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Goven the recent positive new and with £30mln cash suffiencrnt for the foreseeable intended to add to SCLP over the coming weeks
It's one of the best bio techs for risk reward in the £100mln+ space in my regard
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.
What we can say is that the Data from the original 16 subjects convinced SHAPRA and it was good enough for them to allow those protocol changes. We can be fairly certain that the current trial in SA is now assessing Covidity as a Booster.
If this Booster Data is positive and meets the Trials objectives it will mean that gaining MRHA approval would be very straightforward. Probably brings the timeline back on track for a UK Booster Ph3 Trial after the Covid delays we have suffered.
I think only Scancell can answer that question. As far as I know, we've not been told how many patients they planned to recruit to the UK arm of the trial, which as you know was intended to test Covidity purely as a booster to previously vaccinated patients and we have no idea of the split between vaccinated/unvaccinated in the SA trial, so it's impossible to even guess. It will obviously depend entirely on the quality of the data coming from SA and whether they've recruited enough previously vaccinated patients to negate the need for the UK arm.
Scancell will also have to decide on their strategy regarding Covidity going forwards. Are market conditions are right to take Covidity to the next stage themselves or do they already have sufficient data in the bag to secure a partner? Konar mentioned a phase II expansion in an earlier post and I guess it's also possible that SA will provide the necessary safety data to allow Scancell to change the UK arm into a phase II.
Of course the other angle to consider is that this trial is also testing Avidimab for the first time and again we really don't know how that may influence decsion making.
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).
Excellent research - thanks very much.
So it would appear that the changes reflect the protocol amendments announced back in March - ie. that in effect this has now become a trial for Covidity as both a primary vaccine and also a booster for those already vaccinated with an approved vaccine.
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.
Thanks Bermuda re. 'wording', I'm just checking that you saw Johnny's 11.51 yesterday? If Inan's idea is right that would be great but I take the point that there could be other explanations.
(It's confusing that the Covidity discussion has been on the Lindy thread about Modi 1).
Repeat of 07.57, Inan 50758 - "receive 1 or 2 dose ....... looks like they are getting a big enough response from 1 dose to be able to look more closely at the 1 dose only route ..... leaving enough room in the advert for the second dose if a % don't mount a sufficient response so can receive 2 . Obviously if approved they need min % to mount a response of sufficient magnitude with 1 dose as it would be impossible to test for those that only require 1 shot, so you can see that the data coming from the trial may indicate that 1 shot is sufficient ... But gives us a massive "hint" that it works -so this is the first signal that Covid vaccine works and may be better than expected ..."
I wonder if Posters here agree with Inan's thoughts ?
Inan 50758 just now - "receive 1 or 2 dose .......
looks like they are getting a big enough response from 1 dose to be able to look more closely at the 1 dose only route .....
leaving enough room in the advert for the second dose if a % don't mount a sufficient response so can receive 2 . Obviously if approved they need min % to mount a response of sufficient magnitude with 1 dose as it would be impossible to test for those that only require 1 shot, so you can see that the data coming from the trial may indicate that 1 shot is sufficient ... But gives us a massive "hint" that it works
so this is the first signal that Covid vaccine works and may be better than expected ..."
C11 a great spot. Thanks to Johnny for his insights which are thankfully positive ! I guess it's 'wait and see' again.
I must admit that I view the new Covidity advert very positively. I think (and hope) that Scancell may have leap frogged into Part 2 of the study.
The RNS 29 July’21 states:-
“COVIDITY-001 Part 2 (UK & South Africa)
After demonstration of safety in Part 1 of the study in South Africa, Scancell will 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 immune responses from this part of the COVIDITY study will allow the Company to assess the ability of SCOV2 to boost the immune response against current and potential future strains of COVID-19 in pre-vaccinated individuals.”
This was 10 months ago and the landscape has changed a lot since then.
Apart from the delays, we have heard nothing negative about Covidity. Let’s suppose that the trial data has all come out good and Scancell want to move on to Part 2 of the trial.
My understanding is that the original logic for having Part 2 in the UK was due to the fact that such a large proportion of the population has already had 2 doses of an approved vaccine.
I do not have figures but suspect that a large proportion of the population of Cape Town will now have had 2 doses of an approved vaccine. (This would not have been the case 10 months ago).
It would make absolute sense for Scancell to run Part 2 in Cape Town to (dare I say it) expedite matters. They have everything in place there rather than applying to MHRA for approval and then waiting ages for first patient dosed in the UK.
It is worth pointing out that the revised Covidity advert states “The study has been reviewed and approved by SAHPRA and the University of Cape Town Human Research Ethics Committee”.
So... Scancell can't recruit 40 volunteers out of a population of 60 million during a pandemic !! Everything about this SA trial demands questions. I bet if they had held it in the UK and blitzed a university for recruitment they would have had no issues.
Only 1 patient that we know of on the SCIB trial and Modi1 not yet even started . SCLP need to get their act together and either bring in new talent capable of the job...or outsource their trials to a competent outfit. At this rate I bet the options granted to LD and RG for July next year will either need a revised strike price or an extention.
My fear has always been that SCLP would not have the ability to develop the science , let's hope Redmile has also had enough and takes action to sort this out.
If they are trying it as you say as a Booster then the progress would be much slower because again they will only proceed after checking that there is no Toxicity. The first subject of the 18 would be dosed and then observed for a period of time before dosing a second subject.
This would explain why after 7/8 weeks we are still recruiting.
I agree wit you J more to it than meets the eye is a “ new “ covid vaccine
Could it be they are trying it as an additional booster against variants ?
Booster for the autum
A great spot C11.
There is definitely a lot more to this than immediately meets the eye. I interpret that new participants will receive only 1 or 2 doses (As opposed to 4 doses for the original participants).
The advert states “Study Duration 2 to 3 months” (I do not completely recall what the original advert said, but I am pretty sure it was about 6 months).
The advert also states “You will receive either 1 or 2 doses of the new COVIDITY vaccine with a needle-free device”.
Compare this to the clinical trials link which states “COVIDITY consists of two doses of the plasmid DNA vaccine SCOV1 (administered on Day 1 and Day 29), followed by two doses of the plasmid DNA vaccine SCOV2 (not before Days 113 and 141 [doses 4 weeks apart]). A final end of study assessment will then be performed 6 weeks after last dose of study vaccine (Day 183 [earliest])”.
Although perhaps disappointing that it would appear the full 40 have not yet been enrolled, a positive spin from seeing the recruitment page recently updated, is that the trial continues and no negative news has come from it to date. Yes we would like things to move a bit faster but slow is better than halted and that shot on goal already in Row Z.
In March we were told that 22 subjects had been enrolled and with the original trial split into two distinct cohort groups of 20 there were only a further 18 subjects needed, that was on the 29th March 2022.
If there are still places to fill the pace of that enrolment is down to the Lung Institute in Cape Town not Scancell PLC.
Anyone care to email Scancell for clarification?
Well, well. The “Research Participants Needed” page on the UCT Lung Institute website has been changed - on 25th May (last Wednesday). You can clearly see this date if you look at the News section.
Those who saw the webpage before, will note the changes that link to the recent trial update RNS. Does this suggest that all 40 candidates have not yet been selected? I would think it does but you will have your own take on it. I also wonder where else this “ad” is published.