Member Info for JohnnyB1

A company called Synexa is named on page 30 (Covidity – Clinical Timeline 2021) of the Scancell AGM presentation:-

https://www.scancell.co.uk/Data/Sites/1/media/docspres/scancell-2021-agm_all_final_corrected.pdf

If you look at the following link to Elizabrth Ross (Head of Client Services at Synexa Life Sciences) on Linked-in there is an article “Synexa is excited to be working with Scancell in the recently initiated Covidity clinical trial of their Covid vaccine. We will be applying our……………………….”.

https://za.linkedin.com/in/elizabeth-ross-2648b068

Unfortunately I cannot open the link as I am not on Linked-in (and I cannot find this article anywhere else).

I was wondering if anybody was able to open the link and copy and paste it? It would be interesting to see what it says. Thank you.

https://theguideliverpool.com/5-3-million-funding-boost-for-liverpool-to-explore-treatments-for-some-of-the-regions-most-common-diseases/

Dr Liz Bishop, Chief Executive of The Clatterbridge Cancer Centre NHS Foundation Trust, said: “We are absolutely delighted to receive this funding award as part of the NIHR Liverpool CRF bid. We now look forward to offering increased opportunities for our patients to take part in early phase clinical trial research to improve cancer outcomes across our region.

“The opening of our flagship cancer hospital in the heart of the Knowledge Quarter in Liverpool has helped to improve collaboration between our health partners and the CRF will heighten this.”

The update on Covidity RNS dated 31 January’22 stated:-

“Scancell has previously shown in preclinical models that both SCOV1 and SCOV2 induce high titre antibodies and potent T cells against both the S and N antigens, and that these responses cross-reacted with the Delta variant. The Company has now confirmed in preclinical studies that although both vaccines induced responses against the Omicron variant, the strongest responses were seen with SCOV2”.

If this Delta-Omicron hybrid does take off, then based on Scancell’s update, I would expect SCOV2 to be effective against it AIMHO. If only we could make some progress with the Covidity trial.

Prime Minister Boris Johnson today announced that DIOSynVax, a biotech spinout of the University of Cambridge, will receive $42million to develop a vaccine candidate that could provide protection against both existing and future variants of SARS-CoV-2 – the virus that causes COVID-19 – as well as other major coronaviruses, including those that cause SARS and MERS.

https://www.cam.ac.uk/research/news/cambridge-vaccine-expert-in-42million-partnership-to-develop-future-proofed-coronavirus-vaccines

CEPI have also tweeted about this:-

https://cepi.net/news_cepi/cepi-and-diosynvax-partner-in-quest-to-develop-broadly-protective-betacoronavirus-vaccine/

With all of this talk about the Hell’s Angels, I am just waiting for Modi-1 first patient dosed.

Could be destination Brighton beach for Mod(-1)s versus Rockers all over again.

Hi Konar,

Thank you for that, maybe I did not explain my point properly.

I realise that “Day 1” is the day the patient gets their first dose of SCOV1. The unknown (to me) is when “enrolment” day is; it could be a number of days before “Day 1”?

I am just trying to get an idea of when Scancell will have full safety, tolerability and immunogenicity data for the first patient. The link states “Time Frame: From enrolment through end of study; approximately 26 weeks”. Without knowing the “enrolment day” we do not know when approximately 26 weeks later is.

Assuming everything is going to plan the first patient dosed will have received their second dose of SCOV2 today (Day 141):-

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

This refers to the outcome measures of safety, tolerability and immunogenicity data. It states “Time Frame: From enrolment through end of study; approximately 26 weeks” (i.e. 182 days).

When they refer to “enrolment” I do not know whether this means “Day 1” when the patient receives their first dose of SCOV1. There could be few days time gap between “enrolment” and “Day 1”.

If “enrolment’ is “Day 1” then full data on safety tolerability and immunogenicity for the FIRST PATIENT should be available in approximately 41 days (182 minus 141) from today. If “enrolment’ is before “Day 1” then this data should be available earlier.

I do not know if this has been mentioned before. Cambridge Healthtech Institute’s 3rd Annual Formulation and Stability conference 23/24 March’22. It has speakers from Scancell and Janssen:-

https://www.bioprocessingeurope.com/formulation#Day1

23 March’22 17.25 Formulation and Delivery Challenges of Novel Biotherapeutics for Cancer
Priscilla Ranglani, PhD, Formulation Development Manager, Scancell, United Kingdom
Novel biotherapeutics and vaccines for cancer treatment can require new approaches to formulation and selection of delivery methods and devices. This presentation reviews strategies being used by Scancell to address these challenges.

