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But Konar they may have to run the SCOV2 arm of the South African trial first - the MHRA may insist on SCOV2 safety data before giving CTA approval for the UK arm - hence my question to jb.

jb - thanks for that. Did they specify whether it has to be SCOV2 safety data or will the MHRA accept SCOV1 results?

Certainly a comprehensive update from Lindy Durrant and Sally Adams. Some have already been mentioned, but the points that stood out for me were:-

1) They seem to be steaming ahead with Modi2 development
2) A much greater emphasis on the glycan mAbs, although they're not yet in pre-clinical development
3) There have been significant changes to the Modi1 trial design. They are now running arms in the neoadjuvant setting (before surgery) both as a monotherapy and in combination with checkpoint inhibitor in head and neck cancer.
4) Ethics approval now received for Modi1 trial and they are currently selecting study centres.
5) Would be good to get clarity from anyone who attended around the supply chain issues for Modi1 manufacture
6) Looks like SCOV2 Covidity vaccine manufacture is nearly complete and shouldn't be too long before it's released

Chelsea, pleased to hear that you had a good day on Monday and all seems to be going well in your world - long may it continue.

This may well already have been discussed here and I've just forgotten, but looking at the management team on Scancell's website, I notice they have a new Head of Clinical Operations. With 3 trials up and running shortly, I'm sure he's going to be very busy.

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

Had been dithering about whether to convert to ADRs and today's news has made my mind up. Reluctantly I've also decided to move on. Will keep a close eye on progress and wish longs here all the very best. I've been investing in bios for several years and researched companies involved across a wide range of disease areas, by far EB has been the most harrowing and really is the worst disease you've never heard of. So most of all I hope that Filsuvez is approved without further delays and that it's the first of a many new approvals for for EB.

I'll be donating a percentage of my profits here to Cure EB and DEBRA UK.

onceaday - some excellent posts, thanks.

joxer - you have to assume that in view of the fact Amryt submitted the data, they believed they were positive and supported their case. Impossible to guess what it's about but could well be in respect of broader labelling rather than a yes/no decision for approval.

Ray, your 11.28 isn't quite right, the primary endpoints aren't all about safety although can understand why you thought they were.

I think the way the trial has been registered on clinicaltrials.gov may be the issue here. For some reason, Scancell has decided to list each and every safety measure as a separate endpoint. So we have 29 different endpoints all around safety but actually they're simply just different measurements, eg, one for temperature, one for pulse, one for blood pressure etc. I haven't ever seen this before, usually there are just one or two endpoints that are inclusive of all the different measures. Worth comparing to previous phase I/II SCIB1 study which just had one primary endpoint - safety and tolerablility.

I think this gives the false impression of a greater emphasis on safety and tolerability but you need to look at all of the primary endpoints - they are equally important. The final primary endpoint is objective response rate - ie. efficacy. If Scancell had simply combined all of the safety and tolerability measures into one endpoint (as they did with previous trial, then we would be left with 3 primary endpoints - safety and tolerablily, Objective Response Rate (efficacy) and Patient's Questionnaire (patient input now a standard part of clinical trials).

The aim of the SCIB1 study is NOT to show non-inferiority between the combination of SCIB1 and Keytruda compared to Keytruda alone . The trial has been designed to demonstrate that adding SCIB1 increases the response rate of patients to Keytruda. Scancell have told us that a reponse rate of 55% is the trigger point indicating that the trial is a success and the combination warrants further development. Anything below that would be a fail. Non-inferiority would be a fail.

hasiba,

You don't need to be a scientist to understand the aims of the trial, there are plenty of places you can go to do some very basic research - Scancell's website, RNSs, clinicaltrials.gov. You will find that non-inferiority is absolutely not a factor in the SCIB1 trial.

Still waiting to find out how a single arm, combination study can demonstrate non-inferiority.

As for my previous investments, my posts are all there to see and am quite happy to be judged by them. MTFB was a loss and a sobering reminder of the risks in biotech whereas Redx has been one of my best investements so far. I simply post as I see it - whereas some post as they would like it to be, regardless of truth.

hasiba,

'Sclp only needs to prove none inferiority…'

Not so, that's not what this trial is about at all and it's very misleading to make such a suggestion. Incidently, can you explain how a combination study can demonstrate non-inferiority?

Some interesting posts here, thanks to all and Jayne, thanks for the insight into the issues facing those living with EB.

Worth having a read of an article published in The Times today which features 9 year old EB sufferer, Gabrielius who is taking part in a clinical trial at Great Ormond Street. The treatment involves infusions of stem cells taken from umbilical cord tissue and the hope is that these infusions can reduce pain and inflammation for a period. Although Filsuvez will hopefully become the first ever treatment approved for EB, Amryt have said that they see it sitting alongside other therapies as and when they come along. You can see how that would work in this case and let's hope that children like Gabrielius won't have long to wait before these new therapies make a real difference to everyday life.

https://www.thetimes.co.uk/article/football-dream-of-boy-with-rare-butterfly-skin-disease-dwnw0pkj2?utm_medium=Social&utm_source=Twitter#Echobox=1637252115

A peer reviewed paper has been published today in Cancers Journal - this one from the Dept. of Surgery, Leiden University Medical Center in collaboration with Scancell. The research is looking at tumour associated glycans as targets for molecular imaging in pancreatic cancer.

