Member Info for BuenaVista

On or before 23:59 on 31 March, although it's not clear whether that is London or Philly time.

Thanks. Very interesting and, I thought, a very good presentation. Got all or nearly all the key points in - nothing missed springs to mind.

re the AVA6103 Phase 1a trial:

13:41 "AVA6103... set to enter the clinic any moment"

15:28 "We expect to dose the first patient [before end of Q1]"

The specificity for FAP is not an absolute. It is a spectrum, and where any particular Avacta candidate sits on that spectrum will depend on its fit to FAP vs the related enzymes, which is why they are working so much on computer models of the FAP 'hole'.

Alan showed early AVA6000 preclinical work demonstrating the specificity for FAP, maybe also shown for AVA3996. I'm sure this vital step is also being carried out for AVA6103, but it will still be on a spectrum.

Avacta can easily craft a licensing arrangement that guarantees the licensor has exclusive access to pre|CISION drugs for, e.g. SCG, that being AVA6000 and first shout at licensing any others and/or being able to use pre|CISION tech inhouse, or with Avacta as consultant, on their own pipeline candidates. Lots of ways this can be sliced.

That said, there are a lot of different cancer indications, trials (incl. for combination therapies) are needed for marketting approval for each one, and SGC would likely be a very long way down the list of target indications for subsequent pre|CISION treatments. A different story for TNBC, but the above could apply there.

I'll have to relisten because I spent the whole time fascinated by how Dave's water bottle related to that Escher pot. It's like one of those "Was it over the line?" controversies in football.

Will start at 14:50

"Avacta CEO Christina Coughlin and CFO Brian Hahn will be in Boston this week for the 46th Annual TD Cowen Health Care Conference in Boston. The company will host investor meetings throughout the day on March 4, with a live presentation at 9:50 AM ET. #AVCT"

https://x.com/avacta/status/2028494606346711329

Well I actually missed your thread title! I was referring to this on LinkedIn: "We’re excited to be heading to Lisbon for BIO-Europe Spring next week!".

I can't see the LinkedIn post as I don't have an account but from the "5m" I'm guessing it had just been posted this morning, but was composed by CC (the "excited"is a giveaway!) at the end of February as she prepared to head to Boston for this week's event.

Next week?

"dr smith" 😂

That's the ASCO Genitourinary Cancers Symposium

Vir Biotechnology Reports Positive Updated Phase 1 Results for PSMA-targeting, PRO-XTEN® Dual-masked T-Cell Engager VIR-5500 in Patients with Metastatic Prostate Cancer: https://investors.vir.bio/news/news-details/2026/Vir-Biotechnology-Reports-Positive-Updated-Phase-1-Results-for-PSMA-targeting-PRO-XTEN-Dual-masked-T-Cell-Engager-VIR-5500-in-Patients-with-Metastatic-Prostate-Cancer/default.aspx

Safety, Pharmacokinetics, and Preliminary Efficacy of VIR-5500 (AMX-500) in Prostate Cancer: https://clinicaltrials.gov/study/NCT05997615?term=VIR-5500

Study started August 2023. I think these small US companies like to shout about their good results in order to promote themselves.

The author is producing reviews of news announcements, not carrying out in-depth detailed reviews of the state of play of everything he's covering!

The same author had also written this: "Avacta Therapeutics (LSE: AVCT) advances FAP-targeting drug conjugate AVA6103 into Phase 1: What’s at stake?"

https://pharmadevicenews.com/avacta-therapeutics-lse-avct-advances-fap-targeting-drug-conjugate-ava6103-into-phase-1-whats-at-stake/

Both reviews appeared three days after Avacta's RNSs were published and were very largely based on what was in the RNSs but do seem to be supplemented by additional, background information such as mention of AVA6000 by name, which does not appear in the RNS on which the above article was based.

I think that review presents a fair assessment of the state of play, namely: "The legitimate value of the synthetic arm is that it enables a structured side-by-side read of two datasets that were never designed to be compared. The risk is that any divergence in animal model selection, dosing schedule, or assay methodology between the original AstraZeneca study and Avacta’s FAP-high model could systematically skew the pharmacokinetic ratios in either direction. Until the full dataset is published in a peer-reviewed journal, the three claimed advantages — faster tumor penetration, a log-higher tumor Cmax, and a nearly three-fold better Tumor Selectivity Index — are internally generated figures without independent validation. That does not make them wrong, but it limits their weight as competitive evidence at this stage."

Peer review will mean a thorough examination of Avacta's methodology and assessment of the validity of the results. Peer review is tough, but necessary.

What do you mean? An offer for a buy out? An offer for a deal for AVA6103? An offer for a deal for AVA6000? An offer for a licensing deal to use pre|CISION with their own pipeline and/or discontinued candidates?

Just a reminder: https://avacta.com/wp-content/uploads/2025/07/Avacta_Corp_23July2025.pdf - slide 20

I'm not sure what you mean Ice. For some time now oncology trials can lead to provisional approval based on a pivotal Phase 2 trial but need a Phase 3 trial to confirm that approval. To speed things up, as cancer is time critical for patients, surrogate end points that are indicative and achieved more swiftly are being used.

A summary of the new FDA guidance:

"While US law has been in place since 1997 stating that approval can be based on a single adequate and well‑controlled study when supported by confirmatory evidence, the FDA’s standard has been a reliance on two pivotal trials. Under the new guidance, the single pivotal trial will still need to be combined with confirmatory evidence, and the approval process will put a stronger focus on controls, endpoints, effect size, and statistical protocols. The paper says the move will “substantially reduce costs for sponsors” and “speed drugs to market”. Estimates suggest that the cost of a single pivotal study may range from $30m to $150m. Makary and Prasad add that as a result of reducing capital costs for drug developers, it should reduce “justification of lofty and rising drug prices for everyday Americans”. Prasad and Makary acknowledge that this guidance may be met with criticism that the FDA “relaxing its standards”, but the pair disagree. [continues]"

https://www.clinicaltrialsarena.com/news/fda-to-allow-one-pivotal-trial-instead-of-two-for-drug-approval/

Full guidance paper (requires free account): https://www.nejm.org/doi/full/10.1056/NEJMsb2517623

- - - - -

You wrote: "once you prove the delivery works in humans, every new payload isn’t a brand new science experiment, starting from scratch like 30 years ago under the old FDA process of evidence and more evidence through trials. If FDA is happy with one strong pivotal backed by mechanism and biomarker data, that massively suits a platform model. Validate the engine once, then you’re just swapping warheads."

Every pipeline drug is novel and unique. Are you saying that every pipeline drug can be approved after one strong pivotal trial—what I wrote earlier—or that, because AVA6000 gets approved for a particular indication or two (or three), all drugs using the pre|CISION dipeptide should be approved ...for all indications? ...without their own pivotal trials?

Aldebaran wrote: "Christina and Bryan going to the TD healthcare conference next week as well. Taking him rather than francis... Wonder why?"

It is a get together for the money people, not the clinical people, and they're (not there or their) going to talk deals, not data.

I'm NOT saying they are (they're) going to sign a deal right there (not their or they're)) and then, but rather to try to persuade the CEOs and CFOs of the major farmers to part with some of their (not there or they're) lovely excess cash very soon.

🤞

Why do you that will be the case?

This change doesn't really affect Avacta as one well designed pivotal Phase 2 trial was always going to be sufficient for approval, to be backed up by subsequent confirmatory Phase 3 trial data of course.

@Aldebaran, where is Francis Wilson speaking next week?