Member Info for JohnnyB1

Hi moonparty, thank you for confirming that, I appreciate it.

After a good start to 2022 the share price has, much to my disappointment, drifted lower.

After the interim results I incorrectly anticipated a Vulpes buy "Director Dealing" RNS. To save people looking them up I have listed the “more recent” Vulpes “Director Dealing” RNS’s below:-

30 April’21 buy 400,000 @ 20.4 pence.
7 June’21 buy 400,000 @ 19.25 pence.
30 July’21 buy 200,000 @ 19.5 pence.
2 November’21 buy 100,000 @ 19 pence.
3 November’21 buy 200,000 @ 19 pence.

So with the share price now at 17.25 pence why haven’t Vulpes bought any more shares to stem the fall in the share price?

I was looking at people’s recent comments about Richard Goodfellow and this got me thinking.

Vulpes is closely associated with Martin Diggle, Non-Executive Director. Let’s suppose a deal was about to happen and Martin Diggle had knowledge of this price sensitive information. Please correct me if I am wrong, but it is my understanding, in such circumstances, that if Vulpes bought Scancell shares this could constitute insider trading.

Maybe the reason Vulpes have not bought is because they are not allowed to as the transaction would be illegal? AIMHO

Violindog, totally agree with you.

Having seen the recent TV news showing the first patient dosed with Transgene’s head and neck cancer vaccine, I can’t help but think that Modi-1 first patient dosed is imminent.

Remembering The Principal Investigator of the Modi-1 trial is Professor Christian Ottensmeier at The Clatterbridge Cancer Centre and University of Liverpool (i.e. the same person overseeing Transgene’s trial). This coupled with the fact that Ottensmeier has recently advertised vacancies for “Research Technician (2 Posts)”:-

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

The conclusions to this study certainly seem to point towards Covidity:-

“The authors observed that non-spike structural and accessory proteins (nucleocapsid, membrane, enveloped, and open reading frame 3A, NC/M/E/3A) harboured a reduced number of mutations relative to S, hence could serve as potential targets for second-generation COVID-19 vaccines”.

“Future vaccination strategies that will collectively target conserved, SARS-CoV-2 variant resistant sites to induce robust memory and effector T cell responses alongside antibody responses may therefore yield durable T cell immunity and broad protection against future SARS-CoV-2 variants”.

https://www.news-medical.net/news/20220206/Booster-vaccines-found-to-augment-T-cell-responses-to-SARS-CoV-2-Omicron.aspx

Separately, Chelsea7, I am very sorry to hear about the loss of your friend.

The Principal Investigator of the Modi-1 trial is Professor Christian Ottensmeier at The Clatterbridge Cancer Centre and University of Liverpool.

I have found a vacancy for Research Technician (2 Posts) via the following link (you will see that it states “Further details can be discussed with Professor Christian Ottensmeier and Mrs Lindsey Chudley (email L.Chudley@liverpool.ac.uk)”:-

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

If you click on the link to the job description pdf at the bottom of the advert it gives more details. Does anyone have an opinion of whether this might have any links to the Modi-1 trial?

I do not know the answer but at least it does imply that cancer trials appear to be resuming.

Apologies, I think I have just answered my own question in my 21.53.

I have changed my mind. I think Scancell will need to wait for both “safety and immunogenicity data” before applying to MHRA for approval to initiate the UK extension to the study.

I refer to the same slide on Lindy’s video. I have just noticed that the UK Phase 1 Arm 3 states “ID” (Pharmajet Tropis) or “IM” (Pharmajet Stratis) "depending on earlier results". So clearly they will need both safety and immunogenicity data to decide on the which delivery method to use.

Lets hope we have a good week.

The question I am wondering about is when will the UK extension of the study start?

The interim results RNS states “The Phase 1 clinical study started on 5 October 2021 in South Africa and 16 patients have been recruited to date with no safety concerns. ………………………. and safety and immunogenicity data is still expected to be available in H1 2022”.

The RNS dated 5 October’21 states “After demonstration of safety in the South African part of the study, the Company plans to seek approval from the Medicines & Healthcare products Regulatory Agency (MHRA) to initiate a UK extension of the study, in which COVIDITY will be given to healthy volunteers who have already received two doses of an approved vaccine. The results from this part of the study will allow the Company to assess the strength and breadth of the immune responses induced in pre-vaccinated individuals, with the potential to provide durable protection against emerging variants”.

I am finding this a bit of a grey area because it says “After demonstration of safety” it does not state “after safety and immunogenicity data”. The interim results state “16 patients have been recruited to date with no safety concerns”. Is this sufficient for Scancell to apply to MHRA for approval to initiate the UK extension to the study?

I suspect that the answer may be yes. Lindy’s Proactive video of 2 December 2021 appears to back this up:-

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

If you go to the slide at 15 minutes 35 seconds into the video this shows the UK Phase 1 starting after safety data in naïve subjects. The UK doses of SCOV2 appear to be ever so slightly later than the SA doses of SCOV2 in months 5 and 6. (However I am not sure whether this is just the way the slide is laid out. The months 1 to 6 definitely refer to the SA Phase 1; it is not clear whether they also relate to the UK Phase 1).

