Member Info for LiveLongnProsper

Quick AI look - FAP expression in MM high, AVA3996/2727d could be relevant here? (Velcade, AKA Bortezomib off patent).

GLA

Spot on (good to see you back!) @Hurst10.

April 28 …

https://www.abstractsonline.com/pp8/#!/20273/presentation/5420

Abstract published – using Tempus AI data to analyse FAP expression across multiple tumor type CAFs, leading to further and better informed pre|CISION® pipeline developments.

April 28 …

https://www.abstractsonline.com/pp8/#!/20273/presentation/3042

Abstract published – looks like a ‘deeper dive’ into AVA6103 than we have already seen in the latest corporate slides. Look forward to that.

April 29 …

https://www.abstractsonline.com/pp8/#!/20273/presentation/10472

“Abstract is embargoed at this time”. Maybe more data?

Presenters / Authors include …

SAB members - William D. Tap, MD (MSK), Lee D. Cranmer, MD, PhD, FACP (Fred Hutch).

Trial leaders include – those above, Prof. Chris Twelves (Co-ordinating and Leeds), Prof. Udai Banerji (Royal Marsden), Prof. Jeff Evans (Beatson), Dr Natalie Cook (Christie), Dr Ruth Plummer (Newcastle), et al.

ThinkQ2 (scientific strategy, PK/PD data analysis, etc.) credited again …

https://www.thinkq2.com/

As are Octa Consulting (trial design, regulatory advice, statistical methodology, etc.) …

https://octaconsulting.com/

Why the embargo, what don’t we know, who knows stuff that we’re not yet privy to?

Personal strategy (not advice, DYOR, etc.), see if it runs down a bit further (actually I really hope not) to the CLN payment deadline – if in shares then a small ‘top up’, if in cash all good, then maybe we start the re-rate after AACR presentations and again after ASCO in May/June, with the promised P1a data update sometime in 2Q/2025? We’ll see.

GLA

Can’t see anythinh on twiX about a ‘private placing’, but like my many green boxes over here I have many muted X’s. So just musing while we wait …

Affimer Limited ‘confirmation statement’ overdue …

https://find-and-update.company-information.service.gov.uk/company/08458974

Dormant company, so not a big deal, over to Brian Hahn to action.

Unless anything to do with Coris sale? Affimer Limited not holding any IP, but I suppose could be a means of transferring some IP if part of a deal?

I mean while while we’re waiting for the usual stuff …

Next CLN payment (shares or cash), next science presentations (AACR, they do look good through), and any evidence of any kind at all of a semblance of a commercial strategy, or even the possibility of a ‘private placing (one that just dealt with the CLN in it’s entirety would ‘clear the decks’).

GLA

Email circular semt out by Sherly Mosessian (SOFIE CSO) today maybe of some interest ..?

(Context - [18F]FAPI-74 PET, fluorine-18 FAP inhibitor, is used to identify FAP expressing CAF’s surrounding tumors via Positron Emission Tomography imaging. Avacta announced a FAPI-PET study in the 23 May 2024 RNS).

“Dear FAPI Community,

For our first newsletter of 2025, I am happy to share that things are off to a roaring start on the FAPI front.

But first – a final highlight of 2024 was the activation of [18F]FAPI-74 production at now FIVE sites in SOFIE’s network – Totowa, NJ; Gilroy, CA; Romeoville, IL; Sanford, FL, and Cleveland, OH. This growth in FAPI-74 manufacturing capability uniquely positions us to support our upcoming [18F]FAPI-74 clinical studies and academic investigator-initiated studies, in addition to companion use of [18F]FAPI-74 in Pharma collaborations. Additional sites are planned for FAPI-74 manufacturing in 2025 so be sure to follow SOFIE’s LinkedIn account for the latest.

We reached a major milestone in February with the completion of recruitment for SOFIE’s [18F]FAPI-74 Phase 2 clinical trials. We are currently performing data analysis and behind the scenes planning for Phase 3 is well underway.

On Wednesday, May 14, I will be speaking at PEGS Boston on “[18F]FAPI-74 PET in Gastrointestinal Cancers – Addressing an Unmet Need”. I hope to see you there in person or virtually.

