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Now that the 1st safety hurdle has been passed , and an increased dose has started how fast can we expect news.? Another two months? Or can we expect an exeleration in the trial and potential news. Does anyone on the BB have knowledge of this type of trial design and timescales?
Judging by past performance, it will be delayed. I would expect Q2 2023 at the earliest
My understanding of the trial design (fwiw)..
The first cohort (3 patients) had the low dose administered, then assessed for signs of toxicity, and the data was then collated and put to the safety board to review and approve progression. All of which took 2 months. Its possible that they may have seen clinical benefit in these patients, but also possibly not. The dose was potentially sub-therapeutic level.
The second cohort (also 3 patients) will be given the full dose. This is the level expected to be therapeutic, but primarily they will be concerned with the safety profile. My gut feel is that the time to dose and report on these patients will be the same as the initial cohort - 2 months. They will still go slow as they will be concerned with side effects at the new dose. It may however take longer to report the results, as they may want to do more analysis on the immune response, but unlikely as they will still have done that analysis on the first cohort.
Once this cohort has been approved its all systems go on the Monotherapy side of the trial. Roughly 30 patients can then be enrolled, dosed and assessed.
For the Checkpoint inhibitor combination therapy, the safety run in begins again, with the low dose given in combination with CIs and the focus on safety.
So to answer your question. I suspect another 2 months for the report on the second cohort, where we might get some additional early clinical data. Followed by another 3-6 months where the extra trial sites initialize and monotherapy patients are dosed and assessed. If I am correct I would hopefully expect some sort of meaningful clinical data by about Q2 2023.
Of course, its worth bearing in mind that if there are any potential suitors to moditope - then they pull the trigger on any offer at any stage - particularly as early data starts to come in. In other words, there is no way i would want to be out of this share whilst waiting on Q2.
Thanks for your explanation Konar. As ever with Scancell we have to have patience and its likely to be longer than we would like.
I've told myself not to expect news on Cohort 2's Safety / Toxicology for a minimum of 2 months, but, when the patients are given the Full Dose of the Full Vaccine ( in approx 1 months time ) there is a very real possibility that Moditope could melt away their tumours, as it did in the mice.
If that happens it would be materially significant to all shareholders and would have to be declared.
Therefore there is a possibility that under those circumstances we would hear that news late September / very early in October. That is probably the earliest we will hear anything else from the ModiFY Trial.
It makes me wonder if Inanaco's clock is now ticking louder......
Chester.
Oh the bells, the bells.....................
Hey C7, I didn't think that Inanaco's Clock was that Big...... ha ha
@chester
you mention that the patients will receive the full dose in 1 months time.. I take it from that you mean the first patient will receive their second injection? Because of course we k ow the first patient in cohort 2 received the first higher dose yesterday, not in a months time.
On your second point.. that a significant clinical response would force an earlier RNS, I would love that to be true (and I can't say for sure that it wouldn't be true). But even if all 3 patients in cohort 2 had tumour eradication, I'm not sure Scancell would announce that. I don't think 3 patients responding would statistically be significant enough. Don't get me wrong, 3 patients losing their tumours would be an incredible sign and would be unbelievable for them... but it could just be a freak occurrence. Lindy has previously said in interview that they have to be very careful about announcing early clinical data for fear of giving false hope to the people on the trial or to the market.
I think more likely that they would look for a clinical response in the monotherapy cohort before confirming anything.
I could be entirely wrong. This is just my educated opinion.
Chester - really sorry but think we have to be a bit careful in suggesting that significant tumour shrinkage will immediately be announced to the market. They won't drop everything and issue an RNS if they spot tumours rapidly shrinking, the standard clinical trial process must be followed and results will be announced in line with that process.
Also, tumour shrinkage will only be picked up on imaging and we have no clue how often the patients will be scanned. It may be that they won't scan until after 12 weeks or 3 doses or whatever, in which case they won't even know how the size of the tumours has changed. Scancell have confirmed that they expect safety and immunogenicity data to be available in H2 2022 and efficacy data in 2023. That suggests imaging data may not be available at the next update, but we should be learning for the first time about the immune response in humans to this vaccine - exciting stuff.
Please don't think I'm trying to nit pick here, but if folk believe there's a chance that Scancell will immediately RNS tumour shrinkage, they're going to be concerned if we hear nothing and assume that it's bad news. In reality, we will be given results (good or bad) as and when the data has been collected, verified and anlaysed.
Hi Konar...you state :
"I don't think 3 patients responding would statistically be significant enough."
