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Fantastic RNS from Amryt this morning.

Since 2009, the FDA have only issued 20 odd priority review vouchers. If the Ease trial is successful and NDA approved, Amryt can either use the voucher or sell it. Most likely they would sell it and just to give some idea, last year 5 vouchers were sold by various companies for between $125 and £125 million.

So Amryt could sell the voucher and effectively the proceeds become non-dilutive funding.

Great stuff.

Basilea Pharma are currently carrying out a phase I/II clinical trial in glioblastoma for their cancer drug BAL101553 (clinical trial register link below).

One of the secondary endpoints of the trial is assessment of levels of circulating tumour cells (11).

They have today published the results in The British Journal of Cancer in a paper 'Detection of circulating tumour cell clusters in human glioblastoma'.

Great to see that they used the Parsortix system for this trial. Even more exciting is the fact that they have used the system to provide the first ever evidence that circulating glioblastoma clusters can cross the blood-brain barrier. Great stuff.

Really positive that Parsortix is being used in clinical trials but especially a pharma sponsored trial.

https://www.nature.com/articles/s41416-018-0186-7

https://clinicaltrials.gov/ct2/show/NCT02490800?term=NCT02490800&rank=1

Thanks for that and it provides a good insight into the situation back in 2009 when the SCIB1 clinical trial was being designed and Scancell were evaluating 3 different delivery methods.

Fast forward 8 or 9 years and it's interesting to see how the field has developed. The research below explains the advantages of DNA vaccines and perhaps and a glimpse of the future? If nothing else, it's worth reading the conclusion.

Some sound bites from rest of the paper:-

- recent clinical data have re-established the value of DNA vaccines, particularly in priming high-level antigen-specific antibody responses.

- DNA vaccination has an excellent safety profile in the clinic

- Nucleic acid (DNA and RNA) vaccines have characteristics that meet these challenges, including ease of production, scalability, consistency between lots, storage, and safety.

- New formulations exploiting sustained vaccine delivery methods, such as slow-releasing micropatches or multilamellar vesicles, are on the horizon

- The strong appeal of needle-free injection and mucosal delivery, the ease of design, and the recent clinical successes with DNA vaccines suggests that this approach is on the precipice of redefining the field of vaccinology.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5718814/

Goodness knows.

As I understand it, the issue with DNA vaccines is being able to deliver the vaccine across several barriers and actually into the cell. Ichor (with Scancell's help) have shown that EP is an effective way of achieving this but there's a huge amount of research going on into the delivery of DNA and mRNA vaccines and it's another field that seems to be advancing very quickly.

For years, Scancell have simply extended their agreement with Ichor for use of their TriGrid device. However, it wasn't a full licensing agreement, just an option to license. As we know, in July they finally exercised that option and signed a full blown licensing agreement. It's not clear from the RNS whether that agreement is restricted to use only with SCIB1 in melanoma. I'm also not sure how it works in practice re. supply of the devices and training of staff to use it. Do Scancell have to buy the machines? Do they hire them in? Who trains the staff to use them and provides technical support? All of these things may have a bearing on whether or not EP is used for the SCIB2 trial.

As both you and Ray have pointed out, Scancell will fully evaluate different methods and will select the system that gives the best results and the best chance of success for SCIB2.

Ray/Chelsea,

Re. discussions yesterday on timescales for SCIB2.

According to Scancell, the manufacture DEVELOPMENT will begin in Q2 which isn't the same thing as the start of manufacture itself. The schedule is for development work to start in Q2 which no doubt will involve further testing and finalising choice of delivery system (nanovesicle) and then for toxicology studies to begin at the back end of this year.

A huge amount of grant funded research is undertaken each and every year by academics and the biotech. industry. There will be standard and accepted ways of dealing with the finances and the IP without any need to set up new companies or risk of anyone stealing IP.

Most likely each component part of the project will be budgeted and funds allocated accordingly and in return an agreement will be drawn up detailing exactly what work will be undertaken including the costs and timescales. So each member of the team will receive funding directly for their own part of the project.

https://www.cancerresearchuk.org/funding-for-researchers/how-we-deliver-research/grand-challenge-award/shortlistedteamdurrant

Agree and if LD's team win the award, I'm not sure it's correct to say that the cash will top up Scancell's bank account. I would have thought the whole thing would be run as a project with the cash held by CRUK and drawn down as and when.

