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Crumbs,

It's interesting - I hadn't paid any attention to BioNTech's collaboration with Genmab, it goes back to 2015 and Genmab have come a long way since then. Now listed on NASDAQ with a $96 billion market cap, 2 approved drugs with blockbuster sales and deals left, right and centre.

I had no idea that back in 2001 they had a collaboration with Scancell to develop glycan mAbs. Obviously came to nothing but I guess it's possible that Genmab is the pharma evaluating Avidimab.

https://www.scancell.co.uk/genmab-and-scancell-announce-cancer-antibody-product-collaboration-%E2%80%94-first-disease-target-identified

Crumbs,

It was a phase I and looks like it had already stopped recruiting at the end of the dose escalation phase and prior to the expansion phase. So as far as I can see, the pause wouldn't affect any patients. It'll be interesting to see what changes BioNTech make to the protocol.

Crumbs,

Would need to check again but I'm pretty sure that it's only paused because they're waiting for the FDA to clear BioNTech's IND - transferring the trial from MabVax to themselves and asking for some changes to trial protocol

Interesting to see that they have a glycan mAb in clinical trials - acquired when they bought MabVax earlier in the year

Chelsea,

I think there is some confusion here regarding interpretation of wording.

From your earlier post:- "good news from CH yesterday in regards to Keith Flaherty leading the U.S. arm of the SCIB 1 Combo"

My interpretation of your comment = CH had confirmed Keith Flaherty would be principal investigator - how else could he lead the US trial?

Not to worry, as you say, at least he is still involved.

Chelsea,

Thanks for taking the time and trouble to report back with CH's reply.

I think we have to be careful how we interpret his response - have another read. We know he always chooses his words very carefully and all he actually said was that Keith Flaherty will 'continue to have an involvement '. 'An involvement' what does that actually mean? Could mean anything at all. If KF was going to be a study investigator for one of the US sites then why not just say so?

Some very large trades going through again today - £3m and £4m at 9.22, 2 x £1m at 9.30, another £1m at 9.44 all at 375p and again presumably part of the same transaction.

Quite a few comments on here today about REVIVE 1/2 trial design and the issue of IV drug users.

IV drug users are particularly prone to ABSSSIs and make up a significant portion of the overall patient population . It's quite normal for IVDU's to be eligible for recruitment to ABSSSI clinical trials. If you look at the 2 phase III trials for Paratek's Omadacycline /which were running at the same time as the Iclaprim trials, you'll see that over 60% of all patients recruited were IVDUs and Paratek went on to secure FDA approval for Omadacycline . The reason why IVDUs are specifically mentioned in results reporting is that they're an important population sub-group for post-hoc analysis.

AFAIK, there is nothing to suggest that there was any issue with the trial design and in any case, do we even know whether the CRO was involved in the design? Nevertheless the RNS today certainly suggests that there has been some sort of an issue. Would have to go back and check my notes from the time but there were several patients lost to follow up, more on the Iclaprim than Vanc arm and they were nearly all IVDUs. Were they lost to follow up because CRO didn't follow protocol? Who knows? We'll probably never find out.

Chelsea,

Yes I'm sure that back in January they were still hoping that they could get the FDA to clear the IND, although I'm not sure they expected it within 2 months.

As I understand it, Poulam Patel has now become head honcho for this trial. If they do manage to open any US sites then Keith Flaherty may well be study investigator for his particular centre but I'd be surprised if Scancell give you any details, other than to confirm he will still be involved (we hope!).

WTP

No, none at all AFAIK and this is likely the original record before the IND was pulled. Points of interest are perhaps that they intended to open 2 UK sites in addition to the US sites. Also regulatory approval (from MHRA) was given on 16th January 2019 and ethics committee approval on 24th January.

They can of course make amendments as and when required - below is a more user friendly link.

https://www.clinicaltrialsregister.eu/ctr-search/trial/2018-002844-10/GB/

The SCIB1 trial now appears on the European Clinical Trials Register - link below. You can download details by using the drop down menu to the right, make sure you select full trial details and not summary details.

https://www.clinicaltrialsregister.eu/ctr-search/search?query=SCIB1

Yep - big trades going through @ 355p - in total over 1m shares and over £3.5m at this price. Assume they're all part of the same transaction.