24 March’22 14.20 Computer Vision for Formulation Screening
Anastasia Holovchenko, PhD, Applied Physicist, Formulation Science & Technology, Janssen, The Netherlands
High-throughput analysis (HTA) is essential stage of formulation screening: it enables analytical techniques for characterization of thousands of samples per day. During the non-automatic sample preparation there is a higher chance of physical sample contamination. To overcome this issue, we developed an automated imaging program which enables AI computer vision for formulation screening purposes, preventing unnecessary measurements on contaminated samples by high-precision AI pre-screening at the beginning of the HTA.

Thank you Bermuda,

I was not aware of the link between Leiden University, Cornelis (Kees) Melief and Isa Pharmaceuticals.

Let’s just hope we get some positive news soon.

I was looking at 2 scientific papers that Scancell posted on Avidimab on 14 February’22. This is one of the links:-

https://www.scancell.co.uk/Data/Sites/1/media/publications/papers/houvast-et-al-2021-avidimab.pdf

I see that some of the named contacts work at the Leiden University Medical Centre in the Netherlands (i.e. Ruben D. Houvast , Kira Thijse, Jesse V. Groen, J. Sven D. Mieog, Bert A. Bonsing, Alexander L. Vahrmeijer, Peter J. K. Kuppen and Cornelis F. M. Sier). I cannot see any other references to these people or Leiden University Medical Centre on Scancell’s website.

Leiden University Medical Centre appears to have collaborations with Janssen (part of Johnson & Johnson). Janssen’s covid vaccine was developed with support from the Molecular Virology group of the Leiden University Medical Centre (LUMC).

On” Linked in” Kira Thijse now works at Janssen as a Vaccine Operator (Perhaps not relevant as she only started there in September’21).

I wonder if Scancell might do a licencing deal with Janssen on AvidiMab.

Separately the only other link I can see with Leiden is the “worldwide licensing and collaboration agreement with ISA Pharmaceuticals (Leiden, the Netherlands) to use the AMPLIVANT® adjuvant technology for the development and commercialisation of Modi-1”:-

https://www.scancell.co.uk/modi-1

If the Government have done their due diligence properly they should be fully aware of Scancell and Covidity.

Chancellor Rishi Sunak speaking in first G20 of year today (this is after Sajid Javid met with Moderna CEO Stéphane Bancel last week):-

https://www.gov.uk/government/news/chancellor-calls-for-strengthened-supply-chain-and-energy-market-resilience-in-first-g20-of-the-year

“The Chancellor also reiterated the importance of preparing for future pandemics, and the need to invest to ensure our health systems are ready to avoid fiscal and economic costs further down the line.

Sunak said that a full global economic recovery “will not be possible until we achieve our immediate priority of getting vaccines from airports to arms”.

Part of the response will be through strengthening existing institutions, and the Chancellor noted the UK’s role in hosting the global Coalition for Epidemic Preparedness and Innovation (CEPI) conference on 8 March, further cementing the UK’s leadership in supporting innovative financing and the Prime Minister’s pledge to reduce the development of vaccines to 100 days”.

On 7 February’22, I posted the following link to vacancies for “Research Technician (2 Posts)” at the Ottensmeier laboratory (The Principal Investigator of the Modi-1 trial is Professor Christian Ottensmeier). Maybe the roles are linked to Modi-1 (and/or Transgene) trials:-

https://my.corehr.com/pls/ulivrecruit/erq_jobspec_version_4.display_form?p_company=1&p_internal_external=E&p_display_in_irish=N&p_process_type=&p_applicant_no=&p_form_profile_detail=&p_display_apply_ind=Y&p_refresh_search=Y&p_recruitment_id=038686

This link now shows that “the requested job is no longer available” (Implying these vacancies have now been filled). You can however still click on the "job description pdf":-

“To this end the group uses vaccines against infection of known immunogens and in early phase clinical trials the evaluation of novel vaccines against cancer antigens”.

Duties include “Organisation of shipments of samples to our collaborators will also be an important part of the role”.

Experience includes “Understanding of Good Clinical Practice in laboratories including an awareness of the regulatory requirements governing clinical trials”.

I really hope that the 2 roles are linked to Modi-1 and the trial is getting close to starting.

I see that Moderna are recruiting around 3,000 people over the next 4 weeks. The last we heard Scancell were on 16 out of 40; at least we are getting there and hopefully more have been recruited and dosed since then. It will be interesting to compare Moderna’s and Scancell’s results in due course. It truly will be a case of the tortoise versus the hare:-

https://www.youtube.com/watch?v=m7NuVjpi72c

Tortoise it is then!

Interesting news on Moderna:-

https://www.ft.com/content/1abd1afe-5774-439e-b2e4-974caa5c0aef

"Moderna, the US biotech company, is in late stage talks with the government about investing in UK research and manufacturing and collaborating with the NHS on clinical trials".

