Hi Wells
It's a good question.
The most recent data - to the ASCO GI Conference in January - had data up to Cohort 3 (3 x 10
7 or 30 million PFU).
I would expect them to be presenting data to Cohort 4 at least - ie 1 x 10
8 (100 million) PFU for the monotherapy arm.
I think it is too early for initial data from the first monotherapy patients at Cohort 5 - 3 x 10
8 (300 million) PFU - because they only dosed the first of the Cohort 5 patients on 16 Jan (IT) and 18 Jan (IV). Those patients would have had their 42nd day SPECT scans due on 27 and 29 March and even if those scans did happen on that schedule, I don't think that gives them enough time for evaluation and 3rd party review of their data.
I might be wrong - but it would be an impressive rush job to update their presentation with early Cohort 5 data by 9 April, and it would only be very early data for those first 2 Cohort 5 patients.
Even if they achieved that, I think what will be far more interesting is the
longer term data for Cohort 3 and 4 patients - across
all cancer types included in the trial. Remember that the 19 Jan presentation was focussed only on the 7 Gastro-intestinal cancer patients. There was an official announcement by the company on 15 Jan, to coincide with the ASCO conference, which gave us a
summary of the wider data set. As of that date they had efficacy data for 31 patients and they gave us some information on the wider group, but it was very limited.
This presentation should give us a lot more detail - similar to the level of detail we saw in the November data. Given the pseudo progression issue, I think we can reasonably hope to see a significant increase in the number of responders, with patients who were initially classed as "stable disease" now seeing a major reduction in their tumours (partial response) or maybe even an elimination - complete response. We may also see a "cluster" of good response in a specific cancer type - which would point to the next likely expansion cohort and maybe a second Fast Track designation from the FDA. For example - the 15 Jan Ann mentioned two PR results in Melanoma. If they had more of those, and/or if the two previous "Partial Response" patients improved to Complete Response, then we might see Melanoma highlighted as a target for Fast Track.
I understand the "sick in the guts nervous" feeling, friend Wells. Apart from worry about your investment I know you had a personal cancer scare not long ago. I suspect most of us here have very strong personal reasons for wanting to see IMU succeed with Vaxinia (and with other platforms), quite apart from the reasonable desire for investment success. All I can advise is - go easy on the Easter chocolate, mate!!
Myself, I felt more anxious ahead of the November data release. I think that data - and the extra info in January - can give us strong confidence that Vaxinia does "work" - and that it has remarkable safety and tolerability as well. What remains to be seen is the breadth and depth of the efficacy, and the upcoming data will start to give us a better indication of that. I'm also mindful of the fact that we are still in dose escalation mode - so whatever the data says this time, it is likely that the next data set again - at 10
8 (100 million) PFU is likely to be even better.
I have focussed my comments on the Monotherapy arms, but we should also be getting the first results for the Combo therapy with Pembrolizumab - probably at 3 x 10
7 or 30 million PFU. That could also be extremely interesting.
Thanks for the question - and best wishes to all
Dave
(20min delay)
