns”. These 22 were the original two “SCOV1 plus SCOV 2” cohorts and the very latest that the LAST ONE of these could have had their final end of study assessment is 28 September’22 (Day 183) (This is in the unlikely event that the last one had their first dose of SCOV1 on the same day as the RNS). These 22 will be sufficient for the first two “SCOV1 plus SCOV 2” cohorts. Clinicaltrials.gov states “Enrolment will attempt to continue until at least 10 evaluable participants receive all protocol-required SCOV2 vaccinations for each immunogenicity analysis population”. So it has to be a fact Scancell has final end of study data for these 2 cohorts.

The other 4 cohorts (SCOV2 only) with total estimated enrolment of 80 participants (20 in each cohort) :-

2 cohorts of “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)”.

2 cohorts of “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)”.

Again we know that we only need at least 10 evaluable participants from each of these 4 cohorts. Surely Scancell must also have (or be very close to having) sufficient data for these 4 cohorts?

CONTINUED ON NEXT POST

Hi Chester,

I only just saw your 10.15, but see that Bermuda has already answered your question (Just as well as I was not certain what the answer was).

ATB

Hi WeTookPelham,

Yes I agree with Chester. According to Companies House the 30 April’22 year end accounts for Scancell Holdings Plc are due by 31 October’22:-

https://find-and-update.company-information.service.gov.uk/company/06564638

Last year they came out Friday 29 October’21, which was the last working day of that month.

I see that the 30 April’22 year end accounts for Scancell Limited and Zakari Therapeutics Limited are both due by 31 January’23. I do not know the reason for this:-

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

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

Hi Bermuda,

Thank you vey much for coming back to me on that, I very much appreciate it.

I agree the trial record on clinicaltrials.gov isn't particularly clear or easy to follow. It does say:-

“The main objectives of this study are to assess the safety, tolerability, immunological activity, and preliminary efficacy of the Modi-1/Modi-1v vaccine, both as monotherapy and in combination with a checkpoint inhibitor (CPI) such as pembrolizumab or nivolumab (where these are standard of care in a non-neoadjuvant setting), in patients with advanced triple negative breast cancer (TNBC), advanced/unresectable human papillomavirus-negative squamous cell carcinoma of the head and neck (SCCHN), high grade serous ovarian carcinoma (HGSOC), or renal cell carcinoma (RCC).”

Your comments about the SOC for the different cancer types help to make more sense of the above. I hadn’t seen the Trinity Delta link previously and agree with your comments about Exhibit 7.

It is all a bit confusing.

ATB

Hi Ray,

If you follow the thread back, I mentioned that in my 00.38 on Sunday:-

"The Royal Marsden NHS Foundation Trust is one of the locations trialling Modi-1. The Clinical Trials website states “Not yet recruiting”; however this has not been updated since 18 May’22 and they may well be recruiting by now".

Hi Bermuda

I hope that you don’t mind me coming back to you with a question regarding your post on Sunday, it states:-

“Before Scancell can open the head and neck arm of the Modi-1 trial, they'll need to run 2 more safety cohorts - low followed by high dose of Modi-1 plus checkpoint inhibitor. Approval from the Safety Review Board is needed to commence the 3rd safety cohort and that will be based on their review of the data from the ongoing (2nd) safety cohort. So the Royal Marsden trial can't be Modi-1”.

What you say does of course make absolute sense. It encouraged me to have a look at Modi-1 on the clinical trial site, it states:-

“The study aims to enrol 144 (114 in non-neoadjuvant cohorts and 30 in the exploratory neoadjuvant SCCHN cohort)”.

There are 3 arms to the trial:-

2 arms for the neoadjuvant SCCHN cohort, one arm taking Modi-1 with pembrolizumab (checkpoint inhibitor) and the other arm taking Modi-1 without pembrolizumab.

This confirms what you have said and states:-

“SCCHN Neoadjuvant expansion cohort only; patients who are treatment-naïve and are scheduled to have tumour resection surgery, in whom a period of 6 weeks of neoadjuvant immunotherapy can be administered. Patients will only be enrolled once the Modi-1 expansion doses and a lack of increased anti-CCP antibodies (with, and without, concomitant pembrolizumab) has been established”.

