Member Info for CTSFO

“ can't wait to see the crook in another interview, he's got some serious, serious explaining to do.”

An interview under caution springs to mind.

They aren’t reinstating 1b. It’s not in the RNS or the Turner Pope note.

“ The Company would, dependent on the data obtained during the Phase 1a and Phase 2 trials, anticipate commencing a potential Phase 3 trial in Q1 2026 for AVA6000 (also subject to funding and regulatory approval).”

We’ll have to see if this P3 is for indications other than or including STS.

Good afternoon everyone.

Re trials stopped early. Not teaching people to suck eggs:

Having a trial stopped early because of proven efficacy is every Pharma’s dream. Stopped early because of harm or no benefit is their nightmare.

Every participant within a trial will be under higher level surveillance and investigation. ADR - Adverse Drug Reactions are constantly being actively looked for. Likewise evidence of efficacy will also be looked for. Unfortunately it’s more common for a trial to be stopped for ADRs. Avacta has a dedicated ADR option if you ring the company switchboard.

But we’re on a winner here. So much is already known about plain doxorubicin, and liposomal doxorubicin, the trial(s) have a huge established dataset to compare against.

GLA

I wish I’d followed this example. Also this side of the bridge 🏴󠁧󠁢󠁷󠁬󠁳󠁿

That’s a fair assessment Ice. Cold strategic thought is called for, I agree. I need to calm TF down. And then buy back in.

GLA

It is stupid to sell at a loss, I accept that. And yes, a bit of a knee jerk. I’ve lost trust. I pathologically hate criminals and people who lie. This goes beyond sentiment, AS has deliberately deceived people. Or he’s simply incompetent. The science is sound, the platform works. Al isn’t and doesn’t. I know the company isn’t going bust, so the shares should recover. I just want everything to settle. I want to see what happens with REX.

I know the SP can change here very quickly, I might well regret my actions. But likewise, a less than spectacular AACR and larger share drop to Heights might push the SP down even further.

I’m going to stick to the science if I post here. Still invested, just not as much.

Above all else I wish everyone a good weekend and better luck going forward.

I was 50% down and have sold the majority at this loss. Worse in the ISA. Not going to be a bitter troll here. I just want a little stability. I know the SP might rocket up, but likewise a drop might occur.

Difficult to trust anything coming from the company at present. I hope and pray the AACR results are good. We’ll get some direction once we know if it’s a poster or proper presentation. Second time I’ve been badly burnt by believing the hype from a CEO. The BGC needs to go.

Thanks Ice, I missed that. So fecking angry at the time I didn’t give it the attention it deserved. Thank you.

Something ‘interesting’ is / has happened. Orphan Drugs have their own legislation and trial procedures to satisfy the FDA. They don’t typically need the formal / standard P1,2,3 trial sequence. I thought Avacta were planning to take advantage of this by having AVA6000 granted ODS for STS.

I’m interested as to why P1,2,3 are now being required? Or have I read it wrong, will there be P1, 2&3 hybrid trial for STS, and formal P1,2,3 trials for other cancers?

This is worth a read:

https://academicentrepreneurship.pubpub.org/pub/einr3b30

At least that’s 40 days without being lied to.

I’m amazed, absolutely amazed, Avacta haven’t branched out into Urology and Gynaecology.

Utter cun£5 all taking the p155.

The graphs are incredible. We need the full dataset now. Big Al needs to pull his nuts out of the fire. Impress the world at AACR.

I didn’t write that to sound so patronising. Sorry. I wish posts could be edited on here.

If you look at the slide decks from Avacta, they show mild, repeat mild, side effects. This is very reassuring. Certainly no cardiotoxic events so far. We need this shown in all the cohorts - which I think they will - and in Q2W. The low free doxorubicin in the blood is what is to be expected. The trials need to show no breakdown in the bone marrow or other sites of more rapid cell division.

Please don’t take this as FUD, deramping, insulting anything like that.

