Member Info for JohnnyB1

This item is from a week ago but I have only just seen it (From a SCIB1 perspective PharmaJet’s Needle-free Injection Systems (NFIS) comparison to electroporation is interesting):-

https://pharmajet.com/pharmajet-presents-multiple-partners-data-demonstrating-superior-immunogenicity-with-their-needle-free-systems-at-bio-international-convention/

“There is a growing body of evidence that shows needle-free delivery can make injectables perform better. PharmaJet’s Needle-free Injection Systems (NFIS) can improve performance by providing a similar, and often better, immunogenicity in the patient with a strong antibody and T-cell response, when used to administer nucleic acid-based vaccines and therapeutics. Currently there are 18 partner publications that show equivalent or better effectiveness when using the PharmaJet NFIS compared with either electroporation or traditional needle and syringe. These include 11 studies comparing delivery methods for DNA vaccines, 1 for an mRNA vaccine, and 2 for live attenuated vaccines”.

CONTINUATION of last message:-

The original 16 participants (of populations 1 and 2 combined) will all have been assessed by around 2 June’22. If these 16 are split 50/50 we need at least another 2 participants assessed from each of populations 1 and 2. We know another 6 (22 in total) had been recruited at the time of the RNS 29 March’22. These 6 would therefore be assessed by 28 September’22 (Day 183) at the latest. AIMHO

I predict sufficient numbers will have been fully assessed by 28 September’22 at the latest AIMHO.

Recent sequence of events:-

29 March’22 RNS “SAHPRA approves clinical trial amendment allowing testing of COVIDITY vaccine candidate in a real-world setting”

25 May’22 Covidity advert on University of Cape Town Lung Institute website was updated.

2 June’22 the clinical trials website was updated.

When I first read the above RNS, I wrongly assumed that the amendment simply meant that previously vaccinated and previously covid infected patients would go through the same 6 month regime of 2 doses of SCOV 1 and 2 doses of SCOV2.

However, after reading the clinical trials update I realised that the RNS was effectively telling us about the dosage amendment (to either 1 or 2 doses of SCOV2 only), the RNS simply did not drill into all the details (The clinical trial update confirms this stating “A protocol amendment submitted in February 2022, permitted the enrolment of participants irrespective of their previous COVID-19 vaccination and/or SARS-CoV-2 infection status, amended the treatment regimen to SCOV2 only, and aligned the administered dose with the doses employed for other DNA vaccines”):-

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

This goes on to say “This study is expected to enrol up to 80 participants at a single centre in South Africa. Enrolment will attempt to continue until at least 10 evaluable participants receive all protocol-required SCOV2 vaccinations for each immunogenicity analysis population. However, should the epidemiology be such that certain populations cannot be enrolled, the Safety Review Committee may determine that enrolment for that population be considered complete”.

I interpret that we need at least 10 evaluable participants from the following 6 populations:-

1. Biological: COVIDITY (2 x SCOV1 and 2 x SCOV2) administered via needle-free intradermal injection (Assessment Day 183)
2. Biological: COVIDITY (2 x SCOV1 and 2 x SCOV2) administered via needle-free intramuscular injection (Assessment Day 183)
3. Biological: COVIDITY (2 x SCOV2 only) administered via needle-free intradermal injection to vaccine naive and/or previously vaccinated participants (Assessment Day 71)
4. Biological: COVIDITY (2 x SCOV2 only) administered via needle-free intramuscular injection to vaccine naive and/or previously vaccinated participants (Assessment Day 71)
5. Biological: COVIDITY (1 x SCOV2 only) administered via needle-free intradermal injection to previously infected participants (Assessment Day 43)
6. Biological: COVIDITY (1 x SCOV2 only) administered via needle-free intramuscular injection to previously infected participants (Assessment Day 43)

We are now on Day 103 since the RNS. Sufficient numbers of populations 3, 4, 5 and 6 could have been assessed (or be close to being assessed) by now.

CONTINUED on next message

Amongst other things this article mentions T-cells and DNA technology:-

https://www.medicalnewstoday.com/articles/pfizer-and-biontech-to-test-universal-covid-19-vaccine-candidate#Technologies

According to the press announcement, Pfizer and BioNTech’s vaccine candidates will include T-cell enhancing shots that protect against severe disease and pan-coronavirus shots that “protect against the broader family of viruses and its mutations.”

When asked about what technologies researchers might use to create such pan-coronavirus shots, Dr. Hawkinson said that it is hard to say. He noted, however, that genome sequencing, RNA and DNA technology, and possibly other molecular techniques may be used.