Obviously when trying to surgically remove tumours, it's vital to be able to distinguish healthy tissue from cancer and whilst it's known that certain glycans are associated with pancreatic cancer, their relative presence in healthy tissue is unknown. This research looked at a number of tumour associated glycans (TAGS) and identified those that were highly expressed on pancreatic tumour cells but had very low levels of expression on healthy cells. They found 5 high potential targets and Scancell has mAbs for 2 of these targets in their pipeline (FG88 and FG129) - both were used in this research

The significance of this to Scancell is that once you know that you have a good target then you can develop mAbs and conjugate them with an imaging agent. You inject/infuse the mAbs into cancer patients, the mAb binds with the target delivering its payload and infected cells show up on imaging for the surgeon to remove.

Good stuff and although I know this is a long post, it's worth just quoting one line from the research paper

'Once employed in vivo, the Lea/c/x-specific mAb FG88.2 subsequently displayed remarkable tumor targeting'

Https://www.mdpi.com/2072-6694/13/22/5777/htm#app1-cancers-13-05777

Cleanerworld,

When Redmile bought Lindy Durrant's stock it didn't take their holdings over a notifiable threshold, therefore no RNS was required. The purchase took their total from 29.11% to 29.66% and it would have needed to cross 30% to be notifiable.

Yep, good to see that despite the pressures of Covid, Redx are making real progress with the clinical development of their pipeline.

hasiba,

Firstly, I should say that nobody here doubts that Redmile's motive is pure profit and it's silly to suggest otherwise, however your comments regarding Redmile and Redx show an astonishing lack of understanding of the sequence of events and the factors driving Redmile's manatory offer. I'm more than happy to explain again to you yet again but I'd be interested to know why on earth you think a hedge fund would suddenly start making predatory moves to acquire its investee companies? What impact do you think that might have on its future business opportunites? If you were a major shareholder or the CEO of a company looking for funding, would you approve an investment from a fund that you know is likely to try to acquire you on the cheap?

Olderandwiser - yep especially on a bank holiday weekend

Burble also interesting to note that the research appears to have been carried out in collaboration with the University of Tübingen as Ana Marcu is named as one of the authors. Prof Rammensee is head of immunology there and was part of Lindy Durrant's Grand Challenge team so I assume this is just the sort of research that would have come from that project.

New peer reviewed research from Scancell was published yesterday - see link below. The work is related to Moditope and gives an insight into how complicated and difficult it is to find the right peptides in the right combination to make an effective Moditope cancer vaccine.

The traditional methods of selecting peptides such as genomic analysis orMHC binding algorithms aren't reliable for citrullinated peptides so Scancell have approached it from a different angle. They've taken tumours from mice (before any treatment) and identified peptides being presented through the HLA-DP4 allele on those tumours. They identified 385 peptides, of which 25 were citrullinated and then narrowed it down to 7 of the most promising to test .

They found that some of the peptides stimulated strong pro-inflammatory responses and others anti-inflammatory and that simply combining all 7 into a vaccine had little impact on tumours. However, when used individually, some produced very strong anti-tumour responses - up to 90% tumour free survival. This might be down to the fact that all 7 are competing with each other for binding resulting in a lower dose of each actually being delivered.

The conclusion seems to be that Scancell believe that this method provides a powerful tool for identifying citrullinated peptides which are strong targets for cancer therapies but that care needs to be taken to avoid competition when used in combination.

Amazing the amount and complexity of the work involved and Scancell really are working at the cutting edge here.

https://www.frontiersin.org/articles/10.3389/fimmu.2021.764462/full

Gerkin - excellent spot, thanks for sharing.

The link to The Times article is below, together with a link to the NCRI press release. As you can see, the researchers at Barts were using Parsortix to capture the CTCs: -

'The researchers used a blood filtration system called Parsortix to identify CTCs based on their larger size compared to other components in the blood, such as white blood cells. It also captures different subtypes of CTCs.'

https://www.thetimes.co.uk/article/blood-test-help-treating-prostate-cancer-risks-t5qdtkln5

https://www.ncri.org.uk/blood-tests-predict-which-prostate-cancer-patients-develop-chemotherapy-resistance/

Nice article below highlighting the advantages of CTC liquid biopsies over ctDNA and Parsortix gets a mention:-

'In contrast, recent developments in the liquid biopsy field mean that “next generation” technologies are able to isolate and count CTCs whilst the cells are alive. The Parsortix® system (developed by Angle PLC) is one example of a next-generation liquid biopsy technology'

'Next-generation liquid biopsies will allow researchers and clinicians to generate patient-specific high-resolution tumour maps, which may be used to develop of new anti-cancer treatments, and to personalise these treatments to individual cancer patients.'

https://bionow.co.uk/news/b618a80d0d7aa8/circulating-tumour-cells-at-the-forefront-of-cancer-diagnosis-and-treatment