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Took me forever to type my 12.25 as was interrupted by phone call which also explains poor punctuation and grammar! Your 11.57 wasn't there when I started.

The study has not appeared yet on any clinical trials register (afaik), it doesn't come up on the NHS clinical trials gateway and we haven't had a 1st patient dosed RNS. In addition, we have not a clue how many study centres are involved, their locations or who the study investigators are. In view of the history, it's not surprise that there is speculation. Rather than just assuming that dosing is going on in the background, it might be worth just thinking about the process and factors that will influence the speed of recruitment. If there is a gap until first patient dosed RNS is received it might help to understand.

1) Does the withdrawal of the IND require re-negotiation/amendment to contract with the CRO
2) Presumably the IND and the CTA named Keith Flaherty as Principal Investigator . Have Scancell had to submit an amendment to the CTA to change to Poulam Patel and are just waiting for the nod from the MHRA.
3) Is it just one trial centre (Nottingham) already screening patients ? - if so all of the following must be ticked to get to that first patient dosed:-

- patient is referred with stage III or IV inoperable melanoma
- they haven't previously been treated for advanced disease
- their standard of care treatment is Keytruda
- they are willing to take part in the trial
- they are the correct HLA type, only 45% of the population are & in 1st SCIB1 trial I believe the first 9 patients screened were the wrong type

etc. etc. etc.

There will also be plenty of other inclusion/exclusion criteria which will be listed when the trial finally appears on a register.

Inanaco,

Every biotech. I've ever invested in when commencing a clinical trial has issued a first patient dosed RNS. They have been regulatory announcments rather than non-regulatory. Moreover, when Scancell commenced the original SCIB1 trial back in 2010 they issued a regulatory RNS to announce the first patient dosed, so they and their nomad clearly thought they had to tell shareholders back in 2010. Not sure why you think they don't have to tell us.

Yes, good news . May be worth having a look at the link in my post of 21st August which is an article from the University of Rochester and gives more detail from Dr. Richard Moore who will be carrying out the study. Interesting to read from the perspective of the investigators.

Courtesy of Waterloo, Summit and ridinilazole get a mention in following article in FT today.

https://www.ft.com/content/5b26b9ec-8d2d-11e9-b8cb-26a9caa9d67b

Violindog,

lol sorry to add to your woes but both RG and LD have share options with an exercise price of 4.5p. Not sure whether you were around back in 2015/6 but these options expired in 2015 without being exercised but were simply reissued to them in Jan 2016. Caused quite a kerfuffle at the time.

I don't personally have any issue with the BOD's share options, other than I would love to get to the stage whereby they have met all the vesting criteria and want to actually exercise any options!

https://investegate.co.uk/scancell-hlds--sclp-/rns/amendment-to-options/201601270900010851N/

Violindog, do you mean the BOD's share options or Ichors?

Thanks for the info.

No, others may know better but I don't think UK companies have to notify the market of the expected publication date of interim results. Not sure whether it's compulsory but most issue a notification of the date for the annual results.

Effect of consolidation would have resulted in a pre suspension equivalent SP of 74.28. Interim funding agreed at 90p, a premium of 21% to pre suspension price. Going to be interesting to watch this unfold.

Inanaco,

Well please tell me, who will be reviewing the master file? Two completely different divisions of the FDA deal with medical devices and new drugs. Scancell have withdrawn their IND, why would the devices division take it upon themselves to review the master file?

You may have missed this sentence from my earlier post:-

'I'm sure Ichor will continue working to resolve the issues raised '

'

Ray,

Yes exactly, a good way of putting it.

Ray,

Ichor haven't submitted an IND, nor will they.

I know I keep banging on about this, but IMO the process and the distinction between who is applying to the FDA for what is important. First and foremost this whole process is unrelated to FDA approval of the Ichor device per se. I'm sure one day Ichor will seek marketing approval for their device but that is a long way down the line and in the meantime it will be used for research purposes only and its use has to be authorised by the FDA on a case by case basis.

In February 2018 Ichor submitted their Master File to the FDA - the FDA may check it for completeness but they don't review it in the sense of approving the device. The purpose of the master file is purely as a point of reference for the FDA when assessing INDs from individual drug companies wanting to use the device in their trials.

The FDA wouldn't therefore have picked up any deficiencies in the data provided by Ichor until they reviewed the first IND received. We have no way of knowing whether those deficiencies relate to the device in general in which case the FDA would have the same issues with subsequent INDs received from other companies, or whether they are related purely to the device when used to deliver SCIB1.

