That definitely shows the Vaccinia study going up by orders of magnitude. Starting at 105 and going to 106 for Cohort 2, then 107 for Cohort 3 and onwards. IF the TGA agreed to that, then Cohort 2 was at 1 million PFU and Cohort 3 is at 10 million.
That would seem entirely reasonable to me, because of the safety shown in the Checkvacc trial, but It all depends on what the TGA agreed to.
The Vaccinia IND approval came through on 13 December 2021, but the Checkvacc trial only started with first patient dosing on 20 October 2021, just 54 days prior. So it is possible the TGA approved the Vaccinia trial ahead of seeing any safety data for Checkvacc.
I'm certainly hoping the Vaccinia dose escalation is logarithmic. If it isn't - for the reason above - then surely the Combo trial with Keytruda would have been approved with a more sensibly aggressive starting dose and dose escalation.
We shall see!
Thanks again
Dave
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