I agree - Scancell communicate what they can, when they can.

I would also add that when it comes to communication, Richard Goodfellow was one of the most responsive and approachable CEO's I have come across. So far, Cliff Holloway appears to be following in the same vein.

Anyway, have a good weekend all - let's hope for news next week.

Sorry, but I think it's quite reasonable to be feeling a little impatient at this stage and to hope that the BOD can now start getting closer to meeting its own timescales.

The record for the EASE trial on the Clinical Trials Register has been updated today with new trial protocol.

Main changes:-

- recruitment increased from 164 to 192 patients

- Primary outcome measure and entry requirements has slightly changed from wounds that were over 21 days old to wounds over 21 days but less than 9 months old

- EB Simplex now excluded

- 2 new trial centres opened in Brazil and trial centre in Denmark has started recruiting

No surprises, all in line with previous announcements from what I can tell.

https://clinicaltrials.gov/ct2/show/NCT03068780?term=amryt&rank=1

Yep, great news.

- Scancell have now fully licensed Ichor's TriGrid EP device

- Tranche 2 of Ichor's options (4.5p exercise price from memory) clearly part of the negotiations and locked in for 2 years.

- Confirmed that SCIB1 combination trial will commence in H2 and will indeed be carried out by Keith Flaherty as principle investigator.

Things finally starting to move now, excellent.

Hang on a minute.

The whole day has been spent arguing about RR's use of the word 'evaluate'. You have accused people of having a problem, lack of understanding, attempting to smear the English language etc. etc. You also said:-

'If you had of understood what Lindy had described in the video and the RNS you would not have used the word Evaluate'

.........and now when it is pointed out that actually it was Scancell themselves who used the word 'evaluate', you don't hold your hands up and admit you've gone off on the wrong tangent, you don't apologise to those you've insulted, you try to claim that it's a contradiction.

Perhaps you should write to Scancell and inform them that they've made a mistake in their use of the English language (according to your scientific research)

You don't need to bother replying as bb will be happy to know that I won't be responding.

Was your 21.23 in response to my 21.21?

Even Scancell use the word evaluate. See slide 10 from their Calculus presentation.

2018 Q1: Start EVALUATION of Modi-specific TCRS

2019 1H: Complete initial EVALUATION of Modi-specific TCRs

http://www.scancell.co.uk/file-manager/PDFs/scancell-presentation-feb18v2.pdf

So Scancell use it and Hardman use it.

I don't know why LD didn't use the word evaluate and the Hardman report did. It's just a word.

The whole point of my post this morning was to try and move on by explaining the process so hopefully folks could see that no matter what verb you use the opportunity is exciting for both Scancell and BioNtech.

I clearly have failed miserably in that and yet another day on the bb has been taken up with a thread that I wish I had never got involved with :) Apologies to the bb!

lol - no, I'm still here. I didn't respond because I had nothing to add.

We're not talking about protecting IP here, we're talking about posts on a bulletin board. I honestly don't know why you keep mentioning that my post wasn't novel, I have never claimed it was. By definition, any post that is simply stating, summarising, reporting back on information given out by Scancell can't possibly be novel.

No problem here. I have no idea why the time taken by BioNTech to carry out step no. 4 in my post is relevant to anything or why you feel it means I have simplified things too far.

RR asked a simple question and Ray answered him - you for some reason took exception to the use of the word 'evaluate'. You now seem to have taken exception to my post which was attempting to provide a simple explanation of the processes involved with the development of the moditope TCR.

This whole thread arose from this very simple and innocuous comment from RR:-

'Ray, the evaluation of TCR and Moditope was due to start Q1 2018'

Nobody was talking about route to markets or risk or anything other than timescales. I would wager that it hadn't crossed anybody's mind that evaluate = risk until you suggested it:)

The process in very simple terms is:-

1) Stimulate human blood
2) Introduce dye that allows identification of CD4 cells responding to Modi1 epitopes
3) Sort cells - single cell per well (across hundreds of wells)
4) BioNTech then expand DNA from that single cell, identify gene encoding the TCR and clone it

Whether you call it evaluation, identitication or just 'working on' isn't that important IMO. What's important is that this collaboration gives Scancell another avenue to explore to maximise the potential of the Moditope platform and it gives BioNTech a completely novel pathway for TCR therapy. This is against a backdrop of growing awareness and expectations for TCR therapy.

isas - yes very probably