I'm sure Ichor will continue working to resolve the issues raised but the FDA won't be sitting there continuing to review the Ichor device because there never has been a stand alone review, all they have ever done is reference the master file to assess Scancell's IND and that master file will continue to sit there.

Hope that makes sense and whatever the reasons behind the delay, it seems it's out of Scancell's control.

Hope that makes sense.

sushifishman,

Does the trial have 6 monthly planned IDMC reviews then? How long do they typically take to report their decision?

Chelsea,

Priority Review Vouchers are awarded by the FDA to companies developing drugs for rare paediatric diseases . If the FDA approves an NDA for that drug then the company can either sell voucher or use it for future drugs of their own.

As the name suggests, the voucher entitles the owner to priority review when it comes to approval. The review period is shortened to 6 months. Only a handful are handed out each year by the FDA and as AstraZeneca have shown today, big pharmaceutical companies are prepared to pay tens of millions to buy vouchers to use with their own drugs because it speeds up the time taken to get their drug to market.

Re. your question on the AGM - I don't know but think you may be confusing John Chiplin and Martin Diggle. I believe JC has moved back to the UK.

Deadly,

Who knows whether any study centres have actually opened for recruitment and started screening patients yet? In fact who knows how many study centres there are, where they are or who the study investigators are? All we know is that Prof. Poulam Patel is now Principal Investigator so I guess it's possible that they're concentrating on just getting Nottingham up and running. There is no sign of the trial yet on any of the clinical trial registers or on the NHS clinical trail portal.

As for AGM, I'm pretty sure the only reason the AGM is early this year is likely to be down to nothing more than logistics. It can't be an easy task to coordinate diaries especially with AL based in USA and I believe MD lives in South Africa. Perhaps one of them are off on some exotic holiday later on? Who knows but I really don't think that it's down to any Scancell related reason.

Finally, noticed your post re. AstraZeneca's RNS this morning and their purchase of a Priority Review Voucher for $95m. Another AIM bio I'm invested in has been granted a Priority Review Voucher for its phase III drug. Market cap of about £35m but holding a priority review voucher it may be about to sell for around $100m - bonkers isn't it?

Below is a link to an article from the University of Rochester regarding Angle's forthcoming ovarian cancer trial.

https://www.urmc.rochester.edu/news/story/5566/scientists-move-closer-toward-ovarian-cancer-detection-diagnosis.aspx

Sorry, have only just noticed your earlier post.

The intended setting for SCIB1 is in resected melanoma as an adjuvant therapy. That means in patients whose tumours have been surgically removed as a therapy to prevent it returning when there is a very high chance of recurrence. SCIB1 has produced some really promising results in this patient population with some amazing survival data.

However, it also unexpectedly produced responses in some patients with late stage inoperable melanoma that had spread to other organs. Whilst this isn't the setting originally envisaged for SCIB1 there is hope that it could increase response rates in these patients when being treated with Keytruda which is now dominating the market. So far from sharing anything the combination with Keytruda actually gives an opportunity to access a market that would be unavailable to them as a monotherapy.

Hope that makes sense and apologies if I'm teaching you to suck eggs but I'm unsure of how well acquainted you are with the history here.

Inanaco,

I mentioned that Keytruda had a complete response rate of 14% in melanoma and you reply:-

'14% like it ... that is now the same as genexine as you have alluded '

To me that suggests that you think Genexine have a 14% complete response rate too otherwise what is the relevance of Genexine to the discussion anyway? Why even mention them? No matter, if I was wrong and you meant something else then I apologise.

All I'm saying is that it's entirely possible that the SCIB1 trial will meet all endpoints and demonstrate synergy but because the patient numbers are small it may not be enough to attract an offer. An improvement in response rates from 40% to 60% is the difference in just 5 patients responding or not as the case may be.

For that reason, my hopes are pinned on SCIB2 as that should hopefully provide the validation for the platform as a whole.

1) Your comment re. Genexine and 14% - no, you're confusing objective response rates (ORR) and complete response rates (CR)- in cervical cancer Keytruda has produced CRs in about 2% of patients

2) 14% of 25 = 3.5 but since you can't have a complete response in half a patient I rounded up to 4, nothing to do with bias and whether I use 3 or 4 the overall point still stands