Hi RuckRover,

The news item on “UK Research and Innovation (UKRI)” website was last updated 2 February 2022. So this information was correct at the time that they updated it on their website. The main point I was trying to make is that UKRI are still interested in Covidity and are following its progress.

This news item on “UK Research and Innovation (UKRI)” website was last updated 2 February 2022. The item specifically mentions their funding of Scancell and gives the up to date position as at that time:-

https://www.ukri.org/news-and-events/tackling-the-impact-of-covid-19/understanding-coronavirus-covid-19-and-epidemics/tackling-new-variants-of-coronavirus/

Clearly Innovate UK didn’t just give out the approximately £2 million funding and simply move on. UKRI are still following the progress of Covidity and reporting back to the Government.

The last paragraph, referring to the items mentioned in the article (including Scancell), states “This critical research, funded by the taxpayer through UKRI, builds on decades of investment into genomics research and will inform government decision making on a daily basis”.

I see that the University of Cape Town Lung Institute has a job advert for a “Research Nurse” (It closes today) based at Centre for Lung Infection and Immunity (CLII). “The successful incumbent will assist with the care and assessment of participants as well as the collection of specimens and research data related to studies of TB and COVID-19”.

https://lunginstitute.co.za/wp-content/uploads/2022/06/UCTLI-CLII-Research-Nurse_June-2022-9.pdf

It is fair to assume that part of the role will be with the Covidity trial. I note that this is a 6 month Fixed Term Contract which just so happens to fit in with the Covidity “estimated study completion date” of December 2022.

Interestingly, I had not realised before that the CLII receives some of its funding from the Welcome Trust, Gates Foundation:-

https://lunginstitute.co.za/clii/

The Welcome Trust also gives financial support to CEPI. Whatever is happening with Covidity will definitely be on both their radar (AIMO).

The Covidity advert on the University of Cape Town Lung Institute web site is the 4th article down on the following link:-

https://lunginstitute.co.za/news/

At the time of my posting this message the advert has 30 “likes”(This is more “likes” than any of their other listed news items).

I ‘liked” the advert on or shortly after 30 May’22; at the time I remember this brought the total “likes” to 18.

I am just wondering what the profile is of people liking this advert. I know at least one (i.e. myself) is a Scancell shareholder. I hope the other 29 aren’t all Scancell shareholders.

I wonder how many are patients who have been dosed?

(I suspect some of the “likes” will be Scancell employees and UCT Lung Institute staff administering the vaccine).

Sorry message subject should read "Pharmaceutical and life sciences industry is poised for a “flurry of deals” in the second half, according to PwC".

“In a new report covering the first half of the year, the professional services firm acknowledges there’s been a slow start to deal activity. But Big Pharmas are flush with cash—especially those that managed to tap into the COVID-19 market—biotech valuations are finally starting to normalize and many large companies face patent cliffs and are in need of new assets to bulk up their pipeline. All of this spells a second half that should be rich with deals”.

https://www.fiercebiotech.com/biotech/ma-down-big-pharma-likely-line-multiple-shots-goal-heading-2nd-half

Zakari Therapeutics Limited was incorporated 19 May 2021. Lindy’s reference to “Over the past year” in today’s RNS fits in with this:-

Prof Lindy Durrant, Chief Executive Officer, Scancell, commented: "Over the past year we have been evaluating the optimal products for Scancell to develop through exploiting our Glymab® platform. We believe we can add considerable value to the antibody portfolio by taking TCB products into the clinic, as opposed to outlicensing them at the preclinical stage. At the same time, the Board continues to evaluate opportunities to enter into revenue generating deals for our antibodies with ADC or CAR companies."

Also Lindy’s terminology “evaluate opportunities” is interesting. Please correct me if I am wrong but I interpret this as the Board actually looking at potential deals on the table in front of them. AIMHO

I see that there were 2 late “unknown” trades:-
100k @ 14.75 pence at 17.08 hours and a "delayed publication" trade of 500k @ 14.125 pence at 16.36 hours.

It is interesting that this DNA Covid Vaccine is also using the Pharmajet delivery system. I wonder if Pharmajet approached the University of Adelaide; hopefully this points to good results so far with Covidity?

https://www.skynews.com.au/australia-news/human-trials-on-cutting-edge-needlefree-painless-covid-19-vaccine-designed-manufactured-in-south-australia-to-start/news-story/96f9046363265f599bba6cfd64fd0a11

“Manufactured at a high-tech facility in Adelaide, the new vaccine has the potential to become a major Australian export and would prevent us from having to rely on limited supplies of imported vaccines”.

