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BioNTech have deals in place with Pfizer, Genentech, Eli Lilly, Sanofi - most of them are 50/50 co-development deals and to meet their obligations they absolutely must progress with the R&D of the targets involved with those deals. The demand on resources just to achieve that is staggeringly high. With over 1000 employees and a largely pre-clinical pipeline they are burning through cash at a rate of knots and that's why they needed to IPO.

I'm hopeful of a deal with BioNTech, but I don't think Scancell will be featuring heavily in any financial decision making on their part.

Chelsea,

They're PDUFA fees - fees that have to be paid to the FDA when submitting an NDA (new drug application). Not to be sneezed at, as next year they're set at just under $3 million.

Ray,

I obviously don't know for sure but I doubt if it's that cut and dry.

I would hope and expect that both companies are communicating closely with each other and also if necessary, the FDA. So Ichor will be clear about what is required and Scancell will be assisting if appropriate and will be aware of any progress. I understand that the FDA have adopted a far more collaborative approach over recent years and also worth remembering that SCIB1 has Orphan Drug Designation. One of the benefits of ODD is greater access to the FDA so hopefully there will be a certain amount of dialogue if needed.

If you go back and read the business update RNS from the 1st July, it seems that at that point Scancell and Ichor believed they had answered all queries and were waiting to hear back from the FDA. Clearly the FDA came back with yet more questions and I guess it was at that stage that Scancell decided to pull the IND.

I'm sure the FDA gave a clear indication of what it wanted and Ichor are now working on that. The good news is that at least when Scancell are in a position to submit a new IND they won't have to wait long for the FDA's decision as turnaround times are only 30 days (from memory)

Guys, we keep talking about Trigrid approval but Ichor aren't applying for approval. This whole IND issue is not related in any shape or form to FDA approval of the Ichor device.

Thanks for the link and no, it hasn't been posted before. Seems that new research is being published almost daily, all adding to the overall understanding of how the immune system interacts with cancer and other diseases at a molecular level. Impossible to imagine where we'll be in another 10 years.

Looks like BioNTech have had to lower the price range for their IPO - now reduced to $15 to $16 (from $18-$20) and looking to raise around $160m instead of the $260 they had hoped for.

Bad luck with timing, wonder whether they considered pulling it altogether for now?

https://www.reuters.com/article/us-biontech-ipo/germanys-biontech-lowers-price-for-u-s-ipo-amid-market-volatility-idUSKBN1WO29B

Chelsea,

Ah right, I think I can see why we're getting our wires crossed a bit. Enrolled doesn't mean treated, it simply means that a patient has given consent to join the trial and this has to happen BEFORE the patient can be screened to ascertain whether or not they meet the entry criteria. So process afaik is as follows:-

1) New patient is referred to Nottingham
2) On the face of it, the patient would qualify and so they will be asked whether they will take part in the trial.
3) Written, informed consent is obtained and the patient has now been enrolled onto the trial
4) Only now can they begin the full clinical screening process - HLA typing etc.
5) They meet entry criteria and are dosed or they don't and do not join the trial

In short, a patient will be enrolled in the trial BEFORE they have been screened and they may or may not subsequently meet the entry criteria.

I hope that makes sense and you can see why the fact the first patient was enrolled 7 weeks ago (presumably) doesn't tell us when the first patient has been dosed.

Ray,

I'm sure they're working on it right now and an RNS announcing the opening of further study centres is more important IMO than the first patient dosed RNS.

I had previously thought that it made sense to abandon US arm of this study and just concentrate on UK, but that was before Scancell told us at the AGM that the NHS won't routinely cover the cost of Keytruda. It puts a slightly different light on things and I can see why they would still want to press on with the IND.

Chelsea,

Ah OK am with you now - but doesn't the fact that we have had no RNS to confirm dosing mean that any patients enrolled early on must have failed to meet the entry criteria for the trial and presumably are now continuing with their SOC treatment outside of the trial?