I understand that at the AGM Lindy said something along the lines of CEPI not a runner as yet - they need clinical data first. Plan for Covidity is to partner up on the back of phase 1.

I hope that there is something in the tweet this time; maybe clinical data has been submitted to CEPI ? (They have sent this tweet a number of times in the past and it has sometimes felt to me as though they are just teasing us).

The year end accounts for 30 April 2021 state the following:-

“Dr Richard Goodfellow (Non-Executive Director)
Dr Richard Goodfellow was CEO of Scancell until 31 December 2017. He has many years’ experience with Scancell and in life sciences generally which he brings to the Board. As well as contributing to the Board, Richard provides business development advice and consulting services to Scancell.”

So clearly RG is in regular contact with Scancell and will be up to date with events (it is not as though they are bringing in Tutankhamun).

Redmile’s last purchase was 9 September’21 when they somewhat “covertly” bought 4,459,681 Shares from Lindy at 20.38 pence. Vulpes’ last purchase was 3 November’21 when they bought 200,000 @ 19 pence.

Redmile and Vulpes will no doubt be as disappointed as other shareholders with the slow progress in the Covidity and SCIB1 trials, coupled with the Modi-1 trial not starting yet. However, they have done their due diligence and will understand the delays. I don’t think that they have lost faith and are simply watching at the sidelines as the SP drops. I really hope that there is a deal being discussed and that is why they have not stepped in and bought shares (i.e. due to insider dealing rules).

In the meantime, if the Modi-1 trial could only start that would be great news.

I know that this was discussed previously. I did not look at Scancell’s website at that time and it is unclear from the conversation thread whether it mentioned this on the website at the time (If it did I apologise for bringing this up again).

Looking at Scancell’s website I see that Richard Goodfellow is now showing as Interim Chief Business Officer:-

https://www.scancell.co.uk/company#board

It states “Richard joined Scancell as a co-founder and was CEO until December 2017. He has many years’ experience with Scancell and in life sciences generally. In January 2022 Richard agreed to become Chief Business Officer on an interim basis until a full time CBO could be appointed”.

The use of the word “agreed” implies that Scancell asked him to take on the role.

On the subject of “uncanny copy and paste”.

The item strikes me as being nonsense; it is just a re-hash of one these individuals issued 2 weeks ago:-

https://uk.finance.yahoo.com/news/scancell-holdings-lon-sclp-debt-065731155.html

Hi Ray. I saw the Pfizer/BioNTech reference to micrograms on the gov.uk link. I wrongly assumed that the reference to “mg” in the Covidity trial link meant “micrograms”. I realise now, that as you quite rightly point out, mg means milligram not microgram. This turns my calculation on its head. I realise now that there are 1,000 mgs in a gram and 1,000,000 micrograms in a gram.

I shall need to exercise extreme care on my next visit to the delicatessen in my local supermarket.

Please forgive me if this is common knowledge. I have only just spotted it and it makes me realise just how ahead of the game Lindy is.

I was looking at the Clinical Trial details for Covidity and noticed that the needle-free injection (intramuscular) dose is 2 x SCOV1 and 2 x SCOV2 @ 1.0 mg each (i.e. 4.0 mg in total).

This is 5 times the needle-free injection (intradermal) dose which is 2 x SCOV1 and 2 x SCOV2 @ 0.2 mg each (i.e. 0.8 mg in total).

This is the link for that information:-

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

I was prompted to look at this after reading an article “Testing fractional doses of COVID-19 vaccines”

https://www.pnas.org/content/119/8/e2116932119

“There are risks to using fractional doses, and logistical questions that remain to be answered. However, the reversibility and large potential benefits of fractional doses suggest that testing—in the short term most likely achieved either via immunogenicity studies or rigorously evaluated rollouts of fractional dosing regimens—has tremendous informational value. Clinical data and epidemiological modeling suggest that switching to fractional doses of some COVID-19 vaccines could potentially save lives by accelerating vaccination in countries still facing supply constraints. Fractional doses may be more efficacious than the current standard of care in many countries and may also have lesser side effects”.

By way of comparison I looked at Pfizer/BioNTech and this states “One dose (0.2 mL) contains 10 micrograms of tozinameran, a COVID-19 mRNA Vaccine (embedded in lipid nanoparticles)”:

https://www.gov.uk/government/publications/regulatory-approval-of-pfizer-biontech-vaccine-for-covid-19/summary-of-product-characteristics-for-covid-19-vaccine-pfizerbiontech-10-micrograms

So unless I am missing something 2 doses Pfizer/BioNTech = 20 mgs. This is 5 times and 25 times Covidity’s intramuscular and intradermal doses (respectively) detailed above.