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I'm fully aware of the MOA of Keytruda and SCIB1 but you're missing the point. How do you prove in a 25 patient, uncontrolled trial that complete responses in 5 patients instead of 4 was down to the combination of SCIB1 and Keytruda and not Keytruda alone ?

In the Keynote-006 trial, Keytruda achieved a 42% response rate and a 14% complete response rate.

Wild,

No, I don't think they should bin the current trial - data coming from this trial will be valuable to support development of the platform and in support of any future applications to the regulators. Hopefully it will also be sufficient to attract investment.

Inanaco,

Genexine already have a deal with Merck and that's the difference! Their trial is a phase I/II - the aim of which is simply to establish whether the combination is safe and merits further development. The bar in HPV cancer is also set much lower as from memory only about 10% to 15% of patients respond to Keytruda alone.

The purpose of the SCIB1 combination is all of the above but also the results must be good enough to attract an offer from big pharma. Scancell already have great data in small numbers and big pharma wasn't interested. On top of that other combinations are moving the bar ever higher, Scancell's results don't have to simply be superior to Keytruda as a monotherapy but they're also completing with other PD-1 combinations.

I hope I'm wrong but I was so pleased when Scancell announced they would be running an 85 patient randomised study for SCIB1 in melanoma and so bitterly disappointed when it was scaled back to a single arm, uncontrolled study. That's why SCIB2 trial is so important and am looking forward to hearing how CRUK are doing on that front.

Wild,

The issue isn't anything to do with how easy it would be for AN Other to copy SCIB1 - it's whether big pharma would be prepared to pay for a product with such a short patent life, even with market exclusivity in the US.

If you want my honest opinion (I know you probably don't lol) but I think Knowlesi is probably right about SCIB1 in it's current form. I can't ever see it getting to market or anybody paying to license it. That's mainly because as Inanaco alluded to yesterday, SCIB1+ is sitting there waiting to be developed and I can't see anybody paying to run a large randomised study with a vaccine that only works in 45% of the population when another is available that covers 90%.

Moreover, for reasons discussed before, I'm not convinced a trial in 25 patients will be enough to persuade big pharma to make a move for SCIB1 and IMO the future of ImmunoBody lies with SCIB2.

Obvs. just my opinion.

It has Orphan Drug status in the US but not Europe or the rest of the world.

Sorry but should point out re. my 20.06 that 'Ichor has lead us up the garden path' is a direct quote (spelling too).

Very possibly, I know they had previously sold some stock and had then been diluted down to 3.5% . Now according to annual report they've dropped below 3% so we won't know how many they've sold or how many they're still holding.

Can only hope that Vulpes' investment will now encourage others to take the plunge.

Just working back catching up on posts - your comment that Ichor has lead us up the garden path is a bit strong. You have no evidence to support that accusation - we don't have a clue what the issue is with the FDA and the Ichor device. For all we know they may have an excellent working relationship with Scancell and may have done everything they possibly could to resolve the situation.

You mentioned earlier that you think Ichor may have been selling their stock. They may be but also looks like L&G have been selling. According to the Annual Report as at August 15th only 2 institutions now hold over 3% of Scancell's stock, Vulpes and Calculus whereas at the end of June L&G held 3.5% (16.3m) so assume they have been reducing their holding.

Right thanks, yep all previous data, clinical and preclinical no matter what the delivery method would be considered in any deal and also would be submitted to regulators either when seeking clinical trial approval, or eventually marketing approval.

Chelsea,

Can you clarify exactly what you mean - are you suggesting the one trial can use both the old and new devices?

Anyway let's hope for better news tomorrow.

That's fine, but in that case don't make an unequivocal statement that dosing for the UK arm will start by the end of June when you are in no position to make that statement.

rats,

Thanks for your response and I do understand where you're coming from. Seems you are indeed correct - they took a gamble and hoped they'd never need to let shareholders know that recruitment to the UK arm ahead of FDA approval would in effect void the IND.

I remain invested here but I think it's a sad day when we accept that it's OK for a company to withhold important information from shareholders and encourages them to believe that it's full steam ahead just because it would have been damaging to reveal it . Anyone with any doubts should listen in to the interview CH gave on the day the UK approval was announced.

I fully accept that we all have different opinions on this and now I've given mine, I'll move on.

Https://www.youtube.com/watch?v=AGcwqSnsm_8

Anyway, I've said my bit and will leave it at that.

The cost here isn't a couple of weeks dithering with the FDA and more fool you if that's how you see it.

Crumbs,

Agree 100%

What has that got to do with it?

rats,

Seriously? You think it's OK to have told investors that recruitment to the UK arm was about to start without adding the proviso that it was subject to clearance of the IND? I can understand the motives but it doesn't make it right or OK in my book.

https://www.proactiveinvestors.co.uk/companies/news/901043/scancell-back-in-the-clinic-with-a-phase-ii-trial-of-its-flagship-skin-cancer-treatment-901043.html

If Vulpes knew this was likely then all shareholders should have known.

From Scancell's RNS of 25th April announcing approval of the UK trial :-

'Dosing in UK arm due to commence during this quarter, as planned'

This RNS even went on to give an update on the situation with the FDA and yet there is no mention that the IND needed to be cleared before the UK study centres could begin recruitment. Nor was it mentioned by Sally Adams during her detailed and comprehensive presentation at the 2018 AGM. It would be interesting to know who was named as the Principal Investigator on the CTA application to the MHRA.