Hi @egosbarYou asked, "are Imugene timing the data cut release...

Hi @egosbar

You asked, "are Imugene timing the data cut release around a time line that would increase their chances of significant reductions in tumour size"

Great question!

LC explained the data cuts in one of the presentations which I vaguely recall required someone from the company &/or FDA to physically go to each site, login to a database and extract what they are after. It's obviously a little bit of a time-consuming process so they only do data cuts when they have a really good reason, such as having enough data and something of interest to present at a conference. i.e. they don't do them simply to give investors a quarterly update (the last update was on 17/01/2024 not six months ago as some posters are incorrectly stating).

Reference:ASX:IMU - Phase 1 CF33-hNIS Study Update - Positive Early Signals (imugene.com)

Also, yes, pseudoprogression has been identified as forming a part of response to treatment by a CF33 based drug.

Posters calling for updates based on 42-day scans clearly haven't taken into account pseudoprogression, which means they need to wait until the 3-month or possibly 6-month mark or longer before the results of the scans can be accurately assessed. At 42 days the doctors don't know if it is progression or pseudoprogression. The later timeframes will provide a better understanding as to whether or not the treatment worked with pseudoprogression occurring and the tumour grew and then shrunk or alternatively, if the treatment didn't work and the tumour grew without later shrinking.

So, for Cohort 5, dosed between January to March this year, doctors will need to wait until between June to September or later to be confident if tumour growth is due to pseudoprogression or a non-response to treatment.

So, June-July might be a suitable timeframe for an update for patients that were in cohorts 1-4 (but not cohort 5 or later). However, bear in mind I believe quite a few of those patients went off the trial not realising tumour growth was likely to be pseudoprogression so there will be no updates available for those patients.

So, to answer your question... I hope they are waiting for the reasons I've explained because, although I'm sure we would all love frequent updates, the reality is that it is a burden, and will more than likely result in inaccurate analysis if they cut the data too soon. We probably won't have a full and accurate understanding of the progress until near the end of the year or even next year.