Ann: Imugene Dose Escalates in PD1-VAXX Phase 1 Clinical Trial, page-295

We may need a bit more patience with the PD1-Vaxx trial. I know a lot of people here are hoping for an announcement of the Phase 3 dose escalation, but that cannot happen until they have completed the Phase 2 dose escalation.

The Announcement of 12 Feb stated that the first patient of the second cohort had been dosed, but they have not announced completion of enrolment for the second cohort.

If we look at the timeline of Announcements for the 1st Cohort, it went like this:

• 1 December - Announcement that they had enrolled the first patient of Cohort1 for dosing at the low dose level of 10 mcg
• 17 December - Announcement that they had completed enrolment of Cohort 1 for dosing at 10 mcg
• 21 January - Announcement that the CRC approved progression to Cohort 2 at the mid dose level of 50 mcg
• 12 February - Announcement that the first patient of Cohort 2 had been dosed at the mid dose level of 50 mcg

It only took 35 days from completing enrolment of Cohort 1 to the announcement of dose escalation, and the first patient of Cohort 2 was dosed 42 days ago. However we have not been told that they have completed enrolment of Cohort 2.

The 17 Dec Announcement re completion of enrolment for Cohort 1 was marked as "Price Sensitive" so it is reasonable to assume that completing enrolment of Cohort 2 would also be "Price Sensitive." ie they must announce it when it happens. No such Announcement has been made.

So my conclusion is that what we are waiting for here is not the approval for Cohort 3 dose escalation. We are still waiting for completion of enrolment of Cohort 2.

Once that announcement is made, we can reasonably hope for an Announcement of Cohort 3 dose escalation approximately 35 days later.

Biotech research is not a rapid thing. This takes time. For the results to be valid we don't want it to be rushed.

Patience is required - and the result is still uncertain - but I believe the risk of failure is less than the current SP would suggest, and the rewards could well be spectacular.

Have a good weekend all!

Cheers

Dave