It certainly will be headline grabbing when we start the UK extension of the study. AIMHO

Looking at the maths.

I refer to the outcome measures (safety and immunogenicity) listed in the study. The time frame for each of these is approximately 26 weeks:-

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

In the interim results Lindy states “In October 2021, we initiated our COVIDITY programme in South Africa and to date have recruited 16 patients with safety and immunogenicity data due during H1 2022”.

The interim results go on to state “……….the Company anticipates recruitment of subjects will speed up again and safety and immunogenicity data is still expected to be available in H1 2022.”

So, even if the remaining 24 patients were by some miracle recruited by say 1 February 2022, it would still take until 2 August 2022 (i.e. 26 weeks) to get safety and immunogenicity data on these patients. However, this takes us beyond H1 2022 so would not fit in with what the Company are stating.

Lindy’s Proactive video was 2 December’21 and we know that 16 patients had been recruited at that time. The last of these 16 would therefore have had their first dose of SCOV1 on 2 December’21 at the latest. Safety and immunogenicity data should therefore be available approximately 26 weeks later, taking us to 2 June’22.

The conclusion I come to is that Lindy will probably release safety and immunogenicity data on or around the beginning of June’22. This will be based on the first 16 patients (Probably also making reference to data to date on the other 24 patients). AIMHO

I have only just spotted the delayed 250,000 @ 18.45 pence “unknown” trade and this got me thinking.

Just a brief summary of what happened when the Full Year results came out:-

Friday 29 October’21, results for year end 30 April’21 issued (the share price dropped).
The same day, Friday 29 October’21, Vulpes Life Science Fund bought 100,000 shares at 19 pence (A Director Dealing RNS in this respect was issued 2 working days later on Tuesday 2 November’21).
Tuesday 2 November’21, Vulpes Life Science Fund bought a further 200,000 shares at 19 pence (A Director Dealing RNS in this respect was issued the next day Wednesday 3 November’21).

Yesterday the Interim results for 6 months to 31 October’21 came out (the share price dropped - not that anyone needs a reminder).
I think you will see where I am going with this. Vulpes Life Science Fund may have bought in the last couple of days (I have noticed some trades in 50,000 sort of multiples). If so we could possibly see a Director Dealing RNS as early as tomorrow. AIMHO

I do not know whether it would warrant a RNS but first patient dosed with SCOV2 in South Africa trial would definitely be news I would like to hear.

The first patient dosed (with SCOV1 on 5 October 2021) should receive their first and second doses of SCOV2 not before 26 January and not before 23 February 2022 (i.e. day 113 and day 141) respectively.

If the patient has not had their first dose of SCOV2 yet, I would have thought that it would be imperative to the whole trial that this happens soon. AIMHO

This is the link if anyone needs it:-

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

Interesting article; it is just a pity they did not choose to use Scancell as the example instead of iBio:-

https://www.biospace.com/article/from-zero-to-hero-biopharma-industry-is-at-a-pivotal-inflection-point/

“It will require alternatives to vaccines that rely on the highly mutable spike protein antigen of SARS-CoV-2 so that we don’t exacerbate the risk of the emergence of a true escape variant,” he said. “Unfortunately,” Isett added, “our industry and many governments appear to be depending upon the current solutions from the existing big players.

Additionally, of all the second-generation vaccine candidates in development, it appears that only a tiny percentage are based on antigens other than the spike protein. iBio, for example, is developing a COVID-19 vaccine that generates immunity by using the virus’s nucleocapsid protein, which mutates far less frequently than the spike protein.

“Near term,” Isett said, “changing hearts and minds seemingly will depend upon our industry’s ability to end the pandemic with next-generation vaccine solutions.

If there was ever an ideal time for a Diggle Wiggle I think it is now.

Definitely RuckRover. I do not know whether he would be subject to any trading restrictions ahead of the results on Wednesday.

The 52,906 @ £0.18665 at 3.54 pm showing as a sell was actually my buy. I have only been holding Scancell since March 2021 and I wanted to reduce my average purchase price (it is now circa £0.209).

CEPI have tweeted a 2 minute video from Thomas Cueni, Director General of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA):-

https://twitter.com/CEPIvaccines/status/1484516339247194115?ref_src=twsrc%5Egoogle%7Ctwcamp%5Eserp%7Ctwgr%5Etweet

“For future pandemics, innovative pharma companies fully support the vision of the 100 days mission. We are committed to invest in R&D on pathogens with pandemic potential. We continue to innovate and commit to build a portfolio of promising vaccine candidates that provide longer lasting and stronger protection and are easier to transport, store and administer”.

In theory Covidity ticks these boxes; hopefully we will soon know whether it does in practice.

This is an interesting article:-

https://www.vox.com/22876661/universal-covid-19-vaccine-variants-omicron

“Conserved regions are often parts of the virus that are critical to its function; the virus ceases functioning if they mutate. “If you target the parts that are conserved, then that would have, theoretically, protective efficacy against any of the coronaviruses that are out there,” Fuller said. That could extend to every past and future variant of SARS-CoV-2 and the broader group or family of coronaviruses it belongs to.”

