I've just been looking back over the time frame of previous Announcements and it tells me that we have entered the start of the period in which we can expect an Announcement of dose escalation to Cohort 4 for the Vaccinia monotherapy (both the IV and Intra-tumoural arms).
We are currently in Cohort 3 for both. Dose escalation from Cohort 1 to 2 was announced 51 days after the announcement of first patient dosed in Cohort 1. The time elapsed from Announcement of first patient dosed in Cohort 2 to the announcement of escalation to Cohort 3 was around two months (59 days).
That Announcement of clearance to escalate to Cohort 3 (and also to commence Cohort 1 of the Combo study with Keytruda) was made on 2 Feb this year, which is now 60 days ago. So we are getting into the time frame in which escalation to Cohort 4 might be expected -
if they actually started dosing Cohort 3 as soon as they announced that Cohort 2 had cleared.
However - they have never stated the date on which Cohort 3 actually started dosing. They did make a "first patient dosed" Ann for Cohort 2 of the IV arm, and that happened 24 days after the announcement that Cohort 1 had cleared - allowing Cohort 2 to commence. The time lapse for the intra-tumoural arm was actually a full 60 days from Announcement that Cohort 1 had cleared (1 Sept) to Announcement that Cohort 2 had started dosing (31 October).
So.... although there has been no Announcement of the date on which Cohort 3 started dosing, we do know from the recent Investor presentations that Cohort 3 was actually in progress at least by the date of those presentations - and the first of those was on 13 March. If dosing started pretty much when the clearance for dose escalation was announced (back on 2 Feb) then an Announcement of dose escalation to Cohort 4 can be expected any day now. On the other hand, if they only started dosing just before the 13 March Investor Presentation then we may not see an Announcement of clearance to go to Cohort 4 until around 13 May.
An announcement of clearance for Dose escalation to Cohort 2 of the Combination study with Keytruda can be expected from around May 1st onwards, which will be 58 days after the Announcement (on 3 March) that the first patients had been dosed in Cohort 1 of that trial.
Cheers
Dave
(20min delay)