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Whoooosh!!!!

'Exatoukan'

Get it now?

Some people here need a sense of humour implant. They are too keen to find a negative to bother reading what has actually been written. Now THAT is hilarious!!!!

Phase 1b TNBC arm was announced 30 Oct 2024

https://avacta.com/wp-content/uploads/2024/11/Avacta_RnD-Science-Day_30Oct2024_final-.pdf (slide 45)

PHASE I: EXPANSION COHORTS

Initiating 2H 2024

Initiate RDE cohort to assess intratumoral PK

Expansions in disease-specific cohorts to begin in 2H 2024:

• Triple negative breast cancer

• Salivary gland cancer

• High grade STS

I'm pretty sure that means it'll be 20+TNBC patients in Phase 1b.

Excellent news for Avacta's renal franchise HurstBot.

And well done to the two (so far) who gave the OP recs. Care to give the whole class the benefit of your spot-on analysis as to why this is such good news for Avacta?

The rationale for tackling SGC first is clearly given in that transcript and is already known for STS. TNBC would require a lot of trialling and consequently a lot of money and CC has already said that Avacta would need to partner in order to get AVA6000 approved for that indication.

Even if AVA6000 could be used as a monotherapy, as opposed to in combination with existing n-line standard of care options, there would still need to be a lot of trials against existing standard of care treatments as comparators to prove that AVA6000 was better than those standards of care.

One thinig I'll say for Professor Eggy: he may be a diehard Reform UK man but at least he doesn't seem as far right as his paymaster, the Russia-loving, Ukraine-hating Tom Winnifrith.

However, if Avacta had not (possibly/probably - it's not decided yet) pivotted to SGC with its no standard of care and had stuck with STS and its larger market, the troll would have truied to knock the company for not going with the 'easier' indication.

Trolls will be trolls and 'the professor' is totally predictable in his "it's not working" line that he's paid by TW, he of the deteriorated dentures, to promote.

Jog on Eggy Soldier

'Professor' Eggy is perhaps the most incompetent of trolls.

Discuss

Note: this is why Chris was so excited pre Christmas and wanted to share this event (but couldn't due to consent and scan timings).

On whether this meant SGC would be prioritised over STS, Chris said it depends. Partly on whether they find a partner with very deep pockets. But also, whether we want to retain 100% of an indication which is likely to move very quickly through an accelerated approval route. "So we can start to book revenue ASAP".

Pharma are actively looking at the data now under NDA. This was one of the reasons Chris was in San Francisco this week.

For Chris, what has been most important is a clear correlation in this SGC data. It's clear the trend was what has excited her. Along with the consistency of results. "We couldn't believe it".

She then moved onto the complete regression in the skin metastasis. A key point here: yes it was complete regression (Chris has said there will be a photo released to show the extent of the reduction but remarked the gentleman's skin was quite leathery and red/purple where the cancer had metastasised all over his neck and chest.

That metastasis has seen a complete regression. Crucially, the way RECIST measures SGC doesn't enable this dramatic shrinkage to be valued in a meaningful/ representative way. Chris remarked when we see the photo it will hit home far harder. This data will be accompanied by a video presentation. It could not happen this week as Chris has been so busy preparing for San Francisco meetings.

On partnerships, she reiterated it's like dating. It's also clear they are considering a range of options (from multi indications deals to individual indications). Again, all led by the data.

We can expect a R&D Spotlight over the next week or two on AVA6103 and Chris reiterated there would be two more important RNS before the end of January.

I assume one is Dx. I do not know what the other event could be. They continue to speak to co-brokers. They met Richard Hughes of Zeus Capital last week so I assume we will also hear on a UK co-broker shortly.

There's not much more to say on the CLN beyond my original note. I have made our thoughts loud and clear.

Fundamentally, it's obvious this was the moment Avacta started to get really excited about AVA6000. It's going to be a very exciting few weeks/months ahead. We haven't even got going in the first line setting yet...!

Best

2/2

Good morning,

As promised, here are my more comprehensive notes from yesterday's call which lasted just over 40 minutes.

The purpose of Chris requesting the call was to contextualise just how good this data is. She (quite impressively in my view) foresaw some as many did on Telegram yesterday - would not see this data for what it is: the makings of AVA6000 in SGC which has no standard of care.

Avacta have been heavily at work on the approval strategy for AVA6000 over the past few months.

