The latest Investing Matters Podcast episode with London Stock Exchange Group's Chris Mayo has just been released. Listen here.
given that the company themselves set the expected timeline for early clinical data release as 4 months, then its fair to say that we are way overdue an update on the current findings irrespective of any subsequent changes.
Just a few questions from me for anyone who is very familiar with the trial design, or has experience of running these things (opinions also welcome)
The first two cohorts of patients are expected to receive the Vimentin peptides only. Is the intention to introduce Alpha Enolase peptide after that? Is this still the plan?
As this trial is being used in a number of indications, will they need to do the safety run in for all indications before they introduce the enolase peptide? For the first two cohorts, how long do we think they will need to be followed up/observed before the green light is given to expand to the next cohort? How long does it take to confirm that they are not suffering from any related side effects? Do we think the company will RNS the first patient dosed with the enhanced product?
It's not worth considering the cash position and burn, without also considering the position of the company. We now have effectively 4 products in trial (SCIB1, Covidity, MODI-1 and the Avidimab platform through the covid trial). All of those trials are expected to deliver significant news/progress within the timescales of the current cash position/burn, with Moditope potentially being a whole industry disruptor. My continued investment is on the basis that any one of these products can generate a commercial deal prior to the money running out. If the money ran out without any of them generating a commercial deal, then that would "likely" be down to them failing to perform to expectation in the trial. In other words, it does feel to me, like it is now or never with the cash position. I can't see any major fund raising requests being supported down the line.
@Chester18 - quite a few times i have seen you write that the "trial was halted". I think maybe you need to be clearer on this. A formal trial "halting" would mean that recruitment has been suspended, usually done where there has been a serious incident that needs investigating. I am not aware (correct me if i am wrong) but the trial was never "halted". Recruitment became practically impossible, due to so many people failing the inclusion criteria, but I don't believe it was ever stopped.
@kashdog - the trial completion date IS NOT the same as any potential data release. The trial complete date is when all data for all patients (including any folllow up investigations) has been compiled, analysed and reported on. Scancell have already said many times that they will release interim data from all of their trials. But then I have made this point to you before... at least a few times I believe.
Burble - thank you for your response. I believe the case i read about was in the "propped up" category, where the sudden removal of the tumour had fatal consequences. Maybe it is something the clinicians have learnt to be more aware of when trying these novel treatments for solid tumors. Hopefully the Modi-1 trial will destroy those tumors in a controlled way!
@Burble
I seem to remember in the early days of Checkpoint Inhibitors, that there were complications resulting from the speed with which tumours were destroyed. If i remember correctly it was to do with such things as the cavity left behind.
Given that moditope in theory works best the more the tumour cells are stressed (making it ideal for late stage bulky tumours) is it possible that Moditope could encounter problems in this area? In some ways it would be a nice problem to have, having to deal with the consequences of nuking tumors, but could this also be a risk to the trial? (i.e. having to pause whilst a death is investigated for example)
And finally, are there any other physiological consequences of the rapid destruction of a tumor? Forgive my layman's terms here, but whilst cell breakdown and turn over is part of the normal function of the body, could such a rapid breakdown lead to some form of toxicity?
Thanks in advance.
and this picture may remain true right up until the day that hasiba sells and Scancell drop a Multi -billion £ deal in an RNS. At which point GF sails off into the distance on their yacht.
Everyone's investment strategy is entirely their own to make, and not subject to judgement by others. Personally i don't have the time to trade backwards and forwards, so i invest in long term promise and hope it delivers.
But all of that is irrelevant to the point I was making, which is the company fail to publicise most of their progress/success. Scancell may well have been a better "year on year winner" if the BoD made more of an effort to support the SP.
with Scancell, the hype often fills the vacuum of missing company announced news. Time and time again Scancell fail to promote their own progress or good news, leaving others to do it for them. I've long since been of the opinion that the BoD are quite content keeping a stable shareholder base at a stable price until such a time as they fully monetise one or all of the platforms.
I think this is incredibly positive news. The fact that they are quadrupling the dose really does back up that its safe with no side effects.
Selecting a candidate to take forward (SCOV2) suggests they are seeing better immune responses from this version (which was to be expected)
Giving single dose to people who have already had covid looks like they are trying to make it as pallitable as possible to the UK booster market. I suspect that most people who have already had booster jabs and been infected would probably think they don't need any more jabs. If we can prove big benefit from just a single "jab" then could get more people willing.
This does seem like they are building a good portfolio of evidence for a larger UK booster trial. I also wonder if the UK government would step in and fund the trial/pre purchase boosters.
The only frustrating part for me is that Scancell are not making more of this in the press. Why are we only finding out about this in detail from the trial registry??
Because the underlying IP is what generates the value in the company in the event of a buyout. The "focus" may be on Modi 1 in the clinic, but if the concept proves successful, then the "land grab" of an entirely new treatment method is controlled by Scancell as a consequence of the ongoing work to identify and patent the SIPTMs.
I am genuinely staggered that you could think this not important to a biotech.
@Bermudashorts - correct we were told that the protocol had changed back in March, yet those changes have not been reflected in the trial registry (which is surprising to me - does responsibility for this reside with the lead clinician?)
Given that we are not seeing those RNS'd protocol changes, i think it is reasonable to consider that there may have been other changes. Picking up on the observation that the recruitment poster now says you will be given "one or two" injections, the original trial was designed to test both SCOV1 and SCOV2 to see which elicited the best response and at what dose. Making an assumption, but if there were further un-announced protocol changes to expand out enough to be considered a phase 2, it might be reasonable to assume that they had selected between SCOV1 and 2 as to which candidate to take forward and at what doses, hence the fewer injections.
@Douve87 - Has there been delays with the covid trial? Judging from the other thread it seems like we have an adjusted protocol - something that could and should be RNS'd or at least updated on the Trials Registry in South Africa (but wasn't last time i checked).
Unless you are maybe misreading this part - "There has still been covid issues with the trials but they are getting better. Movment soon". I read that as challenges with starting the cancer trials due to covid, rather than issues with the covid trial. Again, clarification that could be resolved with an official statement rather than hearsay.
Finally - I have long felt that the company should be doing periodic statements to shareholders to update on progress. Even if the update is that no trial progress has been made. It shouldn't always be driven by mandatory release of news dictated by the minimum required by law.