The link to participate states “University of Adelaide researchers, led by Associate Professor Grubor-Bauk and Professor Gowans, have developed an Omicron COVID-19 Booster vaccine and are calling for healthy volunteers who were previously fully immunised with either AstraZeneca or Pfizer COVID-19 vaccines”.

Sorry I meant to put the link in.

“Scancell Holdings plc Directors and related holdings” were incorrect and the website has now been updated:-

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

Based on the information under “Scancell Holdings plc Directors and related holdings”, detailed on Scancell’s website, I recently suggested that a Director had bought Lindy’s shares. I sent an email to Scancell asking for clarification on this matter.

Keith Green, Director of Finance and Administration, has now kindly sent the following response to my email:-

“Richard Goodfellow has forwarded your email to me and apologies for the delay in replying to you.

If Lindy’s shares had been sold to a Director of Scancell Holdings plc or a PDMR then the Company would have made an announcement to the market. I can confirm that the 2,380,952 shares were sold to a private individual.

Thank you for your analysis of the share movements set out below. Unfortunately, the number of shares shown on the website for ‘Scancell Holdings plc Directors and related holdings’ were incorrect and the website has now been updated to reflect the sale of shares to the private individual.”

I do not know whether this is common knowledge or if it has been posted previously but the following is a link to the Modi-1 trial where people can actually ask to take part:-

https://bepartofresearch.nihr.ac.uk/trial-details/trial-detail?trialId=33483&location=Nottingham&distance=

Despite the previous problems with recruitment it is very interesting to see that Honorary Prof Rod Dawson (Managing Director of the University of Cape Town Lung Institute) is happy for the COVIDITY trial to be expanded in South Africa. It is reassuring that he must like what he has seen so far and definitely wants to be associated with it (AIMHO).

Given the large size of later stage trials, I know Scancell intends to partner Covidity once it has generated proof of concept data from the Phase 1 trial. This makes absolute sense given the costs involved; today’s update from Clover does give an indication of what some of these costs might be:-

https://www.globenewswire.com/news-release/2022/06/05/2456339/0/en/Clover-Provides-Update-on-2022-Corporate-Milestones.html

“Up to US$300 Million Credit Agreement Approved: China Merchants Bank has approved a one-year credit agreement for up to US$300 million to support potential working capital needs during commercial launch. Drawdown on this agreement is subject to a review of Clover’s business condition and changes in Clover’s condition may result in early repayment. Additional terms including the repayment date and interest rate will be fixed at the time of drawdown approval”.

Bermuda, thank you again for getting back to me and for your comprehensive reply, I appreciate it. Chester, thank you too for your comments, it certainly would be good to be back on track.

Hi Bermuda, Thank you very for coming back to me on this.

I would be interested in your view of my 16.34 of yesterday. Do you think that we have effectively moved into Part 2 of the Covidity study or do you feel that we will still need to do Part 2 of the study in the UK?

Separately I guess the 2 to 3 months study duration is 1 dose = approx 2 months duration and 2 doses = approx 3 months duration (with 4 weeks between doses).

Bermuda. I just wanted to come back on the point you make in your 13.30 about changes to the wording of the Covidity advert. I too was not 100% certain about this, so I have tried to find a link to the original Covidity advert to compare it to the new one. The only way I have found of doing this is to do a google search on “Covidity” and then click on “images”.

Amongst the images you will see a small image of the complete original Covidity advert. If you click on this once to enlarge it you should be able to read it (DO NOT click on it again to open it up as it will simply open up the current up to date advert). The differences between the original advert and the current advert are as follows:-

Original advert states:-
You need to:-
Have no history of COVID-19 infection.
Have not previously received a COVID-19 vaccine.
Study duration:- Approximately 6 months.
You will receive 4 injections of the new COVIDITY vaccine with a needle-free device.
Participating in this study will not prevent you from receiving one of the authorised COVID-19 vaccines in the future.

Current advert states:-
You need to:-
Have not had a COVID-19 infection in the last 28 days.
Have not received a COVID-19 vaccine in the last 28 days.
Study duration:- 2 to 3 months.
You will receive either 1 or 2 doses of the new COVIDITY vaccine with a needle-free device.
Participating in this study will not prevent you from receiving one of the authorised COVID-19 vaccines in the future, if you haven’t already been vaccinated with one.