Charles Jillings, CEO of Utilico, energized by strong economic momentum across Latin America. Watch the video here.
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Another key element relates to the change of strategy to keep AVA6K in house rather than licence out. It's must be dam good for them to feel this confident !!
I'm not sure what else the market wants as it's all pretty much crystal clear via content of this threat.
Safety improved substantially Vs straight dox and activation status been known since PK of first dose.
Putting those points to one side, the actions from Avacta since first patient was dosed (3996, move to London, poster presentation, dropping the LFT, sale of animal div etc) coupled with high calibre NED appointments (CM) nail the theory that Precision clearly works.
Silence from AS is golden also. 100% sure if he had any doubt about performance he would be engaging with investors and ramping big time in order to raise further cash. He's clearly very confident in non dilutive finding post read out.
Very exciting Q3 about to commence
Thread of the day folks, great info.
Boom, thanks Wiggly! Exactly.
Boom, thanks Wiggly!
And thanks to Tom for posting clips of AS, NB, and FMcL discussing the expectations before the trial began and what the expectations/drivers are as it progresses.
AS is on record making similar comments ?
DE2 combined with those comments from Neil Bell (stating that in Q4 2021, i.e., in the early stages of the ava6k study, Avacta will have the data to "confirm the mechanism of action of ava6k" and "confirm that the results of the pre-clinal trials translates into humans".
Lead me to believe it certainly works.
Given today's excellent news regarding the further dose escalation, I thought it would be worth while to step back and look where things stand. In order to be successful, ava6k must be 1) safe (at least relative to standard chemo), 2) effective and 3) must bring dox to the TME and be cleaved by the FAPa present (i.e., the Precision mechanism must work).
From the comments here today (and over the past few months), I think it is pretty well accepted that the safety and tolerability profile of ava6k is (very) good. The comment by Neil Bell today is very telling, that the dose escalation "is an endorsement of the emerging safety and tolerability profile in the patients enrolled in this study to date." The fact that the SDMC are happy to double the amount of ava6k given to patients, compared to the first dose, clearly shows the relative safety of the drug. So that's point 1 down.
We also know, based on 40+ years of dox use in cancer patients, that once ava6k cleaves, and dox is released, it is a highly effective drug. This is the major benefit of a pro-drug, this big hurdle comes pre-cleared. So that's point 2 down.
The question then is whether ava6k is cleaving in the TME (and to what extent), i.e., is the Precision technology opperating as seen in the animal models (and as we saw in the April presentation, that data is pretty phenomenal). Neil Bell addressed this in the business update in June 2021 (before dosing began), available on the avacta webpage. There he states (48:45) that in Q4 2021, i.e., in the early stages of the ava6k study, Avacta will have the data to "confirm the mechanism of action of ava6k" and "confirm that the results of the pre-clinal trials translates into humans". This wasn't a throw away statement, rather it was in response to the question of when the next Precision drug would be selected for pre-clinical (IND enabling) studies. His point was that the next drug wouldn't be selected until the mechanism of action was confirmed.
As we know, the second precision drug, ava3396, was selected and moved into pre-clinical studies in Q1 2022, thereby seemingly confirming the mechanism of action. While a big event, it didn't generate the excitment that some (i.e., me) expected. The doubt at the time seemed to focus on safety, was the specificity of ava6k high enough in the TME, or was it being cleaved throughout the body? I think that there was also concern at the time about the situations with dose escalation. These doubts have now been addressed. Hence, it seems to me that point 3 has then been addressed as well.
It will be interesting to see the market reaction to this in the lead up to the data (summary) being released in Q3 or Q4 this year. Will more people be joining the dots, resulting in a steady climb, or will the market remain skeptical with a "we won't know until an official RNS" attitude?