Member Info for JohnnyB1

Janey Godley was on the Lorraine show this morning talking about her ovarian cancer. This is the link:-

https://www.youtube.com/watch?v=BsbJ9vLTjhg

I have just sent Janey a very sensitively worded email advising her about the Modi-1 clinical trial.

I told her that the trial will be at a number of locations including Edinburgh Cancer Centre (NHS Lothian) where they are currently enrolling patients (Janey is speaking from Glasgow in the Lorraine interview).

I sent Janey my very best wishes and said that I hope her chemotherapy is successful and that she will not even need to consider this clinical trial.

“While not wanting to be a "voice of doom and gloom", the risk of a more virulent variant emerging is "way above 5%", the Microsoft co-founder and philanthropist told the Financial Times.

"We're still at risk of this pandemic generating a variant that would be even more transmissive and even more fatal," he said, adding that longer-lasting vaccines which block infection are urgently required.”

https://news.sky.com/story/covid-19-bill-gates-warns-of-an-even-more-transmissive-and-more-fatal-coronavirus-variant-12603539

Cue Covidity, I think.

That is an interesting article. It would be quite a game changer if Covidity could also help people with long covid:-

“Scientists also don’t yet know what level of T cells are required to protect against COVID-19. But Crotty suspects a T-cell vaccine may help people who harbor almost undetectable levels of SARS-CoV-2 for weeks to years, which some researchers believe is one cause of the host of lingering symptoms collectively known as long COVID.

After all, the job of certain T cells is to kill off infected cells. “So if you did have a vaccine that was doing that better,” Crotty speculates, “it may have an added benefit in reducing some aspects of long COVID.”

I refer to the “Change of Registered Holder of Shares” RNS dated 12 April 2022 and point 11 “Additional Information”.

On a closer look at the RNS I see that Vulpes have moved their complete holding of Scancell shares from Barclays Capital Securities to Bank of New York Mellon ("Tri-party agent"). I have found a separate link that explains this:-

https://www.bnymellon.com/content/dam/bnymellon/documents/pdf/articles/triparty-repo-brochure.pdf.coredownload.pdf

I am not familiar with this American arrangement; I have read it a few times but I still do not really understand it. (Initially I interpreted it that Vulpes would use their Scancell shares as collateral for it’s short term borrowing requirements).

I was wondering whether anyone else has any take on this? Perhaps more significant, why the move to an American institution?

Point 11 of the RNS states the following:-

“To give you some background of the transaction here, Barclays Capital Securities Ltd ("BCSL"), a subsidiary wholly owned by Barclays Bank Plc ("BBPlc") has crossed the threshold of 10% of the Outstanding ISC (Issued Share Cap) of the issuer in the usual framework of Business activity. BCSL holds these positions due to buy transactions carried out by a client who themselves happen to be in the "Prime Brokerage" business. These shares were then re-hypothecated from the client within BCSL and pledged with Bank of New York Mellon ("Tri-party agent") for onward financing. BCSL is able to recall these shares at any time. Following our discussions held with business managers and compliance team , in this instance the Prime Brokerage client of BCSL is itself a financing intermediary, providing Prime Brokerage services to their underlying clients, and using BCSL as one of their service providers. As such, BCSL does not have any visibility over the ultimate economic owner/s of the shares being re-hypothecated from its client. Therefore, though we are not in a position to confirm the intent or otherwise of our client to continue accruing positions in this Issuer, Barclays has the right to choose to not finance any further additional positions. Given the magnitude of the position, once it had been identified, the BCSL Prime Brokerage team contacted the client to request that they onward transfer the full position into a custody account away from Barclays. As the client's operations are primarily based in Singapore, the time difference meant this onward trade was only input subsequent to BCSL needing to satisfy its disclosure requirement. Following this transfer having now been booked, BCSL's position in this security is back to Zero(as of March 30th ) and we will be making an updated disclosure to this effect shortly.”

What surprised me about the Modi-1 trial is the scale of it. “The first wave of clinical sites is now open for recruitment and in due course the Company expects up to 20 sites to be open and recruiting patients”.

I do not have any idea of what the trial costs are likely to be but I should imagine it will be very expensive. Looking at the Governments 10 year Cancer Plan makes me wonder whether Scancell may have been granted Government funding for this:-

https://www.gov.uk/government/consultations/10-year-cancer-plan-call-for-evidence/10-year-cancer-plan-call-for-evidence

“Alongside improvements in traditional treatment routes, novel treatments such as cancer immunotherapy (also known as immuno-oncology therapy) have emerged. This development has been fuelled by an increased understanding and characterisation of the immune system’s role in cancer. Immuno-oncology is showing significant promise. It involves the development of innovative and targeted therapies to activate the body’s immune system against tumour cells. The Life Sciences Vision sets out our ambition to grow the UK’s global leadership in this area and begin to explore the potential for cancer vaccines by combining our deep expertise in immuno-oncology with the advanced vaccine capabilities developed through the pandemic. Utilising existing infrastructure and successes, we will support industry to commercialise new cancer treatments.”