Please share your feedback on how this newsletter can better serve you. We want to hear from you!”

Must be quite a lot of interest in the technique if SOFIE are ‘ramping up’ manufacturing – which, presumably, means a lot of BP interest in FAP expressing tumor CAF’s.

GLA

“Novel data from our strategic collaboration with Tempus AI continues to be reported, including at the AACR Annual Meeting in Chicago.”

Slightly odd form of words (to me anyway) - ‘continues to be reported’, so presumably this is still ongoing and making significant findings …?

https://www.abstractsonline.com/pp8/#!/20273/presentation/5420

This abstract has a quite ‘dense’ information content and is worth a careful read. The implication being that it is shaping the pipeline.

GLA

I posed this question on 26 March …

Page 11 – what does the lower dark blue arrow mean – “385/200” – different nomenclature and number to the above one?

Ben on twiX makes this suggestion …

https://x.com/111BEN_111/status/1905946639799357775

Are we developing a dosing regimen that enables a continuing 200mg (after initial 385mg) maintenance dose of dox (only possible with AVA6000, of course) over a much longer duration – and beyond current lifetime limits?

GLA

Soon – Coris update (apparently Dx all gone)?

w/c 21/4 (or before?) – CLN decision, notice of results.

28/4 – AACR

“2699 / 16 - Investigating fibroblast activation protein alpha (FAPα) as a therapeutic target for delivery of pre|CISION® cancer medicines: Expression, spatial localization and functional insights”.

“3139 / 24 - The novel peptide drug conjugate AVA6103 is a FAP-enabled pre|CISION® medicine which targets exatecan, a topoisomerase I inhibitor, to the tumor microenvironment following FAP cleavage”.

29/4 – AACR

“CT151 / 17 - Comparative pharmacokinetics and tumor activation of fibroblast activation protein (FAP)-enabled pre|CISION® peptide drug conjugates”.

End April / Early May – 2024 results.

AVA6000 1a data update 2Q 2025.

AVA6000 1b interim progress update (tbc)?

ASCO May 30 – June 3 Chicago (tbc)?

June 2025 AGM.

Anytime – license deal(s), ‘strategic’ investor(s), potential acquisition?

No doubt missed a few.

GLA

Just spotted that, plus a few other snippets ...

Page 3 – “AVA6000 (FAP-Dox) Phase I completed”? Expansion cohorts ongoing?

Page 3 – “pure-play oncology therapeutics company”, “following the divestment of the diagnostics

Division” – Coris gone then?

Page 5 – Simon Bennett – “SimIPOon” - so that’s what he’s busy with then?

Page 11 – what does the lower dark blue arrow mean – “385/200” – different nomenclature and number to the above one?

Page 11 – significance of 350mg/m2 vs 550mg/m2 – who approved, if approval necessary?

Page 12 – ‘Data cutoff 15 Feb’ – we already have nearly 6 weeks more data - who's 'in the know'.

Page 13 – ‘Median PFS’ not reached as of 16 Feb – are we still going, i.e. ~6+ months?

Page 23,24 – think these slides important (actually ‘stunning’).

Science and trials looking great, commercials and SP appreciation now please Avacta.

GLA

Thanks @gmcc, just catching up.

https://clinicaltrials.gov/study/NCT04969835

These updates are relatively infrequent, so perhaps not insignificant?

As others note, possibly 2 conditions added - Urothelial Carcinoma, Ovarian Carcinoma? Don't think these 2 conditions mentioned on today's slide deck - so wonder if recent additions?

Also, possibly - 5 of 6 UK sites recruiting - checkout the names for SAB members and presenters!

Trial sites have been led by MSK and Fred Hutch so far, hope to see UK participation - but not UK regulatory bureaucracy.

GLA

CC doing excellent job as CMO, chairman still seems to be ‘seated’, looks like the CBO is doing a Parkinson’s Law version of ‘busy’, what’s the new finance guy up to I wonder?

