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Interesting article below from Ben Schumann, Imperial College/Francis Crick which gives some background and context to the field of glycobiology . Some quotes from the article, followed by one from Scancell-

'perhaps no other field is as understated despite such a heavy clinical impact'

' Why is biomedicine still largely turning a blind eye to glycobiology? In my opinion – because they are difficult to deal with'

'glycotime” is rapidly gaining momentum in therapy and diagnosis'

'We (Scancell) remain one of only a few companies worldwide that has the capability to produce high affinity, humanised anti-glycan antibodies'

https://network.febs.org/posts/what-time-is-it-glycotime?channel_id=665-research

Cleanerworld - first and foremost, I was truly sorry to hear of the issues you're facing and sending you my very best wishes and hopes for your results coming back with a benign pathology.

Chester - thanks, although Scancell have confirmed the partial response and patients with stable disease via RNS so I'm not sure it is anecdotal. Agree with your final sentence.

Crumbs - if that is the case, then no matter how good the intentions, they are misguided. I understand the desire to 'help', but when it comes to running clinical trials and dialogue with patients on the trial or potential recruits to the trial, Scancell do not need help and it is absolutely best left to the professionals. I'm assuming that their intentions are good because if they are fishing for information, then they're playing a dangerous game.

Chester - from your excellent summary below:-

'We have heard whispers of continued good results'

That is the second reference on this board today suggesting rumours of good results from the Modi-1 trial. Can you tell me what is the source for these whispers/rumours?

TF -

Ah OK - so when people say that a precedent has been set and they must have the 2nd scan results, the need for consistency stops there and they won't be requiring updates from subsequent scans. Seems inconsistent to me but thanks for clarifying.

Back on 15th April I mentioned that the next big scientific conference is ASCO in June and wondered whether Scancell might attend. Abstract titles have been published today and it's great to see that a Scancell abstract has been submitted and accepted and that the Principal Investigator for the Modi-1 trial, Christian Ottensmeier will be presenting it.

Modi-1, anti-citrullinated neoepitope vaccine, alone and combined with checkpoint inhibitors in patients with head and neck, breast, renal, and ovarian cancers: ModiFy phase I/II basket clinical trial—Report after completion of monotherapy dose-finding.
Presenter: Christian H.H Ottensmeier, MD, PhD, FRCP | The Clatterbridge Cancer Centre NHS Foundation Trust
Abstract: 2566

| Poster Bd #: 408

https://conferences.asco.org/am/dates-know

TF - if folk are suggesting that an RNS is overdue and have confirmed that they're expecting it because the first update has set a precedent and consistency now must be maintained by reporting the 2nd scan result, then logic suggests that they'll also expect an update after the following scan - ie. on a scan by scan basis.

WW - I have no idea whether the 2nd scan result for those patients would be considered worthy of an RNS in terms of the overall trial. Evaluation of data from 100% of available patients at the outset of a trial when you are making decisions about dosing levels and ongoing protocol is very different from evaluation of a subset of patients mid trial. In fact, publishing results from that subset could be misleading and it might be dangerous to make investment decisions on that basis. Raising questions about PR and IR is one thing, but I don't believe any of us have sufficient information to make any judgement calls whatsoever about the quality of dissemination of clinical trial results from Scancell. I'm happy to trust that Lindy Durrant and her team, in conjunction with the study investigators will update the market as and when they have the data and in line with industry guidelines.

Yet again we'll have to agree to disagree .

At no stage have Scancell raised expectations that they will continue to report on these 14 patients on a scan by scan basis in isolation as they continue through the trial.

WTP,

The suggestion that a clinical trial update has been delayed to allow time to get share options in place is an interesting one and I hope you understand the implications.

Of course the timing of the share options could simply be down to the fact that the Remuneration Committee have carried out an annual review as we're at Scancell's financial year end and there is no connection whatsoever with any of Scancell's clinical trials. Previous awards have been made at exactly the same time of year so this does seem likely.

1) Scancell are at their financial year end and the Remuneration Committee have met an carried out an annual review . Worth noting that previous announcements re. Chairman's options have been made at this time of year.

2) As you and wigwammer seem to be suggesting, Scancell have delayed publication of clinical trial updates to secure a lower strike price for the recently issued strike price.

There is no delay and there is no benchmark - updates will come when meaningful data has been analysed and is available and not a single one of us has the data or the ability to interpret it required to know when that time is.

Burble,

One of your links seems to be behind a paywall so have posted a link below which has a good summary of the Moderna results.

There was a brief discussion about the Moderna vax on here during AACR and at the time I went back and did a comparison with the SCIB1 results. The results for both vaccines were actually very similar with 18 month RFS tracking at 79% for the Moderna/Keytruda combination and 80% for SCIB1. However, when it came to safety, a quarter of the Moderna patients experienced adverse events at grade 3 or above versus just 2 SCIB1 patients, but I believe both of those were put down to the electroporation device rather than SCIB1 itself.

So with the caveat that it was in very small numbers, SCIB1 as an off the shelf vaccine achieved broadly similar results in a safer, quicker and more cost effective way as a monotherapy to Moderna's personalised vaccine given as a combination with Keytruda. The whole Ichor/FDA debacle was very costly and you do wonder where Scancell would be now had that combination trial run by Keith Flaherty in the US gone ahead.