This is the link to the Life Sciences Vision:-

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1013597/life-sciences-vision-2021.pdf

“Government has recently made a series of significant interventions to improve the availability of capital. It is providing £200m in funding through the Life Sciences Investment Programme. In addition, through the UK-UAE Sovereign Investment Partnership, Mubadala has made an £800m commitment to investment in the UK Life Science sector. On top of this £1bn, work is underway to support greater investment into the Life Sciences by Institutional Investors and Pension Funds.”

“Clinical research is fundamental to healthcare innovation. It is the single most important way we turn cutting-edge science into more effective diagnosis, treatment and prevention – which improves care quality and patient outcomes, bolsters the efficiency of health service delivery and improves NHS staff retention and wellbeing. It is a precondition of the success of this Life Sciences Vision that the Sector continues to support and invest in the UK’s clinical research infrastructure and that the vision for the Future of UK Clinical Research Delivery is delivered in full, as part of the overarching ambition for 2.4% of GDP to be spent on R&D by 2027.”

Either the RNS is wrong and they have mistakenly used out of date figures or Vulpes have sold 250,000 shares in the last couple of days (In which case we will soon get a Director Dealing RNS).

Today’s RNS states “Vulpes Life Science Fund, a Substantial Shareholder in the Company with 117,479,029 ordinary shares representing approximately 14.41% of the issued share capital of the Company”.

This does not tally with the Director Dealing RNS on 3 March’22 that states “Vulpes Life Science Fund, a person closely associated with Martin Diggle, Non-Executive Director of the Company, has purchased 250,000 ordinary shares of 0.1 pence each ("Ordinary Shares") in the Company on 2 March 2022 at a price of 12 pence per share. Following the purchase, Vulpes Life Science Fund holds 117,729,029 Ordinary Shares representing 14.4% of the Company's issued share captial.”

I feel that WTP’s comment about the 100 share sells across the last few days is totally valid. While I don’t pretend to understand what market makers get up to, I can only detail the facts (All details taken from this website).

During the last 3 trading days there has been a total of 99 trades in Scancell shares. The top 5 most traded volumes of shares during this period were as follows:-

7 transactions @ 100 shares (all sales)
5 transactions @ 10,000 shares (2 sales, 2 buys & 1 “unknown”)
5 transactions @ 50,000 shares (all sales)
3 transactions @ 20,000 shares (all sales)
3 transactions @ 25,000 shares (all sales)

The volume of 100 share sales seems to be:-
i) Against the laws of average.
ii) Illogical. Who in their right mind trades 100 shares for circa £10 a time (plus commission)? I think we can rule out dividend re-investment LOL.

My thoughts are clearly something is afoot, someone has an agenda and wants the share price to drop.

I see that CEPI have again tweeted the article that mentions Scancell:-

https://twitter.com/CEPIvaccines/status/1510516199377063941?ref_src=twsrc%5Egoogle%7Ctwcamp%5Eserp%7Ctwgr%5Etweet

They tend to do this every now and again, probably just to tease us.

Beroni Group Announces Appointment of Dr. John Chiplin to Board of Directors:-

https://www.globenewswire.com/news-release/2022/03/31/2413855/0/en/Beroni-Group-Announces-Appointment-of-Dr-John-Chiplin-to-Board-of-Directors.html

Just a reminder.

Professor Christian Ottensmeier (the principal investigator for Modi-1 trial) is the speaker:-

“Targeting T regulatory cells to improve cancer and immunotherapy – man to mouse (and back).”

https://www.imperial.ac.uk/events/146950/targeting-t-regulatory-cells-to-improve-cancer-and-immunotherapy-man-to-mouse-and-back/

The fact that Scancell are happy to widen the selection criteria implies to me that they must be completely happy and confident with the outcome measures on the 22 patients to date.

Thursday 31 March is 26 weeks since the first patient was enrolled on 30 September’21. Scancell could well have all the safety, tolerability and immunogenicity data for this patient (data for some of the other original 15 should not be too far behind).

It might help to expedite matters if Scancell just get around to updating the damn advert:-

https://lunginstitute.co.za/2021/11/25/covidity-research-participants-needed/

(That said, maybe they have a list of previous applicants that were not suitable under the original criteria but are now suitable under the revised criteria).

Thursday 31 March’22, Imperial College London.

I see that Professor Christian Ottensmeier (the principal investigator for Modi-1 trial) is the speaker:-

“Targeting T regulatory cells to improve cancer and immunotherapy – man to mouse (and back).”

https://www.imperial.ac.uk/events/146950/targeting-t-regulatory-cells-to-improve-cancer-and-immunotherapy-man-to-mouse-and-back/

I hope that you get well soon Burble.