Reassuring, solid update with some impressive figures. Good to see the potential to extract further value from both Lojuxta and Myalept too.

Some interesting numbers in the report below which was published today and is looking at trends in clinical trials for PD-1 and PD-L1 checkpoint inhibitors, of course that includes Keytruda. Just a few extracts:-

'Since 2006, 3,362 trials have been launched to test PD-1/PD-L1 mAbs alone or in combination with other agents, and 2,975 of them are still active as of September 2019, planning to recruit over 500,000 patients.'

'76% of the active trials are testing combination regimens of PD-1/PD-L1 mAbs with other cancer therapies'

'The shift from monotherapy to combination therapy in the clinical trial space in recent years has resulted in 14 approvals of combination therapies by the FDA.'

https://www.nature.com/articles/d41573-019-00182-w

Re. your 14.56 post:-

It's not correct to say that 2 of Valirx's products have nearly reached phase III - they're nowhere near that stage. VAL401 has only been tested in 8 patients and none of them even completed treatment. We have no idea how many patients have been treated with VAL201 but we do know that they are still trying to establish the optimum dosing levels and regime. It will take years and many millions of £££ in funding to take either product into a phase III trial.

Chelsea,

Just to be clear, Scancell didn't say at the AGM that they would be giving regular updates, just that they would RNS the first patient dosed.

I'm sure you're right, I'm sure they have been screening patients but there are probably less patients than you think being prescribed Keytruda as a first line monotherapy for late stage melanoma so the throughput of patients each week/month is going to be low. You mentioned that patients will be drawn from other areas but I think it's highly unlikely that they will travel from 100 miles away to take part in this trial. Don't forget they are very sick and the dosing regime is every 3 weeks for up to 2 years . That's a huge commitment.

So in short, I don't think there is a big problem with enrolling patients - just that there aren't many of them and none so far have met the entry criteria.

ps. hope your cold gets better soon.

Chelsea,

Ichor were granted options over 3 tranches of shares, all with an exercise price of 4.5p :-

TRANCHE 1 -
1,592,310 shares vested way back in 2010 and were exercised in 2013. I don't know for sure but would assume Ichor sold these long ago (lock in period was waived by Scancell in 2013)

TRANCHE 2
3,184,620 shares which were exercised in July 2018 as part and parcel of the Ichor licensing agreement. However, they have a 2 year lock-in period and so can't be sold until July 2020.

TRANCHE 3
3,184,620 shares which vest on completion of a phase II trial. Although the original phase I/IIa trial is complete, I can't find any notification that this tranche has vested and these options certainly haven't been exercised by Ichor.

So the only stock that Ichor could possibly hold and be selling is the original 1.5m+ 2010 tranche 1 shares but as I mentioned, I would assume that they were sold long ago therefore, I don't think Ichor are the culprit. Either way, any selling won't generate a TR1 because even all 3 tranches added together are below the notifiable threshold.

Finally, I agree that just blaming the BOD is easy and I genuinely try not to fall into that trap, I'm sorry if you feel that's what I've been doing. On the other hand the 'BOD can do no wrong and let's blame everyone else' mantra is just as easy and just as dangerous. Sometimes, it's not a question of blame so much as just understanding the issues.

I can't understand why they didn't just switch back to the original mark I device, we'd likely be sitting here discussing the results now if they had. For some reason they've stuck rigidly with waiting for the new device. Sally Adam's explanation was that it's because this is the device that will be used commercially. That would be fair enough if this was a phase III trial and would be leading to marketing approval - but it's not. Further trials will be needed, so plenty of time to change delivery method in future trials.

Perhaps they had other reasons or perhaps Ichor wouldn't play ball and couldn't/wouldn't support the use of the mark I device. From memory, they've already extended Scancell's licensing option 2 or 3 times and maybe they just weren't prepared to do so again. If so, the choice facing Scancell was to just wait or walk away.

Whatever the reasons though, SCIB1 has stalled for now and the sooner they get some momentum behind the current trial the better, although as I have previously posted, IMO the best hope for ImmunoBody lies with SCIB2.

No, I'm sure plenty has been happening with Moditope and Avidimab - I was talking only about the SCIB1 trial. Not quite sure whether you're asking me to justify why I said they sat and waited or whether you're asking me why I think they did.