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C7

Are the comments in your 15.46 directed at me?

Johnny,

Please don't misunderstand my post - the last thing I want is for you to have regrets about what was a genuine attempt to help a fellow human being. I just wanted to put it out there that a drive to help Scancell with their PR around this trial (as we have seen previously) isn't necessarily a good idea, it was a general point.

I'm absolutely certain that Johnny's message was sensitively handled and sent with the very best of intentions and will be received in the manner it was sent. It's completely natural to want to help and to point people in Scancell's direction, however the whole field of promoting clinical trials is an ethical minefield and extreme caution is required! I know posters here won't see this as promotion but an ethics committee might just see unsolicited contact from Scancell shareholders to figures with a high profile in the media differently.

There is also the risk of unintended and unforeseen consequences. eg. A badly worded tweet from someone with a large media following could result in scancell and the trial centres being inundated with requests and enquiries from patients who don't come anywhere near meeting the entry requirements of the trial but have been given hope. I remember a comment from Scancell during the early days of the SCIB1 trial that they were having to deal with desperate people contacting them directly. This would not only be difficult for Scancell but potentially could irritate the study investigators.

Recruitment to clinical trials is a specialist area and Scancell have appointed a CRO and study investigators to handle it. Information on the trial and how to apply is freely available to the general public via the NHS clinical trials gateway which I'm sure would be one of the first ports of call for any patients interested in taking part in a clinical trail. So FWIW, my own opinion is that when it comes to PR and raising awareness around the Modi-1 trial, it's probably best left to Scancell.

'**I absolutely accept that mRNA vaccines were needed, I just wish that the big pharmas pushed for a more robust, comprehensive, and long term universal vaccine for covids.'

You think they didn't? !!

Violindog,

I sense and understand your frustration. It may help to revisit the facts:-

1) LD did say in the Proactive interview back in Dec that the principal investigator was "super keen and already lining up patients" however, she also added "but we have to go through due process unfortunately". So she didn't actually say Liverpool were ready to go, in fact she made it clear that they weren't. Nevertheless other comments she made in the interview clearly raised expectations that recruitment was due to commence very soon, albeit with a caveat regarding the impact of covid on clinical trials.
2) At the end of January we knew for certain that covid had delayed the trial and they hoped to open for recruitment during H1 2022. (see interims)
3) We now know that the trial is open for recrutiment and actively enrolling patients. This was announced via RNS and is confirmed on the clinical trials register, so there can be no doubt that this is the case.
4) At the moment only 2 study centres are open - Nottingham and Edinburgh. We shouldn't assume that the reason others are not yet open is down to the fact that they're waiting for training/supplies or any action from Scancell. It may well be they simply are at full capacity and Scancell have to wait for their slot or it may be that they are not due to open at this stage of the trial (see comments below).

It's important to bear in mind the overall trial design. We shouldn't overlook the fact that at this stage the trial will only be recruiting for the first safety cohort. This will involve a minimum of just 3 patients and they can only be ovarian or breast cancer patients. The opening of trial centres is likely to be planned around the design of the trial and it doesn't make sense to open 20 centres on day 1 to recruit just 3 patients. When the safety cohorts have been completed, the final dose decided and the trial moves into the expansion phase is when you want to see all systems go, with as many centres up and running as possible. So at this stage, I wouldn't get too hung up on the number of centres open.

I'm sure Scancell will RNS the first patient dosed.

https://polaris.brighterir.com/public/scancell/news/rns/story/x2k0j7x

.....and a cruel irony that he died far too early from the very disease he had devoted his career to.

Cleanerworld,

Re. your 7.55 - Prof. Cerundolo sadly died in 2020.

Tim,

Thanks for sharing.

violindog -

If they were waiting for all study centres to be ready then wouldn't the status of the trial be 'not yet recruiting'? If your theory is correct and they're waiting for all study centres to be ready, it means that Scancell have given false information on the clinical trials register. clinicaltrials.gov shows that the status of the trial is 'recruiting', the actual start date (when 1st patient was enrolled) is given as 7th April and both the Nottingham and Edinburgh study centres are shown as recruiting. If these details have been officially recorded on the clinical trials register then surely we can accept that they're true and represent the current situation?

Redx to present on RXC004 clinical trials at ASCO . ASCO is the biggest cancer research conference in the world with around 40,000 attendees and it's excellent to see the RXC004 abstract from Redx selected for presentation.

https://www.londonstockexchange.com/news-article/REDX/redx-to-present-at-asco/15428279

There has been a major update to the clinical trial record for the RXC004/Opdivo combination trial.