They’ve proven the safety of the drug, we’ve all seen that, but there have been mild side effects. So it’s not purely drug delivery into the tumour and nothing else. The more recent cohorts will give information on this.

What we really must see is enhanced cytotoxicity, and a change in the rate of development of multi drug resistance. If this is being suggested, then it’s excellent news. Just equalling plain doxorubicin won’t be enough.

The ongoing trials may, repeat may, not be a trial against plain doxorubicin, but against things like liposomal doxorubicin or other delivery systems.

BUT… and this is important… this is as much about the delivery platform as it is about doxorubicin. If they get it right with a better warhead, we’ll quickly forget we ever did anything with doxorubicin.

Touk, I agree. For all our sakes I hope they’ve got something very special to present at AACR. The change in tone / enthusiasm / excitement about the drug is being picked up by everyone. The company needs to sort itself out, pronto.

Ice, sorry to say this, the P1a data simply isn’t enough. It’s encouraging, it suggests it works, but the numbers here are tiny compared to what is needed for a PL from the FDA, MHRA, or EMA. All Pharma regulators have really tightened scrutiny.

Still think ODD for STS is the best route to market. From a patient perspective, I hope they JV this.

ATBD, fair comment. I’ve read and reread that RNS. My take was the “subject to funding” comment meant ‘subject to this funding taking place now’ for work up till the end of 2025. They said this money would give a 2 year runway. 2026 and P3 is anyone’s guess.

Agree the FDA comments are very vague. They imply an update from Q2W and Q3W will take place towards the end of 1H24 I think? Might have said early 2H24.

Sorry to everyone going through the pain I am this morning. I think BV has nailed it with the post the IIs decided the price they’d buy in at. It is what it is.

The clarity around the proposed trials is helpful, more expensive, but helpful.

AVA6000 getting ODS for use in STS was an idea for a fast track to market. The regulatory framework for orphan drugs and their trials allows P2 and P3 to be hybridised. So quicker. This can still happen. And it’s properly funded.

The assumption that AVA6000 would simplify replace plain doxorubicin for all of doxorubicin’s present indications had always worried me. AVA6000 is more than a safe delivery system. You’d have to know, either by biopsy or accepted large data, the tumour your targeting is FAP rich. So it is different to go everywhere plain doxorubicin.

But BV, myself, and others have said time and time again oncologists will want to try AVA6000 in their patients. Whether off licence or as part of oncology unit trials. Formal P1, P2, P3 trials for the non orphan drug status tumours will therefore be of benefit in the longer term. The product license for AVA6000 will include these cancers, and by default AVA6000 becomes the drug of choice.

Other delivery platforms: doxorubicin is available as a plain agent or a liposomal encapsulated product. Drug research is ongoing to develop adjuvant agents that eliminate / markedly reduce the cardio-toxicity of plain doxorubicin. We have to be aware of these within the market when AVA6000 is launched.

My prediction: AVA6000 will get its first PL for sarcoma, most probably Soft Tissue Sarcoma. Using ODS trial regs this will be relatively quick. Orphan Drug Status for other rare cancers will be applied for and granted.

The big P1, P2, P3 trials for more common cancers will be JVs.

I hope we hear news about the Q2W trial soon.

This might be very unpopular - not sure removing AS this week, or next month, is in the best interest. More uncertainty we don’t need. But something needs to be done long term.

Morning BV. The broker’s note shows Avacta having £16.6 million in the bank on 1st Jan 2024, and markedly reduced burn in 4Q23. So not cash strapped. But not sure if enough for an Auditor to sign off as a going concern. I’m wondering why here and now? If good news at AACR then they would have seen the sp rise - I hope! It all seems unnecessarily hurried and undervalued. Or is there something else at play here?

link to the note:

https://*********************/companies/uk/other/avacta-group-plc/research/capital-access-group/avacta-group-33m-raise-to-progress-drug-pipeline/23_2024022902475859814

link to the note:

https://*********************/companies/uk/other/avacta-group-plc/research/capital-access-group/avacta-group-33m-raise-to-progress-drug-pipeline/23_2024022902475859814