RE: Combination tech bought …14 Apr 2026 15:16
We are dosing with Exatecan, at least 5 * more powerful than the next most potent drug.
Dose escalation might have to be I think with everyone's collective input.
FDA, who are alert to this trial, might also be polled for an opinion, or may have already negotiated themselves with such.
Slide 19 includes a Q3W / Q2W schedule.
CC "From the outset we will take forward two different dosing regimens in every three weeks, and in every two weeks.
We've developed this clinical trial design to optimize the data collection, but also in collaboration with our multiple investigators, - experts in these four different disease settings, - to look at exactly what is the dosing regimen, and how do we want to take that forward.
So you can see we will dose escalate in all four diseases across those every three and every two week regimen, identify the recommended dose for expansion, or the MTD in both the every three weeks and in the every two weeks, and then move into the expansion cohorts with this one."
So either four indications being dealt with by investigators at three centres, or perhaps a fourth centre to be announced.
Three centres in a continent the size of America doesn't seem a lot to me.
Slide 14
Curtis: The next experiment we ran - so again these are the tumor and plasma concentrations of released exatecan at two hours post dosing with AVA6103, again in a HEK-FAP tumor model.
This is where we see how impressive AVA6103 is in its performance, because in a preclinical setting, the concentrations of released exatecan in the tumor are already 99 fold higher than we're seeing in the plasma, and will continue when AVA6103 gets to the clinic.
**We will be doing exactly the same as we are doing with AVA6000 where we'll be measuring the tumor plasma concentrations of released exatecan in the patient tumor and plasma at 24 hours post dosing**. (Patient biopsy permission permitting).