“You could have a universal vaccine that covers every single coronavirus, but if the immunity it elicits wanes, it’s not that good,” Morens said. “I would define a universal vaccine not only to cover all the viruses, [but also] to induce durable immunity.”

I feel that Covidity certainly has the potential to fall under the above definition of a “universal vaccine”.

CEPI have tweeted with a link to an article by Richard Hackett:-

https://thehill.com/opinion/healthcare/589734-covid-is-here-for-the-long-haul-we-need-a-variant-proof-vaccine

“Developing broadly protective vaccines will not be easy. While current COVID-19 vaccines work by generating antibodies to neutralize the changeable spike protein that the virus uses to enter human cells, broadly protective vaccines will need to target components of the virus that stimulate the immune system but do not mutate. Ideally, a broadly protective vaccine would provide immunity that endures for years or even a lifetime. Such a vaccine would dramatically reduce and perhaps even eliminate the risk of future coronavirus pandemics”.

“Last year CEPI launched a $200 million program to support the development of vaccines providing broad protection against SARS-CoV-2 and other coronaviruses. Some of that funding is already being put to work across projects with industry and academic groups, and further awards will be announced in the coming weeks”.

I look forward to hearing an update on Covidity, perhaps with the interim results on 26 January.

I wonder if this morning’s buying might be linked to this:-

https://www.theguardian.com/business/2022/jan/11/wellcome-trust-covid-vaccines

“The Wellcome Trust, Britain’s biggest charity, is ramping up spending on science research to £16bn over the next 10 years, with a focus on funding next-generation Covid vaccines, after it reaped the highest investment returns in a quarter of a century.”
Farrar said some of the money would go towards funding second- and third-generation Covid vaccines as part of Wellcome’s infectious diseases programme, as the virus becomes endemic.
“The vaccines have saved hundreds of thousands, if not millions of lives, but they’re not perfect,” he said. Second-generation vaccines that work against Omicron are around the corner, from Pfizer/BioNTech and others, but he stressed the importance of developing third-generation vaccines that might stop transmission over the next few years.

https://www.pharmiweb.com/press-release/2022-01-11/needle-free-injectors-market-sales-are-expected-to-reach-us-123-bn-in-2021-surging-at-114-cagr

“Sales of needle-free injectors skyrocketed during the COVID-19 pandemic. Many pharmaceutical companies started administrating SARS-CoV-2 vaccine by using needle-free injection systems. For instance, in September 2021, Pharmajet, announced that its partner, Scancell has selected its devices to administer two SARS-CoV-2 DNA vaccine candidate, SCOV1 and SCOV2. The vaccines will be exclusively administered using the Pharmajet Tropis and Pharmajet Stratis Needle-free injection systems”.

After the close on 22 December’21 there was a transfer of approximately 41 million shares for circa £8 million. The transfer price was 19.5 pence and this was also the closing share price on the day.

I think that it is fair to say that, at the time, most people who commented expected to see a RNS within the next few days detailing a “TR-1 Notification of Major Holdings”. No RNS has been fortcoming and someone posted to say that this was just a transfer between funds (e.g. one Redmile fund to another).

I must emphasise that I was unsure whether to even comment on this as I started from the position of knowing next to nothing on the subject of “TR-1 Notification of Major Holdings”. I have done a bit of searching on google and found the following information:-

https://irsociety.org.uk/files/disclosure_transparency.pdf

I do not know whether it is up to date/current and I do not pretend to understand it all, but certain points stand out to me (I refer to the bottom of page 25 thereof) :-
1. “Where the shareholder is party to or instructed a transaction, he will be deemed to have learned of the transaction no later than two trading days following the transaction”. The shareholder should then file a TR-1 form. This is what some people on this BB were saying at the time. Most of Scancell’s RNS’s in respect of a “TR-1 Notification of Major Holdings” seem to fit in with this. Take the following for example:-

https://www.lse.co.uk/rns/SCLP/holdings-in-company-e7g20r3spe4u40u.html

Here Calculus Capital Ltd reduced their holding percentage on the 14 October 2020 and the RNS was issued the following day.

2. “If a transaction is conditional upon the approval by public authorities or future uncertain events outside the control of the parties, the shareholder is deemed to have learned of the transaction only when the relevant approvals are obtained or the event happens”.
I believe that the following RNS is an example of this:-

https://www.lse.co.uk/rns/SCLP/holdings-in-company-h438ss6n5esue7g.html

In this case the threshold was reached 12 August 2020, yet this was not notified until 24 August and the RNS was issued 25 August. This relates to the time that Redmile made a subscription for £5 million of shares at a price of 5.5 pence. I was not a shareholder at this time but I suspect that the RNS was delayed because the transaction was all linked to the Placing and Open Offer.

What I am trying to say is maybe it is a possibility that the 41 million share trade is subject to other events and that is why we have not yet received a RNS for “TR-1 Notification of Major Holdings”? AIMHO