GreenRoc Accelerates their World Class Project to Production as Early as 2028. Watch the full video here.
Good to see something on the SCIB1 trial, but I can infer some positives and negatives from the video.
The trial design slide shows that there is a 35 day analysis for the first cohort then a 25 week analysis on cohort two, before expanding into Simon Stage 2.
We know the first patient in trial arm 2 (SCIB1 and Pembrolizumab) was dosed in November 2021, so we can possibly assume that the assessment periods for the initial cohort of patients has been completed - but that is assuming they managed to recruit enough patients to hit the cohort numbers, which is not necessarily true given that standard treatment evolved in that time.
Arm 1 on the slide (scib1, nivolumab and ippilumab) was only approved in June of this year, so at best we can only be part way through cohort 2 with quite a few weeks before we can expand into Simon Stage 2 of this arm. This is the disappointment for me - just how far we are STILL away from completion of this study after all these years (originally scheduled to END in 2018!)
The main positive take away though is that (assuming the pembrolizumab arm has now expanded to Simon Stage 2) they have seen enough of a clinical response in the earlier cohorts to progress into the later phases. This is further backed up by the increase in number of trial sites. Given that the purpose of a Simon Style study is to give you off ramps where the patients aren't responding in sufficient quantity, and we haven't seemingly taken those off ramps, then this bodes well for the success of the trial to date. AIMHO
then when you have read them, carefully file them alongside updates from Sino Oil and Gas, CIC Fuels, CIC Gold, CIC Precious Metals, CIC Capital, CIC Capital Fund, CIC Securitisation..
Don't know if this point has been made, but Scancell have visibility of 12 months of Scib1/CI trials in Melanoma.
Do you think they would be doing ongoing pre-clinical research in new indications and publishing this work at industry events if the SCIb1 trial was doing anything but well?
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?
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.
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.