Yesterday's RNS conveyed what Chris called 'a hidden message for institutional investors and pharma'. The RNS put them on notice we are going to seek an accelerated route for SGC. I.e. so they see we have a strategy in place.

Avacta is screening lots of patients in P1b. I did not get a chance to ask whether the withpower figures shareholders have quoted on here were correct but I got the impression (from her enthusiasm around recruitment and regular references to 'multiple sites') they probably are.

Avacta had hoped to announce the dosing of P1b yesterday in tandem with the RNS. But it was slightly delayed (thus, imminent really does mean imminent).

Back to SGC and why Chris believes it's likely the "one which will pull away from the pack". Again, she referenced the lack of guidelines for SGC. The box for 'preferred regimen' under metastatic SGC is blank. The bar is low. There is no standard of care.

There are very few cancers where the guidelines are blank. The advantage here is the FDA cannot ask Avacta to use drug X as a comparator for the trial. This enables much more flexibility for Avacta when designing the trial endpoints, which as we all know is crucial.

The investigators are all heavily involved in our planning here. It is also likely (and this is more subtext to yesterday's announcement) that we will be able to move very quickly in terms of an accelerated route to approval. She did not say how quick and I did not ask as she was in full flow at this point.

Onto the data. "It really is tremendous". The patients were mainly enrolled over September and October. "As you can imagine, when the CT scans started to roll in, we couldn't believe it"... "they were not only dramatic but consistent". Chris noted SGC often has 'weird' metastatic patterns so this consistency in efficacy was really quite noticeable.

1/2

So the "two more important RNS before the end of January" turned out to just be the expected CLN repayment? Possibly the co-broker announcement of Tuesday, 4 February was expected to be one? Maybe CC intended to RNS the 29 January R&D Spotlight focussing on AVA6103 and AI? And to RNS the first dosing in Phase 1b? If she still intends an RNS for the dosing then the 'slight delay' has run on for six weeks, which isn't a slight delay.

WAG wrote: "Yes it’s rubbish that this information was only disseminated to a small group but is reasonable to assume that Christine assumed the info would be shared widely."

That's rubbish. Public domain information should be made available to the whole market at the same time.

And it's Christina.

If CC were to do what she did with Avacta on Nasdaq, the litigation firms would be sniffing eagerly around her and opening class actions.

Who knows? Who cares? OP gives no sauce = ignore

Is there any particular slides in the 59 slide Daiichi Sankyo deck that you'd ike to draw our attention to?

If it was HurstBot, there would be no sauce, just assertions.

Anyway... "The total cash consideration for this acquisition amounts to up to $1.15 billion. This includes an upfront payment of $1 billion, with the possibility of an additional $150 million milestone payment contingent upon success-based regulatory approval" - and that is just for one drug 18 onths away from completing Phase 1.

$1bn for Avacta would be 220p per share, but Avacta has not one but two platforms, not just a single standalone drug in Phase 1, and absolutely nothing more...

Https://www.londonstockexchange.com/news-article/GSK/gsk-completes-acquisition-of-idrx-inc/16911162

"As announced previously, the acquisition includes lead molecule IDRX-42, an investigational, highly selective tyrosine kinase inhibitor (TKI) that is designed to improve outcomes for patients with GIST. IDRX-42 has demonstrated activity against all clinically relevant primary and secondary KIT mutations, a key medical need in current GIST treatment."

IDRX-42 is in Phase 1, started 1 Aug 2022, estimated completion 13 Sep 2026: https://clinicaltrials.gov/search?term=IDRX-42

That is the only trial of IDRX-42 currently taking place.

You know, for once I thoroughly agree with you wyndrum. Mankind has slogged its way up the slope of civilisation and now we find ourselves on a plateau, but a plateau with cliffs all around and the only question, as we rush around looking for the future, is which cliff will we tumble over like, to cliché it, lemmings. Going back, de-escalating our societies, is no longer an option now that the techbros and imperialist autocrats are in charge.

Ironic that people are encouraged to distrust expertise but believe AI unquestioningly.

DeepSeek, the Chinese AI-powered chatbot, apparently has never heard of the Tiananmen Square protest.

I saw videos the other day of a polar bear being rescued from the sea.

Soon we'll none of us know what's true and what's fake or misinformation or disinformation. Within a generation all the youngsters will have lost their minds to the internet.

This is better than a sleeping draught.