My question is about the remaining arm of the trial i.e. the 114 non-neoadjuvant group. Referring to this group it states:-

“The main objectives of this study are to assess the safety, tolerability, immunological activity, and preliminary efficacy of the Modi-1/Modi-1v vaccine, both as monotherapy and in combination with a checkpoint inhibitor (CPI) such as pembrolizumab or nivolumab (where these are standard of care in a non-neoadjuvant setting), in patients with advanced triple negative breast cancer (TNBC), advanced/unresectable human papillomavirus-negative squamous cell carcinoma of the head and neck (SCCHN), high grade serous ovarian carcinoma (HGSOC), or renal cell carcinoma (RCC).”

I interpret that this arm also includes patients with head and neck (SCCHN), however in this case it is non-neoadjuvant. Is it possible that some patients with SCCHN in this arm are receiving Modi-1 as a monotherapy (i.e. without a CPI)? If it is then maybe there is a possibility that Modi-1 is indeed being trialled on a SCCHN patient at the Royal Marsden?

(You will gather that I have read this as a “lay person” trying to understand it all. Forgive me if my question is in any way stupid).

Hi Debs1,

I am no expert but feel that your 12.44 could well be significant. You say:-

“A friends daughter has an inoperable neck cancer, no treatments touching it at all, off to Royal Marsden Hosp. for a trial treatment and after 8 weeks the tumour has reduced by more than 33%!! I can't ask too many q's but I don't think a SCLP trial as her mum said it had only been tested on monkeys - our tests are only on lab rats - is that correct?”

I hope that your friend’s daughter will continue to make such good progress.

The Royal Marsden NHS Foundation Trust is one of the locations trialling Modi-1. The Clinical Trials website states “Not yet recruiting”; however this has not been updated since 18 May’22 and they may well be recruiting by now.

The 8 weeks timeline also seems to fit in as well (RNS 16 August’22 stating First patient dosed in cohort 2 of ModiFY).

I understand that Modi-1 was tested on mice and like you I am not aware of it being tested on monkeys. The reference to monkeys may have just been an error in the information that your friend was given.

It might be another drug. I know for example that Transgene are trialling a Head and neck cancer vaccine TG4050 at 3 sites in the UK including NHS Clatterbridge Cancer Center. However, it is not being trialled at The Royal Marsden NHS Foundation Trust:-

https://clinicaltrials.gov/ct2/show/NCT04183166?term=Transgene&cntry=GB&draw=2&rank=6

Hi Lofas,
I think that would be unlikely. Moderna’s is a MRNA vaccine. The link also states that it is personalised for individual patients (Which I suspect makes it more expensive per patient than SCIB!). AIMHO
ATB

Let’s hope that we continue to hear only positive news on SCIB as this certainly demonstrates its potential:-

https://www.cnbc.com/2022/10/12/moderna-and-merck-will-jointly-develop-a-cancer-vaccine-for-high-risk-melanoma-patients.html

New roles are being advertised:-

Scientist, T-cell immunology (Translational Research) (In Oxford)

2 x Technician, Translational Research (One in Oxford and one in Nottingham)

https://www.scancell.co.uk/careers

As Lindy said in the December’21 Proactive interview “I'm not sure if I’m supposed to say that, but lets put it that way, I’m still smiling”

I am glad to see she is still smiling in the photograph.

Take cake all :-)

Nicely followed by a 340k buy @ 14p (Showing on google):-

https://www.google.com/finance/quote/SCLP:LON?sa=X&ved=2ahUKEwjg19Wdnc7vAhVMQUEAHSVrBMkQ3ecFMAB6BAgFEBI

I see that the clinical trial website has been updated today:-

https://clinicaltrials.gov/ct2/show/NCT04079166

I see that Sheffield Teaching Hospital NHS Foundation Trust is now “Recruiting”. I haven't been able to spot any other changes.

TF Thanks for that, I appreciate it. With updates due H2 and now we are in the 4th quarter let's hope we get some positive news soon. ATB.

