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WTP

Until we find out more about the trial it's hard to say. We will learn much more when the trial appears on one of the registers or perhaps if LD does some media. Here are some of the questions that spring to mind:-

1) How many study centres make up the 'first wave', where are they and who are the investigators?
2) Is it correct that patients in all 4 cancer types can receive Modi-1 either as a monotherapy or in combination with a checkpoint inhibitor?
3) If in combination - is it a specific checkpoint inhibitor or can it be any? If any, can it be anti PD-L1 as well as PD-1?
4) Assume that as it's a SOC treatment, the checkpoint inhibitor will be funded by the NHS?
5) What is the dosing frequency and period?

Looking forward to finding out more.

Wild,

Hope you had a good break and good to hear from you.

Well done to all who have managed to bank some profit today and let's hope there are plenty more opportunities to do so in the future.

Guys,

When you're replying to these posts by hitting the reply button on a thread you're actually creating post after post with titles like 'oh dear', 'Mates rates placing incoming, 'another pump and dump' etc. etc. Much better to reply by creating a new thread with a new title.

James007,

Just to be clear, as others have said, cash in the bank as at Oct 21 was over £35m and from memory cash burn was somewhere around £15m per annum so a placing is not imminent and by bio standards Scancell have a decent cash runway. Also don't forget the Covid work is largely funded by Government grants. If and when Scancell need more funds, it's good to know that they have the backing of top quality pharma specialist funds like Redmile.

TF,

No I meant the 4 cancer types specified for the trial.

By the way, that's how the RNS reads to me - ie. it has been opened up to patients to renal, TNBC and ovarian cancer patients who are already receiving a checkpoint inhibitor as their SOC, but it will be good to seee the full details when it appears on clinicaltrials.gov, including which study centres have already been set up and which investigators are involved.

Modi1 is the main reason why many longs have remained invested and it's absolutely fantastic to see it finally enter the clinic. Looking forward to seeing the full trial details, but seems like it's going to be a decent size with up to 20 trial centres. Also appears that Scancell have indeed been waiting for a protocol amendment from the MHRA and the trial will now be in combination or as a monotherapy in all cancer types (rather than just H&N).

New peer reviewed research from Scancell was published last week in the frontiers in Immunology Journal.

It's looking at the role of homocitrullination in cancer and shows that preclinical research into Modi2 is continuing apace. The conclusion:-

'In vivo studies show that these responses can provide a strong anti-tumor effect that is dependent on tumor expression of MHCII. The results contribute to our understanding of Hcit as a cellular mechanism beyond the scope of autoimmune disease and may open exciting new avenues for the treatment of cancer in a diverse HLA-background.'

https://www.frontiersin.org/articles/10.3389/fimmu.2022.873947/full

Ray,

No I don't think clinical trial approval is dependent on manufacture. I'd be grateful If there's any way you could double check re. Sally's comments. If they're combining all 3 peptides then I wonder how they can start the trial with just Vimenitn? I guess they'll have 2 different batches one with and one without enolase. In her last interview I think LD wouldn't confirm whether or not the enolase manufacture was completed. From memory she made a cryptic comment about having a smile on her face. Would be good to get a definitive answer.

Crumbs,

Don't forget the issues regarding the manufacture of the enolase peptide. I believe Scancell have confirmed those issues have now been resolved but we don't yet have confirmation that it's been manufactured and delivered. If it has or if delivery is imminent then I guess it's entirely possible that they might tweak the trial design to start with all 3 peptides rather than just the two vimentin. If so, the MHRA would need to approve an amendment to the trial protocol.

All pure speculation of course but in the absence of any update from Scancell, that's all we've got at the moment!

The approval process for medical devices is very different in Europe and FDA assessment is considered much more stringent. Parsortix already has a European CE mark, however, the absolute gold standard is FDA approval and before spending huge amounts on marketing in Europe, it makes commercial sense to try and secure FDA approval first.

Nice mention for Scancell in this article from Mewburn Ellis:-

https://www.mewburn.com/news-insights/a-much-needed-boost-the-future-of-coronavirus-vaccines

Skerries,

Yes, I agree and have no doubt that they will be able to raise the funds required, I'm more interested in what form the funding will take. Will it be a standard equity placing? If so it will be really interesting to see the funds involved, the price they're willing to pay and how Redmile play it. A real positive for retail investors looking at Redx is the quality of its major shareholders and it would be great to see that continue.

Yes, quietly getting on with the job in hand.

Clearly Redx need to raise funds at some stage this year and the type and terms of the fundraise will tell us a great deal about the direction of travel for this Company.

Prior to today's announcement, the strategy was clear - test SCOV1 as a primary vax in previously unvaccinated patients and then boost with SCOV2. The data produced would demonstrate safety, possible signals of efficacy and inform Scancell's decision as to which PharmaJet device to take forward into further trials. The UK arm would then test just SCOV2 as a booster to vaccinated patients. Now the SA trial is open to previously vaccinated patients, I assume that they are in effect boosting those patients twice - firstly with SCOV1 followed by SCOV2, so we have quite a mix of patients with both vaccines being tested as a booster.

I'd like to understand what exactly has prompted Scancell to request this change in protocol and whether there are any implications for the UK arm of the trial or the overall strategy for Covidity. I don't think anyone could disagree that recruitment has been disappointingly slow to this trial and I assume the changes are an attempt to proactively tackle that problem.

Burble,

Re. your 7.12, wouldn't the original protocol of dosing with SCOV1 and then boosting the same patients with SCOV2 have given all the data they needed to secure MHRA approval for the UK trial? I'm struggling to see how today's news achieves anything other than speeding up recruitment as it doesn't apprear to have been accompanied by an increase in overall patient numbers. Yes there will be more data in a wider setting but in much smaller patient populations - guess that's the trade off.

Kashdog,

Neither the South African Clinical Trials Registry nor clinicaltrials.gov has been updated since October 2021 so it's probably unlikely that those dates are still valid.

Burble,

That sounds nasty, take care of yourself.

Mumbo_Jumbo

It isn't 4/47 to data - it's 4/16. The data reported today are only for evaluable RCC patients.

Crumbs - have you been drinking? :)

I'm not sure what updates people are hoping for with Covidity. We've been told that they're pressing on with recruitment, that the second SCOV2 arm of the trial has commenced and we know the full details of trial design, study centre, principal investigator etc. Normal practice would be to RNS first patient in and last patient out plus any interim data along the way. The last update was only 7 weeks ago and we have to assume that still stands.

I suspect that it's the Modi1 trial that is the main frustration for most and agree it would be good to know what progress has been made with the trial preparations. In light of the fact that the enolase peptide manufacture issue seems to have been solved, I do wonder whether we'll see any tweaks to the trial design.