Only partially funded by the investigators, it's a shame IMU never seem to provide actual financial forecasts given such heavy cash burn.
There's also the issue of dose levels - how much PD1-VAXX are these patients receiving? They have not yet disclosed this. As I've mentioned several times now - the best result was seen in the lowest dose patient cohort and toxicities ramped up after this. Why doesn't IMU disclose this?
Neo-POLEM is effectively just another monotherapy PD1-VAXX trial. Why should holders now expect a different outcome to the previous trial? Why won't IMU disclose the dose regime so that holders may determine their own likelihood of success?
A bit of history:
IMU stated that their original PD1-VAXX p1a would consist of numerous dose expansion cohorts (9-18 patients). Then, once the optimal dose was established, the last remaining cohort would add an additional 10 patients.
This clearly didn't happen, t
here was a total of 14 patients enrolled in the p1a dose expansion study and only 4 of those were dosed in the final 'optimum' cohort.
This P1a dose expansion monotherapy trial looks to have been cut short after a Grade 5 adverse event (fatal).
IMU look to have rushed through the P1a monotherapy, based on their own submission to clinicaltrials.gov, and into p1b (combination). They now appear to have terminated the trial with a total of 24 patients enrolled. This is against a planned patient population of at least 67 but up to 94.
Note: This information can only be deduced from historic updates and recent changes made to the trial as detailed on clinicaltrials.gov - No PD1-VAXX update has been provided to shareholders since this program was mothballed.
https://clinicaltrials.gov/study/NCT04432207?intr=pd1-vaxx&rank=2
(20min delay)