Ann: Imugene Dose Escalates in PD1-VAXX Phase 1 Clinical Trial, page-300

Hi Footnort

I understand where you are coming from but I think you will find there is only one Trial, with multiple locations both in Australia and the USA. There are not separate trials for the two countries. This is the same as with the Her-Vaxx Phase 1b and the current Phase 2 - multiple locations across several countries, but only one trial.

The three Cohorts have to be "at least 3 patients each" but the trial patients do not all have to be at the same location. Australia started recruiting first, with dosing of patient 1 of Cohort 1 announced on 1 December. On 17 December they completed enrolment of Cohort 1 - which means they had at least 3 patients who had received their first dose of PD1-Vaxx.

The IDMC makes a decision on dose escalation after "the last patient in a cohort has completed 30 days of treatment." They were extremely speedy with that for Cohort 1. The decision to dose escalate came just 35 days after completion of enrolment, so just 5 days after the completion of 30 days treatment. Really - that is quite amazingly efficient.

The first patient of Cohort 2 was indeed enrolled in the USA at Hackensack as announced on 12 Feb. It is unclear whether the intention is for all of Cohort 2 to be enrolled in the USA, or whether they will include potential enrolments from the Australian sites. I'm assuming that enrolment of Cohort 2 is not complete because they made completion of enrolments for Cohort 1 a "price sensitive" announcement but they have not made any such announcement for Cohort 2.

We could reasonably expect an announcement re dose escalation 35 days after they announce the completion of Cohort 2 enrolment. I don't see how they could do it any faster than that, and it could take longer.

We will only get a surprise if the company has completed enrolment of Cohort 2 but has decided not to announce that. I believe it is at their discretion to decide what is price sensitive and must be announced, and what is not, but it would be very inconsistent of them to make the Cohort 1 enrolment completion a PS Announcement and then make no announcement at all about Cohort 2 enrolment completion.

I have seen Snouty's post claiming that "cohort 2 has been dosed" and that "cohort 3 commences after Easter." Unless Snouty has inside info from somewhere then that is either just a guess, or he simply means that Cohort 2 has started but not completed - which is correct - ie we know at least one patient has started, and that Cohort 3 is unlikely to commence before Easter - which is of course almost certainly correct because Cohort 3 cannot start unless Cohort 2 has completed 30 days of treatment and Easter is almost here. Therefore, Cohort 3 will indeed commence "after Easter." However the real question is "how long after Easter?"

Everyone is hanging around and getting a bit restless waiting for the next piece of good news. I get that. I have a crop of beautiful oranges growing in my garden. Every year they seem tastier than they were the previous year. Fresh picked and freshly squeezed OJ each delightful morning. Paradise!

The only thing is - I have to look after the trees and wait for them to ripen. No amount of wanting makes it happen faster. So I have learned to enjoy the process of watching them grow and not focus too hard on the ultimate reward. When it finally comes, it will be all the sweeter.

I see beautiful blue skies outside today. Life awaits - go get some!!!! ⛵️

Best wishes to all

Dave