Maybe someone should let them know about Covidity:-

https://www.forbes.com/sites/williamhaseltine/2022/10/03/two-are-better-than-one-expanding-our-covid-19-vaccine-antigens/

“New research published in Science Translational Medicine suggests an mRNA vaccine that targets both the SARS-CoV-2 spike protein (S) as well as the nucleocapsid protein (N) may offer stronger and broader protection than current, spike-only vaccines. This research opens the possibility that one vaccine may protect against current and future variants”.

“The nucleocapsid protein is a structural protein with an integral role in viral assembly and the packaging of genetic material (Figure 1). It is 90% conservedbetween SARS-CoV-1 and SARS-CoV-2, compared to 76% for the spike protein. These two features combined make it a very promising target for vaccine design”.

“…………………...Analyses of people infected with SARS-CoV-1 have indicated that N-specific T cell immunity can be very long lasting, with some individuals retaining memory T cells up to 17 years after initial infection. These same T cells managed to recognize the SARS-CoV-2 nucleocapsid protein, mounting a quick and specific immune response.”

There is also a link to the research article:-

https://www.science.org/doi/10.1126/scitranslmed.abq1945

"The company is in active discussions with a prospective partner for potentially funding the development of a second-generation COVID-19 vaccine," Valneva said.

"These ongoing discussions may continue for several months and may not lead to an agreement," added Valneva.

https://www.reuters.com/business/healthcare-pharmaceuticals/talks-second-gen-covid-vaccine-could-fail-valneva-warns-2022-09-26/

This is interesting from Scancell’s perspective. It proves that there are potential partners out there who are willing to fund the right second generation Covid-19 vaccine. It is all down to Scancell’s Covidity coming up with the Phase 1 trial results that we are all hoping for.

The timing also coincides with today’s closing date for the 2 jobs on Scancell’s website. The one job being “Research Scientist – Antibody Discovery” whose duties appear to be Glymab related:-

https://www.scancell.co.uk/research-scientist-antibody-discovery

There was also a late "unknown" trade yesterday of 152,000 @ 13.25p at 17.06.

I suspect it is highly unlikely that the second manufacturer that Vergeire refers to is Scancell. However, this does tell me that governments do enter into non disclosure agreements for second generation Covid vaccines.

The Philippines Government is now preparing for the procurement of second-generation vaccines covering the old Covid-19 strain and Omicron variants.

https://businessmirror.com.ph/2022/09/13/govt-prepares-first-acquisition-of-2nd-gen-covid-19-vaccines/

“She added: “These vaccines, based on their studies, are targeting or can cover both the original strain of Covid-19 and Omicron variants. One manufacturer is finishing registration for approval in the United States, we are now talking with them and we are preparing the term sheet.”

“For another manufacturer, we are working on a non-disclosure agreement. If we are able to proceed with these transactions, we will be able to procure the next generation of Covid-19 vaccine by the first quarter of next year,” Vergeire said.”

No mention of Scancell but some points do stand out to me:-

https://cepi.net/news_cepi/the-race-to-future-proof-coronavirus-vaccines/

“Several of CEPI’s partners are looking towards mid-2023 to start Phase 1 human trials in healthy volunteers, though, and the hope is that mid- and final- stage trials could follow swiftly after that if results from initial human tests are promising.”

If Covidity have the kind of Phase 1 trial results we are hoping for they should not be short of potential partners to expedite this forward. I would hope that they are in discussions already. AIMHO

The article also states:-

“At the core of the scientific problem is immunogen design: how to move on from vaccines that focus solely on prominent bits of the coronavirus’ infamous ‘spike’ protein – parts we now know are frustratingly vulnerable to mutation – to find areas that are more stable and hence more likely to ensure a vaccine can protect against more than just one coronavirus and against multiple variants.

“We now know that the spike will evolve and change over time. So, to get beyond that, we need to look for conserved epitopes, (stable parts of the viral antigens that are common across several variants and several coronaviruses)” says Saville. “But usually those conserved epitopes are hidden, so a lot of the work being done at the moment is to try and expose them”

Adds Chris da Costa: “The idea is to have common structural elements of coronaviruses that are conserved across different sub-groups as they evolve over time”.

That way, even when the more exposed parts of the coronavirus’s spike pick up mutations, a vaccine would still elicit an immune response because it targets parts that remain conserved as the virus mutates.”