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..and a retweet from Scancell for good measure

ok that got a little jumbled in the editing... you get what i mean!

What this tells me is the might of the US army is that we are the same track and a fair few laps ahead of the US army.

and given it only took two months to complete the first cohort, we can reasonably expect this cohort to complete in the coming weeks. Once cohort two is complete then it's ramping up to all monotherapy indications (which will probably mean more trial sites opening) and starting the combination cohorts. Lots to happen in the not too distant future.

@Bermuda - do you think this could result in a protocol change for the current SCIB1 trial? Or would this be the basis for a separate trial in the Neoadjuvant setting post approval? Or I suppose even a phase 3 in all clinical settings?

Oh Lindy... why do you toy with me so??

you highlight a good point Chelsea7 and I think this is the real risk of shareholder exhaustion. The longer people have held, the lower their target sale price will drop. Ambitions of pounds may fall to pence.

brought in by the last CEO.. I always assumed they left at the same time.

It's my belief that there was a fundamental disagreement on the future direction and Lindy had the backing of the major shareholders.

@Chester - for sure. Even a quick look at the pre-clinical results show that tumour shrinkage usually started day 4 post moditope injection. I think lots of shareholders will be eagerly looking to the first full mono treatment cohort to see if those results can be widely reproduced. Industry shaker? Probably. Gamechanger? Possibly. World Changing? not without possibility.

Exciting to think that its been 2 weeks now since the first patient was dosed with the full therapeutic dose of all 3 peptides of Modi1.
I wonder if that person has noticed any change themselves? Has there been significant improvement? Right now there could be someone out there experiencing a dramatic turn around in their prognosis. Fingers crossed for them and all our study participants.

@Ruck assuming they are not appointing now for the next stage of the plans.

@Chester we will have to agree to disagree on this. A clinical response in 3 patients would not be considered materially significant IMHO

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.

@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).

@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.

@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.

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.

it's just a cut and paste job for content. The "author" isn't interested in the details.

@stakis this is exactly as the trial is designed and approved. This is a novel treatment, its never been in humans before and these are seriously unwell people. You don't just go slamming it into dozens of people and hope for the best. The initial cohort have all had two doses and trial can now move on according to plan. As Chester says, acceleration will come down the line once the first two cohorts have cleared dosing.

@Bermuda thanks for posting that link. I know we discussed the peptides/cohorts thing before but couldn't remember where the info had come from.

On your second point.. I'm ngl, I was looking for a bit of a cherry on top of the already good news. I do think the initial safety cohort is a huge step forward. I dont imagine adding another peptide is going to make too much difference to the safety profile, but you never know. Looking at the updated trial design it does look like we cam accelerate quickly as a monotherapy following the second cohort.

One thing you might have insight into (again I couldn't tell from the trial details).. do the low dose cohort have the option to take the higher therapeutic dose now? If not we (as investors) and the subsequent patients owe a huge debt of gratitude to those 3 that agreed to take the low dose.