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Avacta had 1st PK data at the end of 2021/early 22 and the CEO stated the following during Vox interview;

Re Pk data;

‘That will tell us whether the preCISON platform is activating the drug in the tumour predominantly compared to healthy tissue”

Neil Bell, when discussing the trial during Q3 21, also referenced that Q4 21 would be highly critical as we would receive confirmation of the precision mechanism of action and at that point would move on 3996 (market at the time totally overlooked this and quite honestly continues to overlook what is taking place here)

Avacta know it works as do the safety committee. Activation is confirmed (a fact) and safety profile will be improved vs straight Dox.

Please listen to Alistair Smith on this link and give me a good solid response as to why you think Avacta don't yet know whether it works!?

https://twitter.com/i/status/1518318918858858496

Live,

I would think If the Tumors are shrinking then it means dox is being released in the tumor.

It's almost as if they know FAPa activation works and are now building infrastructure to optimize the patient selection to deliver the AVA6k solution......

Interesting... Now why would Avacta be spending in this area if AVA6K was not working!!!

@ MrA.

You asked -why do you assume none were due to disease progression?-

I assume this is the case as the trial criteria is set as follows:

Patients in Phase Ia will receive escalating doses of AVA6000 following a 3+3 design, commencing with a starting dose of 80mg/m2, once every 3 weeks (Q3W) starting on Cycle 1, Day 1 (C1D1), until DISEASE PROGRESSION

Final comment.

If AVA6k was not working, it is extremely likely that 100% of the patients that have taken part in this trial would have seen disease progression.

This is what cancer does when it is not treated - it progresses. and spreads.

Would the safety committee allow the trial to continue if patients were all showing signs of disease progression?

Further thoughts on this...

Cohort 2 has taken longer than expected, which based on the trial progression criteria could be considered as positive.

It suggests:

There has been no DISEASE PROGRESSION
There has been no unacceptable toxicities

There may have sadly been death (but unlikely as this would suggest disease progression, which would have halted the trial)?

Could it be that these patients are not reaching the max exposure due to the safety profile and the dosing is continuing for longer than expected?

I do not know the answers but it would seem that the longer the DE period per cohort lasts the more optimistic the final outcome becomes.

As per below

Experimental: AVA6000 Phase 1a
Patients in Phase Ia will receive escalating doses of AVA6000 following a 3+3 design, commencing with a starting dose of 80mg/m2, once every 3 weeks (Q3W) starting on Cycle 1, Day 1 (C1D1), until DISEASE PROGRESSION, unacceptable toxicities, withdrawal from treatment for other reasons, reaching maximum lifetime cumulative exposure to doxorubicin (or other anthracyclines), or death, whichever occurs first.

Per previous post, can we conclude that with Cohort 2 'progressing well' and cohort 3 imminent that there has been no disease progression, otherwise the trial would have stopped. If no disease progression then Ava6k must be preventing it?

Welcome thoughts from fellow LTH.

With cohort 1 complete, cohort 2 'progressing well' and cohort 3 imminent, I think we can conclude, based on the trial continuation requirements, that we are not witnessing any disease progressing.

This would suggest 'it works'

As always ignore the trolls. Q3 starts next week!

..

Bit early to assume that I think. Let's see how the day unfolds

To be out of this overnight !

That's a crazy buy on the open market.

Has someone just read the Business update RNS planned for release tomorrow?

He has to say something, so what will it be?

1. I wont comment today on the progress of AVA6k and you will all have to wait until read out which is expected XX date.

2. I wont comment today on the progress of AVA6k and you will all have to wait until read out on XX date but we remain very happy with the data which remains remarkably consistent (or words similar)

If he says the above I think we shall have fireworks. Its simply not possible to be 'happy' with the data at this stage and for AVA6k not to be working IMO!

3. Surprise the market by sharing some key data in the bus update, such as biopsies/TMS activation, trial sites, USA etc

Hopefully it is 2 or 3.

Up over 30% in past 5 days..... Certainly moving against the market trend. Could it be connected to Ava6k? Let's hope so.

If there was a risk that the data would disappoint the market Alastair would have been giving weekly interviews pumping the opportunity which would have been followed by the typical AIM placing..

it's notable that Alistair sees better value or greater options post read out than he has done to this point.

That Alistair decided it would be best to address the cash / funding post Ava6k read out rather than prior.

The strategy suggests confidence.

Bein, not sure why you say that about the Dx business. Affimers as a Dx tool vs Mabs have many selling points and I wouldn't rule out a large scale licence deal (it's cheaper, it's arguably more precise but most importantly it's not Mabs which could be banned / frowned upon at some stage in the future).

Remember when Neil Bell informed market that 3996 would be selected following confirmation of the precision mechanism of action??

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