Previously there was just one study centre open for recruitment (Christies Manchester) and centres at UCL London and Glasgow were set up but not recruiting. Yesterday the record was updated to show the following centres:-

Indianapolis, Indiana, United States
Washington University School of Medicine, United States
MD Anderson, Texas, United States
Lumi Research, Texas, United States
Seoul National University Hospital, Korea
Severance Hospital, Seoul, Korea
Asan Medical Center, Seoul, Korea
Samsung Medical Center, Seoul, Korea
Hospital del Mar, Barcelona, Spain
Hospital Universitario Vall d'Hebrón, Barcelona, Spain
Hospital Clìnic de Barcelona, Barcelona, Spain
Hospital Universitario 12 de Octubre, Madrid, Spain
Hospital Universitario Virgen del Rocio, Sevilla, Spain
The Royal Marsden, London
Oxford Cancer Centre, Oxford
The Royal Marsden, Surrey
Beatson West of Scotland Cancer Centre, Glasgow
UCL, London
Christies, Manchester

7 of these are already recruiting and so they have gone from just Christies Manchester recruiting to centres in the USA, Korea, Spain and the UK actively recruiting and 19 study centres overall. Wow, that's pretty impressive.

Ray,

Unless we hear otherwise, I think it's best to rely on the trial record on clinicaltrials.gov to find out which study centres are open for recruitment. The record should be updated as and when the centres start enrolling or when new centres are set up. Of course there may be a delay in updating but at least you know it's completely reliable.

Chelsea11 - yes she was

Regarding the Modi1 trial, it's also worth pointing out that the trial can now be found on the NIHR NHS Clinical Trials Gateway - a searchable database for members of the public looking to take part in clinical trials.

https://bepartofresearch.nihr.ac.uk/results/search-results?query=scancell&location=

LL

Vulpes don't hold any convertible loan notes. They held £1m of worth and converted all of them back in Oct 2020, so only Redmile now hold any CLNs.

The Modi-1 trial has now appeared on clinicaltrails.gov and so we can finally see the full trial details. Points of note:-

1) The actual study start date is given as 7th April and this is defined as the date the first patient was enrolled. So looks like the first patient has been enrolled and subject to screening we may therefore get the first patient dosed RNS quite quickly.
2) The vaccine will be administered by the NanoPass microneedle device
3) It looks like all patients can be treated with either Modi-1 alone or in combination, if in combination it can be with any SOC checkpoint inhibitor (ie. Opdivo or Keytruda) but head and neck cancer combination patients will only be given Keytruda
4) Study centres currently recruiting are:- Edinburgh and Nottingham
5) Study centres to open for recruitment, Brighton, Bristol, Cardiff, Guy's London, Imperial College London, UCL London, Christies Manchester, Newcastle, Preston, Sheffield, Royal Marsden and of course the Clatterbridge Centre Liverpool.

Need to have another read, but I can't see the dosing period.

https://clinicaltrials.gov/ct2/show/NCT05329532?term=scancell&draw=2&rank=1

Ciaskin,

Indeed. I understand that GSK are after Sierra's myelofibrosis drug, momelotinib because it fits in with their haematology strategy. Highly likely that that they will review Sierra's other assetts and they're only going to take those forward that fit in with their own pipeline and porftfolio of drugs. Either Sareum will be lucky and their drug will be one of them or unlucky and it may end up being left on the shelf. If that happens, I assume there'll be a clause in the licensing deal that allows Sareum to take the drug back. It looks like Sareum is only entitled to 27.5% of any milestone payments under the deal anyway - (assume because they co-owned the IP with CRUK?).

Crumbs,

I think there are some targeted therapies available for ovarian cancer following chemo, but they're used as maintenance therapies and at best will extend life. So whilst treatment options for ovarian cancer have improved, they're still poor.

Chelsea,

It's hard to answer that because we haven't seen the full trial details and don't yet know the dosing period. For example, let's assume the dosing period is 6 months and after that the patients will have to be followed up for final scans, blood tests etc. Data has to be collected, verified and analysed. . If you think that at the earliest, it's likely to be late April/early May before even the first patient is dosed then 2023 for preliminary efficacy data is really pretty quick for an oncology trial.

Having said all of that, I guess it's possible that we may get some interim efficacy data along the way. Unfortunately with the exception of the H&N cohorts, most of these patients will have late stage bulky tumours which means that any tumour shirnkage will become evident and so interim efficacy data may be available earlier (as opposed to having to wait for survival to demonstrate efficacy).

Awonda,

I've emailed Scancell to ask whether the trial design published in the Trinity Delta note is the new design (after protocol amendments). If so, the safety run in has been amended to bring in the enolase peptide at an earlier stage. Previously the trial was starting with a 3 cohort safety run-in - each consisting of between 3 and 6 patients. The first 2 cohorts were low and high dose vimentin only and the third was a cohort of vimentin plus enolase. Now they appear to be going straight from low dose vimentin to high dose vimentin plus enolase. In effect they have removed a cohort which will obviously speed up the trial.

Also yesterday I posted that the RNS read as if all patients would be treated either with Modi-1 as a monotherapy or in combination with a checkpoint inhibitor as SOC. If the Trinity Delta design is the latest then that only applies to the renal and head and neck cancer patients.

I can't see any other changes but of course we've only ever been shown the outline trial design so there may well be other changes to recruitment criteria, endpoints etc.

Chuggley,

Thanks for taking the time and trouble to share your 7.26