I have just read a very interesting article on T-Cell responses to Covid 19. Covidity definitely appears to be on the right path:-

https://www.science.org/doi/10.1126/sciimmunol.abo1303

“Mounting evidence suggests T-cell contributions to the host immune response are required for early, broad, and durable protection from SARS-CoV-2, especially in the setting of new variants of concern (VOC).”

“The durability of the T-cell response is still under investigation; however, robust SARS-CoV-2-specific CD4+ and CD8+ T cell responses have been observed up to one year post infection and at least six months post vaccination (6, 20, 21). Also, as previously shown, memory T cells to SARS-CoV-1 have been detected 17 years after exposure, suggesting that T cells may provide durable protection against severe COVID-19 disease.”

“As viral variants continue to evade host immune defenses, a second generation of vaccines or novel, tailored boosters may be necessary to enhance immunity to future SARS-CoV-2 VOC. The rapid rise in the prevalence of the heavily spike-protein-mutated Omicron variant in South Africa and across the globe, and the Delta subvariant AY.4.2 in the UK (48), serve as an important reminder that variants will continue to emerge, resulting in decreased efficacy of the humoral response generated by previous infection with ancestral strains or vaccination. Furthermore, SARS-CoV-2 spike protein is capable of inducing host cell fusion, allowing cell-to-cell viral transmission that is refractory to antibody neutralization (49). These findings underscore the importance of cellular immunity and T-cell recognition of viral variant epitopes and the cytotoxic clearance of virally infected cells. A thorough understanding of the T-cell response is needed to design the next generation of vaccines that target a broad spectrum of SARS- CoV-2 antigens recognized by T cells.”

The wording of the jobs advert is encouraging:-

“Scancell is currently conducting a Phase 2 trial of its ImmunoBody® vaccine in melanoma patients, a Phase 1 trial of a COVID-19 vaccine and is also progressing to a first-in-human study of its Moditope® vaccine in patients with advanced solid tumours”.

I really hope that Scancell are now “progressing” in respect of the Modi-1 trial.

Thank you WeTookPelham, I agree the website does look a lot tidier and easier to follow.

I was not aware of wayback machine/ web archive; it is a useful thing to look at.

Unfortunately having looked at it I realise that I was wrong, the wording of the bit I highlighted is the same as it was previously (Sorry, it was my mistake):-

https://web.archive.org/web/20211226013325/https://www.scancell.co.uk/modi-1

I do not recall what the wording on Scancell’s website was previously but the Modi-1 page on the updated website now states:-

“The first-in-human clinical study of Modi-1 is designed to explore the safety, immunological activity and preliminary efficacy of the vaccine in patients with solid tumours, including those with advanced head and neck, ovarian, triple-negative breast and renal carcinomas.”

(Compare this wording with The Modi-1 Clinical trial application approved RNS dated 26 August’21, this states:-“The Modi-1 clinical trial WILL BE a first-in-human clinical trial in patients with triple negative breast cancer, ovarian cancer, head and neck cancer, and renal cancer.”)

Perhaps I am misinterpreting or maybe I am being over optimistic but to me this reads present tense as though the trial is starting.

This wording is similar to the wording about Covidity on the website:-

“The first in human (FIH) study is designed to explore the safety, tolerability, and immunogenicity of COVIDITY in healthy adults when administered by needle-free injection”.

RNS tomorrow? Lets hope so AIMHO (either that or egg on my face).

Scancell posted three Scientific Papers on their website on 14 February’22:-

https://www.scancell.co.uk/scientific-papers-posters

Two of these Scientific Papers relate to Avidimab and todays RNS makes reference to both of these:-

1. Targeting Glycans and Heavily Glycosylated Proteins for Tumor Imaging.

2. An Immunohistochemical Evaluation of Tumor-Associated Glycans and Mucins as Targets for Molecular Imaging of Pancreatic Ductal Adenocarcinoma.

The third Scientific Paper relates to Moditope:-

PAD-2-mediated citrullination of nucleophosmin provides an effective target for tumor immunotherapy

Perhaps it is purely coincidence or maybe we are about to get some kind of update on Moditope. We can only hope.

By my calculations the full outcome measures of safety, tolerability and immunogenicity for the first patient enrolled should be available on or around 31 March’22. (The time frame is from enrolment through to end of study, approximately 26 weeks).

The first patient was enrolled into the Covidity trial on 30 September’21 and should have had their second dose of SCOV2 on 28 February’22.

For information this is the link to the trial (I had not realised previously but if you click on “Actual Study start date” this is the date on which the first participant was enrolled):-

https://clinicaltrials.gov/ct2/show/NCT05047445?term=covidity&draw=2&rank=1

I see Scancell have tweeted the same article.

Thank you for that Bermuda and Cleaner.

I see that Synexa Life Sciences have offices in Cape Town and Leiden, The Netherlands.