Hi Mr K
Good question. My thoughts:
They have not included a suggested timeframe for an update on the MAST trial but an announcement of further MAST trial data
is implied.
Why?
Well.... the first thing listed for H2 24 (ie could happen at any time now) is "
Vaxinia IT expansion open other indication."
You would know this already I think, but for newcomers - the MAST trial is open to patients with potentially
any solid cancer type - because that gives IMU some early indications as to cancer types where the treatment will be most effective. The company then plans to run "expansion cohorts" in those specific cancer types - especially if they find a cancer type where Vaxinia seems effective and where the current standard treatment is NOT very effective.
So when the first cut of clinical data back in November showed two excellent results in Biliary Cancer, IMU successfully applied to the FDA for "Fast Track designation for Vaxinia in Biliary Cancer and arranged to hold an expansion cohort in that specific cancer type.
As far back as November Leslie and Dr Woodard confirmed that they intend to have expansion cohorts in
other cancer types a well, and there has been a bit of speculation here on HC as to which cancer type will be next. The answer is: they will decide on that when they have more data. So - where the presentation states "Vaxinia IT expansion open other indication" we know that they plan to announce (and commence) the second expansion cohort any time between now and the end of the year. To do that, they first have to crunch the more recent data and determine which cancer types are showing the best response to Vaxinia. I think we can also assume that they will be using that data to apply to the FDA for a further Fast Track designation.
Which is why I say that the line "Vaxinia IT expansion open other indication" implies that the next Vaxinia MAST trial update will also be happening any time from now till the end of this year.
A note on timing and trial speed:
They announced "First patient dosed" in the Biliary Cancer expansion cohort on 10 July, which is 8 months after the decision to run that expansion. However we can expect a
much faster start up for the next expansion cohort. The reason they waited 8 months for the Biliary Cancer expansion was explained by Dr Woodard in the Investor Update video way back in November. The reason - they were delaying commencement until the dose escalation study cleared them to administer Vaxinia at much higher dosage levels.
Remember that the initial encouraging results in Biliary Cancer were achieved at
low dose levels. They are now cleared to commence dosage at 1 x 10
9 (1 billion PFU) - so by delaying the start of the expansion cohort they can now run it at a
high dosage level which greatly increases their chance of demonstrating real clinical effectiveness.
They have not yet announced an "Optimum Biologic Dose" - so it is possible that they will go even higher than 1 x 10
9 in the wider dose escalation study - but the fact that they have now started the Biliary expansion cohort tells me that they do think the OBD will probably be at around this level, and that the results at the last cleared level (3 x 10
8 ) indicate greater clinical effectiveness than was seen at the lower dose levels.
Anyway - we will know more when they finally crunch the data, get it 3rd party reviewed, and release it to the public. They have said all along that they intend to do that to coincide with presentation at a major conference.
Until then, we all continue to wait and those who are prone to nerves will continue to worry.
Myself, I intend to enjoy every day.....
Best wishes
Dave