Chelsea,

Sorry has been a long day and am being really slow tonight so am not quite with you. I agree that they couldn't under any circumstances keep patients waiting - if patients meet recruitment criteria then I'm sure they'll treat them straight away.

On a more positive note, Ichor appointed Flextronics to design and manufacture the new Trigrid electroporation device. They have recently added a write-up on the process to their website which highlights some of the improvements/benefits of the new device.

https://flex.com/case-studies/innovative-drug-delivery-device-transforms-immunotherapy

Chelsea,

You're correct in saying that patients must have a life expectancy of three months or more but I'm not sure what that tells us about whether any patients have been dosed yet?

The BOD clearly stated at the AGM that they would issue an RNS when the first patient had been dosed. Scancell's RNS of 19th August suggested that there were UK patients awaiting enrolment into the trial and if that's true, as we are over 7 weeks in, it seems highly likely that those patients would have been through screening. As there has been no RNS then presumably those first patients didn't meet the entry criteria. Perhaps others are being screened right now.

The real issue is that with just one trial centre open then recruitment is likely to be painfully slow. I don't know how many new patients are referred to Nottingham each month with advanced, inoperable melanoma and who would routinely be prescribed Keytruda as their SOC treatment but I would guess it's not many.

The sooner Scancell can open other centres the better and in the meantime let's hope that first patient dosed RNS comes quickly now.

Nothing Scancell related I'm afraid.

Nice RNS!

'Under the terms of the agreement 4D's proprietary MicroRx® platform will be paired with MSD's expertise in the development and commercialisation of novel vaccines, to discover and develop LBPs as vaccines in up to three undisclosed indications. 4D has the right, subject to certain conditions, to cause MSD to purchase $5 million in ordinary shares in 4D during the first 12 months of the collaboration. In addition to an upfront cash payment, for each indication, 4D will be eligible to receive up to $347.5 million in option exercise and development and regulatory milestone payments, plus tiered royalties on annual net sales of any licensed products derived from the collaboration. MSD will be responsible for development, manufacturing and commercialisation following the exercise of any of its exclusive options.'

https://www.londonstockexchange.com/exchange/news/market-news/market-news-detail/DDDD/14257278.html

Not much other than the fact that the University of Nottingham's fabulous new Centre for Cancer Sciences is almost complete. I assume that LD and her UoN team will be moving across to the new centre. If so, I wonder how this affects Scancell and whether they'll be leasing lab space in the new building?

https://www.nottingham.ac.uk/ccs/

CH is presenting again this year at the Investival Showcase

https://www.lsxleaders.com/investival-showcase

AP101 has been granted FDA Fast Track Designation - excellent news.

IF (note use of capital letters) the EASE trial is successful this could potentially could save months and months when it comes to review of the NDA . Of course this is on top of the Pediatric Rare Disease designation (and the valuable Priority Review Voucher) already awarded by the FDA back in August last year.

Good stuff.

https://www.londonstockexchange.com/exchange/news/market-news/market-news-detail/AMYT/14247980.html

Have just read your 9.35. The two sentences are entirely consistent with each other and with my original point - I have not changed my position at all.

Why would you post such a petty comment? It's becoming almost impossible to post on this bb.

I apologise to others for yet again clogging up the bb with these silly arguments and thanks to those who have tried to bring it back on topic. With ESMO going on this weekend, there are so many things that the bb should be talking about.

Seriously? It's all now OK because it was a concern? !!

This whole discussion originated from a post that stated it was a concern - we have wasted all of this time and effort for what?

Do you think that readers of this bb are so stupid that they didn't appreciate I was voicing a concern , an opinion? Do you think they thought I was posting the official line of big pharma?

Crumbs, thanks for that link to James Gulley tweet.

Over recent months it has seemed that everybody has been focused on personalised cancer vaccines based on selecting antigens specific to each individual patient. Of course, Scancell's approach with ImmunoBody is to target tumour associated antigens that are common to all patients and commonly over-expressed on tumours.

Good to see over the last couple of days several tweets coming out of ESMO highlighting Scancell's approach and the utility of tumour associated antigens - perhaps pendulum is swinging back again?