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The purpose of the vid was to talk about getting the research and the clinical development people better integrated. She was thus only talking about Tx.

Teamwork and communication are always important, vital even, in a commercal enterprise. The interface between research and clinical development - preclinicai - is always a bone of contention between the two and pharma companies will alternate between having it closely associated with research and with clinical depending on which fiefdom has the upper hand in the company politicking at any particular time. The important thing, made easier by Avacta being a small company, is that these research and clinical development people meet face to face so that they can gauge who they are dealing with on a personal level, hopefully get along with one another and build trust for future (non face-to-face) email, phone and videocall interactions.

As well as the clinical experience of drugs in development being fed back to the research people in order to refine the pipeline (especially regarding efficacy and side-effects but also solubility/stability/delivery), in a bigger company that has a marketing function, market research on unmet medical needs would be a major input into deciding future research directions. For Avacta, the newly established SAB will perform that function as well as providing advice on AVA6000 (and AVA3996) development (dosing regimen, target indications, potential combination therapies.)

She was also only talking about the around 30 Avacta research staff at White City and the remote clinical development team. She didn't say those remote ones were also Avacta staff

Avacta will have contracted a lot of the activities out - GMP production of AVA6000 for the trial, stability studies, clinical oversight (Andrew Saunders, etc), clinical data and statistical analysis, even drug discovery chemistry, computational chemistry, animal studies, who knows what. If they really only have 30 or so employees, including management and office staff, then they would have to use contract people/companies for virtually everything, although that's not the impression I got previously about their research activities, where I thought they had their own people.

This perhaps explains the 'remote clinical development team' - it is made up of contract individuals and companies, not Avacta staff, and that's why they and the research people hadn't been working closely together.

Again, as with C2, C3 has either finished and we're onto C4 and they haven't told us, or it has finished or is about to finish but the SDMC hasn't met, or there's been a patient drop out or a DLT and they've had to add an extra patient.

However, CC loves a Wednesday RNS. Or even a Tuesday afternoon RNS.

Thank you for keeping us informed Rob. Good to know that at least someone has read the BB memo about listing all purchases and sales here.

Hmm... Anyone got any ideas about who's in the remote clinical development team where they are and what they do?

HurstBot, do you think CAR Ts or WAG ONs are the future for Avacta? Genuinely interested in your opinion.

Don't care as long as LEGO is still on the lid

And to spell it out for WeAreGreat: https://www.google.com/search?q=q2w+avacta

Https://avacta.com/successful-completion-of-fifth-dose-escalation-in-ava6000-phase-1-clinical-study/

Https://www.hl.co.uk/shares/shares-search-results/e/eli-lilly-usd

Wonderful news for Avacta. Thank you HurstBot's developers.

X = Twitter, as was

RAH = Right As Hole

12 = Twelve

Thank you Google. I don't know what I'd do without you.

Could anyone explain what Google means?

My experience of all the Telegram discussion groups I've joined is that they are fiefdoms that don't tolerate views differing from that of the boss. AKA a waste of time.

7 mm's on 70p ask

parlez-vous

Firstly, re "or even start on a hugher dose if allowed by the authorities". A dosing regimen (dose level and schedule) is defined for every approved drug based on clinical trial experience, so the maximum dose is defined, but lower doses can be given - patients can be 'titrated' to the best place in the risk(side effects) / benefit(efficacy) spectrum.

As regards the study with SOPHIE, my understanding is that this will be to characterise the FAP levels in the indications they are looking at; those indications having been chosen according to prior knowledge/belief about which indications (down to the level of subtypes) have high FAP levels, although I don't think there is much if any empirical data about FAP at the sub-type level other than what has been collected so far in this Phase 1a study.

The susceptibility of different cancers to different modes of attack using pre|CISION drugs will likely not be changed much if at all and the choice of treatment will in any case be complicated by the availability of (and the marketting power of big pharma behind) recent effective drugs used in combination therapies. A lot will depend on what pre|CISION drugs follow on after AVA6000.

I don't know Bella. Well, tbh, I haven't a clue about that. What I do know though is that the clinicians don't have to give the highest possible dose from the off. They could, like I think it was you who said about your husband's treatment(?), start low if there's any doubt about what would be best, and then increase the dose level if they felt it was warranted (balance of possible total regression vs longer lifetime considersation) and that would also extend the length of time the patient could be on treatment.

See between the ***'s

NCT05641896 Brief Summary

Prospective, multi-center, open label, non-randomized clinical trial to assess efficacy of [18F]FAPI-74 to detect FAP expressing cells in patients diagnosed with gastrointestinal cancers, including hepatocellular carcinoma, cholangiocarcinoma, gastric, pancreatic and colorectal cancer. The [18F]FAPI-74 PET scan will be acquired in patients with proven GI cancers after initial staging using institutional standard methods. ***The PET scan results will be compared to FAP immunohistochemistry (as the primary objective) and histopathology (as the secondary objective) of the biopsied or resected tissues.***

So this looks like the new technique under investigation, [18F]FAPI-74 PET scans, is to be correlated against the existing methods of assessing disease load, FAP immunohistochemistry and histopathology. There is no mention that I could see of stage 4 or metastasis so they are only looking at primary tumours in the GI tract.

The study with Avacta is with patients who have stage 4, metastasised cancers, so whole body scanning is required and that will identify 1) where the tumours are so that they can be followed up by biopsies and/or scans during AVA6000 treatment, and 2) how strong the signal is initially - i.e. how much FAP is present - as that will identify what level of FAP each scanned patient has for their particular instance of a cancer indication. This latter is important because 1) Avacta have up until now been going on an old listing of a small number of measurements of FAP levels in various metastasised cancer indications (which showed a lot of intra-indication variation), and 2) the study will characterise not just high/medium (and possibly low) FAP levels for various cancers but will (due to the small number of patients to be scanned) be a start, but only a start, in characterising intra-indication variability between patients.

The outcome when the characterisation is done will be that clinicians will be able to say with a reasonable degree of certainty (and without need of PET scanning) which cancers have high/medium levels of FAP and a good estimate of how much FAP individual patients will have (again without the need to PET scan them).

Oh how we wish!😅

No, it's looking like English comprehension 101 for you. Clue to the answer: "characterize ... at the time of study entry."

Spot the disconnect:

"...characterize the FAP-positive disease burden at the time of study entry in selected patients."

"Enough to know the cause if the imaging is brighter/ smaller than previous images."

Free advanced English comprehension course for the first corrrect entry.