Science is great (AVA6103 could make a huge 'dent'), would like to understand what exactly happened re ‘permission’ to increase Dox dose limit for AVA6000 (seems like a way understated development?).

Need to clarify P1b focus regarding STS. Having said that, recruitment seems to be progressing. if the Withpower site is correct, ’32 spots left’, so on the basis of 60-90 possible patients, should mean 28-58 underway (but also subject to STS clarification).

Conference season upon us and, in true Avacta fashion, as far as ‘communicating’ goes, they drop some placeholder pages on the website under ‘Events & Presentations’ – this after hiring even more ‘communications’ type folks (Carly, Renee, et al) – guess you’ve just ‘gotta’ laugh.

Not wishing to end on a downbeat note (as per @SharkAttack’s Warren quote – my expectations are high, and I am personally very positive), but in the absence of evidence of commercial progress we may well see the ‘usual suspects’ turn up again as we approach the next CLN payment. Getting Coris ‘over the line’ soon should help sentiment though.

GLA

Plenty of upcoming opportunities, a couple of possible candidates …?

AACR April 25-30 Chicago …

https://www.aacr.org/meeting/aacr-annual-meeting-2025/program/

ASCO May 30 – June 3 Chicago …

https://conferences.asco.org/am/attend

Watch this space.

GLA

Looks like James Heseltine seems to have moved to KPMG, Sarah Murphy promoted to Group FC (source linkedin -apologies if already posted)?

We still have a Dx CCO and COO (be surprised if they go with Launch), maybe working on the Coris deal?

Dx disposal (in full) should leave us with a significantly ‘slimmed down’ operation. Scientists, CSO, CBO, CFO, small admin and finance team.

Can’t help thinking that the CEO is also doing the job of a CMO – which I think is actually necessary, as the top Oncology doctors in our ‘ecosphere’ will only talk to a company Oncologist (and MD) with a similar standing (as per CC).

All the more reason for the Chair, CBO and CFO to really step up to the mark on the commercial front.

(Just a few passing thoughts for discussion).

GLA

‘More questions than answers’ – indeed.

Does seem to be a bit of an Avacta ‘thing’. I mean the partial updates, the hints (sometimes with furtive smiles), the often unexpected (but always incomplete) data releases, the suggestion of potential partners, the allusions to new pipeline products, etc., etc

(Yet I continue to make small additions, more-or-less tracking dilution).

I’m now just waiting for a clear signal to take the ‘red pill’ that gets me out of the ‘rabbit hole’, back through the ‘wardrobe’, and to the ‘end of the rainbow’ - where my ‘pot of gold’ is surely waiting.

GLA

@Almostrich, agree - Novartis really need the pre|CISION® platform.

They have no ADC’s and no platform. pre|CISION® could also be the platform they need to support RLT development - and compete with Lilly (CanSEEK™ - aka pre|CISION® , but limited license).

Would also get them back to competing with Daiichi/AZN, Merck, et al with a targeted Exatecan (AVA6103) therapy.

Not to mention the immediate opportunity with AVA6000, and potential AVA6000 ‘combo’ therapies.

GLA

Another excellent post from RAH via SpacetwiX …

https://x.com/RAH00084/status/1898364360919253280

In the context of PFS, we’re beyond the current SGS ‘standard’ of 3.5 months and apparently now ‘waiting’ (?) to see how long before 50%+ patients progress with disease (sounds harsh, I know).

While we understand that some patients are continuing to improve beyond treatment with AVA6000, i.e. after it is withdrawn (which is great), could (are) we be continuing to treat patients beyond the trial design period?

Big question for me is – are we stopping treatment of patients, who would otherwise benefit from continuation of dosing with AVA6000, simply because they have exceeded their lifetime limit of Doxorubicin (note – no lifetime limit of AVA6000 set), and are not suffering from any serious side effects?

Seems to me, that given AVA6000 is dox to the TME (mostly only), without the dose limiting side effects of ‘straight’ dox, then we should be petitioning for an increase in the lifetime dose specifically for AVA6000?

Or does this come with FDA ‘fast track’?

GLA

Looking for a nice round number in the otherwise not very round numbers (shares or £’s) … the 2 trades are close enough to CHF7.5m.

