Member Info for Bella6532

'Programs granted Fast Track designation are subject to more frequent interactions with the FDA during clinical development and may be eligible for accelerated approval and/or priority review if certain criteria are met.TUB-040 is currently being evaluated in a multicenter, first-in-human, dose-escalation and optimization Phase I/IIa study. The trial is designed to evaluate the safety, tolerability, pharmacokinetics, and efficacy of TUB-040 as monotherapy and is being conducted in the US, UK, Spain, Belgium and Germany. Phase Ia includes dose escalation and will determine the safety and the maximum tolerated dose or identified dose for optimization, while Phase IIa will focus on dose optimization, safety, and preliminary efficacy of TU...'

Good to see what steps others are taking within the ssme marketplace as it often gives a clue to what we will be doing going forward...including potential specialist funding amounts...with US being the bigger spenders...

These are the three statements that stood out to me...

'Exatecan failed in the clinic due to a limited therapeutic index and significant PK issues '

'We believe that pre|CISION-enabling can transform this payload (exatecan) to a highly successful anti-cancer

drug'...

'Therapeutic Index: The MTD of AVA6103 Is 75-fold higher than that of conventional exatecan'

'Anti-cancer drug'....not just a means to reduce side effects.

OK so Exatecan is an anti-cancer drug but it failed, however, within the PreCision format AVA6103 is now the new anti-cancer drug...

Seems to me they are now pushing the 'killing' narrative much more than previously.

It also looks like the Tempus collaboration is going to be key in increasing the probability of

technical and regulatory success.

Yeah PL75...I'm not an oncologyst nor do I have any medical training...I guess you understood every bit of it...and no, not everyone in the room would have understood every bit of it either.

It starts out very much in laymsns terms..but then gets rather heavy on the science/technical side...yes a tad difficult to digest.

I note it says Full Pipeline Revealed...would that be off putting to investors who then see us as only a 3 product company...!!

Yes..'may'...not a good look...

Collaborating in Platform development with upfront payment and option to licence...

Surely this is what Avacta will be looking for...

Https://news.abbvie.com/2024-10-31-AbbVie-and-EvolveImmune-Therapeutics-Announce-Collaboration-and-Option-to-License-Agreement-to-Develop-Next-Generation-Cancer-Biotherapeutics

Https://news.abbvie.com/2024-10-31-AbbVie-and-EvolveImmune-Therapeutics-Announce-Collaboration-and-Option-to-License-Agreement-to-Develop-Next-Generation-Cancer-Biotherapeutics

They won't have said anything more than has already bedn said in the public domain. They will, hopefully, have exchanged contact details/arranged follow ups with some...wink wink.

All depends who attended, their authority level and how much they actually understood (scientific credentials). Markets still a bit spooked by Budget.

No investor currently owns over 3%...

3% is only around 11m shares or around £5.8m

It's not a huge amount.

Avacta needs someone to come in with £20 -£40m.

That sort of investment will be for an equivalent shareholding...

The SP will need to rise to vompensate fir new shares bring issued.

It seems quite obvious some on here are not reading what is being put out by the company and don't understand how this industry works.

They only have 3 things on their agenda right now gor the near term.

1. Get one or more specialist financial investors onboard.

2. Dispose of DX at best price.

3. Start Nasdaq listing process.

They have funding to continue with AVA6000 trial and this will tick on regardless.

They are working with FDA and that will tick on regardless.

Pipeline in house work will continue regardless.

When and how quickly they can get another product into clinic will depend on 1, 2, or 3...

The likes of Avacta and the videos are simply case studies for these company to sell their services to others...not to really help Avacta...

Or a deal has been done but not yet signed off....

As BV said...we've just got to suck it up and wait...

There are a couple of other ways to look at it....

When she says we are not doing deals - perhaps she means with new Partners...but an extension of an existing agreement with an existing partner could be possible.

or they are NOT doing any deals right now but have the potential of one or more in the offering based on P2 data and an MOU could be forthcoming on this basis from one or more.

or they are NOT prepared to do product deals right now because they want to get one or more Specialist Investors onboard (finance Partners) who will front the pipeline research and with their help get much better product deals down the road. Rather like Levicept who have Medicxi, Pfizer Ventures, Gilde Healthcare and Advent Life Sciences onboard as financial investors...

PL75...haha...as JT says in his X post...AVA6103 is the bee's knees...I was just shouting from the roof top so perhaps others might hear/wake up to what we had been told...75x...that's pretty significant idn't it?...

Great summary from JiveTurkey...onward and upward as they say...

We already knew this as we were told the following on 24 Oct...

'With the advances in the platform, we are now seeing a 75-fold increase in therapeutic index with our recently announced exatecan program, AVA6103 in preclinical models, suggesting that AVA6103 could have an unprecedentedl safety profile in the clinic. Potent topoisomerase I inhibitors are the payloads of ADC therapies in the clinic, although the non-specific release of these payloads can lead to severe off-target toxicities. Given the lack of these toxicities in our first program and the broad reach of the topoisomerase I inhibitor class, we see our next programs as having great potential for true impact in patients with high unmet need."

The reaction on here wasn't exactly exstatic either...guys it's huge...huger than huge and THIS IS WHAT CC WAS TALKING ABOUT WHEN SHE SAID WE WOULD BE EXCITED WHEN THEY REVEALED THE NEW PIPELINE. It's not the pipeline is the results they've observed in lab...75x....75 f'ing x's.....

When Ministers say...'up to'..it's speak for 'it may or may not happen'...

Thanks for your response BV...

Beware the wording...'up to'...