Looking forward to Scancell finally getting the iSCIB1+ trial up and running.

https://www.evaluate.com/vantage/articles/events/conferences-trial-results/aacr-2023-more-hope-modernas-neoantigen

ee,

I'm not sure I agree that there should be more updates than would usually be expected - why so? The trial will have been designed and contracts with the CRO, study centres and study investigators agreed with set reporting of data and results. The moment you start requesting additional reporting, extra updates etc. then you're building in additional cost and diverting resources from what they should be doing. If Scancell start issuing more updates than normal, they also lay themselves open to appearing to hype the results which could damage the credibility of the study.

As discussed earlier, in terms of therapeutic clinical trials for this number of patients, the trial is already about as quick as you're going to get in terms of delivery of efficacy data and I'm sure Scancell will update the market as often as they can as and when meaningful data becomes avialable.

Regarding your question about the neoadjuvant arm in head and neck cancer, I think they have to wait until cohort 4 is complete and they have selected the optimum dose for combination with CPI's before they can start to recruit to that cohort.

WTP,

I'm not sure anyone thinks it'll be years, but we won't be getting scan by scan updates and working out when each patient has had their first or second scan may tell us nothing in terms of the timing of any RNS. That's not to say that information isn't interesting or worthy of discussion - it is and hopefully those who have been posting will continue to do so, but news will be driven only by the trial protocol.

In the early days of a phase I dose escalation, news comes thick and fast as it's standard practice to RNS approvals to escalate the dose and recruitment to each new cohort as it opens. We have already seen this from Scancell with the Modi- 1 trial and previously with SCIB1. When all of the expanded cohorts are recruiting and the trial is simply running at the optimum dose, news won't be as frequent and will be released as and when meaningful data is available. Results from just one scan from a handful of patients are unlikely to be published.

Lindy's comments regarding the frequency of updates refer to the following:-

1) As an open label, non randomised trial, we don't have to wait until all patients have been treated for data to be unblinded before we have any clue as to whether or not Modi-1 is working.
2) Modi-1 is recruiting patients with bulky tumours in situ and imaging will very quickly show whether or not patients are responding. Although Scancell will want to monitor any response over time to ensure that it's durable, they don't have to wait for survival data. With the SCIB1 trial, the 16 patients Scancell always refer to were resected patients, ie. their tumour had been removed before treatment and efficacy was measured in terms of the number of years of relapse free survival which meant long waits for updates. That won't be the case here.

So news flow will be about as quick and frequent as you can get with a cancer trial, but sill will only come when enough meaningful data has been gathered, verified and analysed in enough patients once they are all receiving the full dose.

corr - 'to cover these options'

Sorry, trying to do 2 things at once.

Johnny,

I'm not sure that we do know that RG has exercised his options. All we know is that Scancell have made a block listing to cover RG's these options. The shares will sit unallotted until they are exercised so we'll have to keep an eye on the 6 monthly block lisitng return to work out whether or not he has exercised his options.

ee,

Some fair points and should have been clear that my comments weren't related to the options announced today - as you say they're not excessive. Whilst NEDs obviously don't have the same level of control, they should contribute to the overall stragegy and success of the company and I believe there is an argument for performance linked options but clearly the performance targets need to be appropriate.

violindog

An exercise price at a premium would sort of defeat the whole object - not sure I'd feel very incentivised or valued as a NED to be told that I was being granted options with a strike price at a premium to the current price.

Having said that, IMO all share options issued by public companies should be linked to performance targets and if those targets aren't met then the options lapse - no extensions, no replacing and no lowering of targets.

WTP

Scancell's year end is 30th April and it's probably just that the Remuneration Committee have carried out their annual review and have decided that their new Chairman and Susan Clement-Davies should receive some share options.

Exactly the same thing happened with John Chiplin. He was appointed in January and in April was awarded 3m share options. From memory David Evans also had 3m. So routine housekeeping IMO.

Konar/Burble

I don't think it's an attempt to cherry pick patients - don't forget that patients who have failed on checkpoint inhibitors are being recruited to the monotherapy arm of the trial which is a tougher setting than combining with another round of CPI's.

If they introduce another sub-set of patients and set up a combination arm for those who have failed on CPI's then it will have an impact on costs, not just in terms of powering the trial but also in terms of the (significant) costs of Keytruda/Opdivo. As I understand it, at the moment, the NHS is covering the cost of the checkpoint inhibitors because they are the recommened SOC treatment for the patient. If the PD-1/L1 fails then I'm not sure that the standard of care would be to try a second or third round and therefore the NHS may well be reluctant to cover the cost in a clinical trial.

Given that this is just a phase I/IIa and the primary aim of the trial is to discover how, where and why Modi-1 works best, it's possible/likely that Scancell would prefer to take all the data coming from this trial and use it to inform the design of future trials which may/may not include those who have failed and progressed on checkpoint inhibitors.

Konar,

Hopefully they intend to RNS, but wouldn't expect them to do so until first patient has been dosed. Can you remember what the dosing regime is for the combination groups in terms of the relation between dosing of the CPI and Modi1?

I should have added that it's hard to see that they would want to, or indeed be allowed to start screening patients unless they had been given approval to open that cohort, but I suppose it is possible.