....but these 3 patients would represent a 100% response rate . These 3 patients are unfortunately dying...receiving last chance treatment... so tumor eradication would not be a statistical chance it would be the miracle of Scancell. I do get your meaning that 3 is a small number and the trial is targeting many multiples of this and it may be considered prudent to wait for a larger picture to develop. That said , if Scancell can cure this next cohort and achieve a 100% response...its surely worth all the publicity it deserves.
Konar,
Sorry posts crossed - took me so long to write my post (interrupted by phone)
I have heard people mention Moditope melting the tumours in mice a few times on this BB. I have only held shares since March’21, so this was before my time.
Was this ever mentioned in a RNS or any news story or was it something that Lindy said in an interview? (I had a quick look and could not see a RNS).
This is not just for my benefit but I think it would also be helpful for potential new shareholders.
Thank you.
JB1 - Pre-Clinical only.
@violindog I hear you. 100% response rate would be amazing for those 3 patients and "likely" would suggest that Scancell are onto a world changing product, but I don't believe 3 from 3 would be statistically significant enough to result in major publicity. More likely would be that Christian Ottensmeir would be accelerating patient recruitment.
@Berm - you nail the point far better than me. I
It's about expectations. If investors think that a clinical response in cohort 2 will result in a daily mail headline, then anything less will be met with worry. The results will be reported by Scancell only when the science is solid, confirmed and repeatable (and I am basing that opinion on their track record).
Johnny,
Lindy Durrant has mentioned tumours melting away more than once - an example is below taken from a proactive interview back in 2021 (at about 2.20 minutes in).
'...........and suddenly those cancers disappeared in all our preclinical models. In all our years working with these things we've never seen anything like it, even big bulky tumours just melted away. So we're really excited that if we get into patients now and they just do a fraction of what they've done in our model system, we should make a big impact on some of these patients'
https://www.youtube.com/watch?v=Y2n7Nh0BBAo
Bermuda, Thank you for the link to the video and for going to the trouble of typing up what Lindy said. It will be useful for any potential new shareholders to watch.
C11 thank you too.
Hi KonarA and Bermudashorts
All listed companies have a duty of care to protect their shareholders. I have read, been told and believe that in the course of a companies function if something 'Materially Significant' that could affect the SP occurs, the company has a duty to ensure shareholders are informed and not put at a disadvantage by non-shareholders becoming aware of that 'Materially Significant' event.
If something as amazing as a 'Tumour Melting Away' or even 'Tumours Melting Away' during a trial is not reported, those close to that trial would be able to take advantage of that information.
How you square this with waiting 'let's say 4 months' for a data readout to update those who have invested directly in the company I do not know.
Also, Scancell know that this is a possibly because of the mouse model results so they must have discussed this as a possibility and would ensure they know if it is actually happening.
As investors we cannot be put in such a dis-advantageous position.
If you can explain to me how that could happen and not be reported I would be very surprised and shocked.
Chester.
Hi KonarA
I have just re-read the RNS and it does not state that the full dose of the ModiTope + Vimentin was given to the 1st Patient in Cohort 2.
I would presume, maybe incorrectly, that Cohort 2 will start with a low dose now the Vimentin has been added. In a months time if all is safe then the Full Doses will be administered. This is my interpretation because it is not stated by Scancell.
Chester.
https://www.trinitydelta.org/research-notes/a-fresh-impetus-in-delivering-immune-oncology-vaccines/
Exhibit 7 in above link. Cohort 2 = High dose.
The original trial protocol had the dose escate in cohort 2 and then introduce enolase peptides in a later cohort. This was condensed to make cohort 2 as above.
@Chester we will have to agree to disagree on this. A clinical response in 3 patients would not be considered materially significant IMHO
Sorry but when I hear efficacy data In '23. Covidity Phase 1 Study completion date Dec '22 (Estimated). Everything sounds like years to go yet. AIMO.
Morning All, thanks for the posts guys specifically your logic behind timelines.
We have been told that safety and immunogenicity data will still be available this H22022 which could well coincide with the AGM, some 8-12 weeks away.
Dracula...................."""..Sorry but when I hear efficacy data In '23. Covidity Phase 1 Study completion date Dec '22 (Estimated). Everything sounds like years to go yet. AIMO."""
It doesn"t sound "years" away to me fella
Morning C7 / All.
I think any discussion around timings is contextual. More than 1 year (eg. 2+) could be considered as “years” and maybe Drac is correct on some elements of delivery / news BUT we reasonably expect multiple inflection points in a shorter timeframe (as you rightly point out and has been communicated formally by Scancell).
That’s where my head is at anyway!
C7,
I think you make a great point. Many of us have expressed frustration at lack of news on all fronts. There has to be a substantial update before or at the AGM (which isn't that far off)