I can think of one Swiss BP that isn’t doing very well with ADCs and is trying to target FAP with their RLT products (kind of like Point/Lilly ‘can’ – maybe - do?). Well, you never know?

Trial progress updates and 6103 planning just make pre|CISION® look even more valuable.

GLA

Is this an Avacta ‘sense of humour’, i.e. updating a contact page in the absence of any comm’s?

Or, is this change in advance of some actual comm’s - Wed / Thur being prime RNS days?

Or, is it just a Web Dev with time on their hands fixing some punctuation?

‘Gripping stuff’, eh …

GLA

Discussion on twiX just now re number of patients recruited to 1b so far.

We could well be using this Tempus service to help with that ..?

https://www.tempus.com/oncology/clinical-trial-matching/?srsltid=AfmBOop-dmonhb0Pzay2jyZIQUYLac7MVLizUXL07f0hHVVKi04akYcp

Plus we have a remarkably strong team on the trial, led by Chris Twelves …

”Name Chris Twelves, MD – Role Principal Investigator – Affiliation St James's University Hospital, Leeds, UK”.

Other SAB members involved in the trial (as ‘contacts’) …

Memorial Sloan Kettering Cancer Center, Dr William Tap (plus Dr Alan Ho),

Fred Hutchinson Cancer Center, Professor Lee Cranmer,

Trial ‘contacts’ not on the SAB …

The Beatson West of Scotland Cancer Centre, NHS Greater Glasgow & Clyde, Professor Jeff Evans,

The Royal Marsden, NHS Foundation Trust, Professor Udai Banerji,

The Christie NHS Foundation Trust, Dr Natalie Cook,

The Freeman Hospital, Newcastle-upon-Tyne NHS Foundation Trust, Professor Ruth Plummer.

Dr Twelves presented our poster at ESMO in Sept.

Also note the poster co-authors include - Dr’s Banerji, Tap, Cranmer, Ruth Plummer, Natalie Cook and (also a CT contact) Prof Jeff Evans.

Not to mention the enthusiasm recently shown by Dr Virgilio Sacchini.

Now who are the BP ‘sponsors’ ...?

GLA

What’s going on then ..?

Placing inbound?

Concern over next CLN payment in shares?

‘Walk down’ to let the short close?

‘Walk down’ to a particular target for a ‘strategic’ investment and/or Nasdaq listing?

Investors getting fed up waiting for Dx sale?

Investors getting nervous about funding trials? (Taking a high(ish) view for 1b 90 patients @ $100k = $9m or ~£7m).

Just a loss of confidence in management collective commercial capability?

Chairman has been ‘judged’ on 6 month ‘promise’. CBO seemingly done ‘nowt’ for being so ‘busy’.

Fortunately, CEO and scientists doing a great job with AVA6000 trials, AVA6103 pre-clinical and pipeline generally. Science great, IP strong, trials progress very encouraging.

Best outcome (IMO) acquisition by BP at a sensible price – accelerate trials, FDA ‘fast track for AVA6000, progress AVA6103 and pipeline generally, benefit patients, reward LTH’s.

See what happens next.

GLA

Https://www.youtube.com/watch?v=N-CEKComvX8

Why Pfizer bought Seagen, starts to get relevant from 2:50.

ADC targeting to cancer site carrying warhead / payload – chemo, nuclear, tactical (immuno etc. presumably?).

Can replace [conventional] chemo via targeting … etc.

AI makes diagnosis and treatment planning more accurate … etc.

Sound familiar so far ..?

Pfizer investing 2x ‘what it made from Covid treatments’ to address the ‘scourge of cancer’.

‘If we discover medicines that really double and triple survival, then it’s very good business’.

Most of our pipeline drugs for cancer

Seems like they are looking for treatments to reduce and manage cancer, without current treatments side effects, not necessarily anticipating a cure for a while?

Avacta are doing this stuff (possibly better?), just with PDC’s and on a ‘shoestring’.

If we are not in discussion with a BP or 2 by now, then I would be very surprised.

GLA